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U.S. Department of Health and Human Services

Safety

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Alimta (pemetrexed for injection) lyophilized powder, for solution for, intravenous use

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Requirement for Premedication and Concomitant Medication to Reduce Toxicity
  • Vitamin Supplementation: Prior to treatment with Alimta, initiate supplementation with oral folic acid and intramuscular vitamin B12 to reduce the severity of hematologic and gastrointestinal toxicity of Alimta. Do not substitute oral vitamin B12 for intramuscular vitamin B12. In clinical studies, the incidence of the following Grade 3-4 toxicities were higher in patients with mesothelioma who were never supplemented as compared to patients who were fully supplemented with folic acid and vitamin B12 prior to and throughout Alimta treatment: neutropenia [38% versus 23%], thrombocytopenia [9%versus 5%], febrile neutropenia [9% versus 0.6%], and infection with neutropenia [6% versus. 0].
  • Corticosteroids: Administer dexamethasone the day before, the day of, and the day after Alimta administration
 
Required Laboratory Monitoring
  • Obtain a complete blood count and renal function tests at the beginning of each cycle and as needed. Do not initiate a cycle of treatment unless the ANC is 1500 cells/mm3, the platelet count is 100,000 cells/mm3, and creatinine clearance is 45 mL/min
 

USE IN SPECIFIC POPULATIONS

Patients with Hepatic Impairment
  • There was no effect of elevated AST, ALT, or total bilirubin on the pharmacokinetics of pemetrexed. However, no formal studies have been conducted to examine the pharmacokinetics of pemetrexed in patients with hepatic impairment

 

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