Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
BOXED WARNING (edited)
BONE MARROW SUPPRESSION
- HYCAMTIN can cause severe myelosuppression. Administer only to patients with baseline neutrophil counts of greater than or equal to 1,500 cells/mm3 and platelet counts greater than or equal to 100,000 cells/mm3. Monitor blood cell counts.
WARNINGS and PRECAUTIONS
Bone Marrow Suppression
- Neutropenia: pancytopenia has been reported.
- Pregnancy Category D
- Hycamtin can cause fetal harm when administered to a pregnant woman. Topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis. There are no adequate and well controlled studies of Hycamtin in pregnant women. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving Hycamtin, the patient should be apprised of the potential hazard to the fetus.
USE IN SPECIFIC POPULATIONS
- Rats excrete high concentrations of topotecan into milk. Lactating female rats given 4.72 mg/m2 IV (about twice the clinical dose on a mg/m2 basis) excreted topotecan into milk at concentrations up to 48-fold higher than those in plasma. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Hycamtin, discontinue breastfeeding when women are receiving Hycamtin.
Postmarketing Reports of Adverse Reactions
- Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Hycamtin