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Alimta

pemetrexed
Antifolate Antimetabolite Eli Lilly FDA Approved 2004
Indications Dosing Forms Contraindications Warnings Adverse Reactions Pharmacology Clinical Studies Tumor Types
1. Indications and Usage

Non-squamous non-small cell lung cancer — initial treatment in combination with cisplatin (locally advanced or metastatic); maintenance treatment after 4 cycles of non-pemetrexed platinum-based chemotherapy; single agent after prior chemotherapy; Malignant pleural mesothelioma — in combination with cisplatin (unresectable or non-surgical candidates).

2. Dosage and Administration

500 mg/m² IV over 10 minutes on Day 1 of each 21-day cycle
Supplementation required: Folic acid 400-1000 mcg PO daily starting 7 days before first dose, continued throughout and 21 days after last dose; Vitamin B12 1000 mcg IM within 1-3 weeks before first dose, then every 3 cycles
Pre-medication: Dexamethasone 4 mg PO BID day before, day of, and day after to reduce skin reactions
Renal: D/C if CrCl <45 mL/min

3. Dosage Forms and Strengths

Injection: 100 mg, 500 mg lyophilized powder for reconstitution

4. Contraindications

CrCl <45 mL/min.

5. Warnings and Precautions
  • Myelosuppression: Dose-limiting. Grade 3-4 neutropenia (15%), anemia (5%), thrombocytopenia (4%). Folic acid and B12 supplementation significantly reduce toxicity.
  • Renal Toxicity: Can cause renal failure. Monitor CrCl before each dose. Avoid NSAIDs in patients with CrCl 45-79 for 2 days before, day of, and 2 days after.
  • Bullous/Exfoliative Dermatitis: Fatal cases reported. Pre-medicate with corticosteroids.
  • ILD/Pneumonitis: Interrupt and evaluate for new respiratory symptoms.
6. Adverse Reactions
Most Common Adverse Reactions

Nausea (31%), fatigue (25%), anorexia (22%), vomiting (16%), neutropenia (15%), stomatitis (15%), constipation (11%), rash (10%), diarrhea (13%), pharyngitis (9%)

Nausea
31%
Fatigue
25%
Anorexia
22%
Vomiting
16%
Neutropenia
15%
Stomatitis
15%
Diarrhea
13%
Constipation
11%
Rash
10%
Pharyngitis
9%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

12. Clinical Pharmacology
Mechanism of Action

Pemetrexed is a multi-targeted antifolate that inhibits thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT) — all folate-dependent enzymes involved in the de novo biosynthesis of thymidine and purine nucleotides. Inhibition of these enzymes leads to depletion of nucleotide precursors required for DNA and RNA synthesis, causing cell death. It is polyglutamated intracellularly by folylpolyglutamate synthetase, which increases its intracellular retention and potency.

Pharmacokinetics

Half-life: 3.5 hours. Protein binding: ~81%. Not significantly metabolized. Primarily excreted unchanged in urine (70-90% within 24 hours). Clearance: 91.8 mL/min. Vd: 16.1 L. Clearance correlated with CrCl.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
Approved Tumor Types
External Resources