What is the indication and dosing for Repatha (evolocumab) in patients with high cholesterol?

Repatha (Evolocumab) Indications and Dosing for High Cholesterol

Repatha (evolocumab) is indicated for adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) as an adjunct to diet, either alone or with other lipid-lowering therapies, with a standard dosage of 140 mg every 2 weeks or 420 mg once monthly administered subcutaneously. 1, 2

Indications

Repatha is FDA-approved for:

1. Primary hyperlipidemia in adults:

   • As an adjunct to diet, alone or with other LDL-C-lowering therapies 2
   • Particularly valuable for patients unable to reach LDL-C goals with statins and ezetimibe 1

2. Cardiovascular disease risk reduction:

   • To reduce risk of major adverse cardiovascular events (CV death, MI, stroke, unstable angina requiring hospitalization, coronary revascularization) in adults with established cardiovascular disease 2

3. Familial hypercholesterolemia:

   • For heterozygous familial hypercholesterolemia (HeFH) in adults and pediatric patients aged 10 years and older 2
   • For homozygous familial hypercholesterolemia (HoFH) in adults and pediatric patients aged 10 years and older 2

Dosing Regimens

Standard Dosing:

• 140 mg every 2 weeks OR 420 mg once monthly subcutaneously for:
  • Adults with established cardiovascular disease
  • Adults with primary hyperlipidemia
  • Pediatric patients ≥10 years with HeFH 2

HoFH-Specific Dosing:

• Initial dose: 420 mg once monthly subcutaneously
• Can be increased to 420 mg every 2 weeks if clinically meaningful response not achieved after 12 weeks 1, 2
• For patients on lipid apheresis: 420 mg every 2 weeks (administered after apheresis session) 2

Administration Guidelines

• Administer subcutaneously in the abdomen, thigh, or upper arm 1
• Allow Repatha to warm to room temperature before administration:
  • 30 minutes for prefilled autoinjector or syringe
  • 45 minutes for on-body infusor with prefilled cartridge 2
• Visually inspect solution before use (should be clear to opalescent, colorless to pale yellow) 2

Monitoring

• LDL-C can be measured as early as 4 weeks after initiation 1, 2
• For patients on the monthly 420 mg regimen, measure LDL-C just prior to the next scheduled dose, as levels may vary during the dosing interval 1, 2

Missed Doses

If a dose is missed:

• Within 7 days: administer and resume original schedule
• More than 7 days:
  • For every 2-week dosing: wait until next scheduled dose
  • For monthly dosing: administer and start new schedule based on this date 2

Efficacy

• Reduces LDL-C by 50-65% from baseline when added to statins 1
• Significantly reduces cardiovascular events when added to statin therapy 3

Clinical Pearls

• Patient selection: Consider Repatha particularly for:

  • Patients with familial hypercholesterolemia not achieving targets with statins and ezetimibe 1
  • Statin-intolerant patients who cannot achieve adequate LDL-C reduction with other therapies 1, 4
  • Very high-risk patients not achieving LDL-C goals despite maximally tolerated statin therapy and ezetimibe 1

• Caution: Some presentations contain dry natural rubber (latex derivative) in the needle cover - consider latex-free options for sensitive individuals 2