ZINECARD 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, in their physician's opinion, would benefit from continuing therapy with doxorubicin. It is not recommended for use with the initiation of doxorubicin therapy (see WARNINGS).

The recommended dosage ratio of ZINECARD:doxorubicin is 10:1 (eg, 500 mg/m² ZINECARD:50 mg/m² doxorubicin). In patients with moderate to severe renal dysfunction (creatinine clearance values < 40 mL/min), the recommended dosage ratio of ZINECARD:doxorubicin is 5:1 (eg. 250 mg/m² ZINECARD:50 mg/m² doxorubicin). Creatinine clearance can be determined from a 24-hour urinary creatinine collection or estimated using the Crockroft-Gault equation (assuming stable renal function):

Since a doxorubicin dose reduction is recommended in the presence of hyperbilirubinemia, the ZINECARD dosage should be proportionately reduced (maintaining the 10:1 ratio) in patients with hepatic impairment. ZINECARD must be reconstituted with 0.167 Molar (M/6) Sodium Lactate Injection, USP, to give a concentration of 10 mg ZINECARD for each mL of sodium lactate. The reconstituted solution should be given by slow I.V. push or rapid drip intravenous infusion from a bag. After completing the infusion of ZINECARD, and prior to a total elapsed time of 30 minutes (from the beginning of the ZINECARD infusion), the intravenous injection of doxorubicin should be given.

Reconstituted ZINECARD, when transferred to an empty infusion bag, is stable for 6 hours from the time of reconstitution when stored at controlled room temperature, 15^°to 30^°C (59^° to 86^°F) or under refrigeration, 2^° to 8^°C (36^° to 46^°F). DISCARD UNUSED SOLUTIONS.

The reconstituted ZINECARD solution may be diluted with either 0.9% Sodium Chloride Injection, USP or 5.0% Dextrose Injection, USP to a concentration range of 1.3 to 5.0 mg/mL in intravenous infusion bags. The resultant solutions are stable for 6 hours when stored at controlled room temperature, 15^° to 30^°C (59^° to 86^°F) or under refrigeration, 2^° to 8^°C (36^° to 46^°F). DISCARD UNUSED SOLUTIONS.

Incompatibility

ZINECARD should not be mixed with other drugs.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Handling and Disposal:   Caution in the handling and preparation of the reconstituted solution must be exercised and the use of gloves is recommended. If ZINECARD powder or solutions contact the skin or mucosae, immediately wash thoroughly with soap and water.

Procedures normally used for proper handling and disposal of anticancer drugs should be considered for use with ZINECARD. Several guidelines on this subject have been published. ^1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

ZINECARD® (dexrazoxane for injection) is available in the following strengths as sterile, pyrogen-free lyophilizates.

NDC 0013-8715-62          250 mg single dose vial with a red flip-top seal, packaged in single vial packs.

(This package also contains a 25 mL vial of 0.167 Molar (M/6) Sodium Lactate Injection, USP.)

NDC 0013-8725-89          500 mg single dose vial with a blue flip-top seal, packaged in single vial packs.

(This package also contains a 50 mL vial of 0.167 Molar (M/6) Sodium Lactate Injection, USP.)

Store at 25^°C (77^°F); excursions permitted to 15^° to 30^°C (59^° to 86^°F) [see USP Controlled Room Temperature]. Reconstituted solutions of ZINECARD are stable for 6 hours at controlled room temperature or under refrigeration, 2^° to 8^°C (36^° to 46^°F). DISCARD UNUSED SOLUTIONS.

REFERENCES

1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society. 1999; 32-41.
2. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. Washington, DC: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Dept of Health and Human Services, Public Health Service Publication NIH 92-2621.
3. AMA Council on Scientific Affairs. Guidelines for Handling Parenteral Antineoplastics. JAMA. 1985; 253: 1590-1591.
4. National Study Commission on Cytotoxic Exposure-Recommendations for Handling Cytotoxic Agents. 1987. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
5. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983; 1:426-428.
6. Jones RB, Frank R, Mass T. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA - A Cancer J for Clin. 1983; 33: 258- 263.
7. American Society of Hospital Pharmacists. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990; 47:1033- 1049.
8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work Practice Guidelines.) Am J Health-Syst Pharm. 1996; 53: 1669-1685.

Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017, Revised 05/20/2005

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