What is the recommended dosage of Repatha (Evolocumab)?

Repatha (Evolocumab) Dosing Recommendations

For adults with established cardiovascular disease or primary hypercholesterolemia, administer Repatha 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once monthly—both regimens provide equivalent cardiovascular benefit and robust LDL-C reduction. 1, 2

Standard Adult Dosing

Primary Hypercholesterolemia and ASCVD:

• 140 mg subcutaneously every 2 weeks (provides 64% additional LDL-C reduction when added to maximally tolerated statin therapy) 2, 3
• 420 mg subcutaneously once monthly (provides 58% additional LDL-C reduction when added to maximally tolerated statin therapy) 2, 3
• Both dosing regimens are FDA-approved and clinically equivalent—choice is based on patient preference 1, 2
• When switching between regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen 1

Pediatric Dosing (≥10 Years)

Heterozygous Familial Hypercholesterolemia (HeFH):

• Same as adult dosing: 140 mg every 2 weeks OR 420 mg once monthly 2, 1
• Administration sites include abdomen, thigh, or upper arm 2

Homozygous Familial Hypercholesterolemia (HoFH)

Initial Dosing:

• Start with 420 mg subcutaneously once monthly 2, 1
• Assess response at 12 weeks 1

Dose Escalation:

• If inadequate LDL-C reduction after 12 weeks, increase to 420 mg every 2 weeks 2, 1

Patients on LDL Apheresis:

• May initiate at 420 mg every 2 weeks to correspond with apheresis schedule 2
• Administer Repatha after the apheresis session is complete 2, 1

Administration Details

Preparation:

• Allow Repatha to warm to room temperature for at least 30 minutes if refrigerated (for prefilled autoinjector or syringe) 1
• Visually inspect—solution should be clear to opalescent, colorless to pale yellow 1
• Do not use if cloudy, discolored, or contains particles 1

420 mg Dose Administration:

• Use the prefilled single-dose on-body infusor OR give 3 consecutive 140 mg injections within 30 minutes at different injection sites 2, 3
• Rotate injection sites (abdomen, thigh, or upper arm) 2, 3

Missed Dose Management

Within 7 days of missed dose:

• Administer immediately and resume original schedule 1

More than 7 days after missed dose:

• For every 2-week dosing: wait until next scheduled dose 1
• For monthly dosing: administer immediately and start new schedule based on this date 1

Monitoring

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

Clinical Efficacy Supporting These Doses

• In the FOURIER trial (27,564 patients with prior ASCVD), evolocumab reduced LDL-C by 59% (from median 92 to 30 mg/dL) 2
• Reduced cardiovascular death, MI, stroke, revascularization, or hospitalization for unstable angina by 15% (HR 0.85; 95% CI 0.79-0.92; P<0.001) 3
• Reduced cardiovascular death, MI, or stroke by 20% (HR 0.80; 95% CI 0.73-0.88; P<0.001) 2

Safety Considerations

Contraindications:

• History of hypersensitivity to evolocumab 2, 3

Latex Warning:

• Some presentations contain dry natural rubber (latex derivative) in needle covers—prescribe latex-free presentation for latex-sensitive patients 3, 1

Common Adverse Effects:

• Nasopharyngitis, upper respiratory tract infection, influenza, back pain, injection site reactions 2, 3
• No evidence of increased cognitive adverse effects in FOURIER or EBBINGHAUS trials 2, 3

Hypersensitivity Management:

• If serious hypersensitivity reaction occurs, discontinue therapy immediately, treat according to standard of care, and monitor until symptoms resolve 2