BiCNU-100MG (CARMUSTINE FOR INJECTION USP 100MG) & DEHYDRATED ALCOHOL INJECTION USP AS A COMBIPACK

Product Information

Registration Status: Active

BiCNU-100MG (CARMUSTINE FOR INJECTION USP 100MG) & DEHYDRATED ALCOHOL INJECTION USP AS A COMBIPACK is approved to be sold in Singapore with effective from 2018-06-07. It is marketed by ADVAGEN PTE LTD, with the registration number of SIN15502P.

This product contains Carmustine 100 mg/ vial in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for INTRAVENOUS use.

This product is manufactured by Emcure Pharmaceuticals Limited (OSD and Potent Injectables) in INDIA.

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.

Carmustine

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.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank