Description
Indication & Scope
Praluent® is a prescription PCSK9 inhibitor indicated, in combination with diet and other lipid-lowering therapies, for adults with primary hypercholesterolemia or mixed dyslipidemia to reduce LDL cholesterol when statins alone are insufficient or not tolerated. It is also indicated to reduce the risk of myocardial infarction, ischemic stroke, and unstable angina requiring hospitalization in adults with established atherosclerotic cardiovascular disease (ASCVD). In addition, it is approved for lipid-lowering treatment in patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
- Mechanism: Alirocumab is a fully human monoclonal antibody that binds PCSK9, preventing PCSK9-mediated degradation of LDL receptors and increasing hepatic clearance of LDL cholesterol.
- Drug class: PCSK9 inhibitor (human monoclonal antibody).
- Clinical use: Treatment of primary hypercholesterolemia, mixed dyslipidemia, heterozygous familial hypercholesterolemia, and reduction of cardiovascular risk in patients with ASCVD.
| Generic Name | Alirocumab Injection |
| Brand Name | Praluent® |
| Ingredient | Alirocumab |
| Dosage Form | Prefilled Pen |
| Package | 1.0 ml: 75 mg/pen/carton |
| Conditions Treated | Primary hypercholesterolemia, mixed dyslipidemia, heterozygous familial hypercholesterolemia, atherosclerotic cardiovascular disease |
| Taboos | Hypersensitivity to alirocumab or any component of the product |
| Place of origin | France; Ireland |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store refrigerated at 2–8°C, protected from light. Do not freeze. May be stored at ≤25°C for up to 30 days before use. |
| Manufacturer | SANOFI WINTHROP INDUSTRIE; Genzyme Ireland Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval Number | SJ20190042 |
| Approval Date | May 29, 2024 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: The recommended starting dose is 75 mg by subcutaneous injection every 2 weeks. If additional LDL-C reduction is needed, the dose may be increased to 150 mg every 2 weeks.
Time: Allow the prefilled pen to reach room temperature for 30–40 minutes before injection.
Instructions for use: Inject subcutaneously into the abdomen, thigh, or upper arm. Rotate injection sites and continue a cholesterol-lowering diet throughout treatment.
Interaction: No clinically significant CYP-mediated drug interactions are known. Praluent® may be used with statins, ezetimibe, fibrates, and other cardiovascular medicines.
Side effects: Common adverse reactions include injection-site reactions, nasopharyngitis, upper respiratory tract infection, influenza, myalgia, arthralgia, and headache. Rare serious hypersensitivity reactions have been reported.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is Praluent® used for?
It is used to lower LDL cholesterol and reduce the risk of major cardiovascular events in patients with ASCVD.
How is Praluent® administered?
It is administered by subcutaneous injection every 2 weeks using a prefilled pen.
Can Praluent® be used with statins?
Yes. It is commonly used together with statins or other lipid-lowering therapies, or alone in patients who cannot tolerate statins.
What are the common side effects?
Injection-site reactions, upper respiratory tract infection, influenza-like symptoms, muscle pain, joint pain, and headache.
Praluent® | Alirocumab | High Cholesterol | DengYueRX
INN: Alirocumab
Indications: Hypercholesterolemia
Dosage Form: Prefilled Pen
Strength: 1.0 mL: 75 mg/Pen
Original price was: $73.29.$62.29Current price is: $62.29.
