RECENT MAJOR CHANGES

INDICATIONS AND USAGE

ALIMTA® is a folate analog metabolic inhibitor indicated for:

• Nonsquamous Non-Small Cell Lung Cancer: initial treatment in combination with cisplatin. (1.1)
• Nonsquamous Non-Small Cell Lung Cancer as a single-agent after prior chemotherapy (1.2)
• Mesothelioma: in combination with cisplatin (1.3)

DOSAGE AND ADMINISTRATION

• Combination use in Non-Small Cell Lung Cancer and Mesothelioma: Recommended dose of ALIMTA is 500 mg/m2 i.v. on Day 1 of each 21-day cycle in combination with cisplatin 75 mg/m2 i.v. beginning 30 minutes after ALIMTA administration. (2.1)
• Single-Agent use in Non-Small Cell Lung Cancer: Recommended dose of ALIMTA is 500 mg/m2 i.v. on Day 1 of each 21-day cycle. (2.2)
• Dose Reductions: Dose reductions or discontinuation may be needed based on toxicities from the preceding cycle of therapy. (2.4)

DOSAGE FORMS AND STRENGTHS

• 100 mg vial for injection (3)
• 500 mg vial for injection (3)

CONTRAINDICATIONS

History of severe hypersensitivity reaction to pemetrexed. (4)

WARNINGS AND PRECAUTIONS

• Premedication regimen: Instruct patients to take folic acid and vitamin B12. 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 cells/mm3, platelets ≥100,000 cells/mm3, and CrCl ≥45 mL/min. (