Dexrazoxane

What it is and how it works

Mechanism of Action 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.

Indications

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/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use dexrazoxane for injection with doxorubicin initiation.

Dosage and administration (summary)

• Reconstitute vial contents and dilute before use. • Administer dexrazoxane for injection by intravenous infusion over 15 minutes. • DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. ( 2.1 , 2.3 ) • 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 for injection. • Reduce dose by 50% for patients with creatinine clearance <40 mL/min. ( 2.2 , 8.6 ) Recommended Dose Administer dexrazoxane for injection via intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH.

Contraindications

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

Warnings and precautions

• 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. ( 5.5 , 8.1 , 8.3 ) Myelosuppression Dexrazoxane for injection may add to the myelosuppression caused by chemotherapeutic agents. Obtain a complete blood count prior to and during each course of therapy, and administer dexrazoxane for injection and chemotherapy only when adequate hematologic parameters are met.

Pregnancy

Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, dexrazoxane for injection can cause fetal harm when administered to pregnant women . Available human data with dexrazoxane for injection use in pregnant women is not sufficient to inform the drug-associated risk.

Storage and supply

Dexrazoxane for injection is available in the following strengths as sterile, pyrogen-free lyophilized. NDC 72266-235-01 250 mg single dose vial with a green flip-top seal, packaged in single vial packs. NDC 72266-101-01 500 mg single dose vial with a blue flip-top seal, packaged in single vial packs. Store at 20° to 25 °C (68° to 77°F) .

Source: Dexrazoxane For Injection (Dexrazoxane) — US FDA prescribing information, 2025-06-17, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.