Dexrazoxane

Dexrazoxane for Injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy. Dexrazoxane for Injection is a cytoprotective agent indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use Dexrazoxane for Injection with doxorubicin initiation.

The mechanism by which Dexrazoxane for Injection exerts its cytoprotective activity is not fully understood. Dexrazoxane is a cyclic derivative of EDTA that penetrates cell membranes. Results of laboratory studies suggest that dexrazoxane is converted intracellularly to a ring-opened chelating agent that interferes with iron-mediated free radical generation thought to be responsible, in part, for anthracycline-induced cardiomyopathy.

• Reconstitute vial contents and dilute before use. • Administer Dexrazoxane for Injection by intravenous infusion over 15 minutes. • DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. • The recommended dosage ratio of Dexrazoxane for Injection to doxorubicin is 10:1 (e.g., 500 mg/m 2 Dexrazoxane for Injection to 50 mg/m 2 doxorubicin). Do not administer doxorubicin before Dexrazoxane. • Reduce dose by 50% for patients with creatinine clearance <40 mL/min.

Do not use Dexrazoxane for Injection with non-anthracycline chemotherapy regimens. Dexrazoxane for Injection should not be used with non-anthracycline chemotherapy regimens.

• Myelosuppression: Dexrazoxane for Injection may increase the myelosuppresive effects of chemotherapeutic agents. Perform hematological monitoring. • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

In clinical studies, Dexrazoxane for Injection was administered to patients also receiving chemotherapeutic agents for cancer. Pain on injection was observed more frequently in patients receiving Dexrazoxane for Injection versus placebo.

No drug interactions have been identified.

Store at 20° to 25°C (68° to 77°F).