Product Information
Registration Status: ActiveGLIADEL WAFER is approved to be sold in Singapore with effective from 2007-08-31. It is marketed by BIOPRO PHARMACEUTICAL (SINGAPORE) PTE LTD, with the registration number of SIN13348P.
This product contains Carmustine 7.7mg in the form of IMPLANT. It is approved for INTRALESIONAL use.
This product is manufactured by EISAI INC in UNITED STATES.
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.
Description
A cell-cycle phase nonspecific alkylating antineoplastic agent. It is used in the treatment of brain tumors and various other malignant neoplasms. (From Martindale, The Extra Pharmacopoeia, 30th ed, p462) This substance may reasonably be anticipated to be a carcinogen according to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985). (From Merck Index, 11th ed)
Indication
For the treatment of brain tumors, multiple myeloma, Hodgkin's disease and Non-Hodgkin's lymphomas.
Mechanism of Action
Carmustine causes cross-links in DNA and RNA, leading to the inhibition of DNA synthesis, RNA production and RNA translation (protein synthesis). Carmustine also binds to and modifies (carbamoylates) glutathione reductase. This leads to cell death.
Pharmacokinetics
- Absorption
- 5 to 28% bioavailability
- Distribution
- Metabolism
- Hepatic and rapid with active metabolites. Metabolites may persist in the plasma for several days.
- Elimination
Toxicity
The oral LD50s in rat and mouse are 20 mg/kg and 45 mg/kg, respectively. Side effects include leukopenia, thrombocytopenia, nausea. Toxic effects include pulmonary fibrosis (20-0%) and bone marrow toxicity.
Active Ingredient/Synonyms
BCNU | Bicnu (tn) | bis-chloroethylnitrosourea | Bischloroethyl nitrosourea | Carmustina | Carmustine | Carmustinum | N,N'-Bis(2-chloroethyl)-N-nitrosourea | Carmustine |
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.