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Decreased Renal Function: Pemetrexed is primarily eliminated unchanged by renal excretion. No dosage adjustment is needed in patients with CrCl >45 mL/min. Insufficient numbers of patients have been studied with CrCl <45 mL/min to give a dose recommendation. Therefore, pemetrexed should not be administered to patients whose CrCl <45 mL/min.
One (1) patient with severe renal impairment (CrCl 19 mL/min) who did not receive folic acid and vitamin B12 died of drug-related toxicity following administration of pemetrexed alone.
Use With Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) with Mild to Moderate Renal Insufficiency: Caution should be used when administering ibuprofen concurrently with Pemetrexed to patients with mild to moderate renal insufficiency (CrCl 45-79 mL/min). Other NSAIDs should also be used with caution.
Required Laboratory Monitoring: Patients should not begin a new cycle of treatment unless the ANC is ≥1500 cells/mm3, the platelet count is >100,000 cells/mm3 and CrCl ≥45 mL/min.
Use in pregnancy: Pregnancy Category D: Based on its mechanism of action, pemetrexed can cause fetal harm when administered to a pregnant woman. Pemetrexed administered intraperitoneally to mice during organogenesis was embryotoxic, fetotoxic and teratogenic in mice at >1/833rd the recommended human dose. If pemetrexed is used during pregnancy, or if the patient becomes pregnant while taking Pemxcel, the patients should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Women should be advised to use effective contraceptive measures to prevent pregnancy during treatment with pemetrexed.
