COPIKTRA Capsule Ref.[10038] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

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.

Dosage Forms and Strengths
StrengthDescription
25 mgWhite to off-white opaque and Swedish orange opaque capsule printed in black ink with “duv 25 mg”
15 mgPink opaque capsule printed in black ink with “duv 15 mg”
How Supplied

COPIKTRA (duvelisib) capsules are supplied as follows:

Capsule StrengthDescriptionPackage ConfigurationNDC No.
25 mg White to off-white and
Swedish orange opaque
capsules marked with "duv
25 mg" in black ink
• 14-day (28ct) single blister pack
• 14-day (28ct) carton (1 × 28ct
blister pack per carton)
• 28-day (56ct) carton (2 × 28ct
blister packs per carton)
• 28-day (56ct) HDPE bottles
• 71779-125-04
• 71779-125-03
• 71779-125-02
• 71779-125-01
15 mg Pink opaque capsules
marked with “duv 15 mg” in black ink
• 14-day (28ct) single blister pack
• 28-day (56ct) carton (2 × 28ct
blister packs per carton)
• 56-count HDPE bottles
• 71779-115-03
• 71779-115-02
• 71779-115-01

Abbreviations: HDPE = high-density polyethylene; NDC = National Drug Code; no. = number

Drugs

Drug Countries
COPIKTRA Estonia, Ireland, Lithuania, Poland, United States

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