Source: FDA, National Drug Code (US) Revision Year: 2019
COPIKTRA (duvelisib) is a dual inhibitor of phosphatidylinositol 3-kinases PI3K-δ and PI3K-γ.
Duvelisib is a white-to-off-white crystalline solid with the empirical formula C22H17ClN6O•H2O and a molecular weight of 434.88 g/mol. Hydration can vary with relative humidity. Duvelisib contains a single chiral center as (S) enantiomer. Duvelisib is soluble in ethanol and practically insoluble in water. Duvelisib is described chemically as a hydrate of (S)3(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one and has the following chemical structure:
COPIKTRA capsules are for oral administration and are supplied as white to off-white opaque and Swedish orange opaque capsules (25 mg, on anhydrous basis) or pink opaque capsules (15 mg, on anhydrous basis), and contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Capsule shells contain gelatin, titanium dioxide, black ink, and red iron oxide.
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COPIKTRA (duvelisib) capsules are supplied as follows:
Abbreviations: HDPE = high-density polyethylene; NDC = National Drug Code; no. = number |
| Drug | Countries | |
|---|---|---|
| COPIKTRA | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United States |
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