CABOMETYX FILM COATED TABLET 60MG

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.

Active Ingredient / Synonyms

Cabozantinib | Cabozantinib |

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.

Pharmacodynamics

Cabozantinib suppresses metastasis, angiogenesis, and oncognesis by inhibiting receptor tyrosine kinases.

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:

Cabozantinib is eliminated mostly by the feces (54%) and also by the urine (27%).

Half-life

Cabozantinib has a long half-life of 55 hours.

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.

References

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

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Approval Information

CABOMETYX FILM COATED TABLET 60MG was registered with Health Science Authority of Singapore by IPSEN PHARMA PTE LTD. It is marketed with the registration number of SIN15608P with effective from 2019-01-03.

This product contains 60mg of Cabozantinib in the form of TABLET, FILM COATED.

The medicine was manufactured by Patheon Inc. in CANADA

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: L01XE26

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