What is the recommended dosing regimen for Repatha (evolocumab)?

Repatha (Evolocumab) Dosing

For adults with ASCVD, primary hypercholesterolemia, or heterozygous familial hypercholesterolemia (HeFH), administer 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once monthly. 1

Standard Dosing by Indication

Adults with ASCVD or Primary Hypercholesterolemia (including HeFH)

• 140 mg subcutaneously every 2 weeks 1
• Alternative: 420 mg subcutaneously once monthly 1
• Both regimens provide comparable LDL-C reduction (64% and 58% respectively when added to maximally tolerated statin therapy) 1
• Administer in the thigh, abdomen, or upper arm 1

Pediatric Patients (≥10 years) with HeFH

• 140 mg subcutaneously every 2 weeks OR 420 mg once monthly 1
• Same administration sites as adults 1

Homozygous Familial Hypercholesterolemia (HoFH)

Initial dosing:

• 420 mg subcutaneously once monthly 1

If inadequate LDL-C reduction after 12 weeks:

• Increase to 420 mg every 2 weeks 1
• This up-titration improved mean LDL-C reduction from -19.6% at week 12 to -29.7% after 12 weeks of the higher frequency dosing 2

Patients on LDL Apheresis (HoFH)

• Initiate 420 mg subcutaneously every 2 weeks to correspond with apheresis schedule 1
• Administer evolocumab after apheresis is complete 1
• Evolocumab may allow discontinuation of apheresis in select patients: 84% of patients avoided apheresis at 6 weeks, and 77% did not require apheresis at 24 weeks when pre-LA LDL-C was ≤4.9 mmol/L 3

Administration Details

420 mg Dose Administration

• Use the prefilled single-dose on-body infuser, OR 1
• Give 3 consecutive 140 mg injections within 30 minutes at different injection sites 1

Injection Sites

• Thigh, abdomen, or upper arm 1
• Rotate injection sites 1

Clinical Efficacy

• Evolocumab reduces LDL-C by approximately 60% when added to statin therapy 4, 5
• In the FOURIER trial (27,564 patients with prior MI, stroke, or PAD), evolocumab reduced the primary endpoint of CV death, MI, stroke, revascularization, or hospitalization for unstable angina (HR 0.85; 95% CI 0.79-0.92; P<0.001) 1, 5
• Median LDL-C achieved was 30 mg/dL (0.78 mmol/L) in FOURIER 5

Safety Considerations

Contraindications

• History of hypersensitivity to evolocumab 1

Common Adverse Effects

• Nasopharyngitis, upper respiratory tract infection, influenza, back pain, injection site reactions 1
• In patients with ASCVD: diabetes, nasopharyngitis, upper respiratory tract infection 1
• No evidence of increased cognitive adverse effects in FOURIER or EBBINGHAUS trials 1

Important Warnings

• Hypersensitivity reactions occurred during clinical trials 1
• If serious hypersensitivity occurs, discontinue therapy immediately and treat according to standard of care 1
• Advise latex-sensitive patients that needle covers contain latex 1

Prescribing Considerations

• Subcutaneous administration can be performed at home 1
• May require prior authorization 1
• No clinically significant drug-drug interactions identified 1
• Long-term safety demonstrated over median 4.1 years in patients with familial hypercholesterolemia 2