Mesothelioma TreatmentMesothelioma Alerts
FDA Safety Changes: Pemetrexed Injection (Alimta)
November 3, 2006 — The US Food and Drug Administration (FDA) has approved drug safety labeling revisions to advise of the potential for dose-limiting myelosuppression in patients receiving treatment with pemetrexed injection.
Pemetrexed Injection (Alimta) Linked to Dose-Limiting Myelosuppression
On July 28, the FDA approved safety labeling revisions for pemetrexed injection (Alimta, made by Eli Lilly and Company) to warn of the risk for myelosuppression associated with its use. Bone marrow suppression is usually the dose-limiting toxicity, as manifested by neutropenia, thrombocytopenia, and anemia (or pancytopenia).
The FDA advises that dose reductions for subsequent cycles be based on nadir absolute neutrophil count, platelet count, and maximum nonhematologic toxicity observed during the previous cycle.
Pemetrexed injection is indicated for use with cisplatin in the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery; it is also indicated as a single agent for the treatment of patients with locally advanced or metastatic non–small cell lung cancer after prior chemotherapy.
