Product Information
Registration Status: ActiveCABOMETYX FILM COATED TABLET 20MG is approved to be sold in Singapore with effective from 2019-01-03. It is marketed by IPSEN PHARMA PTE LTD, with the registration number of SIN15606P.
This product contains Cabozantinib 20mg in the form of TABLET, FILM COATED. It is approved for ORAL use.
This product is manufactured by Patheon Inc. in CANADA.
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
Cabozantinib was approved in 2012 and is a non-specific tyrosine kinase inhibitor. It is marketed as Cometriq, which is indicated for the treatment of metastatic medullary thyroid cancer. It's label includes a black box warning of gastrointestinal perforations, fistulas, and hemorrhage. The FDA approved cabozantinib as Cabometyx for patients with advanced renal cell carcinoma in April 2016.
Indication
For the treatment of metastatic medullary thyroid cancer and for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
Mechanism of Action
Cabozantinib inhibits specific receptor tyrosine kinases such as VEGFR-1, -2 and -3, KIT, TRKB, FLT-3, AXL, RET, MET, and TIE-2.
Pharmacokinetics
- Absorption
- After oral administration, peak plasma concentration was achieved in 2-5 hours.
- Distribution
- The volume of distribution is 349L.
- Metabolism
- Cabozantinib is metabolized mostly by CYP3A4 and, to a minor extent, by CYP2C9. Both enzyme produce an N-oxide metabolite.
- Elimination
Clearance
At steady state, the clearance is 4.4 L/hr.
Toxicity
Cabozantinib has a black box warning of serious gastrointestinal fistulas and perforations, and potentially fatal hemoptysis and gastrointestinal hemorrhage.
Active Ingredient/Synonyms
Cabozantinib | Cabozantinib |
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.