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CABOMETYX Film-coated tablet (2020)

Active ingredients: Cabozantinib

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.

Chemical substance
Description
Cabozantinib

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

PVC/PCTFE blister with push-through aluminum foil backing containing 7 film-coated tablets. Each carton contains 4 blisters with 28 film-coated tablets.

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

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Ipsen Pharma, 65 quai Georges Gorse, 92100, Boulogne-Billancourt, France

Date of first authorisation: 09 September 2016

Marketing authorization number:

Cabometyx 20 mg film-coated tablets:

EU/1/16/1136/001

EU/1/16/1136/002

Cabometyx 40 mg film-coated tablets:

EU/1/16/1136/003

EU/1/16/1136/004

Cabometyx 60 mg film-coated tablets:

EU/1/16/1136/005

EU/1/16/1136/006