PEMAZYRE Tablet Ref.[10156] Active ingredients: Pemigatinib

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

Product description

Pemigatinib is a kinase inhibitor with the chemical name 3-(2,6-difluoro-3,5-dimethoxyphenyl)-1-ethyl-8-(morpholin-4-ylmethyl)-1,3,4,7-tetrahydro-2Hpyrrolo[3',2':5,6]pyrido[4,3d]pyrimidin-2-one. Pemigatinib has a molecular formula of C24H27F2N5O4 and molecular mass of 487.5 g/mole.

Pemigatinib has the following chemical structure:

Pemigatinib is a white to off-white solid that is not hygroscopic. The solubility of pemigatinib is pH dependent with decreasing solubility observed with increasing pH. PEMAZYRE tablets are uncoated and for oral administration. Tablets are available containing 4.5 mg, 9 mg, or 13.5 mg of pemigatinib active ingredient. The inactive ingredients include magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

Dosage Forms and Strengths

Tablets:

  • 4.5 mg: round, white to off-white tablet debossed on one side with “I” and “4.5” on the other side.
  • 9 mg: oval, white to off-white tablet debossed on one side with “I” and “9” on the other side.
  • 13.5 mg: round, white to off-white tablet debossed on one side with “I” and “13.5” on the other side.
How Supplied

PEMAZYRE tablets are available as follows:

  • 4.5 mg: Round, white to off-white debossed on one side with “I” and “4.5” on the other side in bottles of 14 with child-resistant closure, NDC 50881-026-01
  • 9 mg: Oval, white to off-white debossed on one side with “I” and “9” on the other side in bottles of 14 with child-resistant closure, NDC 50881-027-01
  • 13.5 mg: Round, white to off-white debossed on one side with “I” and “13.5” on the other side in bottles of 14 with child-resistant closure, NDC 50881-028-01

Drugs

Drug Countries
PEMAZYRE Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Poland, United Kingdom, United States
 
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