AYVAKIT Film-coated tablet Ref.[9993] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Avapritinib is a kinase inhibitor with the chemical name (S)1(4-fluorophenyl)1(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazin-yl)pyrimidin-5-yl)ethan-1-amine. The molecular formula is C26H27FN10, and the molecular weight is 498.57 g/mol.

Avapritinib has the following chemical structure:

The solubility of avapritinib in 0.1N HCl (pH 1.0) and buffer solutions at pH 2.5, 4.0, and 7.0 (at 25°C) is 3.6 mg/mL, 0.14 mg/mL, 0.07 mg/mL and <0.001 mg/mL respectively, indicating a decrease in solubility with increasing pH.

AYVAKIT (avapritinib) film-coated tablets for oral use are supplied with three strengths that contain 100 mg, 200 mg or 300 mg of avapritinib. The tablets also contain inactive ingredients: copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The blue printing ink contains ammonium hydroxide, black iron oxide, esterified shellac, FD&C blue 1, isopropyl alcohol, n-butyl alcohol, propylene glycol, and titanium dioxide.

Dosage Forms and Strengths

Tablets:

  • 100 mg, round, white film-coated, printed with blue ink “BLU” on one side and “100” on the other side.
  • 200 mg, capsule shaped, white film-coated, printed with blue ink “BLU” on one side and “200” on the other side.
  • 300 mg, capsule shaped, white film-coated, printed with blue ink “BLU” on one side and “300” on the other side.
How Supplied

AYVAKIT (avapritinib) tablets are supplied as follows:

  • 100 mg, round, white film-coated tablet, printed with blue ink “BLU” on one side and “100” on the other side; available in bottles of 30 tablets (NDC 72064-110-30).
  • 200 mg, capsule shaped, white film-coated tablet, printed with blue ink “BLU” on one side and “200” on the other side; available in bottles of 30 tablets (NDC 72064-120-30).
  • 300 mg, capsule shaped, white film-coated tablet, printed with blue ink “BLU” on one side and “300” on the other side; available in bottles of 30 tablets (NDC 72064-130-30).

Drugs

Drug Countries
AYVAKIT United States

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