Dexrazoxane
These highlights do not include all the information needed to use DEXRAZOXANE FOR INJECTION safely and effectively. See Full Prescribing Information for DEXRAZOXANE FOR INJECTION. DEXRAZOXANE for injection, for intravenous useInitial U.S. Approval: 1995
e9550d22-6069-a6de-9968-6a18c9e0448f
HUMAN PRESCRIPTION DRUG LABEL
Aug 31, 2020
Almaject, Inc.
DUNS: 116626205
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexrazoxane for Injection
PRODUCT DETAILS
INGREDIENTS (2)
Drug Labeling Information
INFORMATION FOR PATIENTS SECTION
17 PATIENT COUNSELING INFORMATION
17.1 Myelosuppression
Treatment with Dexrazoxane for Injection is associated with leukopenia, neutropenia, and thrombocytopenia. Perform hematological monitoring [see Warnings and Precautions (5.1), (5.6)].
17.2 Embryo-Fetal Toxicity
Counsel patients on pregnancy planning and prevention. Advise female patients of reproductive potential that Dexrazoxane for Injection can cause fetal harm and to use highly effective contraception during treatment [see Warnings and Precautions (5.5)and Use in Specific Populations (8.1, 8.6)].
NONCLINICAL TOXICOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term carcinogenicity studies have been carried out with dexrazoxane in animals. Nevertheless, a study by the National Cancer Institute has reported that long-term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice [see Warnings and Precautions (5.4)].
Dexrazoxane was not mutagenic in the bacterial reverse mutation (Ames) test, but was found to be clastogenic to human lymphocytes in vitro and to mouse bone marrow erythrocytes in vivo (micronucleus test).
Dexrazoxane for Injection has the potential to impair fertility in male patients based on effects in repeat-dose toxicology studies. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (1/3 the human dose on a mg/m2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (approximately equal to the human dose on a mg/m2 basis).