Dexrazoxane for injection is the generic equivalent of the brand-name drug Dexrazoxane. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Dexrazoxane for injection through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & 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/…
Adverse Reactions
6 ADVERSE REACTIONS 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fosun Pharma USA Inc. at 1-866-611-3762 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying condit…
Drug Interactions
7 DRUG INTERACTIONS No drug interactions have been identified [see Clinical Pharmacology (12.3)] .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Reconstitute vial contents and dilute before use. ( 2.3 ) • 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. ( 2.1 ) • Reduce dose by 50% for patients with creatini…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Myelosuppression Treatment with dexrazoxane for injection is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring [see Warnings and Precautions ( 5.1 )]. Embryo-Fetal Toxicity Advise female patients of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with dexrazoxane for injection and for 6 months after the last dose. Advise male patients with female partners of reproductive…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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