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ZINECARD® (dexrazoxane) Highlights

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

  • Reconstitute vial contents and dilute before use. (2.3)
  • Administer ZINECARD by intravenous infusion over 15 minutes.
  • DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. (2.1, 2.3)
  • The recommended dosage ratio of ZINECARD to doxorubicin is 10:1 (e.g., 500 mg/m2 ZINECARD to 50 mg/m2 doxorubicin). Do not administer doxorubicin before ZINECARD. (2.1)
  • Reduce dose by 50% for patients with creatinine clearance <40 mL/min. (2.2, 8.7)

DOSAGE FORMS AND STRENGTHS

250 mg or 500 mg single dose vials as sterile, pyrogen-free lyophilizates. (3)

CONTRAINDICATIONS

ZINECARD should not be used with non-anthracycline chemotherapy regimens. (4)

WARNINGS AND PRECAUTIONS

  • Myelosuppression: ZINECARD may increase the myelosuppresive effects of chemotherapeutic agents. Perform hematological monitoring. (5.1)
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise female patients of reproductive potential of the potential hazard to the fetus. (5.5, 8.1)

ADVERSE REACTIONS

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

  • Nursing Mothers: Discontinue drug or nursing. (8.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 10/2016

What's New

No Current Announcements.

Contact Pfizer Medical

Report an Adverse Event
1-800-438-1985

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