What is the maximum recommended dose of Repatha (evolocumab)?

Maximum Dosage of Repatha (Evolocumab)

The maximum recommended dose of Repatha (evolocumab) is 420 mg administered subcutaneously every 2 weeks, which is specifically indicated for patients with homozygous familial hypercholesterolemia (HoFH) who require additional LDL-C reduction after 12 weeks of monthly therapy. 1, 2

Standard Dosing Regimens

For most patients, Repatha is administered in one of two standard dosing regimens:

• For adults with ASCVD or primary hypercholesterolemia (including heterozygous familial hypercholesterolemia):

  • 140 mg subcutaneously every 2 weeks OR
  • 420 mg subcutaneously once monthly 1, 2

• For pediatric patients (≥10 years) with heterozygous familial hypercholesterolemia (HeFH):

  • Same dosing as adults: 140 mg every 2 weeks OR 420 mg monthly 1, 2

Special Population: Homozygous Familial Hypercholesterolemia (HoFH)

• Initial dosing for HoFH (adults and pediatric patients ≥10 years):

  • 420 mg subcutaneously once monthly 1, 2

• Dose escalation for HoFH:

  • If additional LDL-C reduction is needed after 12 weeks of monthly therapy, the dose may be increased to 420 mg every 2 weeks 1, 2
  • This represents the maximum approved dose of Repatha

Administration of 420 mg Dose

The 420 mg dose can be administered in one of two ways:

1. Using the prefilled single-dose on-body infuser
2. Administering three 140 mg injections consecutively within 30 minutes 1

Special Considerations for Patients on LDL Apheresis

• For patients with HoFH on LDL apheresis, the recommended dose is 420 mg every 2 weeks 1
• Administration should occur after the apheresis procedure is complete 1

Efficacy

• When added to statin therapy, evolocumab 140 mg every 2 weeks and 420 mg every 4 weeks reduces LDL-C by approximately 64% and 58%, respectively 1
• In clinical trials, Repatha demonstrated a 15% relative risk reduction in composite cardiovascular endpoints and a 20% reduction in the combined endpoint of cardiovascular death, MI, or stroke 2, 3

Safety Considerations

• No dose adjustments are required based on renal or hepatic function
• The most common adverse effects include nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions 1, 2
• Hypersensitivity reactions may occur and require discontinuation of therapy 1
• Latex-sensitive patients should be advised that needle covers contain latex 1

Clinical Pearl

When prescribing the maximum dose (420 mg every 2 weeks), ensure proper patient education regarding the administration technique, especially if using multiple injections to achieve the full dose. Long-term safety and efficacy data support the use of evolocumab at this dosage in appropriate patients, with studies demonstrating sustained LDL-C reduction over a median of 4.1 years 4.