Praluent Alirocumab 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:
Starting Dose: 75 mg once every 2 weeks.
Dose Adjustment: If LDL-C response is inadequate after 4 to 8 weeks, the dose may be increased to a maximum of 150 mg once every 2 weeks.
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 for 30–40 minutes before use. Do not use if stored at room temperature for more than 24 hours.
Do not shake or heat the solution.
3. Mechanism of Action
PCSK9 Inhibition:
Alirocumab is a monoclonal antibody that binds to proprotein convertase subtilisin/kexin type 9 (PCSK9).
LDLR Recycling:
It inhibits PCSK9 from binding to the low-density lipoprotein receptor (LDLR). This prevents the degradation of LDLR in the liver, thereby increasing the number of LDLRs available to clear LDL-C from the bloodstream.
4. Safety and Warnings
Hypersensitivity Reactions:
Hypersensitivity reactions (e.g., angioedema, urticaria, rash) have been reported. If a severe hypersensitivity reaction occurs, discontinue Alirocumab and initiate appropriate therapy.
Immunogenicity:
Patients may develop anti-drug antibodies (ADAs).
5. Adverse Reactions
Most Common:
Nasopharyngitis, influenza, urinary tract infection, diarrhea, bronchitis, myalgia, and injection site reactions (e.g., erythema, itching, swelling, pain).
6. Drug Interactions
Statins:
Alirocumab does not affect the pharmacokinetics of CYP3A4 or CYP2C9 substrates. No dose adjustment is required for concomitant use with statins (e.g., atorvastatin, rosuvastatin).
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Alirocumab (recombinant human IgG1κ monoclonal antibody).
Appearance: Clear to slightly opalescent, colorless to slightly yellow solution.
Storage:
Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.