FDA Updates Safety Info for Topotecan Hydrochloride

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The FDA has updated the safety labeling for Hycamtin injection by adding a boxed warning for severe myelosuppression.
The FDA has updated the safety labeling for Hycamtin injection by adding a boxed warning for severe myelosuppression.

The U.S. Food and Drug Administration (FDA) has updated the safety labeling for topotecan hydrochloride (Hycamtin) injection by adding a boxed warning for severe bone marrow suppression.

The label change now states that "Hycamtin can cause severe myelosuppression." The drug should only be administered to patients with baseline neutrophil counts greater than or equal to 1,500 cells/mm3 and platelet counts greater than or equal to 100,000 cells/mm3.

The warning advises clinicians to monitor blood cell counts.

Previous labeling for topotecan included a warning that pancytopenia has been reported in patients being treated with topotecan.

RELATED: FDA Approves Gefitinib as First-Line Treatment for EGFR+ Metastatic NSCLC

Topotecan for injection was initially approved by the FDA, but this boxed warning added in June 2015 is the first for the drug.

Topotecan for injection is a topoisomerase inhibitor indicated for the treatment of patients with metastatic ovarian cancer, small cell lung cancer, and advanced, recurrent, or persistent cervical cancer.

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