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  • Repatha
    / Amgen


    Active Ingredient
    Evolocumab 140 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Pen

    2 X 140 mg/ml

    partial basket chart 58858 18536

    Pre-filled Syringe

    1 X 140 mg/ml

    partial basket chart

    Related information


    Dosage

    Prior to initiating Repatha, secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
    Primary hypercholesterolaemia and mixed dyslipidaemia in adults: 
    The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
    Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 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 Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
    Patients with renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment.
    Patients with hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment.
    Elderly patients (age ≥ 65 years): No dose adjustment is necessary in elderly patients.
    Paediatric population: The safety and efficacy of Repatha in children aged less than 18 years has not been established in the indication for primary hypercholesterolaemia and mixed dyslipidaemia. No data are available.
    The safety and efficacy of Repatha in children aged less than 12 years has not been established in the indication for homozygous familial hypercholesterolaemia. No data are available.
    Method of administration: Subcutaneous use. Repatha 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. Repatha 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 is intended for patient self-administration after proper training. Administration of Repatha can also be performed by an individual who has been trained to administer the product. For single use only.


    recommended drugs

    Indications

    Hypercholesterolaemia and mixed dyslipidaemia: Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, 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 adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.
    Established atherosclerotic cardiovascular disease: Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial 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.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Renal impairment: There is limited experience with Repatha in patients with severe renal impairment (defined as eGFR< 30 mL/min/1.73 m²). Repatha should be used with caution in patients with severe renal impairment.
    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 C) have not been studied. Repatha 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 allergic reactions.
    Repatha 140 mg solution for injection in pre-filled pen: The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may
    cause allergic reactions.
    Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’.


    Side Effects

    The most commonly reported adverse reactions during pivotal trials, at the recommended doses, were nasopharyngitis (7.4%), upper respiratory tract infection (4.6%), back pain (4.4%), arthralgia (3.9%), influenza (3.2%), and injection site reactions (2.2%). The safety profile in the homozygous familial
    hypercholesterolemia population was consistent with that demonstrated in the primary hypercholesterolemia and mixed dyslipidemia population.
    See prescribing information for full details.


    Drug interactions

    No formal drug-drug interaction studies have been conducted for Repatha.
    The pharmacokinetic interaction between statins and evolocumab was evaluated in the Repatha 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 Repatha.
    No studies on pharmacokinetic and pharmacodynamics interaction between Repatha and lipid-lowering drugs other than statins and ezetimibe have been conducted.


    Pregnancy and Lactation

    Pregnancy: There are no or limited amount of data from the use of Repatha in pregnant women. 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.
    See prescribing information for full details.


    Overdose

    No adverse effects were observed in animal studies at exposures up to 300-fold higher than those in patients treated with Repatha at 420 mg once monthly.
    There is no specific treatment for Repatha overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.


    Important notes

    Storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Keep in the original carton in order to protect from light. If removed from the refrigerator, Evolocumab may be stored at room temperature (up to 25°C) in the original carton and must be used within 30 days.
    Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


    Manufacturer
    Amgen Europe B.V., Breda, Netherlands.
    Licence holder
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