E.P.A.R s  Editing

Jakavi

What is Jakavi and what is it used for?

Jakavi is a medicine used to treat the following conditions:• splenomegaly (enlarged spleen) or other disease-related symptoms such as fever, night sweats, bone pain and weight loss in adults who have myelofibrosis. Myelofibrosis is a disease in which the bone marrow becomes very dense and rigid and produces abnormal, immature blood cells.• polycythaemia vera in adults in whom the medicine hydroxycarbamide (also known as hydroxyurea) does not work or causes unacceptable side effects. In polycythaemia vera, too many red blood cells are produced, which can cause reduced blood flow to the organs due to 'thickening' of the blood and occasionally the formation of blood clots.• acute or chronic graft-versus-host disease (when transplanted cells attack the body) in people aged 12 and older who have had a transplantation and for whom corticosteroids or other systemic therapies (treatments given by mouth or injection) did not work well enough.Jakavi contains the active substance ruxolitinib.

How is Jakavi used?

The medicine can only be obtained with a prescription. Treatment with Jakavi should only be started by a doctor who is experienced in treating patients with cancer medicines.Jakavi is available as tablets taken twice a day. The recommended dose depends on the condition it is used for.The dose should be reduced or the treatment should be stopped if certain side effects occur.For more information about using Jakavi, see the package leaflet or contact your doctor or pharmacist.

How does Jakavi work?

The active substance in Jakavi, ruxolitinib, works by blocking a group of enzymes known as Janus kinases (JAKs), which are involved in the production and growth of blood cells. In myelofibrosis and polycythaemia vera, there is too much JAK activity, leading to the abnormal production of blood cells.Send us aThese blood cells migrate to organs, including the spleen, causing the organs to become enlarged. JAKs are also involved in the development and activation of blood cells that play a role in graft-versushost disease. By blocking JAKs, Jakavi reduces the production of blood cells, thereby reducing the symptoms of the diseases.

What benefits of Jakavi have been shown in studies?

MyelofibrosisJakavi was more effective than placebo and the best available treatment for reducing the size of the spleen in two main studies involving 528 patients. In the first study, the target 35% reduction in spleen size after 6 months was achieved in 42% of patients treated with Jakavi (65 out of 155) compared with less than 1% of patients given placebo (1 out of 153). In the second study, the target 35% reduction in spleen size after one year was achieved in 29% of patients treated with Jakavi (41 out of 144) compared with none of the 72 patients receiving the best available treatment, such as cancer medicines, hormones and immunosuppressants.Polycythaemia veraJakavi improved patients' condition in one main study which involved 222 patients in whom hydroxycarbamide did not work or caused unacceptable side effects. Improvement was measured as requiring fewer than one phlebotomy treatment (to remove excess blood from the body) and a reduction in spleen size of at least 35%. In this study, 21% (23 out of 110) of patients given Jakavi had an improvement in their condition after 8 months of treatment, compared with 1% (1 out of 112) of patients given the best available treatment.Graft-versus-host diseaseJakavi was effective at reducing the symptoms of both acute and chronic graft-versus-host disease in 2 main studies.The first study involved 309 patients with acute graft-versus-host disease after allogeneic stem cell transplantation (using stem cells from a donor) in whom corticosteroid therapy did not work. It looked at the proportion of patients who had reduced symptoms (partial response) or no sign of symptoms (complete response) after 4 weeks of treatment with Jakavi or the best available treatment for their disease. In this study 62% of patients (96 out of 154) who received Jakavi had either a complete or a partial response to treatment compared with 39% of patients (61 out of 155) who received another therapy.The second study involved 329 patients with chronic graft-versus-host disease after allogeneic stem cell transplantation in whom corticosteroid therapy did not work. In this study, after 24 weeks of treatment 50% of patients who received Jakavi (82 out of 165) had either a complete or partial response compared with 26% (42 out of 164) of patients who received the best available treatment for their disease.

What is the risk associated with Jakavi?

In myelofibrosis, the most common side effects with Jakavi (which may affect more than 1 in 10 people) include thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils), bleeding, bruising, hypertriglyceridaemia (high blood fat levels), dizziness, and raised liver enzyme levels.In polycythaemia vera, the most common side effects with Jakavi (which may affect more than 1 in 10 people) include thrombocytopenia, anaemia, weight gain, headache, dizziness, hypercholesterolaemia (high blood cholesterol levels) and raised liver enzyme levels.In acute graft-versus-host disease, the most common side effects with Jakavi (which may affect more than 1 in 10 people) include thrombocytopenia, anaemia, neutropenia, cytomegalovirus infection, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), urinary tract (structures that carry urine) infections, hypercholesterolaemia and raised liver enzyme levels.In chronic graft-versus-host disease, the most common side effects with Jakavi (which may affect more than 1 in 10 people) include thrombocytopenia, anaemia, neutropenia, hypertension, headache, urinary tract infections, hypercholesterolaemia and raised liver enzyme levels.Women who are pregnant or breastfeeding must not take Jakavi. For the full list of side effects and restrictions of Jakavi, see the package leaflet.

Why has Jakavi been authorised in the EU?

The European Medicines Agency decided that Jakavi's benefits are greater than its risks and it can be authorised for use in the EU.In myelofibrosis, the reduction in spleen size and in symptoms in patients taking Jakavi is clinically important and patients' quality of life is improved. In polycythaemia vera the Agency considered that Jakavi is of benefit to patients when treatment with hydroxycarbamide does not work or causes unacceptable side effects. In the treatment of graft-versus-host disease, Jakavi has been shown to reduce the symptoms.In terms of safety, the Agency considered that Jakavi's side effects can be appropriately managed.

What measures are being taken to ensure the safe and effective use of Jakavi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jakavi have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Jakavi are continuously monitored. Side effects reported with Jakavi are carefully evaluated and any necessary action taken to protect patients.

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Jalra

What is Jalra and what is it used for?

Jalra is a diabetes medicine that is used together with diet and exercise to control the blood glucose (sugar) in adults with type 2 diabetes. It is used alone when metformin (another diabetes medicine) is not suitable, or together with other diabetes medicines, including insulin, when these medicines do not provide adequate control of the blood glucose.Jalra contains the active substance vildagliptin.

How is Jalra used?

The medicine can only be obtained with a prescription and is available as 50-mg tablets. The recommended dose of Jalra is:• one tablet in the morning and another in the evening (100 mg per day) when used alone, with metformin, with a thiazolidinedione, with metformin plus a sulphonylurea, or with insulin (with or without metformin);• one tablet in the morning (50 mg per day) when taken with a sulphonylurea. A lower dose of the sulphonylurea may also be considered to reduce the risk of hypoglycaemia (low blood glucose levels).In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily.Because vildagliptin has been associated with liver problems, the doctor should carry out tests to check the patient's liver function before treatment with Jalra and at regular intervals during treatment.For more information about using Jalra, see the package leaflet or contact your doctor or pharmacist.

How does Jalra work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Jalra, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor. It works by blocking the breakdown of incretin hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By blocking the breakdown of incretin hormones in the blood, vildagliptin prolongstheir action, stimulating the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood glucose is low.Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

What benefits of Jalra have been shown in studies?

Jalra on its own or as an add-on treatment has been studied in 11 main studies involving a total of over 6,000 patients with type 2 diabetes and insufficient control of blood glucose levels. In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.Jalra was effective at reducing levels of HbA1c but was less effective than metformin, rosiglitazone (a thiazolidinedione) or gliclazide (a sulphonylurea). In a study comparing Jalra with metformin, significantly better results were seen with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks compared with a reduction of around 1 percentage point in patients treated with Jalra.When used as an add-on to metformin and to pioglitazone (a thiazolidinedione), Jalra reduced HbA1c levels by 0.8 to 1.0 percentage points. When used with glimepiride (a sulphonylurea), Jalra caused a reduction of around 0.6 percentage points. In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3 to a rise of 0.2 percentage points.As an add-on to metformin plus glimepiride, Jalra reduced HbA1c levels by 1 percentage point, compared with a reduction of 0.3 percentage points in patients taking placebo.Finally, when used as an add-on to insulin treatment, Jalra caused a greater reduction in HbA1c levels than adding placebo, but the size of this effect in one study was small, possibly due to the fact that the study included long-term patients who were less likely to show improvement. However, in another study, the size of this effect was significant. Patients taking Jalra in addition to insulin, with or without metformin, had a reduction in HbA1c levels of 0.77 percentage points, compared with 0.05 percentage points in patients taking placebo in addition to insulin.

What are the risks associated with Jalra?

The most common side effect with Jalra (which may affect up to 1 in 10 people) is dizziness. For the full list of all side effects reported with the medicine, including side effects occurring when it is taken with other diabetes medicines, see the package leaflet.For the full list of restrictions, see the package leaflet.

Why is Jalra authorised in the EU?

Studies have shown Jalra to be effective as add-on to metformin, a thiazolidinedione or a sulphonylurea (dual therapy), a sulphonylurea and metformin (triple therapy) or insulin with or without metformin. Jalra on its own has also been shown to be effective in reducing blood glucose but less so than metformin. Jalra should therefore be used only in patients for whom metformin is inappropriate either because of side effects occurring with metformin or because they have a condition that makes metformin unsuitable for them. The side effects of Jalra were mostly mild and resolved over time.Jalra (Jalra (vildagliptin)The European Medicines Agency decided that Jalra's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Jalra?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jalra have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Jalra are continuously monitored. Suspected side effects reported with the medicine are carefully evaluated and any necessary action taken to protect patients.

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Janumet

What is Janumet?

Janumet is a medicine that contains two active substances, sitagliptin and metformin hydrochloride. It is available as tablets (50 mg sitagliptin / 850 mg metformin hydrochloride; and 50 mg sitagliptin / 1,000 mg metformin hydrochloride).

What is Janumet used for?

Janumet is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels. It is used in addition to diet and exercise in the following ways:• in patients who are not satisfactorily controlled on metformin (an antidiabetes medicine) used on its own;• in patients who are already taking a combination of sitagliptin and metformin as separate tablets;• in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin (other types of antidiabetes medicine) in patients who are not satisfactorily controlled on this medicine and metformin.The medicine can only be obtained with a prescription.

How is Janumet used?

Janumet is taken twice a day. The strength of tablet to use depends on the dose of the other antidiabetes medicines that the patient was taking before. If Janumet is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).The maximum dose of sitagliptin is 100 mg a day. Janumet should be taken with food to avoid any stomach problems caused by metformin.

How does Janumet work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substances in Janumet, sitagliptin and metformin hydrochloride, each have a different mode of action.Sitagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of 'incretin' hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing the levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when the blood glucose is low. Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Sitagliptin has been authorised in the European Union (EU) as Januvia and Xelevia since 2007, and as Tesavel since 2008.Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut. Metformin has been available in the EU since the 1950s.As a result of the action of both active substances, blood glucose levels are reduced and this helps to control type 2 diabetes.

How has Janumet been studied?

Sitagliptin on its own as Januvia/Xelevia/Tesavel can be used with metformin, and with both metformin and a sulphonylurea, in type 2 diabetes patients. The company presented the results of three studies of Januvia/Xelevia to support the use of Janumet in patients who were not satisfactorily controlled on their existing metformin treatment. Two of the studies looked at sitagliptin as an add-on to metformin: the first compared it with placebo (a dummy treatment) in 701 patients, and the second compared it with glipizide (a sulphonylurea) in 1,172 patients. The third study compared sitagliptin with placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.The results of three further studies were used to support the use of Janumet. The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Janumet with that of metformin or sitagliptin alone. The second included 278 patients who were not satisfactorily controlled on the combination of metformin and rosiglitazone (a PPAR-gamma agonist) and compared the effects of adding sitagliptin or placebo. The third included 641 patients who were not satisfactorily controlled on a stable dose of insulin, three-quarters of whom were also taking metformin. This study also compared the effects of adding sitagliptin or placebo.In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.The company carried out additional studies to show that the active substances in Janumet are absorbed by the body in the same way as the two medicines given separately.

What benefit has Janumet shown during the studies?

Janumet was more effective than metformin alone. Adding 100 mg sitagliptin to metformin reduced HbA1c levels by 0.67% (from around 8.0%) after 24 weeks, compared with a fall of 0.02% in the patients adding placebo. The effectiveness of adding sitagliptin to metformin was similar to that of adding glipizide. In the study in which sitagliptin was added to glimepiride and metformin, the levels of HbA1c were reduced by 0.59% after 24 weeks, compared with an increase of 0.30% in the patients adding placebo.In the first of the three further studies, Janumet was more effective than metformin or sitagliptin alone. In the second, HbA1c levels were reduced by 1.03% after 18 weeks in patients adding sitagliptin to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo. Finally, they were reduced by 0.59% after 24 weeks in patients adding sitagliptin to insulin, compared with a fall of 0.03% in those adding placebo. There was no difference in this effect between the patients also taking metformin and those not taking it.

What is the risk associated with Janumet?

The most common side effect with Janumet (seen in between 1 and 10 patients in 100) is nausea (feeling sick). For the full list of all side effects reported with Janumet, see the package leaflet.Janumet must not be used in people who are hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients. It must not be used in patients who have diabetic ketoacidosis or pre-coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack. It must also not be used in patients who consume excessive amounts of alcohol or are alcoholic, or in women who are breast-feeding. For the full list of restrictions, see the package leaflet.

Why has Janumet been approved?

CHMP decided that Janumet's benefits are greater than its risks and recommended that it be given marketing authorisation.

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Januvia

What is Januvia?

Januvia is a medicine that contains the active substance sitagliptin. It is available as tablets (25, 50 and 100 mg).

What is Januvia used for?

Januvia is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels. It is used in addition to diet and exercise in the following ways:• on its own, in patients who are not satisfactorily controlled on diet and exercise and in whom metformin (an antidiabetes medicine) is not suitable;• in combination with metformin or a PPAR-gamma agonist (a type of antidiabetes medicine) such as a thiazolidinedione, in patients who are not satisfactorily controlled on metformin or the PPARgamma agonist used on its own;• in combination with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled with a sulphonylurea used on its own and in whom metformin is not suitable;• in combination with both metformin, and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
The medicine can only be obtained with a prescription.

How is Januvia used?

Januvia is taken at a dose of 100 mg once a day. If Januvia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).In patients with moderately or severely reduced kidney function the dose of Januvia should be reduced.

How does Januvia work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Januvia, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of 'incretin' hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Sitagliptin does not work when the blood glucose is low. Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes.

How has Januvia been studied?

Januvia was studied in nine studies involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:• four of the studies compared Januvia with placebo (a dummy treatment). Januvia or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;• two studies compared Januvia with other antidiabetes medicines. One study compared Januvia with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients. The other study compared Januvia with metformin, used on their own, in 1,058 patients;• three additional studies compared Januvia with placebo when they were added to other antidiabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.In all of the studies, the main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

What benefit has Januvia shown during the studies?

Januvia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines. In patients taking Januvia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks. In contrast, they rose by0.12% and 0.18%, respectively, in the patients taking placebo. Adding Januvia to metformin reduced HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo. When added to pioglitazone, Januvia reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.In the studies comparing Januvia with other medicines, the effectiveness of adding Januvia to metformin was similar to that of adding glipizide. When taken on their own, Januvia and metformin produced similar reductions in HbA1c levels, but the effectiveness of Januvia seemed to be slightly lower than that of metformin.In the additional studies, adding Januvia to glimepiride (with or without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in the patients adding placebo. HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Januvia to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo. Finally, they were reduced by 0.59% in patients adding Januvia to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.

What is the risk associated with Januvia?

Serious side effects reported with Januvia include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions). Hypoglycaemia has been reported in combination with a sulphonylurea in 4.7-13.8% of patients and with insulin in 9.6% of patients. For the full list of all side effects reported with Januvia, see the package leaflet.Januvia must not be used in people who are hypersensitive (allergic) to sitagliptin or any of the other ingredients.

Why has Januvia been approved?

The CHMP decided that Januvia's benefits are greater than its risks and recommended that it be given marketing authorisation.

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Jardiance

What is Jardiance and what is it used for?

Jardiance is a medicine used with diet and exercise to treat adults whose type 2 diabetes is not adequately controlled. It can be used on its own in patients who cannot take metformin (another treatment for diabetes). It can also be used as an 'add-on' to other diabetes medicines.Jardiance is also used in adults to treat symptoms of long-term heart failure (a condition in which the heart does not pump blood to the body as well as it should).Jardiance contains the active substance empagliflozin.

How is Jardiance used?

Jardiance is available as tablets (10 and 25 mg) and can only be obtained with a prescription.For diabetes, the recommended starting dose is 10 mg once a day, which can be increased, if necessary, to 25 mg daily in suitable patients.If Jardiance is used in combination with insulin or sulphonylureas (medicines that make the body produce insulin), the doses of these may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).For heart failure, the recommended dose is 10 mg once a day.For more information about using Jardiance, see the package leaflet or contact your healthcare provider.

How does Jardiance work?

Type 2 diabetes is a disease in which the body does not make enough insulin or is unable to use insulin effectively. This leads to the inability to control the level of glucose (sugar) in the blood, causing blood glucose to rise.The active substance in Jardiance, empagliflozin, works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine. By blocking the action of SGLT2, empagliflozincauses more glucose to be removed via the kidney, through the urine, thereby reducing the levels of glucose in the blood.Empagliflozin also helps the body to remove sodium. This lowers blood pressure and makes it easier for the heart to pump blood.

What benefits of Jardiance have been shown in studies?

A beneficial effect of Jardiance on blood glucose has been shown in four main studies involving over 2,700 patients. Jardiance was compared with placebo (a dummy treatment) when used alone or added to treatment with other diabetes medicines (metformin, pioglitazone, or metformin plus either pioglitazone or sulphonylurea). The main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, after 24 weeks of treatment. When blood sugar levels decrease, HbA1C levels also decrease.All the studies showed a modest but clinically meaningful decrease in HbA1c with Jardiance compared with placebo: in the study investigating use of Jardiance without other medicines, the reduction in HbA1c was 0.74% more than placebo with the 10 mg dose and 0.85% more than placebo with the 25 mg dose. Modest but clinically meaningful reductions in HbA1c were also seen when Jardiance was added to other medicines. In addition, the results indicated that Jardiance treatment was associated with a beneficial fall in body weight and blood pressure.Supportive evidence was provided from a further six studies. Some of these were continuations of the main studies, and suggested that the benefits of the medicine continued with longer therapy. There was also supportive evidence suggesting benefit when the medicine was combined with insulin.Another main study showed that adding Jardiance to usual treatment reduced harmful cardiovascular (heart and blood vessels) effects. The study involved patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack and stroke). The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease. On average, patients in the study were followed up for 3.1 years. In those receiving Jardiance, cardiovascular events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of patients receiving placebo.In the treatment of heart failure, irrespective of diabetes, a beneficial effect of Jardiance was shown in two studies involving 3,730 and 5,988 patients who were given either Jardiance or placebo. In the first study, of the patients taking Jardiance for around 14 months, 19.4% (361 out of 1,863) were hospitalised for heart failure or died of cardiovascular causes, compared with 24.7% (462 out of 1,867) of those who were taking placebo. In the second study, 13.8% (415 out of 2,997) of patients taking Jardiance for around 23 months were hospitalised for heart failure or died of cardiovascular causes, compared with 17.1% (511 out of 2,991) of patients who received placebo.

What are the risks associated with Jardiance?

The most common side effect with Jardiance (which may affect more than 1 in 10 people) is hypoglycaemia (low blood sugar) when the medicine is taken with sulphonylurea or insulin, and reduced amounts of fluids in the body when used to treat heart failure. For the full list of side effects and restrictions with Jardiance, see the package leaflet.

Why is Jardiance authorised in the EU?

Jardiance was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines with different mechanisms of action. Jardiance was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease and patients who suffered from long-term heart failure irrespective of diabetes. In addition, beneficial reductions in weight and blood pressure were seen in patients treated with Jardiance. Regarding safety, overall the side effects were considered manageable. The European Medicines Agency therefore decided that Jardiance's benefits are greater than its risks and it can be authorised for use in the EU.The blood glucose lowering effects of the medicine are lower in patients with kidney problems, and the EMA recommended that the medicine not be used in some patients, depending on their kidney function.

What measures are being taken to ensure the safe and effective use of Jardiance?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jardiance have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Jardiance are continuously monitored. Suspected side effects reported with Jardiance are carefully evaluated and any necessary action taken to protect patients.

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Javlor

What is Javlor?

Javlor is a concentrate for solution for infusion (drip into a vein). It contains the active substance vinflunine (25 mg/l).

What is Javlor used for?

Javlor is used for the treatment of adults with advanced or metastatic 'transitional cell carcinoma of the urothelial tract' (a cancer that affects the lining of the bladder and the rest of the urinary tract). 'Metastatic' means that the cancer has spread to other parts of the body. Javlor is used when previous treatment with a platinum-containing anticancer medicine has failed.The medicine can only be obtained with a prescription.

How is Javlor used?

Treatment with Javlor should be started under the supervision of a doctor qualified to use anticancer medicines and is only given in specialised hospital units. Before administering Javlor, patients should have a blood test to check their blood cell and haemoglobin levels. This is because low levels of haemoglobin (a protein found in red blood cells that carries oxygen around the body) and blood cells (white blood cells and platelets) are frequent side effect of the medicine.The dose of Javlor to be given is based on the patient's body surface area (calculated using height and weight). The recommended dose is 320 mg per m2. Javlor is given as a drip into a vein over a period of20 minutes once every three weeks. The doctor may need to adjust the dose by taking into account the patient's age, liver or kidney function and certain side effects that the patient may be experiencing. The doctor may also delay or stop doses if the patient experiences certain side effects, including low levels of platelets and neutrophils (a type of white blood cell), and certain side effects affecting the heart, liver or lungs. Measures to prevent constipation, such as laxatives, are recommended after Javlor is given in the first week. For more information, see the summary of product characteristics (also part of the EPAR).

How does Javlor work?

The active substance in Javlor, vinflunine, belongs to the group of anticancer medicines known as the vinca alkaloids. It attaches to a protein in cells called 'tubulin', which is important in the formation of the internal 'skeleton' that cells need to assemble when they divide. By attaching to tubulin in cancer cells, vinflunine stops the formation of the skeleton, preventing the division and spread of the cancer cells.

How has Javlor been studied?

In one main study of 370 adults with advanced or metastatic transitional cell carcinoma of the urothelial tract, patients who were given Javlor treatment were compared with patients who were not given any anticancer medicine. During the study all patients received best supportive care (any medicines or techniques to help patients, but not other anticancer medicines). All the patients had previously received treatment with a platinum-containing medicine which failed. The main measure of effectiveness was how long the patients lived. The study also looked separately at the results in eligible patients who fulfilled strict criteria such as having had a worsening of the disease after treatment with a platinum-containing medicine.

What benefit has Javlor shown during the studies?

Javlor with best supportive care was more effective than best supportive care alone in prolonging the lives of patients with advanced or metastatic transitional cell carcinoma of the urothelial tract. Among all patients in the study, there was no clear evidence of a difference in survival between patients who received Javlor and those who did not. However, there was a difference among patients who fulfilled the strict criteria entry requirements for the study. In this group, those given Javlor lived for 6.9 months compared with 4.3 months for patients who were not given the Javlor.

What is the risk associated with Javlor?

The most common side effects with Javlor (seen in more than 1 patient in 10) are neutropenia, leucopenia (low white blood cell counts), anaemia (low red blood cell counts), thrombocytopenia (low platelet count), loss of appetite, constipation, abdominal (stomach) pain, vomiting, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), diarrhoea, alopecia (hair loss), myalgia (muscle pain), asthenia (weakness) or fatigue (tiredness), injection site reaction, fever and weight loss. For the full list of all side effects reported with Javlor, see the package leaflet.Javlor must not be used in people who are hypersensitive (allergic) to vinflunine or other vinca alkaloids. It must not be used in patients who have or have had a severe infection within the past two weeks or in patients with a neutrophil count of less than 1,500 per mm3 for the first administration or less than 1,000/mm3 for subsequent administrations or a platelet count less than 100,000 per mm3. It must also not be used in breastfeeding mothers.

Why has Javlor been approved?

The CHMP decided that Javlor's benefits are greater than its risks and recommended that Javlor be given marketing authorisation.

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Jayempi

What is Jayempi and what is it used for?

Jayempi is an immunosuppressant medicine (a medicine that reduces the activity of the immune system) that is used, on its own or with other medicines, to:• prevent the body from rejecting a transplanted kidney, liver, heart, lung or pancreas;• treat relapsing multiple sclerosis, a disease of the brain and spinal cord in which inflammation attacks the protective covering (sheath) around nerves and damages the nerves themselves;• treat generalised myasthenia gravis (a disease that affects nerves and causes muscle weakness).• treat the following autoimmune diseases (caused by the body's own defence system attacking normal tissue) in patients for whom corticosteroid medicines are not suitable:
-severe rheumatoid arthritis or chronic polyarthritis (long-term damage and inflammation of multiple joints) which cannot be controlled by other medicines;
-chronic inflammatory bowel diseases (diseases of the gut such as Crohn's disease and ulcerative colitis);
-autoimmune hepatitis, a liver disease;
-systemic lupus erythematosus (a condition causing swollen joints, tiredness and rashes);
-dermatomyositis (worsening muscle inflammation and weakness together with skin rash);
-polyarteritis nodosa (inflammation of blood vessels);
-pemphigus vulgaris and bullous pemphigoid (diseases causing blistering of the skin and mucous membranes, moist body surfaces such as the lining of the mouth);
-Behcet's disease (a disease in which the immune system attacks its own blood vessels causing recurrent inflammation, especially of the eyes and the mouth and genital mucous membranes);
-refractory autoimmune haemolytic anaemia (a disease in which the red blood cells are destroyed);
-refractory idiopathic thrombocytopenic purpura (bleeding under the skin due to damage to the platelets and reduction of their numbers);
Jayempi is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' containing the same active substance, but is given in a different way. The reference medicine for Jayempi is Imurek and is available as tablets, while Jayempi is available as a liquid to be taken by mouth.Jayempi contains the active substance azathioprine.

How is Jayempi used?

Jayempi should be started by a doctor experienced in the use and monitoring of immunosuppressants.The medicine can only be obtained with a prescription.Jayempi is taken by mouth, using the syringe provided in the pack, at least 1 hour before or 2 hours after a meal or milk. The dose depends on the disease Jayempi is being used to prevent or treat and on whether it is used alone or with other medicines, and is calculated on the basis of the patient's weight.For more information about using Jayempi, see the package leaflet or contact your doctor or pharmacist.

How does Jayempi work?

The active substance in Jayempi, azathioprine, is a pro-drug of 6-mercaptopurine, which means it is converted into 6-mercaptopurine in the body. It acts by blocking the production of purines, molecules that are needed by the body cells to produce DNA and RNA (genetic material). This prevents the production of genetic material in the cells (such as B and T lymphocytes) involved in the immune response, thereby suppressing the immune system.The reference medicine, Imurek, and other medicines containing mercaptopurine in tablet form have been used in the EU for several years to treat patients with autoimmune diseases.

What benefits of Jayempi have been shown in studies?

Because azathioprine has been used for the treatment of autoimmune diseases in the EU for a number of years in tablet form, the company that markets Jayempi presented results from studies previously carried out with azathioprine tablets published in the scientific literature.As for every medicine, the company provided studies on the quality of Jayempi. A study was also carried out to show that Jayempi is 'bioequivalent' to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect. Although Jayempi did not show bioequivalence to Imurek, there was no real difference in the blood concentration of 6-mercaptopurine between the two formulations. Therefore, it was concluded that no clinically relevant difference in terms of safety and effectiveness is expected between the liquid and the tablet formulation

What are the risks associated with Jayempi?

The most important side effects with Jayempi include bone marrow depression (a condition in which the bone marrow cannot make enough blood cells) that most frequently manifests as leucopenia (low white blood cell counts) and thrombocytopenia (low blood platelet counts); viral, fungal and bacterial infections; life-threatening liver injury; hypersensitivity (allergic reaction), Stevens-Johnson syndromeand toxic epidermal necrolysis (life-threatening reactions with flu-like symptoms and painful rash and blistering in the skin, mouth, eyes and genitals).Jayempi must not be used in people allergic to the active substance azathioprine, to 6-mercaptopurine or to any of the other ingredients. Patients must not be given any live vaccine, especially the BCG, smallpox and yellow fever vaccines, until at least 3 months after the end of treatment with azathioprine. Jayempi must not be used in breastfeeding women.For the full list of side effects and restrictions of Jayempi, see the package leaflet.

Why is Jayempi authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Jayempi has been shown to have comparable quality to Imurek, and that the two medicines are expected to have the same effect. The Agency also noted that the risks of using the medicine are well known.The European Medicines Agency therefore decided that Jayempi's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Jayempi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jayempi have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Jayempi are continuously monitored. Suspected side effects reported with Jayempi are carefully evaluated and any necessary action taken to protect patients.

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Jcovden

What is Jcovden and what is it used for?

Jcovden is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus.Jcovden is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein found on SARS-CoV-2.Jcovden does not contain SARS-CoV-2 itself and cannot cause COVID-19.

How is Jcovden used?

Jcovden is given as an injection, usually into the muscle of the upper arm.A booster dose may be given at least 2 months after the first dose of Jcovden in people aged 18 years and older. A booster dose may also be given after a primary vaccination course with an mRNA or adenoviral vector vaccine. The timing of a Jcovden booster dose depends on when a booster would normally be given for such vaccines.The vaccine should be used according to official recommendations issued at national level by public health bodies. For more information about using Jcovden, see the package leaflet or consult a healthcare professional.

How does Jcovden work?

Jcovden works by preparing the body to defend itself against COVID-19. It is made up of another virus (an adenovirus) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body's cells.1 Previously known as COVID-19 Vaccine JanssenThe adenovirus passes the SARS-CoV-2 gene into the vaccinated person's cells. The cells can then use the gene to produce the spike protein. The person's immune system will recognise the spike protein as foreign and produce antibodies and activate T cells (white blood cells) to target it.Later, if the person comes into contact with the SARS-CoV-2 virus, the person's immune system will recognise the spike protein on the virus and be ready to defend the body against it.The adenovirus in the vaccine cannot reproduce and does not cause the disease.

What benefits of Jcovden have been shown in studies?

Results from a clinical trial involving people in the United States, South Africa and Latin American countries found that Jcovden was effective at preventing COVID-19 in people from 18 years of age. This study involved over 44,000 people. Half received a single dose of the vaccine and half were given placebo (a dummy injection). People did not know if they had been given Jcovden or placebo.The trial found a 67% reduction in the number of symptomatic COVID-19 cases after 2 weeks in people who received Jcovden (116 cases out of 19,630 people) compared with people given placebo (348 of 19,691 people). This means that the vaccine had a 67% efficacy.Further data showed a rise in antibody levels when a booster dose was given after completion of a primary course with Jcovden, an mRNA vaccine, or another adenoviral vector vaccine in people from 18 years of age.

Can children be vaccinated with Jcovden?

Jcovden is not currently authorised for use in children.

Can immunocompromised people be vaccinated with Jcovden?

There are no data on immunocompromised people (people with weakened immune systems). Although immunocompromised people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can still be vaccinated as they may be at higher risk from COVID-19.

Can pregnant or breast-feeding women be vaccinated with Jcovden?

Animal studies do not show any harmful effects of Jcovden in pregnancy. However, data on the use of Jcovden during pregnancy are very limited. There are no studies of Jcovden on breast-feeding but no risk from breast-feeding is expected.The decision on whether to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the benefits and risks.

Can people with allergies be vaccinated with Jcovden?

People who have an allergy to one of the components of the vaccine listed in section 6 of the package leaflet should not receive the vaccine.Allergic reactions (hypersensitivity) have occurred in people receiving the vaccine, including rare cases of anaphylaxis (severe allergic reaction). As for all vaccines, Jcovden should be given under close medical supervision, with the appropriate medical treatment available in case of allergic reactions.

How well does Jcovden work for people of different ethnicities and genders?

The clinical trials included people of different ethnicities and genders. The vaccine worked across genders and ethnic groups.

What are the risks associated with Jcovden?

For the full list of side effects and restrictions with Jcovden, see the package leaflet.The most common side effects with Jcovden are usually mild or moderate and get better within 1 or 2 days after vaccination.The most common side effects are pain at the injection site, tiredness, headache, muscle pain and nausea. They may affect more than 1 in 10 people.Fever, chills, as well as redness and swelling at injection site may affect up to 1 in 10 people. Dizziness, shaking, coughing, mouth and throat pain, sneezing, diarrhoea, vomiting, rash, joint pain, muscle weakness, backache, pain in the arms and legs, weakness and feeling generally unwell may affect up to 1 in 100 people. Rare side effects (which may affect up to 1 in 1,000 people) are lymphadenopathy (enlarged lymph nodes), itchy rash, hypersensitivity (allergy), paraesthesia (unusual sensations like numbness, tingling or pins and needles), hypoesthesia (reduced sensation to touch, pain and temperature), facial paralysis, tinnitus (ringing or buzzing in the ears), venous thromboembolism (formation of blood clots in veins) and sweating.For booster vaccinations, the number and severity of reactions tend to be higher when people have previously been vaccinated with a vaccine other than Jcovden compared to people who have completed a primary course with Jcovden.Thrombosis (formation of blood clots in the blood vessels) in combination with thrombocytopenia (low levels of blood platelets), known as TTS (thrombosis with thrombocytopenia syndrome), and GuillainBarre syndrome (a neurological disorder in which the body's immune system damages nerve cells) may affect up to 1 in 10,000 people.Allergic reactions, including anaphylaxis (severe allergic reaction), have occurred in people receiving the vaccine. As for all vaccines, Jcovden should be given under close supervision with appropriate medical treatment available.A very small number of cases of immune thrombocytopenia (a condition in which the immune system mistakenly targets blood platelets, reducing their levels and affecting normal blood clotting), capillary leak syndrome (fluid leakage from small blood vessels causing tissue swelling and a drop in blood pressure), cutaneous small vessel vasculitis (inflammation of blood vessels in the skin), transverse myelitis (a neurological condition characterised by an inflammation in the spinal cord), myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) have occurred with Jcovden.Jcovden must not be given to people who have previously had capillary leak syndrome; it must also not be given to people who have had TTS following vaccination with any COVID-19 vaccine.

Why is Jcovden authorised in the EU?

Jcovden offers a good level of protection against COVID-19 which is critical during the current pandemic. The main trial showed that the vaccine has around 67% efficacy. Most side effects are mild to moderate in severity and last only a few days.The European Medicines Agency therefore decided that Jcovden's benefits are greater than its risks and it can be authorised for use in the EU.Jcovden was originally given 'conditional authorisation' because there was more evidence to come about the vaccine. The company has provided comprehensive information, including data regarding its safety and efficacy, confirming the findings from earlier studies previously submitted. In addition, the company has completed all requested studies on the pharmaceutical quality of the vaccine. As a result, the conditional authorisation has been switched to a standard one.

What measures are being taken to ensure the safe and effective use of Jcovden?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jcovden have been included in the summary of product characteristics and the package leaflet.A risk management plan (RMP) for Jcovden is also in place and contains important information about the vaccine's safety, how to collect further information and how to minimise any potential risks. A summary of the RMP is available.Safety measures for Jcovden are implemented in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is rapidly collected and analysed. The company that markets Jcovden will provide regular safety reports.As for all medicines, data on the use of Jcovden are continuously monitored. Suspected side effects reported with Jcovden are carefully evaluated and any necessary action taken to protect patients.

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Jemperli

What is Jemperli and what is it used for?

Jemperli is a cancer medicine for treating certain types of endometrial cancer (cancer of the womb) that are advanced or have come back and have got worse despite treatment involving a platinumbased cancer medicine.Jemperli is for endometrial cancer where the cancer cells have genetic abnormalities (called mismatch repair deficiency and high microsatellite instability) which prevent them from correcting mistakes that occur during cell division.Jemperli contains the active substance dostarlimab.

How is Jemperli used?

Treatment with Jemperli must be started and supervised by a doctor experienced in treating cancer.The medicine can only be obtained with a prescription.Jemperli is given by infusion (drip) into a vein over 30 minutes. The dose is 500 mg once every 3 weeks for the first 4 doses and then 1,000 mg every 6 weeks. Treatment can be continued as long as Jemperli continues to work. The doctor may interrupt Jemperli treatment or stop it altogether if certain side effects occur.For more information about using Jemperli, see the package leaflet or contact your doctor or pharmacist.

How does Jemperli work?

The active substance in Jemperli, dostarlimab, is a monoclonal antibody, a protein that has been designed to block a receptor (target) called PD-1 on certain cells of the immune system (the body's natural defences). Some cancers can make proteins (PD-L1 and PD-L2) that combine with PD-1 to switch off the activity of the immune cells, preventing them from attacking the cancer. By blocking PD-1, dostarlimab stops the cancer switching off these immune cells, thereby increasing the immune system's ability to kill the cancer cells.

What benefits of Jemperli have been shown in studies?

Jemperli was found effective in a study involving 108 women with endometrial cancer that was advanced or had come back and had got worse despite treatment that included a platinum-containing medicine. The cancers involved mismatch repair deficiency or high microsatellite instability. At follow up after at least 24 weeks, the cancer had shrunk or could no longer be detected in 43.5% of women receiving Jemperli.

What are the risks associated with Jemperli?

The most common side effects with Jemperli (which may affect more than 1 in 10 people) are anaemia (low count of red blood cells), nausea (feeling sick), diarrhoea, vomiting, joint pain, itching, rash, fever and hypothyroidism (low levels of thyroid hormones). The most serious side effects are related to the medicine's effects on the immune system, such as inflammation in various body organs and tissues, rash and reactions to the infusion.For the full list of side effects and restrictions of Jemperli, see the package leaflet.

Why is Jemperli authorised in the EU?

Endometrial cancer that has returned after treatment is difficult to treat with cancer medicines. The European Medicines Agency considered that the beneficial effects of Jemperli on endometrial cancer seem to last longer than with other treatments available in the EU. If this is confirmed, women treated with Jemperli are likely to live longer than those receiving other treatments. The side effects seen with Jemperli are in line with the way the medicine works and are acceptable.The Agency therefore decided that Jemperli's benefits are greater than its risks and it can be authorised for use in the EU.Jemperli has been given 'conditional authorisation'. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Jemperli?

Since Jemperli has been given conditional authorisation, the company that markets Jemperli will provide data from an ongoing study on the medicine's effectiveness, with patients followed up for at least 12 months. The company will also provide data from a study in patients with endometrial cancer when it is advanced or has come back and has not been treated with other cancer medicines; the study will look at Jemperli given together with other cancer medicines compared with these other cancer medicines given alone.

What measures are being taken to ensure the safe and effective use of Jemperli?

The company that markets Jemperli will provide a patient card about signs and symptoms of immune system side effects of the medicine, and the need to get immediate medical help if these side effects occur.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jemperli have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Jemperli are continuously monitored. Side effects reported with Jemperli are carefully evaluated and any necessary action taken to protect patients.

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Jentadueto

What is Jentadueto?

Jentadueto is a medicine that contains the active substances linagliptin and metformin hydrochloride.It is available as tablets (2.5 mg/850 mg and 2.5 mg/1,000 mg).

What is Jentadueto used for?

Jentadueto is used in adults with type 2 diabetes to improve the control of blood glucose (sugar) levels. It is used in addition to diet and exercise in the following ways:• in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own;• in patients who are already taking a combination of linagliptin and metformin as separate tablets;• in combination with a sulphonylurea or insulin (other types of diabetes medicines) in patients who are not satisfactorily controlled on this medicine and metformin.The medicine can only be obtained with a prescription.

How is Jentadueto used?

Jentadueto is taken twice a day. The strength of tablet to use depends on the dose of the other diabetes medicines that the patient was taking before. If Jentadueto is taken with a sulphonylurea or insulin, the dose of these medicines may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).The maximum dose is 5 mg of linagliptin and 2,000 mg of metformin per day. Jentadueto should be taken with food to reduce stomach problems caused by metformin.

How does Jentadueto work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substances in Jentadueto, linagliptin and metformin hydrochloride, each working in a different way.Linagliptin is a dipeptidyl-peptidase-4 (DPP 4) inhibitor. It works by blocking the breakdown of 'incretin' hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Linagliptin does not work when the blood glucose is low. Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Together, these processes reduce blood glucose levels and help to control type 2 diabetes. Linagliptin has been authorised in the European Union (EU) as Trajenta since 2011.Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.Metformin has been available in the EU since the 1950s.As a result of the action of both active substances, blood glucose levels are reduced and this helps to control type 2 diabetes.

How has Jentadueto been studied?

The company presented the results of four studies with linagliptin in patients with type 2 diabetes, which were used to support the approval of Trajenta in the EU, comparing linagliptin given at 5 mg once per day with placebo (a dummy treatment). The studies looked at the effectiveness of linagliptin used on its own (503 patients), in combination with metformin (701 patients), with metformin plus a sulphonylurea (1,058 patients) or with another diabetes medicine pioglitazone (389 patients).Another study was carried out involving 791 patients with type 2 diabetes, where the combination of linagliptin plus metformin given twice per day was compared with giving metformin alone, linagliptin alone or placebo. Linagliptin was given at 2.5 mg twice per day in the combination treatment and at 5 mg once per day in the single treatment. Metformin was given at either 500 mg or 1,000 mg twice per day, for both the combination and the single treatment.A further study was carried out involving 491 patients with type 2 diabetes taking metformin twice per day, where placebo or linagliptin at either 2.5 mg twice per day or at 5 mg once per day was added to their treatment. The study compared the effects of adding linagliptin to metformin in these ways, since metformin needs to be taken at least twice per day.Another study carried out in 1040 patients with type 2 diabetes compared patients taking 5 mg linagliptin and insulin given with metformin, with patients taking placebo given with insulin and metformin.In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment. This gives an indication of how well blood glucose is controlled.

What benefit has Jentadueto shown during the studies?

The studies with linagliptin showed that it was more effective than placebo at reducing HbA1c levels.When used on its own, linagliptin gave a reduction of 0.46 points compared with a rise of 0.22 points. When given in combination, linagliptin with metformin gave a reduction of 0.56 points compared with a rise of 0.10 points; linagliptin with metformin plus a sulphonylurea gave a reduction of 0.72 points compared with 0.10 points.The study with the combination of linagliptin and metformin showed that it was more effective than linagliptin or metformin alone, as well as placebo, at reducing HbA1c levels. The combination gave a reduction of 1.22 points when metformin was given at 500 mg and a reduction of 1.59 points when metformin was given at 1,000 mg. This compared with a reduction of 0.45 with linagliptin alone, 0.64 with 500 mg metformin alone, 1.07 with 1,000 mg metformin alone, and 0.13 with placebo.The study looking at adding linagliptin 2.5 mg twice per day or 5 mg once per day to metformin showed a similar reduction in HbA1c levels compared with placebo (0.74 and 0.80 points more than placebo respectively).The study looking at linagliptin in combination with metformin and insulin showed that this combination was more effective than the combination of insulin and metformin at reducing HbA1c levels (reduction of 0.77 percentage points was seen with linagliptin compared with a reduction of 0.10 percentage points with placebo).

What is the risk associated with Jentadueto?

The most frequent side effect with the combination of linagliptin plus metformin was diarrhoea (seen in around 2% of patients, with a similar rate seen in patients taking metformin plus placebo). When linagliptin and metformin were given with a sulphonylurea or insulin, hypoglycaemia was the most frequent side effect (seen in more than 1 patient in 10). For the full list of all side effects reported with Jentadueto, see the package leaflet.Jentadueto must not be used in patients with:• diabetic ketoacidosis or diabetic pre-coma (dangerous complications of diabetes);• moderately to severely reduced kidney function or with acute (sudden) conditions which can affect kidney function such as dehydration, severe infection or shock;• a condition that could lead to reduced supply of oxygen to body tissues (such as in patients who are being treated for worsening heart failure, have recently had a heart attack, have difficulty breathing or a steep fall in blood pressure);• liver impairment, or problems with alcoholism or alcohol intoxication.For the full list of restrictions, see the package leaflet.

Why has Jentadueto been approved?

The CHMP concluded that the combination of linagliptin and metformin has been shown to be effective at lowering HbA1c levels, and that linagliptin 2.5 mg twice per day was as effective as 5 mg once per day, which is approved in the EU for use on its own and in combination with metformin and with metformin plus a sulphonylurea or insulin. The CHMP noted that fixed dose combinations may increase the likelihood of patients taking their medicine correctly. With regard to side effects, the Committee considered that in general the risks seen were only slightly greater than those seen with placebo.Therefore the CHMP decided that Jentadueto's benefits are greater than its risks and recommended that it be given marketing authorisation.

What extra measures are being taken to ensure the safe and effective use of Jentadueto?

A risk management plan has been developed to ensure that Jentadueto is used as safely and effectively as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Jentadueto, including the appropriate precautions to be followed by healthcare professionals and patients.

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Jetrea

What is Jetrea and what is it used for?

Jetrea is a medicine used to treat adults with vitreomacular traction, an eye disease that can cause severe visual disturbance.It contains the active substance ocriplasmin.

How is Jetrea used?

Jetrea is a solution for injection into the eye. It can only be obtained with a prescription and must be given by a qualified ophthalmologist (eye specialist) experienced in intravitreal injections (injections into the vitreous humour, the jelly-like material at the back of the eye). The procedure should be carried out under sterile conditions.The recommended dose is 0.125 mg given as a single injection into the affected eye which should not be repeated. The other eye should not be treated with Jetrea for at least 7 days.The ophthalmologist may prescribe antibiotic eye drops before and after treatment with Jetrea to prevent eye infections.

How does Jetrea work?

Vitreomacular traction is caused by vitreomacular adhesion in which the vitreous humour has an abnormally strong attachment to the central part of the retina (the light sensitive membrane at theback of the eye). When the vitreous humour shrinks with aging, this strong attachment results in a pulling force on the retina, which causes retinal swelling and leads to blurred or distorted vision.The active substance in Jetrea, ocriplasmin, is similar to human plasmin, a naturally occurring enzyme in the eye which is capable of breaking down proteins between the vitreous humour and the retina which are responsible for the adhesion, thereby reducing retinal swelling and improving vision.

What benefits of Jetrea have been shown in studies?

Jetrea has been shown in studies to be effective in resolving the adhesion between the vitreous humour and the retina, reducing the need for surgery.In two main studies involving 652 adults with vitreomacular adhesion and decreased vision, patients were given a single intravitreal injection of 0.125 mg Jetrea or a placebo injection (a dummy treatment). After 28 days, the results were that adhesions had cleared in 25% and 28% of patients who were given Jetrea injection (61 out of 219 and 62 out of 245), compared with 13% and 6% of those who received placebo (14 out of 107 and 5 out of 81). Successful treatment of vitreomacular adhesion can help reverse disturbances of the vision caused by vitreomacular traction, and prevent further loss of vision from untreated and progressive traction at the retina.

What are the risks associated with Jetrea?

The side effects seen with Jetrea affect the eye. The most common side effects are vitreous floaters (small, often irregular, dark shapes in the field of vision), eye pain, photopsia (flashes of light in the field of vision) and chromatopsia (changes in colour perception), as well as conjunctival haemorrhage (bleeding of the membrane that lies over the white part of the eye). For the full list of all side effects reported with Jetrea, see the package leaflet.Jetrea must not be used in patients who have or are thought to have infections in or around the eyes.For the full list of restrictions, see the package leaflet.

Why is Jetrea approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Jetrea outweigh its risks and recommended that it be approved for use in the EU. Studies have shown that Jetrea was effective in treating vitreomacular adhesion and it is therefore expected to be effective in preventing worsening of vision which may occur with untreated and progressive vitreomacular traction. Although the effects shown were modest (resolution of vitreomacular adhesion in a quarter of patients), they were considered to be significant as treatment may improve vision and prevent the need for surgery. Regarding its safety, the most common side effects were short-lived and considered manageable, and often occurred as a response to the injection procedure or were linked to the resolution of the disease itself. The risk of more serious side effects such as decreased vision that is non-reversible, other changes to the retinal function or supporting structures of the lens appear to be small.

What measures are being taken to ensure the safe and effective use of Jetrea?

The company that markets Jetrea must ensure that all healthcare professionals who are expected to use Jetrea receive the summary of product characteristics for the medicine as well as an information pack to be given to patients.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jetrea have also been included in the summary of product characteristics and the package leaflet.

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Jevtana

What is Jevtana and what is it used for?

Jevtana is a cancer medicine used to treat men with metastatic castration-resistant prostate cancer. This is cancer that affects the prostate gland in men that produces the liquid in semen. Jevtana is used when the cancer has spread to other parts of the body (metastatic) despite treatments to prevent the production of testosterone or after surgical removal of the testes (castration). Jevtana is used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine).Jevtana contains the active substance cabazitaxel.

How is Jevtana used?

Jevtana can only be obtained with a prescription and should only be used in units specialising in chemotherapy (medicines to treat cancer) under the supervision of a doctor experienced in the use of chemotherapy.Jevtana is available as a concentrate and a solvent to be made up into a solution for infusion (drip) into a vein. It is given once every three weeks as an infusion lasting one hour, at a dose of 25 mg per square metre body surface area (calculated using the patient's weight and height). It is given in combination with prednisone or prednisolone, taken daily throughout treatment.The dose of Jevtana should be reduced or treatment stopped if the patient has certain side effects. The doses should also be reduced in patients with mildly or moderately reduced liver function.Before receiving Jevtana infusions, patients should first be given medicines to prevent allergic reactions and medicines to prevent vomiting.For more information, see the package leaflet.

How does Jevtana work?

The active substance in Jevtana, cabazitaxel, belongs to the group of cancer medicines known as'taxanes'. Cabazitaxel works by blocking the ability of cancer cells to break down their internal 'skeleton' that allows them to divide and multiply. With their skeleton still in place, the cells cannot divide and they eventually die. Jevtana also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.

What benefits of Jevtana have been shown in studies?

Jevtana prolonged overall survival (the average length of time the patients lived) in one main study involving 755 men with metastatic castration-resistant prostate cancer who had previously been treated with docetaxel. The effects of Jevtana were compared with another cancer medicine, mitoxantrone. Both medicines were given in combination with prednisone or prednisolone. The average overall survival for patients treated with Jevtana was 15.1 months compared with 12.7 months for patients given mitoxantrone.

What are the risks associated with Jevtana?

The most common side effects with Jevtana (seen in more than 1 patient in 10) include anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low counts of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts) and diarrhoea. Some of these effects were severe. For the full list of all side effects reported with Jevtana, see the package leaflet.Jevtana must not be used in people who are hypersensitive (allergic) to cabazitaxel, to any other taxane, or to any of the other ingredients. It must not be given to patients whose blood neutrophil count is below 1,500/mm3, who have severely reduced liver function or who recently received or are about to receive a yellow fever vaccine.

Why has Jevtana been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the ability of Jevtana to prolong overall survival in castration-resistant metastatic prostate cancer patients was clinically important. It decided that Jevtana's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Jevtana?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jevtana have been included in the summary of product characteristics and the package leaflet.

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Jinarc

What is Jinarc and what is it used for?

Jinarc is a medicine used to treat adults with autosomal dominant polycystic kidney disease. This is an inherited condition in which numerous fluid-filled cysts develop in the kidneys, which eventually reduce kidney function and can cause the kidneys to fail. Jinarc can be started in patients with normal to severely reduced kidney function and whose disease is progressing rapidly.Jinarc contains the active substance tolvaptan.

How is Jinarc used?

Jinarc can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in treating autosomal dominant polycystic kidney disease and with knowledge about the risks of treatment with Jinarc.Jinarc is available as tablets (15, 30, 45, 60 and 90 mg). Patients should be started with a dose of 45 mg in the morning and 15 mg in the evening (45+15 mg), and the dose should then be increased to 60+30 mg or 90+30 mg, depending on the medicine's side effects. The morning dose should be taken at least 30 minutes before the morning meal, whereas the evening dose can be taken with or without food. Doses may need to be reduced in patients taking certain other medicines. Patients should drink plenty of water or other fluids (except grapefruit juice) while on treatment.For more information about using Jinarc, see the package leaflet or contact your doctor or pharmacist.

How does Jinarc work?

The active substance in Jinarc, tolvaptan, is a vasopressin-2-receptor antagonist: it blocks receptors (targets) in the kidneys for the hormone vasopressin. Vasopressin controls the amount of water and sodium that the kidneys remove. In autosomal dominant polycystic kidney disease, it is thought that kidney cells do not respond normally to vasopressin, leading to the formation of fluid-filled cysts. By blocking vasopressin receptors in the kidneys, Jinarc can slow down cyst formation.

What benefits of Jinarc have been shown in studies?

Jinarc was shown to be effective at slowing down cyst formation when compared with placebo (a dummy treatment) in two main studies involving adults with autosomal dominant polycystic kidney disease who had rapidly progressing disease.The first study included 1,445 patients with normal or moderately reduced kidney function, and measured the change in kidney size after 3 years of treatment. Kidney size increases with disease severity due to swelling caused by cyst formation. In patients taking placebo, the total size of the kidneys increased by 19% whereas in those taking Jinarc the increase was 10%. The effects of treatment were greatest in the first year. Subsequent supportive results confirmed that increase in kidney size over 5 years was slower with Jinarc.The second study included 1,370 patients with moderately to severely reduced kidney function. Results showed that in patients treated with Jinarc the decline in kidney function was 35% less than with placebo after 1 year of treatment. In 262 patients with severely reduced kidney function, the decline in kidney function was 17% less with Jinarc after 1 year of treatment compared with placebo.

What are the risks associated with Jinarc?

The most common side effects with Jinarc (which may affect more than 2 in 10 people) are thirst, polyuria (increase in urine production), nocturia (need to pass urine at night) and pollakiuria (increased need to pass urine during the day). Jinarc may increase blood levels of certain liver enzymes (a sign of possible liver problems). For the full list of side effects reported with Jinarc, see the package leaflet.Jinarc must not be started in certain patients with increased blood levels of liver enzymes or with signs or symptoms of liver injury. Blood tests to check the patient's liver function should be performed before starting treatment with Jinarc, and then repeated every month for 18 months and every three months thereafter. Patients should also be monitored for symptoms of liver injury (such as loss of appetite, nausea and vomiting, itching, tiredness and pain in the upper-right side of the belly) during treatment. Jinarc must not be used in patients who are anuric (cannot pass urine or have difficulty in passing it), volume depleted (have reduced amounts of fluids in the body) and in patients who cannot perceive or respond to thirst. It must not be used in patients with hypernatraemia (increased sodium levels in the blood) and in patients who are allergic to tolvaptan or medicines that are similar to tolvaptan, so-called benzazepines or their derivatives. Jinarc must also not be used in pregnant and breastfeeding women. For the full list of restrictions, see the package leaflet.

Why is Jinarc authorised in the EU?

The European Medicines Agency decided that Jinarc's benefits are greater than its risks and that it can be authorised for use in the EU. The Agency noted the unmet need for treatments for autosomal dominant polycystic kidney disease and considered that Jinarc is effective at slowing down cyst formation and the decline in kidney function in patients with the condition. While the most common side effects are manageable, the Agency identified liver toxicity as the most important risk with Jinarc, which was addressed by putting in place several measures (see below).

What measures are being taken to ensure the safe and effective use of Jinarc?

The company that markets Jinarc will provide patients and doctors expected to use the medicine with information on the risk of liver toxicity and on the importance of preventing pregnancy duringtreatment. The company will also carry out a study to further investigate the safety of the medicine, including the risk of liver toxicity.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jinarc have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Jinarc are continuously monitored. Side effects reported with Jinarc are carefully evaluated and any necessary action taken to protect patients.

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Jivi

What is Jivi and what is it used for?

Jivi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII. Jivi can be used in adults and children from 12 years of age who have been treated previously.Jivi contains the active substance damoctocog alfa pegol.

How is Jivi used?

Jivi is given by injection into a vein. The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as on the severity of the haemophilia, the extent and location of the bleeding and the patient's condition and weight. Patients or their carers may be able to inject Jivi themselves at home once they have been trained appropriately.Jivi can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia. For more information about using Jivi, see the package leaflet or contact your doctor or pharmacist.

How does Jivi work?

Patients with haemophilia A lack factor VIII, a protein needed for blood to clot and, as a result, they bleed readily. The active substance in Jivi, damoctocog alfa pegol, works in the same way as the body's factor VIII. It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of the bleeding disorder.Part of the active substance is a substance called polyethylene glycol, 'PEG', which is included to help the medicine remain in the body for longer and thereby prolong its action.

What benefits of Jivi have been shown in studies?

Jivi has been shown to be effective at reducing the number of bleeding episodes in patients with severe haemophilia and stopping bleeding when it occurs.In a study of 134 patients from 12 years of age, 114 patients given Jivi as a preventive treatment had around 2 bleeding episodes per year. The 20 patients who were given Jivi for treating bleeding when it occurred had around 23 bleeding episodes a year. In a second part of the study, 17 patients received Jivi to control bleeding during 20 major surgeries. Jivi was rated good or excellent at stopping bleeding in all surgeries.In a second study in 61 children aged below 12 years, Jivi given as preventive treatment reduced the number of bleeding episodes to around 3 episodes a year.

What are the risks associated with Jivi?

The most common side effect with Jivi (which may affect more than 1 in 10 people) is headache. Hypersensitivity (allergic) reactions are common with Jivi (affecting up to 1 in 10 people) and may include swelling, burning and stinging at the injection site, chills, flushing, tingling, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing. In some cases these reactions can become severe.Following treatment with factor VIII products, including Jivi, some patients may develop inhibitors (antibodies) against factor VIII, preventing the medicine from working effectively and resulting in a loss of bleeding control. In such cases, a specialised haemophilia centre should be contacted.Jivi must not be used in patients with allergy to mouse or hamster proteins.For the full list of side effects and restrictions, see the package leaflet.

Why is Jivi authorised in the EU?

The European Medicines Agency decided that Jivi's benefits are greater than its risks and it can be authorised for use in the EU.Studies show that Jivi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products. However, laboratory studies show that PEG, which is part of the active substance in Jivi, may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment. Since this could potentially cause problems especially in children below 12 years of age, Jivi is only approved for use in adults and children from 12 years of age.

What measures are being taken to ensure the safe and effective use of Jivi?

The company that markets Jivi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jivi have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Jivi are continuously monitored. Side effects reported with Jivi are carefully evaluated and any necessary action taken to protect patients.

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Jorveza

What is Jorveza and what is it used for?

Jorveza is a medicine used to treat adults with eosinophilic oesophagitis. Eosinophilic oesophagitis is inflammation of the oesophagus (the passage that leads from the mouth to the stomach), which causes symptoms such as dysphagia (difficulty swallowing) and blockage of the oesophagus. It is caused by a large build-up of white blood cells called eosinophils in the lining of the oesophagus.Eosinophilic oesophagitis is rare, and Jorveza was designated an 'orphan medicine' (a medicine used in rare diseases) on 5 August 2013. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3131181.Jorveza contains the active substance budesonide.

How is Jorveza used?

Jorveza can only be obtained with a prescription and treatment should be started by a doctor experienced with diagnosing and treating eosinophilic oesophagitis.Jorveza is available as orodispersible tablets (0.5 mg and 1 mg). The tablet is placed on the tongue and pressed against the roof of the mouth for at least two minutes until it dissolves. During this time the patient should steadily swallow the saliva with the dissolved medicine. Tablets must not be chewed or swallowed whole.The recommended dose to bring symptoms under control is one 1-mg tablet twice a day for 6 to 12 weeks. To keep the condition under control, treatment with Jorveza can be continued with one 0.5-mg or 1-mg tablet twice a day, depending on how long the patient has had the condition and how severe it is. The doctor will decide how long the treatment should last.For more information about using Jorveza, see the package leaflet or contact your doctor or pharmacist.

How does Jorveza work?

The active substance in Jorveza, budesonide, is a corticosteroid. Corticosteroids attach to targets (receptors) on immune cells and reduce the release of substances that lead to inflammation.After Jorveza dissolves in the mouth, the saliva carries it to the oesophagus where it reduces the inflammation and relieves the symptoms of eosinophilic oesophagitis.

What benefits of Jorveza have been shown in studies?

Jorveza was effective in two main studies involving 292 adults with eosinophilic oesophagitis.In the first study involving 88 patients with active eosinophilic oesophagitis, treatment with 1 mg of Jorveza twice a day was compared with placebo (a dummy treatment). The main measure of effectiveness was the level of eosinophils in the oesophagus and improvement in symptoms. After 6 weeks, around 58% of the patients taking Jorveza had reduced eosinophil levels and no symptoms or only minimal symptoms, whereas none of the patients taking placebo had these effects.In the second study, involving 204 patients whose symptoms of eosinophilic oesophagitis were under control, treatment with 0.5 mg or 1 mg Jorveza twice a day was compared with placebo. After 48 weeks, symptoms were satisfactorily controlled in around 74% of patients taking 0.5 mg Jorveza twice a day and 75% of those taking 1 mg twice a day, compared with 4% in those receiving placebo.

What are the risks associated with Jorveza?

The most common side effects with Jorveza (which may affect more than 1 in 10 people) are fungal infections in the mouth, pharynx (throat) and oesophagus.For the full list of side effects and restrictions with Jorveza, see the package leaflet.

Why is Jorveza authorised in the EU?

The European Medicines Agency decided that Jorveza's benefits are greater than its risks and it can be authorised for use in the EU.Patients with eosinophilic oesophagitis often do not have other treatment options. The Agency concluded that Jorveza improves the symptoms of eosinophilic oesophagitis and reduces the excess of eosinophils. Jorveza is also effective in preventing recurrent episodes of the disease. Side effects of Jorveza, which mainly affect the mouth and throat, are manageable.

What measures are being taken to ensure the safe and effective use of Jorveza?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jorveza have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Jorveza are continuously monitored. Side effects reported with Jorveza are carefully evaluated and any necessary action taken to protect patients.

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Juluca

What is Juluca and what is it used for?

Juluca is a medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).Juluca is only used for patients whose levels of HIV-1 in the blood (viral load) have been below 50 copies/ml for at least 6 months on their current HIV treatment combination. It is not suitable for patients in whom any HIV medicine has stopped working or who are infected with HIV that is resistant to medicines that work in the same way as Juluca's active substances.The active substances in Juluca are dolutegravir and rilpivirine.

How is Juluca used?

Juluca can only be obtained with a prescription and should be prescribed by doctors experienced in managing HIV infection.The recommended dose is one tablet once daily with a meal. Each tablet contains 50 mg dolutegravir and 25 mg rilpivirine. For more information about using Juluca, see the package leaflet or contact your doctor or pharmacist.

How does Juluca work?

The two active substances in Juluca, dolutegravir and rilpivirine, block the actions of enzymes that the virus needs to make copies of itself in the cells it has infected. Dolutegravir, an integrase inhibitor, blocks an enzyme called integrase, while rilpivirine, a non-nucleoside reverse-transcriptase inhibitor, blocks the activity of another enzyme called reverse transcriptase.Juluca does not cure HIV infection, but reduces the amount of virus in the body and keeps it at a low level. This holds off damage to the immune system and the development of infections and diseases associated with AIDS.Both active substances are already available in the EU: dolutegravir has been authorised since 2014 and rilpivirine has been authorised since 2011.

What benefits of Juluca have been shown in studies?

Two main studies found that the combination of dolutegravir and rilpivirine (the active substances in Juluca) was effective at keeping HIV infection under control. The studies involved a total of 1,024 patients whose HIV infection was well controlled for at least 6 months on a combination of three HIV medicines that included a class of HIV medicines called nucleoside (or nucleotide) reverse transcriptase inhibitors (NRTIs). The studies compared the effectiveness of switching to the combination of dolutegravir and rilpivirine with that of remaining on the current combination of HIV medicines. The proportion of patients who had undetectable levels of HIV (below 50 copies/ml) after 48 weeks was the same for patients switching compared with those remaining on the current medicines (95% in both cases).

What are the risks associated with Juluca?

The most common side effects with Juluca (which may affect up to 1 in 10 people) are diarrhoea and headache. The most serious side effects (which may affect up to 1 in 100 people) include allergic reactions that include rash or liver damage.Juluca must not be used together with certain medicines such as fampridine (a multiple sclerosis medicine, also called dalfampridine), as this may increase the level of such medicines in the body, resulting in serious side effects.Juluca must also not be used with the following medicines because they may reduce its effectiveness:• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for epilepsy);• rifampicin, rifapentine (antibiotics);• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);• dexamethasone given by mouth or by injection (a steroid anti-inflammatory and immunosuppressant medicine), except when used as a single-dose treatment;• St John's wort (a herbal medicine used for treating depression).For the full list of restrictions and side effects of Juluca, see the package leaflet.

Why is Juluca authorised in the EU?

The European Medicines Agency considered that Juluca's effectiveness was comparable to that of combination treatment with three HIV medicines that include NRTIs. Because Juluca does not contain an NRTI, it is free of long-term side effects caused by NRTIs. The side effects of Juluca are well known and manageable.The Agency decided that Juluca's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Juluca?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Juluca have been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Juluca are continuously monitored. Side effects reported with Juluca are carefully evaluated and any necessary action taken to protect patients.

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Jylamvo

What is Jylamvo and what is it used for?

Jylamvo is an anti-inflammatory and cancer medicine used to treat the following conditions:• active rheumatoid arthritis (a disease causing inflammation in joints) in adults;• severe juvenile idiopathic arthritis (inflammation of joints in children) in patients from 3 years of age when NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough;• severe disabling psoriasis (an inflammatory disease causing red, scaly patches on the skin) in adults when other treatments have not worked well enough;• severe psoriatic arthritis (inflammation of joints that occurs in patients with psoriasis) in adults;• acute lymphoblastic leukaemia (ALL), a cancer of white blood cells, in adults and children over the age of 3 years.Jylamvo contains the active substance methotrexate.Jylamvo is a 'hybrid medicine'. This means that it is similar to a 'reference medicine' containing the same active substance, but Jylamvo is given in a different way. The reference medicine for Jylamvo is Methotrexat Lederle injection.

How is Jylamvo used?

Jylamvo is available as a liquid to be taken by mouth and it can only be obtained with a prescription. It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.For inflammatory conditions it is taken once a week, on the same day each week. The doctor may check with the patient or the patient's carer that the medicine can reliably be taken once a week. The dose that the patient takes each week depends on which inflammatory condition it is being used for, how well the treatment is working and, in the case of children, on the child's height and weight. In most cases, methotrexate medicines are used for long-term treatment.For acute lymphoblastic leukaemia, the dose of Jylamvo depends on the patient's height and weight. How often methotrexate is given depends on the other medicines it is used with.For more information about using Jylamvo, see the package leaflet or contact your doctor or pharmacist.

How does Jylamvo work?

The active substance in Jylamvo, methotrexate, stops cells from growing by interfering with the production of DNA. This especially affects fast-growing cells such as cancer cells. The way methotrexate works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.

What benefits of Jylamvo have been shown in studies?

The company provided data from the published literature on the benefits and risks of methotrexate in the approved uses.As for every medicine, the company provided studies on the quality of Jylamvo. The company also carried out studies that showed that it is bioequivalent to other methotrexate medicines used to treat inflammatory conditions and ALL (Methotrexat Lederle and Ebetrexat tablets). Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the risks associated with Jylamvo?

The most common side effects with Jylamvo (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver. The most serious side effects include reduced production of blood cells, damage to the lung, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), and severe allergic and skin reactions.Jylamo must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system. It must not be used if the patient is breastfeeding or is receiving live vaccines.For the full list of side effects and restrictions of Jylamvo, see the package leaflet.

Why is Jylamvo authorised in the EU?

The European Medicines Agency decided that Jylamvo was of comparable quality and was bioequivalent to the methotrexate-containing medicines Methotrexat Lederle and Ebetrexat. The Agency therefore decided that Jylamvo's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Jylamvo?

The company that markets Jylamvo will supply a guide for healthcare professionals and a patient alert card, on how to use the medicine correctly and how to avoid medication errors. The company will also send out follow-up questionnaires for dosing errors that result in overdose.Jylamvo Jylamvo (methotrexate)Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jylamvo have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Jylamvo are continuously monitored. Side effects reported with Jylamvo are carefully evaluated and any necessary action taken to protect patients.

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Jyseleca

What is Jyseleca and what is it used for?

Jyseleca is a medicine for treating adults with:• moderate to severe rheumatoid arthritis, a disease in which the immune system (the body's natural defences) attacks healthy tissue causing inflammation and pain in joints.Jyseleca is used alone or with another medicine, methotrexate, after treatment with one or more disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or ha caused unacceptable side effects. DMARDs are medicines, such as methotrexate, that slow down the worsening of the disease.• moderately to severely active ulcerative colitis, a condition in which the immune system attacks healthy tissue in parts of the intestine, causing periodical inflammation leading to sores and bleeding.In this case, Jyseleca is given to patients for whom conventional or biological therapies have not worked well enough, have stopped working or are not tolerated.Jyseleca contains the active substance filgotinib.

How is Jyseleca used?

Jyseleca can only be obtained with a prescription, and treatment should be started by a doctor experienced in treating rheumatoid arthritis or ulcerative colitis.Jyseleca is available as tablets to be taken by mouth once a day.Treatment with Jyseleca is only started if blood tests show that the levels of haemoglobin (the protein in blood that carries oxygen) and certain white blood cells are above a set limit. The doctor may interrupt treatment if the levels drop below the set limit.Treatment should be discontinued in patients with ulcerative colitis who have not shown an adequate benefit from the treatment in the first 22 weeks.For more information about using Jyseleca, see the package leaflet or contact your doctor or pharmacist.

How does Jyseleca work?

Filgotinib, the active substance in Jyseleca, reduces the activity of the immune system. It does this by blocking the action of enzymes known as Janus kinases (JAKs). These enzymes play an important role in the inflammatory processes that occur in rheumatoid arthritis and ulcerative colitis. By blocking the enzymes' action, filgotinib can help to reduce the symptoms of these diseases.

What benefits of Jyseleca have been shown in studies?

Rheumatoid arthritisThree studies showed that Jyseleca was effective at improving symptoms by at least 20% in patients with moderate or severe rheumatoid arthritis.The first study involved 1,755 patients whose condition was not controlled well enough with methotrexate. All patients continued to take methotrexate during the study. Symptoms improved after12 weeks in 77% of patients taking Jyseleca compared with 71% of patients treated with adalimumab (another rheumatoid arthritis medicine) and 50% of those receiving placebo (a dummy treatment).The second study involved 448 patients whose condition was not controlled well enough with biological DMARDs (medicines made from living cells). All patients continued to take conventional DMARDs, with around 80% of them taking methotrexate. Symptoms improved after 12 weeks in 66% of patients taking Jyseleca compared with 31% of those receiving placebo.The third study involved 1,249 patients who had not previously taken methotrexate but were at a high risk of their disease worsening. Symptoms improved after 24 weeks in 81% of patients taking both Jyseleca and methotrexate compared with 78% of those taking Jyseleca alone and 71% of those taking methotrexate alone.Ulcerative colitisOne study in patients who had or had not been treated with a biological agent before showed that Jyseleca was effective at treating ulcerative colitis.After 10 weeks of treatment, 26% of the patients who had not used biological agents before and were given Jyseleca experienced mild to no symptoms compared with 15% of patients given a placebo. Of the patients who had previously used biological agents, 11% of those taking Jyseleca had mild to no symptoms compared with 4% of patients who were given a placebo. After 58 weeks, 37% of patients taking Jyseleca had mild to no symptoms, compared with 11% of those given a placebo.

What are the risks associated with Jyseleca?

For the complete list of side effects and restrictions with Jyseleca, see the package leaflet.The most common side effects with Jyseleca (which may affect up to 1 in 10 people) are nausea (feeling sick), upper respiratory tract infection (nose and throat infection), urinary tract infection, dizziness and lymphopenia (low levels of lymphocytes, a type of white blood cells).Jyseleca must not be used in patients with active tuberculosis or other serious infections. It must also not be used during pregnancy or breast-feeding. Women who are able to have children must use contraception during treatment with Jyseleca and for at least one week after stopping treatment.Jyseleca should only be used if no suitable treatment alternatives are available in patients aged 65 years or above, in patients with a history of cardiovascular disease (such as heart attack or stroke) orwith risk factors for such a disease (such as current or previous long-term smokers), or in patients at increased risk of cancer.

Why is Jyseleca authorised in the EU?

Studies have shown that Jyseleca alone or in combination with methotrexate is effective for treating moderate to severe rheumatoid arthritis when previous treatment with DMARDs had not worked well enough. They have also shown that it is effective for treating adults with moderately to severely active ulcerative colitis for whom conventional or biological treatments did not work or are not tolerated.In general, the side effects of Jyseleca were similar to those of other medicines of its class, and the most important side effect is infection. Specific warnings and information material are available to help manage these risks.The European Medicines Agency decided that Jyseleca's benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Jyseleca?

The company that markets Jyseleca will provide educational materials to healthcare professionals and patients (patient alert card) about the risks with the medicine, particularly the risk of serious infections, blood clots, major cardiovascular events and malignancies in certain patients. They will also include a reminder that Jyseleca should not be taken during pregnancy and that women taking Jyseleca must use contraception during treatment and for at least one week after stopping treatment.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jyseleca have also been included in the summary of product characteristics and the package leaflet.As for all medicines, data on the use of Jyseleca are continuously monitored. Side effects reported with Jyseleca are carefully evaluated and any necessary action taken to protect patients.

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