Repatha

, nephrotic syndrome, hypothyroidism) should be excluded. Posology Primary hypercholesterolaemia and mixed dyslipidaemia (including heterozygous familial hypercholesterolaemia) Adults and paediatric patients (aged 10 years and over) The recommended dose of evolocumab is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.

Homozygous familial hypercholesterolaemia in adults and paediatric patients aged 10 years and over The initial recommended dose is 420 mg once monthly. After 12 weeks of treatment, dose frequency can be up-titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved.

Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule. Established atherosclerotic cardiovascular disease in adults The recommended dose of evolocumab is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.

Special populations Elderly patients (age ≥ 65 years) No dose adjustment is necessary in elderly patients. 2). 4 for patients with moderate and severe hepatic impairment. Paediatric population The safety and effectiveness of Repatha have not been established in paediatric patients with heterozygous familial hypercholesterolaemia (HeFH) or homozygous familial hypercholesterolaemia (HoFH) who are younger than 10 years old or in paediatric patients with other types of hyperlipidaemia.

4 Method of administration Subcutaneous use. Evolocumab is for subcutaneous injection into the abdomen, thigh or upper arm region. Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red, or hard.

Evolocumab must not be administered intravenously or intramuscularly. Repatha 140 mg solution for injection in pre-filled syringe The 140 mg dose should be delivered using a single pre-filled syringe. The 420 mg dose should be delivered using three pre-filled syringes administered consecutively within 30 minutes.

Repatha 140 mg solution for injection in pre-filled pen The 140 mg dose should be delivered using a single pre-filled pen. The 420 mg dose should be delivered using three pre-filled pens administered consecutively within 30 minutes.

Repatha 420 mg solution for injection in cartridge The 420 mg dose should be delivered using a single cartridge with the automated mini-doser. Repatha is intended for patient self-administration after proper training. Administration of evolocumab can also be performed by an individual who has been trained to administer the product.

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 (SOC) Adverse reactions Frequency category Infections and infestations Influenza Common Nasopharyngitis Common Upper respiratory tract infection Common Immune system disorders Hypersensitivity Common Rash Common Urticaria Uncommon Nervous system disorders Headache Common Gastrointestinal disorders Nausea Common Skin and subcutaneous tissue disorders Angioedema Rare Musculoskeletal and connective tissue disorders Back pain Common Arthralgia Common Myalgia Common General disorders and administration site conditions Injection site reactions1 Common Influenza-like illness Uncommon 1 See section Description of selected adverse reactions.

3) months in subjects on placebo who switched to Repatha in an open-label extension study. Description of selected adverse reactions Injection site reactions The most frequent injection site reactions were injection site bruising, erythema, haemorrhage, injection site pain, and swelling.

Paediatric population The safety and effectiveness of Repatha have been established in paediatric patients with heterozygous and homozygous familial hypercholesterolaemia. A clinical study to evaluate the effects of Repatha was conducted in 158 paediatric patients aged ≥ 10 to < 18 years old with heterozygous familial hypercholesterolaemia.

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. 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.

5 Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

1.