VITRAKVI Capsule / Oral solution Ref.[10108] Active ingredients: Larotrectinib

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

Product description

Larotrectinib is a kinase inhibitor. VITRAKVI (larotrectinib) capsules and oral solution are formulated using larotrectinib sulfate. The molecular formula for larotrectinib sulfate is C21H24F2N6O6S and the molecular weight is 526.51 g/mol for the sulfate salt and 428.44 g/mol for the free base.

The chemical name is (3S)N{5-[(2R)2(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl}-3-hydroxy-1-pyrrolidinecarboxamide sulfate.

Larotrectinib sulfate has the following chemical structure:

Larotrectinib sulfate is an off-white to pinkish yellow solid that is not hygroscopic. The aqueous solubility of larotrectinib at 37°C is pH dependent (very soluble at pH 1.0 and freely soluble at pH 6.8, according to USP descriptive terms of solubility).

VITRAKVI (larotrectinib) capsules and oral solution are for oral use. Each capsule contains 25 mg or 100 mg larotrectinib (30.7 mg and 123 mg larotrectinib sulfate, respectively) in a hard gelatin capsule. The capsule is composed of gelatin, titanium dioxide, and edible ink.

The oral solution contains 20 mg/mL larotrectinib (24.6 mg/mL larotrectinib sulfate) and the following inactive ingredients: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol, citric acid, sodium phosphate, sodium citrate dihydrate, propylene glycol and flavoring. Preserved with methylparaben and potassium sorbate.

Dosage Forms and Strengths

Capsules:

  • 25 mg: white opaque hard gelatin capsule, size 2, with blue printing of “BAYER” cross and “25 mg” on body of capsules. 25 mg larotrectinib is equivalent to 30.7 mg larotrectinib sulfate.
  • 100 mg: white opaque hard gelatin capsule, size 0, with blue printing of “BAYER” cross and “100 mg” on body of capsule. 100 mg larotrectinib is equivalent to 123 mg larotrectinib sulfate.

Oral Solution:

  • 20 mg/mL: clear yellow to orange solution. 20 mg/mL larotrectinib is equivalent to 24.6 mg/mL larotrectinib sulfate.
How Supplied

Capsules

25 mg: Hard gelatin opaque white capsule size #2 with blue printing of “BAYER” cross and “25 mg” on the body of the capsule.

  • 60 count bottle NDC# 50419-390-01

100 mg: Hard gelatin opaque white capsule size #0 with blue printing of “BAYER” cross and “100 mg” on the body of the capsule.

  • 60 count bottle NDC# 50419-391-01

Oral Solution

20 mg/mL: Clear yellow to orange solution.

  • 100 mL bottle NDC# 50419-392-01

Drugs

Drug Countries
VITRAKVI Austria, Brazil, Canada, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Turkey, United Kingdom, United States
 
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