Dexrazoxane for Injection
Drug Details
- Generic Name
- Dexrazoxane for Injection
- Brand Names
- Dexrazoxane
- Application Number
- ANDA207321
- Sponsor
- Fosun Pharma USA Inc.
- NDC Codes
- 6
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- DEXRAZOXANE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE 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 [see Warnings and Precautions (5.2) ]. 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. ( 1 )