STEPS

New Drug Reviews

Evolocumab (Repatha) for the Treatment of Hyperlipidemia

 


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Am Fam Physician. 2016 Nov 15;94(10):843-846.

Evolocumab (Repatha) is an injectable human monoclonal antibody labeled for decreasing low-density lipoprotein (LDL) cholesterol. Evolocumab is the second approved inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), which prevents the PCSK9 protein from degrading LDL receptors, thereby increasing LDL clearance and reducing serum cholesterol.1 It is labeled for use in combination with a healthy diet and other lipid-lowering therapies in one of three disease conditions: clinical atherosclerotic coronary or vascular disease, heterozygous familial hypercholesterolemia, and homozygous familial hypercholesterolemia.2 As with alirocumab (Praluent), the other injectable monoclonal antibody in this class, evolocumab is not labeled for the prevention of premature mortality or to decrease cardiovascular events.

View/Print Table

DrugDosageDose formCost*

Evolocumab (Repatha)

140 mg per mL every two weeks (for heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease)

Prefilled single-use syringe

$1,127

420 mg per mL monthly (for homozygous familial hypercholesterolemia)

Single-use on-body infuser

$1,411


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed July 28, 2016) and Walgreens.

DrugDosageDose formCost*

Evolocumab (Repatha)

140 mg per mL every two weeks (for heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease)

Prefilled single-use syringe

$1,127

420 mg per mL monthly (for homozygous familial hypercholesterolemia)

Single-use on-body infuser

$1,411


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed July 28, 2016) and Walgreens.

SAFETY

Limited investigation of evolocumab has not identified significant safety issues, and it is unknown if there are any long-term clinically important effects of pharmacologically induced extreme reduction of LDL cholesterol. Evolocumab has not been studied in children younger than 13 years. Because it is a monoclonal antibody, evolocumab has the potential for immunogenicity-related adverse effects. There are no safety data available on women who are pregnant or breastfeeding.

TOLERABILITY

Patients have noted hypersensitivity reactions such as rash (1% vs. 0.5% with placebo)

Address correspondence to Deborah R. Erlich, MD, MMedEd, at deborah.erlich@tufts.edu. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

REFERENCES

show all references

1. U.S. Food and Drug Administration. FDA news release: FDA approves Repatha to treat certain patients with high cholesterol. August 27, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm460082.htm. Accessed February 18, 2016....

2. U.S. National Library of Medicine. DailyMed. Drug label information: Repatha—evolocumab injection, solution. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=709338ae-ab8f-44a9-b7d5-abaabec3493a. Accessed March 17, 2016.

3. Repatha (evolocumab) prescribing information. Amgen. https://www.repathahcp.com/ascvd. Accessed February 18, 2016.

4. Robinson JG, Nedergaard BS, Rogers WJ, et al.; LAPLACE-2 Investigators. Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial. JAMA. 2014;311(18):1870–1883.

5. Blom DJ, Hala T, Bolognese M, et al.; DESCARTES Investigators. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. N Engl J Med. 2014;370(19):1809–1819.

6. Sabatine MS, Giugliano RP, Wiviott SD, et al.; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372(16):1500–1509.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.

A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.



 

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