(2.2) • Dose Reductions: Dose reductions or discontinuation may be needed based on toxicities from the preceding cycle of therapy. (2.4) ----------------------DO SAGE FORMS AND STRENG THS --------------------- • 100 mg vial for injection (3) • 500 mg vial for injection (3)-------------------------------CONT RAINDICATIO NS------------------------------ History of severe hypersensitivity reaction to pemetrexed. (4) ------------------------ WARNI NGS AND PRE CAUTIONS ----------------------- • Premedication regimen: Instruct patients to take folic acid and vitamin B 12. Pretreatment with dexamethasone or equivalent reduces cutaneous reaction. (5.1) • Bone marrow suppression: Reduce doses for subsequent cycles based on hematologic and nonhematologic toxicities. (5.2) • Renal function: Do not administer when CrCl <45 mL/min. (2.4, 5.3)• NSAIDs with renal insufficiency: Use caution in patients with mild to moderate renal insufficiency (CrCl 45-79 mL/min). (5.4) • Lab monitoring: Do not begin next cycle unless ANC ≥1500 c ells/mm 3, platelets ≥100,000 cells/mm3, and CrCl ≥45 mL/min. (5.5) • Pregnancy: Fetal harm can occur when administered to a pregnant woman. Women should be advised to use effective contraception measures to prevent pregnancy during treatment with ALIMTA. (5.6) -------------------------------ADVE RSE REACT IONS ------------------------------ The most common adverse reactions (incidence ≥20%) with single-agent use are fatigue, nausea, and anorexia. Additional common adverse reactions when used in combination with cisplatin include vomiting, neutropenia, leukopenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-L illyRx (1-800-545- 5979) or FDA at 1- 800-FDA-1088 or www.fda.gov/medwatch. ------------------------------- DRU G INTERACT IONS ------------------------------ • NSAIDs: Use caution with NSAIDs.