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U.S. Department of Health and Human Services

Drugs

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FDA Statement on Dexrazoxane

[07-20-2011]

The United States Food and Drug Administration (FDA) is informing the public that on June 23, 2011, the European Medicines Agency (EMA) announced that they will restrict the use of dexrazoxane injection to adult patients with advanced or metastatic breast cancer who have already received a certain amount of the anthracyclines doxorubicin (300 mg/m2) or epirubicin (540 mg/m2).

Dexrazoxane was previously approved in Europe for use in patients to prevent long-term cardiotoxicity caused by either doxorubicin or epirubicin. The EMA based their revised indication on clinical trials that reported cases of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in children receiving dexrazoxane in combination with other drugs known to be associated with secondary leukemias.1,2 Three cases of AML in adult patients with breast cancer receiving dexrazoxane in France have been reported.

The EMA’s revised indication is consistent with the current FDA-approved drug label for dexrazoxane.

In the United States, dexrazoxane is approved to reduce the incidence or severity of cardiomyopathy (heart damage) associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative dose of 300 mg/m2 and who will continue to receive doxorubicin to maintain tumor control. Dexrazoxane is not recommended for use in women who are initiating treatment with doxorubicin. Dexrazoxane is also approved to decrease damage caused by anthracycline-based chemotherapy extravasation (inadvertent exposure to skin and subcutaneous tissues). Dexrazoxane is not approved in the United States for use in pediatric patients. 

Healthcare professionals who prescribe dexrazoxane for adult patients with breast cancer should follow the recommendations in the drug label. Healthcare professionals who treat pediatric oncology patients with dexrazoxane should be aware that such use is “off-label” and should consider the potential risk of AML and MDS with dexrazoxane use in children.

Patients and caregivers should discuss any questions or concerns about dexrazoxane with their healthcare professional.
 

References

1. Tebbi CK, London WB, Friedman D, Villaluna D, De Alarcon PA, Constine LS, et al. Dexrazoxane-associated risk for acute myeloid leukemia/myelodysplastic syndrome and other secondary malignancies in pediatric Hodgkin's disease. J Clin Oncol. 2007; 25:493-500.

2. Salzer WL, Devidas M, Carroll WL, Winick N, Pullen J, Hunger SP, et al. Long-term results of the pediatric oncology group studies for childhood acute lymphoblastic leukemia 1984-2001: a report from the children's oncology group. Leukemia. 2010;24:355-70.