Evolocumab


Generic Medicine Info
Indications and Dosage
Subcutaneous
Heterozygous familial hypercholesterolaemia
Child: Adjunct to diet, alone or in combination with statin and/or other lipid-lowering therapies: ≥10 years 140 mg once every 2 weeks or 420 mg once monthly. Treatment recommendations may vary between countries (refer to specific product guidelines).

Subcutaneous
Heterozygous familial hypercholesterolaemia, Mixed dyslipidaemia, Nonfamilial hypercholesterolaemia
Adult: Adjunct to diet, alone or in combination with statin and/or other lipid-lowering therapies: 140 mg once every 2 weeks or 420 mg once monthly. Treatment recommendations may vary between countries (refer to specific product guidelines).

Subcutaneous
Homozygous familial hypercholesterolaemia
Adult: In combination with other lipid-lowering therapies: Initially, 420 mg once monthly. After 12 weeks, dose may be increased to 420 mg once every 2 weeks if necessary. Patients on apheresis: 420 mg once every 2 weeks.
Child: In combination with other lipid-lowering therapies: ≥10 years Same as adult dose. Treatment recommendations may vary between countries (refer to specific product guidelines).

Subcutaneous
Cardiovascular risk reduction
Adult: To reduce the risk of CV events (e.g. MI, stroke, unstable angina requiring hospitalisation, coronary revascularisation) by decreasing LDL-C levels in patients with established atherosclerotic CV disease: Alone or in combination with the maximally tolerated statin dose and/or other lipid-lowering therapies: 140 mg once every 2 weeks or 420 mg once monthly. Treatment recommendations may vary between countries (refer to specific product guidelines).
What are the brands available for Evolocumab in Hong Kong?
Contraindications
Hypersensitivity.
Special Precautions
Moderate to severe hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. angioedema, urticaria, rash).
Gastrointestinal disorders: Nausea.
General disorders and administration site conditions: Inj site reactions (e.g. bruising, haemorrhage, erythema, pain, swelling).
Musculoskeletal and connective tissue disorders: Back pain, arthralgia, myalgia.
Nervous system disorders: Headache, dizziness.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, URTI, cough, sinusitis, influenza.
Vascular disorders: Hypertension.
Monitoring Parameters
Evaluate and exclude secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g. nephrotic syndrome, hypothyroidism) prior to treatment initiation. Monitor lipid profile (fasting or nonfasting) at baseline; fasting lipid profile 4-12 weeks after treatment initiation and every 3-12 months thereafter. Assess for signs and symptoms of hypersensitivity reactions.
Action
Description:
Mechanism of Action: Evolocumab is a human IgG2 monoclonal antibody which binds to proprotein convertase subtilisin kexin type 9 (PCSK9). It inhibits PCSK9 from binding to low-density lipoprotein receptors (LDLR) in the liver, thereby increasing the number of available receptors to clear circulating LDL from the blood and leading to reduced LDL-cholesterol (LDL-C) levels.
Onset: 4 hours (PCSK9 suppression).
Pharmacokinetics:
Absorption: Bioavailability: Approx 72%. Time to peak plasma concentration: 3-4 days.
Distribution: Crosses the placenta.
Metabolism: Metabolised via nonsaturable proteolysis.
Excretion: Elimination half-life: 11-17 days.
Storage
Store between 2-8°C. Do not freeze. Alternatively, may store at room temperature (between 20-25°C) for up to 30 days. Protect from light.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AX13 - evolocumab ; Belongs to the class of other lipid modifying agents.
References
Anon. Evolocumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/12/2024.

Brayfield A, Cadart C (eds). Evolocumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/12/2024.

Evolocumab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/12/2024.

Joint Formulary Committee. Evolocumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/12/2024.

Repatha 140 mg Solution for Injection in Pre-filled Pen (Amgen Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/12/2024.

Repatha 140 mg Solution for Injection in Pre-filled Syringe (Amgen Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/12/2024.

Repatha 420 mg Solution for Injection in Cartridge (Amgen Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/12/2024.

Repatha Injection, Solution (Amgen USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/12/2024.

Repatha Solution for Injection in Pre-filled Syringe or Pre-filled Autoinjector 140 mg/mL (Amgen Biopharmaceuticals Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/12/2024.

Disclaimer: This information is independently developed by MIMS based on Evolocumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com
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