Drug Action
Evolocumab binds to a pro-protein involved in the regulation of LDL receptors on liver cells; receptor numbers are increased, which results in increased uptake of LDL-cholesterol from the blood.
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Drug reference
Evolocumab binds to a pro-protein involved in the regulation of LDL receptors on liver cells; receptor numbers are increased, which results in increased uptake of LDL-cholesterol from the blood.
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Primary hypercholesterolaemia or mixed dyslipidaemia in patients who have not responded adequately to other appropriate measures (in combination with a statin, or with a statin and other lipid-lowering therapies, or with other lipid-lowering therapies or alone if a statin contra- indicated or not tolerated) | Established atherosclerotic cardiovascular disease (in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies, or with other lipid- lowering therapies or alone if a statin contra-indicated or not tolerated) ▶BY SUBCUTANEOUS INJECTION ▶Adult: 140 mg every 2 weeks, alternatively 420 mg every month, to be administered into the thigh, abdomen or upper arm Homozygous familial hypercholesterolaemia (in combination with other lipid-lowering therapies) ▶BY SUBCUTANEOUS INJECTION ▶Adult: Initially 420 mg every month; increased if necessary to 420 mg every 2 weeks, if inadequate response after 12 weeks of treatment, to be administered into the thigh, abdomen or upper arm Homozygous familial hypercholesterolaemia in patients on apheresis (in combination with other lipid-lowering therapies) ▶BY SUBCUTANEOUS INJECTION ▶Adult: 420 mg every 2 weeks, to correspond with apheresis schedule, to be administered into the thigh, abdomen or upper arm
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NICE decisions ▶Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia (June 2016) NICE TA394 Evolocumab (Repatha ®) is recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if: . it is given at a dose of 140 mg every 2 weeks, and . low-density lipoprotein cholesterol (LDL-C) concentrations are persistently above the thresholds specified in the NICE documentation, and . the manufacturer provides evolocumab with the discount agreed in the patient access scheme. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta394 Scottish Medicines Consortium (SMC) decisions SMC No. 1148/16 The Scottish Medicines Consortium has advised (February 2017) that evolocumab (Repatha ®) is accepted for restricted use within NHS Scotland for the treatment of primary hypercholesterolaemia (heterozygous familial hypercholesterolaemia and non-familial) or mixed dyslipidaemia (alone or in combination with other lipid lowering therapies, as specified within its license), for specialist use only when administered at a dose of 140 mg every 2 weeks and only in patients at high cardiovascular risk as follows: . patients with heterozygous familial hypercholesterolaemia (HeFH) and LDL-C 5 mmol/L or greater for primary prevention of cardiovascular events, or . patients with HeFH and LDL-C 3.5 mmol/L or greater for secondary prevention of cardiovascular events, or . patients with high risk due to previous cardiovascular events and LDL-C 4 mmol/L or greater, or . patients with recurrent/polyvascular disease and LDL-C 3.5 mmol/L or greater. This advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.
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▶Common or very common Arthralgia. back pain. increased risk of infection. nausea. skin reactions ▶Rare or very rare Angioedema
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Manufacturer advises avoid unless essential—limited information available.
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Manufacturer advises avoid—no information available.
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Manufacturer advises caution in moderate to severe impairment (risk of reduced efficacy; no information available in severe impairment).
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Manufacturer advises caution if eGFR Cardiovascular system less than 30 mL/minute/1.73 m2—no information available. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8°C)—consult product literature for further information regarding storage outside refrigerator.
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There can be variation in the licensing of different medicines containing the same drug. Solution for injection ▶Repatha SureClick (Amgen Ltd) A Evolocumab 140 mg per 1 ml Repatha SureClick 140mg/1ml solution for injection pre-filled pens | 2 pre-filled disposable injection P £340.20 DT = £340.20
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Patients and their carers should be given training in subcutaneous injection technique.
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140 mg every 2 weeks, alternatively 420 mg
First-line fragment. Read the complete Indications and Dose section above.
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Initially 420 mg every month; increased if
First-line fragment. Read the complete Indications and Dose section above.
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420 mg every 2 weeks, to correspond with
First-line fragment. Read the complete Indications and Dose section above.
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