Repatha

HOS-097020 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most commonly reported adverse reactions at the recommended doses are nasopharyngitis (7.4%), upper respiratory tract infection (4.6%), back pain (4.4%), arthralgia (3.9%), influenza (3.2%), and 5 injection site reactions (2.2%). The safety profile in the homozygous familial hypercholesterolaemia population was consistent with that demonstrated in the primary hypercholesterolaemia and mixed dyslipidaemia population. Tabulated list of adverse reactions Adverse reactions reported in pivotal, controlled clinical studies, and spontaneous reporting, are displayed by system organ class and frequency in table 1 below using the following convention: 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) and very rare (< 1/10 000). Table 1. Adverse reactions MedDRA system organ class Adverse reactions Frequency category (SOC) Infections and infestations Influenza Common Nasopharyngitis Common Upper respiratory tract Common infection Immune system disorders Hypersensitivity Common Rash Common Urticaria Uncommon Nervous system disorders Headache Common Gastrointestinal disorders Nausea Common Skin and subcutaneous tissue Angioedema Rare disorders Musculoskeletal and connective Back pain Common tissue disorders Arthralgia Common Myalgia Common General disorders and Injection site reactions1 Common administration site conditions Influenza-like illness Uncommon 1 See section Description of selected adverse reactions. The safety profile was consistent between subjects with post-baseline LDL-C < 25 mg/dL (0.65 mmol/L) or < 40 mg/dL (1.03 mmol/L) compared to subjects with higher post-baseline LDL-C (≥ 40 mg/dL [1.03 mmol/L]), with median (Q1

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097016 · has-contraindication-information · PDF-Seite 4

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

HOS-097015 · has-indication-information · PDF-Seite 2

Hypercholesterolaemia and mixed dyslipidaemia Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia, as an adjunct to diet: • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Homozygous familial hypercholesterolaemia Repatha is indicated in adults and paediatric patients aged 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. 2 Atherosclerotic cardiovascular disease Repatha is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.

HOS-097018 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. The pharmacokinetic interaction between statins and evolocumab was evaluated in the clinical trials. An approximately 20% increase in the clearance of evolocumab was observed in patients co- administered statins. This increased clearance is in part mediated by statins increasing the concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) which did not adversely impact the pharmacodynamic effect of evolocumab on lipids. No statin dose adjustments are necessary when used in combination with evolocumab. No studies on pharmacokinetic and pharmacodynamics interaction between evolocumab and lipid- lowering medicinal products other than statins and ezetimibe have been conducted.

HOS-097019 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no or limited amount of data from the use of Repatha in pregnant women. Animal studies do not indicate direct or indirect effects with respect to reproductive toxicity (see section 5.3). Repatha should not be used during pregnancy unless the clinical condition of the woman requires treatment with evolocumab. Breast-feeding It is unknown whether evolocumab is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Repatha therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility No data on the effect of evolocumab on human fertility are available. Animal studies did not show any effects on fertility endpoints at area under the concentration time curve (AUC) exposure levels much higher than in patients receiving evolocumab at 420 mg once monthly (see section 5.3).

HOS-097017 · has-warning-information · PDF-Seite 4

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hepatic impairment In patients with moderate hepatic impairment, a reduction in total evolocumab exposure was observed that may lead to a reduced effect on LDL-C reduction. Therefore, close monitoring may be warranted in these patients. Patients with severe hepatic impairment (Child-Pugh class C) have not been studied (see section 5.2). Evolocumab should be used with caution in patients with severe hepatic impairment. Dry natural rubber Repatha 140 mg solution for injection in pre-filled syringe The needle cover of the glass pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause severe allergic reactions. 4 Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.