HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZINECARD safely and effectively. See full prescribing information for ZINECARD.
ZINECARD® (dexrazoxane) for injection
Initial U.S. Approval: 1995
INDICATIONS AND USAGE
ZINECARD 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 ZINECARD with doxorubicin initiation. (1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
250 mg or 500 mg single dose vials as sterile, pyrogen-free lyophilizates. (3)
ZINECARD should not be used with non-anthracycline chemotherapy regimens. (4)
WARNINGS AND PRECAUTIONS
In clinical studies, ZINECARD was administered to patients also receiving chemotherapeutic agents for cancer. Pain on injection was observed more frequently in patients receiving ZINECARD versus placebo. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
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