Clinical Overview
Sirolimus / Rapamycin Tablets (1mg) is a macrocyclic lactone immunosuppressive agent on the WHO Model List framework. It binds intracellularly to immunophilin FKBP-12, but unlike tacrolimus, the sirolimus-FKBP-12 complex binds to and inhibits the mammalian target of rapamycin (mTOR) kinase complex 1 (mTORC1). This blocks IL-2-stimulated progression from G1 to S phase in T-lymphocytes. Completely non-nephrotoxic compared to calcineurin inhibitors. Indicated for prophylaxis of organ rejection in kidney transplant recipients (often to spare calcineurin inhibitor nephrotoxicity) and treatment of lymphangioleiomyomatosis (LAM).
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
Take orally once daily consistently with or without food, with a glass of water. Therapeutic Drug Monitoring (TDM) of whole blood trough levels (C0) is mandatory (target typically 4-12 ng/mL). Take 4 hours after cyclosporine.
General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.
Possible Side Effects
Common: Hypertriglyceridemia, hypercholesterolemia, peripheral edema, thrombocytopenia, leukopenia, stomatitis/mouth ulcers, impaired wound healing. Rare/Severe: Interstitial pneumonitis / pulmonary toxicity, proteinuria / focal segmental glomerulosclerosis, and hepatic artery thrombosis in liver transplant recipients.
*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.
Precautions & Warnings
Black Box Warning: Increased mortality and graft loss in liver and lung transplant recipients; not recommended for liver or lung transplants. Black Box Warning: Impaired wound healing; do not initiate immediately post-surgery. Regularly monitor lipid panel, CBC, and trough blood levels. Non-nephrotoxic alternative to tacrolimus/cyclosporine.
Schedule H (Prescription Required)
This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.
Medical Disclaimer: Statutory Clinical Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice, oncological diagnosis, or chemotherapy protocol guidance. Cancer therapies require specialized administration under the direct supervision of a registered medical oncologist in an accredited healthcare facility.