CABOMETYX Film-coated tablet Ref.[6473] Active ingredients: Cabozantinib

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Ipsen Pharma, 70 rue Balard, 75015 Paris, France

Product name and form

CABOMETYX 20 mg film-coated tablets.

CABOMETYX 40 mg film-coated tablets.

CABOMETYX 60 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

CABOMETYX 20 mg film-coated tablets: The tablets are yellow round with no score and debossed with “XL” on one side and “20” on the other side of the tablet.

CABOMETYX 40 mg film-coated tablets: The tablets are yellow triangle shaped with no score and debossed with “XL” on one side and “40” on the other side of the tablet.

CABOMETYX 60 mg film-coated tablets: The tablets are yellow oval shaped with no score and debossed with “XL” on one side and “60” on the other side of the tablet.

Qualitative and quantitative composition

CABOMETYX 20 mg film-coated tablets

Each film-coated tablet contains cabozantinib (S)-malate equivalent to 20 mg cabozantinib.

Excipients with known effect: Each film-coated tablet contains 15.54 mg lactose.

CABOMETYX 40 mg film-coated tablets

Each film-coated tablet contains cabozantinib (S)-malate equivalent to 40 mg cabozantinib.

Excipients with known effect: Each film-coated tablet contains 31.07 mg lactose.

CABOMETYX 60 mg film-coated tablets

Each film-coated tablet contains cabozantinib (S)-malate equivalent to 60 mg cabozantinib.

Excipients with known effect: Each film-coated tablet contains 46.61 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient

Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodeling, drug resistance, and metastatic progression of cancer. Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors. In addition, cabozantinib inhibits other tyrosine kinases including the GAS6 receptor (AXL), RET, ROS1, TYRO3, MER, the stem cell factor receptor (KIT), TRKB, Fms-like tyrosine kinase-3 (FLT3), and TIE-2.

List of Excipients

Tablet content:

Microcrystalline cellulose
Anhydrous lactose
Hydroxypropyl cellulose
Croscarmellose sodium
Colloidal anhydrous silica
Magnesium stearate

Film-coating:

Hypromellose 2910
Titanium dioxide (E171)
Triacetin
Iron oxide yellow (E172)

Pack sizes and marketing

HDPE bottle with a polypropylene child-resistant closure, three silica gel desiccant canisters and polyester coil. Each bottle contains 30 film-coated tablets.

Marketing authorization holder

Ipsen Pharma, 70 rue Balard, 75015 Paris, France

Marketing authorization dates and numbers

Cabometyx 20 mg film-coated tablets: EU/1/16/1136/002

Cabometyx 40 mg film-coated tablets: EU/1/16/1136/004

Cabometyx 60 mg film-coated tablets: EU/1/16/1136/006

Date of first authorisation: 09 September 2016
Date of latest renewal: 21 April 2021

Drugs

Drug Countries
CABOMETYX Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.