Description
Indication & Scope
Rapamune® Sirolimus Tablets provides prophylaxis of organ rejection in adult renal transplant patients, applicable for combined immunosuppressive therapy with cyclosporine and glucocorticoids.
- Mechanism: Inhibits mammalian target of rapamycin (mTOR), blocks lymphocyte cytokine signal transduction, suppresses lymphocyte proliferation and immune rejection responses, and inhibits vascular smooth muscle proliferation.
- Drug class: mTOR inhibitor, immunosuppressant, organ transplantation anti-rejection agent.
- Clinical use: Maintenance immunosuppressive therapy for renal transplantation; alternative anti-rejection regimen for patients intolerant to calcineurin inhibitors.
| Generic Name | Sirolimus Tablets |
| Brand Name | Rapamune® |
| Ingredient | Sirolimus |
| Dosage Form | Tablets |
| Package | 1mg*10 tablets/box;
1mg*30 tablets/box |
| Conditions Treated | Renal transplant postoperative immune rejection |
| Taboos | Contraindicated in sirolimus hypersensitivity; prohibited for pregnant and lactating patients; contraindicated in active systemic infection patients |
| Place of origin | Little Connell, Newbridge, Co. Kildare, Ireland |
| Prescription type | Prescription-only |
| Storage Conditions | Store at controlled room temperature 20°C–25°C, sealed and protected from light |
| Manufacturer | Pfizer Ireland Pharmaceuticals |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | HJ20130697; HJ20130698 |
| Approval Date | Jul 24, 2023 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: Initial loading dose: 6 mg single dose; maintenance dose: 2 mg once daily.
Time: Once-daily fixed-time administration, consistently with or without meals.
Instructions for use: Take whole tablet with water; maintain consistent administration state (fed/fasting); monitor blood drug concentration regularly.
Interaction: CYP3A4 inhibitors elevate sirolimus blood concentration; cyclosporine increases drug absorption and toxicity risk.
Side effects:
1. Common reactions include hyperlipidemia, oral ulcer, peripheral edema and acne.
2. Rare reactions include pneumonitis, delayed wound healing and thrombocytopenia.
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, indicatiaon, 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 the main clinical purpose of Sirolimus Tablets for kidney transplant patients?
The drug prevents postoperative organ immune rejection and serves as maintenance immunosuppressive therapy.
What is the standard daily maintenance dosage of Sirolimus Tablets?
The standard daily maintenance dosage is 2 mg administered once daily after initial loading dose.
What index needs regular detection during long-term medication of Sirolimus Tablets?
Regular monitoring of sirolimus blood drug concentration is required to ensure therapeutic safety and efficacy.
What common metabolic abnormality may be induced by Sirolimus Tablets?
Elevated blood lipid levels are the most common metabolic adverse reaction of sirolimus.
Rapamune® | Sirolimus Tablets | Prevention of Immune Rejection in Kidney Transplantation | DengYueRX
INN: Sirolimus Tablets
Indications: Prevention of immune rejection in kidney transplantation
Dosage Form: Tablets
Strength: 1mg/tablet
Original price was: $75.72.$64.36Current price is: $64.36.
Low MOQ
WHO-GMP
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Compliance and Regulatory Documents
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