Product Information
Registration Status: ActiveSIN15878P
RAPAMUNE TABLET 0.5 mg is approved to be sold in Singapore with effective from 2020-01-20. It is marketed by PFIZER PTE LTD, with the registration number of SIN15878P.
This product contains Sirolimus 0.5 mg in the form of TABLET, SUGAR COATED. It is approved for ORAL use.
This product is manufactured by Pfizer Ireland Pharmaceuticals (Primary and Secondary packager) in IRELAND, Pfizer Manufacturing Deutschland GmbH (Primary and Secondary packager) in GERMANY, and Alkermes Pharma International Ltd. (drug product intermediate - NanoCrystal Dispersion) in IRELAND.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to immunophilins. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.
Indication
For the prophylaxis of organ rejection in patients receiving renal transplants.
Mechanism of Action
Sirolimus inhibits T lymphocyte activation and proliferation that occurs in response to antigenic and cytokine (Interleukin IL-2, IL-4, and IL-15) stimulation by a mechanism that is distinct from that of other immunosuppressants. Sirolimus also inhibits antibody production. In cells, sirolimus binds to the immunophilin, FK Binding Protein-12 (FKBP-12), to generate an immunosuppressive complex. The sirolimus:FKBP-12 complex has no effect on calcineurin activity. This complex binds to and inhibits the activation of the mammalian Target Of Rapamycin (mTOR), a key regulatory kinase. This inhibition suppresses cytokine-driven T-cell proliferation, inhibiting the progression from the G1 to the S phase of the cell cycle.
Active Ingredient/Synonyms
(-)-Rapamycin | Rapamycin | sirolimús | sirolimus | sirolimusum | Sirolimus |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.