Vitrakvi Description

Dosage Forms, Strengths, Composition and Packaging: See Table 1.

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VITRAKVI (larotrectinib) is supplied as white opaque hard gelatin capsules containing 25 mg and 100 mg of larotrectinib and as oral solution containing 20 mg/mL of larotrectinib.
Capsules: The 25 mg capsules are white opaque hard gelatin capsules (size 2) with blue printing of "BAYER" cross and "25 mg" on the body of capsule. They are supplied in 75 mL bottles of 56 capsules.
The 100 mg capsules are white opaque hard gelatin capsules (size 0) with blue printing of "BAYER" cross and "100 mg" on the body of capsule. They are supplied in 120 mL bottles of 56 capsules.
Oral Solution: The 20 mg/mL oral solution is a colourless to yellow or orange or red or brownish liquid solution of strawberry flavour supplied in brown glass bottles of 50 mLs. Each carton contains two bottles.
Pharmaceutical Information: Common name: larotrectinib sulfate.
Chemical name: (3S)-N-{5-[(2R)-2-(2,5-Difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate.
Molecular formula: C₂₁H₂₄F₂N₆O₆S.
Molecular mass: 526.51 g/mol.
Physicochemical properties: Larotrectinib is a crystalline sulfate salt, appearing as an off-white to yellow to pinkish yellow solid. The solubility of larotrectinib sulfate is pH dependent, having > 10 mg/mL solubility below pH 1.5, ~ 2-3 mg/mL solubility at pH 2.5, and dropping to ~ 1 mg/mL above pH 3.5. Larotrectinib sulfate has only been observed as a single polymorph.