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

Repatha (Evolocumab): Indications and Dosing for High Cholesterol Management

Repatha (evolocumab) is indicated for adults with established cardiovascular disease, primary hyperlipidemia (including heterozygous familial hypercholesterolemia), and homozygous familial hypercholesterolemia, with a standard dose of 140 mg subcutaneously every 2 weeks or 420 mg once monthly for most patients. 1, 2

Specific Indications

Repatha is FDA-approved for:

• Reducing cardiovascular risk: To reduce major adverse cardiovascular events (CV death, MI, stroke, unstable angina requiring hospitalization, coronary revascularization) in adults with established cardiovascular disease 1
• Primary hyperlipidemia: As adjunct to diet, alone or with other LDL-C-lowering therapies in adults 1
• Heterozygous familial hypercholesterolemia (HeFH): For adults and pediatric patients ≥10 years 1, 2
• Homozygous familial hypercholesterolemia (HoFH): As adjunct to other LDL-C-lowering therapies in adults and pediatric patients ≥10 years 1, 2

Dosage Recommendations

Adults with established cardiovascular disease or primary hyperlipidemia:

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

Pediatric patients (≥10 years) with HeFH:

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

Adults and pediatric patients (≥10 years) with HoFH:

• Initial dose: 420 mg subcutaneously once monthly
• May increase to 420 mg every 2 weeks if clinically meaningful response not achieved in 12 weeks 1, 2

Patients on lipid apheresis:

• 420 mg subcutaneously every 2 weeks to correspond with apheresis schedule
• Administer after apheresis session is complete 1, 2

Clinical Considerations for Use

Patient Selection

Repatha should be prioritized for:

• Patients with established ASCVD and LDL-C ≥70 mg/dL despite maximally tolerated statin plus ezetimibe 2
• Patients with familial hypercholesterolemia 2
• Statin-intolerant patients with high cardiovascular risk 2, 3

Efficacy

• Reduces LDL-C by 50-65% when added to statins 2, 4
• Demonstrated 15% relative risk reduction in composite cardiovascular endpoints in the FOURIER trial 2
• 20% reduction in combined endpoint of cardiovascular death, MI, or stroke 2

Administration

• Subcutaneous injection into abdomen, thigh, or upper arm 2
• Allow medication to warm to room temperature for at least 30 minutes before use if refrigerated 1
• Visually inspect solution (should be clear to opalescent, colorless to pale yellow) 1

Monitoring

• LDL-C can be measured as early as 4 weeks after initiation 1
• For patients on monthly dosing, measure LDL-C just prior to the next scheduled dose 1
• No specific laboratory monitoring beyond routine lipid profile assessment is required 2

Considerations in Special Populations

Statin-Intolerant Patients

• Repatha is an effective option for patients who cannot tolerate statins or sufficient statin dosage to achieve therapeutic objectives 3, 4
• Alternative approaches for statin-intolerant patients may include switching to different statins, lowering doses, or using nondaily dosing before adding Repatha 3

Familial Hypercholesterolemia

• Particularly valuable for patients with heterozygous or homozygous familial hypercholesterolemia who cannot achieve LDL-C targets with conventional therapy 4, 5
• Response in HoFH patients may be variable, with better results seen in adults and those with baseline LDL-C <500 mg/dL 6

Practical Considerations

• Common side effects include injection site reactions, nasopharyngitis, and upper respiratory tract infection 2
• Patients with latex sensitivity should be advised that some needle covers contain dry natural rubber 2, 1
• Cost considerations may restrict use despite excellent efficacy and tolerability profile 2, 5

Repatha represents a significant advancement in lipid management, particularly for high-risk patients unable to achieve LDL-C goals with conventional therapy.