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The study was modified after randomization and treatment of 117 patients to require that all patients receive folic acid 350 mcg to 1,000 mcg daily beginning 1 to 3 weeks prior to the first dose of pemetrexed and continuing until 1 to 3 weeks after the last dose, vitamin B 12 1,000 mcg intramuscularly 1 to 3 weeks prior to first dose of pemetrexed and every 9 weeks thereafter, and dexamethasone 4 mg orally, twice daily, for 3 days starting the day prior to each pemetrexed dose

This allows for greater flexibility in dosing or combinations, which may not be available with the standard commercial formulation

Quality Standards: COA and Purity A four-peptide blend raises the bar for verification

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