Evolocumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Heterozygous familial hypercholesterolaemia; Nonfamilial hypercholesterolaemia; Mixed dyslipidaemia Monotherapy or combined with statins and other lipid-lowering drugs: 420 mg once monthly or 140 mg once every 2 weeks. Homozygous familial hypercholesterolaemia Combined with other lipid-lowering drugs: 420 mg once monthly.
Dosage Details
Subcutaneous
Heterozygous familial hypercholesterolaemia, Mixed dyslipidaemia, Nonfamilial hypercholesterolaemia
Adult: As monotherapy or in combination with statins and other lipid-lowering drugs: 140 mg once every 2 weeks or 420 mg once monthly.

Subcutaneous
Familial homozygous hypercholesterolaemia
Adult: In combination with other lipid-lowering drugs: Initially, 420 mg once monthly. May be increased if necessary, after 12 weeks, to 420 mg once every 2 weeks. Patients on apheresis: 420 mg once every 2 weeks.
Child: ≥12 years Same as adult dose.
Special Precautions
Pregnancy and lactation. Renal and hepatic impairment.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. rash, urticaria).
Gastrointestinal disorders: Nausea, diarrhoea, gastroenteritis.
General disorders and administration site conditions: Inj site reactions.
Infections and infestations: Influenza.
Musculoskeletal and connective tissue disorders: Back pain, arthralgia, myalgia.
Nervous system disorders: Headache, dizziness.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, upper respiratory infection, cough, sinusitis.
Vascular disorders: Hypertension.
MonitoringParameters
Monitor lipid profile; LDL-C levels 4-8 weeks after initiation of treatment (in patients with homozygous familial hypercholesterolaemia); signs and symptoms of hypersensitivity.
Action
Description: Evolocumab is a human monoclonal antibody (IgG2 isotype) that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). It inhibits PCSK9 from binding to LDL receptors in the liver thereby increasing receptor numbers, leading to increased uptake of LDL-cholesterol hence lowering its level in the blood.
Onset: Proprotein convertase subtilisin kexin type 9 (PCSK9) suppression: 4 hours.
Pharmacokinetics:
Absorption: Bioavailability: 72%. Time to peak plasma concentration: 3-4 days.
Distribution: Volume of distribution: Approx 3.3 L.
Metabolism: Metabolised via nonsaturable proteolytic pathway.
Excretion: Elimination half-life: 11-17 days.
Storage
Store between 2-8°C. Protect from light. Do not freeze. Any unused portions should be disposed of in accordance with local requirements.
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 30/01/2018.

Anon. Evolocumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 30/01/2018.

Buckingham R (ed). Evolocumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/01/2018.

Joint Formulary Committee. Evolocumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/01/2018.

Repatha Injection, Solution (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 30/01/2018.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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