Pemetrexed Disodium

Pemetrexed for Injection, USP is a white to either light-yellow or green-yellow lyophilized solid or powder available in sterile single-dose clear glass vials for reconstitution, containing 100 mg or 500 mg pemetrexed.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Myelosuppression
  [see Warnings and Precautions (5.1)]
• Renal failure
  [see Warnings and Precautions (5.2)]
• Bullous and exfoliative skin toxicity
  [see Warning and Precautions (5.3)]
• Interstitial pneumonitis
  [see Warnings and Precautions (5.4)]
• Radiation recall
  [see Warnings and Precautions (5.5)]

Ibuprofen increases exposure (AUC) of pemetrexed

• Avoid administration of ibuprofen for 2 days before, the day of and 2 days following administration of pemetrexed
  [see Dosage and Administration (2.5)]
  .
• Monitor patients more frequently for myelosuppression, renal and gastrointestinal toxicity, if concomitant administration of ibuprofen cannot be avoided.

Pemetrexed for injection is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium is a white to off-white color powder, has the chemical name N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo [2,3-d] pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium hemi pentahydrate with a molecular formula of C₂₀H₁₉N₅Na₂O₆•2.5H₂O and a molecular weight of 516.37. The structural formula is as follows:

Pemetrexed for injection, USP is a sterile white to either light-yellow or green-yellow lyophilized solid or powder in single-dose vials to be reconstituted for intravenous infusion. Each 100 mg vial of pemetrexed for injection, USP contains 100 mg pemetrexed (equivalent to 120.8 mg pemetrexed disodium hemipentahydrate) and 106 mg mannitol. Each 500 mg vial of pemetrexed for injection, USP contains 500 mg pemetrexed (equivalent to 604.1 mg pemetrexed disodium hemipentahydrate) and 500 mg mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH.

Pemetrexed is a folate analog metabolic inhibitor that disrupts folate-dependent metabolic processes essential for cell replication.