Label Changes for:
Zinecard (dexrazoxane) for injection
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2012
- Secondary malignancies such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) have been reported in studies of pediatric patients who have received Zinecardin combination with chemotherapy. Zinecard is not indicated for use in pediatric patients. Some adult patients who received Zinecard in combination with anti-cancer agents known to be carcinogenic have also developed secondary malignancies, including AML and MDS.
- Razoxane is the racemic mixture, of which dexrazoxane is the S(+)-enantiomer. Secondary malignancies (primarily acute myeloid leukemia) have been reported in patients treated chronically with oral razoxane. In these patients, the total cumulative dose of razoxane ranged from 26 to 480 grams and the duration of treatment was from 42 to 319 weeks. One case of T-cell lymphoma, one case of B-cell lymphoma, and six to eight cases of cutaneous basal cell or squamous cell carcinoma have also been reported in patients treated with razoxane.
Use in Pregnancy
- Zinecard can cause fetal harm when administered to pregnant women. There is no adequate information about the use of Zinecard in pregnant women. In animal studies in rats and rabbits, dexrazoxane administration during the period of organogenesis was embryotoxic and teratogenic at doses significantly lower than the clinically recommended dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
- It is not known whether dexrazoxane 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 dexrazoxane, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.