Indications: Repatha (evolocumab) injection is a PCSK9 inhibitor antibody indicated as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density LDL-C and other LDL-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C.

Efficacy: Participants taking Repatha had an average reduction in LDL cholesterol of approximately 60%, compared to placebo¹. A significant number of patients in the studied groups were already on maximal statin therapy, and Repatha was studied as an addition to statin therapy as well as in patients who where not on a statin.

Dosing: Administered by subcutaneous injection and is available as a single-use 140 mg prefilled SureClick autoinjector or prefilled syringe that patients can self-administer at the recommended dose for adults of 140 mg every 2 weeks or 420 mg once per month. For adults with HoFH, recommended dose is 420 mg once per month.

Pharmacokinetics: Following a single subcutaneous dose of 140 mg or 420 mg evolocumab administered to healthy adults, median peak serum concentrations were attained in 3 to 4 days, and estimated absolute bioavailability was 72%.

Side Effects/Risks: Common adverse reactions in clinical trials included nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. Allergic reactions such as rash and urticarial have also occurred.

Citation: Highlights of prescribing information: Repatha (evolocumab). FDA website. www.accessdata.fda.gov/drugsatfda_docs/label/2015/125522s000lbl.pdf. Revised August 2015. Accessed August 31, 2015.

1. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm460082.htm