Source: FDA, National Drug Code (US) Revision Year: 2020
COMETRIQ is the (S)-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib (S)malate is described chemically as N(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)N'(4-fluorophenyl)cyclopropane- 1,1-dicarboxamide, (2S)-hydroxybutanedioate. The molecular formula is C28H24FN3O5âĒC4H6O5 and the molecular weight is 635.6 Daltons as malate salt.
The chemical structure of cabozantinib (S)-malate salt is:
Cabozantinib (S)-malate salt is a white to off-white solid that is practically insoluble in aqueous media.
COMETRIQ (cabozantinib) capsules for oral use are supplied as printed hard gelatin capsules containing cabozantinib (S)-malate equivalent to 20 mg or 80 mg cabozantinib and the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate, fumed silica, and stearic acid.
The grey gelatin capsule shells contain black iron oxide and titanium dioxide and the Swedish orange gelatin capsule shells contain red iron oxide, and titanium dioxide. The printing ink contains shellac glaze, black iron oxide, N-butyl alcohol, isopropyl alcohol, propylene glycol, and ammonium hydroxide.
| Dosage Forms and Strengths |
|---|
|
Capsules: 20-mg gelatin capsules, grey with “XL184 20mg” printed in black on the body of the capsule. 80-mg gelatin capsules, Swedish orange with “XL184 80mg” printed in black on the body of the capsule. |
| How Supplied |
|---|
|
COMETRIQ 20 mg capsules are supplied as hard gelatin capsules with grey cap and grey body, printed with “XL184 20mg” in black ink and containing cabozantinib (S)-malate salt equivalent to 20 mg cabozantinib. COMETRIQ 80 mg capsules are supplied as hard gelatin capsules with Swedish orange cap and Swedish orange body, printed with “XL184 80mg” in black ink and containing cabozantinib (S)- malate salt equivalent to 80 mg cabozantinib. COMETRIQ capsules are supplied as follows: Cartons
Manufactured for Exelixis, Inc. Alameda, CA 94502 |
| Drug | Countries | |
|---|---|---|
| COMETRIQ | Austria, Estonia, Finland, Croatia, Ireland, Lithuania, Netherlands, Poland, United Kingdom, United States |
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