Dexrazoxane for Injection

FDA Drug Profile — Dexrazoxane

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/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use Dexrazoxane for Injection with doxorubicin initiation. ( 1 )