Source: FDA, National Drug Code (US) Revision Year: 2020
PIQRAY (alpelisib) is a kinase inhibitor. The chemical name of alpelisib is (2S)N 1[4-Methyl-5-[2-(2,2,2-trifluoro-1,1-dimethylethyl)-4-pyridinyl]-2-thiazolyl]-1,2-pyrrolidinedicarboxamide. Alpelisib is a white to almost white powder. The molecular formula for alpelisib is C19H22F3N5O2S and the relative molecular mass is 441.47 g/mol. The chemical structure of alpelisib is shown below:
PIQRAY film-coated tablets are supplied for oral administration with three strengths that contain 50 mg, 150 mg and 200 mg of alpelisib. The tablets also contain hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. The film-coating contains hypromellose, iron oxide black, iron oxide red, macrogol/polyethylene glycol (PEG) 4000, talc, and titanium dioxide.
| Dosage Forms and Strengths |
|---|
|
Tablets: 50 mg, 150 mg, and 200 mg alpelisib 50 mg: Light pink, unscored, round and curved with beveled edges film-coated tablet, imprinted with “L7” on one side and “NVR” on the other side. 150 mg: Pale red, unscored, ovaloid and curved with beveled edges film-coated tablet, imprinted with “UL7” on one side and “NVR” on the other side. 200 mg: Light red, unscored, ovaloid and curved with beveled edges film-coated tablet, imprinted with “YL7” on one side and “NVR” on the other side. |
| How Supplied |
|---|
|
PIQRAY (alpelisib) 50 mg, 150 mg, and 200 mg film-coated tablets [see Dosage Forms and Strengths (3)]. 300 mg daily dose: Each carton contains 2 blister packs. Each blister pack contains a 14-day supply of 28 tablets (28 tablets, 150 mg alpelisib per tablet). NDC 0078-0708-02 250 mg daily dose: Each carton contains 2 blister packs. Each blister pack contains a 14-day supply of 28 tablets (14 tablets, 200 mg alpelisib per tablet and 14 tablets, 50 mg alpelisib per tablet). NDC 0078-0715-02 200 mg daily dose: Each carton contains 1 blister pack. Each blister pack contains a 28-day supply of 28 tablets (28 tablets, 200 mg alpelisib per tablet). NDC 0078-0701-84 |
| Drug | Countries | |
|---|---|---|
| PIQRAY | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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