From the Guidelines
Repatha (evolocumab) is indicated for adults with established cardiovascular disease or heterozygous familial hypercholesterolemia who require additional LDL cholesterol lowering despite maximally tolerated statin therapy, with a standard dosing of 140 mg subcutaneously every 2 weeks or 420 mg once monthly. The medication works by inhibiting PCSK9, a protein that regulates LDL receptor recycling, thereby increasing LDL receptor availability on liver cells and enhancing clearance of LDL cholesterol from the bloodstream. This mechanism allows Repatha to reduce LDL cholesterol levels by approximately 60% when added to statin therapy, as demonstrated in the FOURIER trial, which enrolled 27,564 patients with prior ASCVD and an additional high-risk feature who were receiving their maximally tolerated statin therapy 1. Key points to consider when prescribing Repatha include:
- The medication is administered as a subcutaneous injection in the abdomen, thigh, or upper arm, and patients can be trained to self-administer the medication using either a prefilled autoinjector (SureClick) or prefilled syringe.
- Before starting Repatha, patients should have optimized statin therapy and other lipid-lowering medications.
- The FOURIER trial demonstrated a 15% relative risk reduction in the composite outcome of cardiovascular death, MI, stroke, hospitalization for angina, or revascularization, and a 20% reduction in the combined endpoint of cardiovascular death, MI, or stroke 1.
- Repatha has been shown to reduce LDL cholesterol levels by 59% from a median of 92 to 30 mg/dL in the treatment arm, with a median follow-up of 2.2 years 1.
- The medication has been approved as adjunctive therapy for patients with ASCVD or familial hypercholesterolemia who are receiving maximally tolerated statin therapy but require additional lowering of LDL cholesterol 1.
From the FDA Drug Label
To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults with established cardiovascular disease As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C As an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C
The indication for Repatha (evolocumab) is to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and to reduce LDL-C in adults and pediatric patients with primary hyperlipidemia, HeFH, or HoFH. The recommended dosing for Repatha is either 140 mg every 2 weeks or 420 mg once monthly administered subcutaneously 2.
- In adults with established cardiovascular disease or primary hyperlipidemia, the recommended dosage is either 140 mg every 2 weeks or 420 mg once monthly.
- In pediatric patients aged 10 years and older with HeFH, the recommended dosage is either 140 mg every 2 weeks or 420 mg once monthly.
- In adults and pediatric patients aged 10 years and older with HoFH, the initial recommended dosage is 420 mg once monthly, which can be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks 2.
From the Research
Indication for Repatha (evolocumab)
- Repatha (evolocumab) is indicated for the treatment of primary hypercholesterolemia or mixed dyslipidemia, and homozygous familial hypercholesterolemia 3, 4.
- It is used in patients who are unable to reach LDL-C goals despite treatment with statins with or without other lipid-lowering therapies, and in patients who do not tolerate or are not able to receive statins 3, 4.
Dosing for Repatha (evolocumab)
- The recommended dosage of Repatha (evolocumab) is 140 mg every 2 weeks or 420 mg once monthly, administered subcutaneously 3, 5, 6, 7.
- The dosage can be adjusted based on the patient's response to treatment and their individual needs 3, 4.
Efficacy of Repatha (evolocumab)
- Repatha (evolocumab) has been shown to significantly reduce LDL-C levels in patients with primary hypercholesterolemia or mixed dyslipidemia, and homozygous familial hypercholesterolemia 3, 5, 4, 6, 7.
- It has also been shown to reduce the risk of cardiovascular events, including cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization 5, 6.