Source: FDA, National Drug Code (US) Revision Year: 2020
TIBSOVO (ivosidenib) is an inhibitor of isocitrate dehydrogenase 1 (IDH1) enzyme. The chemical name is (2S)N{(1S)1(2-chlorophenyl)2[(3,3-difluorocyclobutyl)-amino]-2-oxoethyl}1(4-cyanopyridin-2-yl)N(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-carboxamide.
The chemical structure is:
The molecular formula is C28H22C1F3N6O3 and the molecular weight is 583.0 g/mol. Ivosidenib is practically insoluble in aqueous solutions between pH 1.2 and 7.4.
TIBSOVO (ivosidenib) is available as a film-coated 250 mg tablet for oral administration. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet coating includes FD&C blue #2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin.
| Dosage Forms and Strengths |
|---|
|
Tablets: 250 mg as a blue oval-shaped film-coated tablet debossed “IVO” on one side and “250” on the other side. |
| How Supplied |
|---|
|
250 mg tablet: Blue oval-shaped film-coated tablet debossed “IVO” on one side and “250” on the other side.
|
| Drug | Countries | |
|---|---|---|
| TIBSOVO | Austria, Cyprus, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Romania, United Kingdom, United States |
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