REVTORPYK Powder for solution for injection Ref.[116743] Active ingredients: Gedatolisib

Source: FDA, National Drug Code (US)  Revision Year: 2026 

Product description

REVTORPYK for injection contains gedatolisib, a kinase inhibitor. The chemical name of gedatolisib is 1-[4-(4-dimethylaminopiperidine-1-carbonyl)phenyl]-3-[4-(4,6-dimorpholin-4-yl-[1,3,5]triazin2-yl)phenyl]urea. The molecular formula for gedatolisib is C32H41N9O4 and the molecular weight is 615.74 g/mol. Gedatolisib is a white to off-white crystalline solid that is insoluble in water. The chemical structure of gedatolisib is shown below:

REVTORPYK for injection is a sterile, preservative-free, lyophilized white to off-white cake or powder with cake supplied in a single-dose vial. Each vial delivers 180 mg of gedatolisib. The lyophilized powder also contains 720 mg of hydroxypropyl β cyclodextrin and 48.6 mg of lactic acid and may include hydrochloric acid and/or sodium hydroxide for pH adjustment.

Dosage Forms and Strengths

REVTORPYK is supplied as a sterile, white to off-white lyophilized powder for injection containing 180 mg gedatolisib in a single-dose vial for reconstitution and further dilution.

How Supplied

REVTORPYK for injection is a white to off-white lyophilized powder supplied as:

Carton ContentNDC
One 180 mg single-dose vialNDC 84577-751-01

Drugs

Drug Countries
REVTORPYK United States

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