Vazkepa · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-099617 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most frequently reported adverse reactions associated with icosapent ethyl are bleeding (11.8 %), peripheral oedema (7.8 %), atrial fibrillation (5.8 %), constipation (5.4 %), musculoskeletal pain (4.3 %), gout (4.3 %) and rash (3.0 %). Tabulated list of adverse reactions Adverse reactions are listed below and classified according to frequency and MedDRA system organ class based on all available interventional and non-interventional clinical trials and spontaneous reporting. Frequency categories are defined according to the following conventions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1 Adverse reactions MedDRA System organ class Adverse reaction Frequency Immune system disorders Hypersensitivity Uncommon Pharyngeal swelling Not known Metabolism and nutrition disorders Gout Common Nervous system disorders Dysgeusia1 Uncommon Cardiac disorders Atrial fibrillation or Common flutter2 Vascular disorders Bleeding2 Very common Gastrointestinal disorders Constipation2 Common Eructation Common Skin and subcutaneous tissue disorders Rash Common Musculoskeletal and connective tissue disorders Musculoskeletal pain Common General disorders and administration site Peripheral oedema Common conditions 1 Dysguesia describes the ‘verbatim’ term: Fishy taste 2 See ‘Description of selected adverse reactions’ Description of selected adverse reactions Bleeding Bleeding occurred in 11.8 % of subjects receiving icosapent ethyl in a placebo-controlled cardiovascular outcomes trial compared with 9.9 % in subjects receiving placebo. Serious bleeding events were reported more frequent

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099613 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance, soya or to any of the excipients listed in section 6.1.

HOS-099612 · has-indication-information · PDF-Seite 2

Vazkepa is indicated to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and • established cardiovascular disease, or • diabetes, and at least one other cardiovascular risk factor. For trial details including cardiovascular risk factors and results with respect to effects on cardiovascular events see section 5.1.

HOS-099615 · has-interaction-information · PDF-Seite 4

Icosapent ethyl was studied at the dose level of four 998 mg capsules/day with the following medicinal products which are typical substrates of cytochrome P450 enzymes: omeprazole, rosiglitazone, warfarin and atorvastatin. No interactions were observed. Patients taking icosapent ethyl along with antithrombotic agents, i.e. antiplatelet agents, including acetylsalicylic acid, and/or anticoagulants, may be at increased risk of bleeding and should be monitored periodically.

HOS-099616 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are a limited amount of data from the use of icosapent ethyl in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Vazkepa during pregnancy unless the benefit of use outweighs the potential risk to the foetus. Breast-feeding It is unknown whether icosapent ethyl is excreted in human milk. Studies from the literature have shown that the active metabolite eicosapentaenoic acid (EPA) is excreted in human milk at levels which correlated to maternal diet. Available toxicological data in rats have shown excretion of icosapent ethyl in milk (see section 5.3). A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Vazkepa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility There are no data on fertility in humans from the use of icosapent ethyl. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

HOS-099614 · has-warning-information · PDF-Seite 3

Allergies to fish and/or shellfish Icosapent ethyl is obtained from the oil of fish. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to icosapent ethyl. Icosapent ethyl should be used with caution in patients with known hypersensitivity to fish and/or shellfish. Hepatic impairment In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) concentrations should be monitored as clinically indicated before the start of treatment and at appropriate intervals during treatment (see sections 4.2 and 5.2). Atrial fibrillation or flutter Icosapent ethyl was associated with an increased risk of atrial fibrillation or flutter requiring hospitalisation in a double-blind placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or flutter (see section 4.8). Patients, particularly those with a relevant medical history, should be monitored for clinical evidence of atrial fibrillation or atrial flutter (e.g. dyspnoea, palpitations, syncope/dizziness, chest discomfort, change in blood pressure, or irregular pulse). Electrocardiographic evaluation should be performed when clinically indicated. Bleeding Treatment with icosapent ethyl has been associated with an increased incidence of bleeding. When icosapent ethyl is administered concomitantly with antithrombotic agents, appropriate laboratory investigations may be considered, whenever clinical signs suggestive of hemorrhage – such as contusion, epistaxis, hematuria, or gastrointestinal bleeding – occur during treatment. Patients should be advised to promptly report any signs or symptoms of bleeding to their physician (see section 4.8). Excipients with known effect Maltitol (E965 ii) This medicinal product contains 30 mg maltitol in each capsule. Patients with rare hereditary problems of fructose intolerance should not take this medicine. 3 Sorbitol (E420 ii) This medicinal product contains 83 mg sorbitol in each capsule. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. Patients with hereditary fru

Auszug; vollständigen Abschnitt im Original lesen.