Repatha Evolocumab Injection

1. Indications and Usage
Primary Hyperlipidemia and Mixed Dyslipidemia:
Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) or mixed dyslipidemia, to lower LDL-C levels.
Atherosclerotic Cardiovascular Disease (ASCVD):
Indicated to further reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established ASCVD.
HoFH:
Indicated as an adjunct to other LDL-C lowering therapies (including statins, other treatments, or LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who have an LDL-C level of ≥100 mg/dL and who have at least one other risk factor.
2. Dosage and Administration
Route of Administration:
For Subcutaneous Injection ONLY.
Recommended Dosage:
Standard Dosing: 140 mg once every 2 weeks OR 420 mg once monthly.
HoFH Dosing: 420 mg once monthly.
Missed Dose: If a dose is missed, administer within 7 days and then return to the regular schedule. If >7 days have passed, skip the missed dose and administer on the next scheduled day.
Administration Instructions:
Allow the pre-filled pen or syringe to reach room temperature (30–45 minutes) before use.
Inject into the abdomen, thigh, or upper arm.
3. Mechanism of Action
PCSK9 Inhibition:
Evolocumab binds to proprotein convertase subtilisin/kexin type 9 (PCSK9).
LDLR Recycling:
It prevents PCSK9 from binding to the low-density lipoprotein receptor (LDLR) on the surface of hepatocytes. This inhibits the degradation of LDLR, increasing the number of receptors available to clear LDL-C from the blood.
4. Safety and Warnings
Hypersensitivity Reactions:
Hypersensitivity reactions (e.g., rash, urticaria, angioedema) have been reported. If a severe hypersensitivity reaction occurs, discontinue Evolocumab and initiate appropriate therapy.
Immunogenicity:
Patients may develop anti-drug antibodies (ADAs).
5. Adverse Reactions
Most Common:
Nasopharyngitis, upper respiratory tract infection, influenza, diarrhea, bronchitis, myalgia, and injection site reactions (e.g., erythema, pain, swelling).
6. Drug Interactions
Statins:
Evolocumab does not inhibit CYP450 enzymes. No dose adjustment is required for concomitant use with statins or other common cardiovascular medications.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Evolocumab (recombinant human IgG2 monoclonal antibody).
Appearance: Clear to slightly opalescent, colorless to pale yellow solution.
Storage:
Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.