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Zinecard

INDICATIONS

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/m² and who will continue to receive doxorubicin therapy to maintain tumor control. It is not recommended for use with the initiation of doxorubicin therapy (see WARNINGS).

DOSAGE AND ADMINISTRATION

The recommended dosage ratio of ZINECARD:doxorubicin is 10:1 (e.g., 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 (e.g., 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):

Males: (weight in kg) x (140 – age in years)
(72) x serum creatinine (mg/100 mL)

Females: (weight in kg) x (140 – age in years) x 0.85
(72) x serum creatinine (mg/100 mL)

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 Sterile Water for Injection, USP. For ZINECARD 250 mg vials, reconstitute with 25 mL. For ZINECARD 500 mg vials, reconstitute with 50 mL. The resultant reconstituted solutions will have a concentration of 10 mg dexrazoxane for each mL of solution. Further dilution with Lactated Ringer's Injection, USP, is necessary prior to administration.

Following reconstitution with Sterile Water for Injection, USP, ZINECARD is stable for 30 minutes at room temperature or if storage is necessary, up to 3 hours from the time of reconstitution when stored under refrigeration, 2° to 8°C (36° to 46°F). The pH of the resultant solution is 1.0 to 3.0. DISCARD UNUSED SOLUTIONS. The reconstituted ZINECARD solution is intended for further dilution with Lactated Ringer's Injection, USP, to a concentration range of 1.3 to 3.0 mg/mL in intravenous infusion bags for rapid drip infusion. DO NOT ADMINISTER VIA IV PUSH. The infusion solutions have a pH of 3.5 to 5.5. The infusion solutions are stable for one hour at room temperature or if storage is necessary, up to 4 hours when stored under refrigeration, 2° to 8°C (36° to 46°F). DISCARD UNUSED SOLUTIONS.

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.

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.

HOW SUPPLIED

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

NDC 0013-8717-62
250 mg single dose vial with a red flip-top seal, packaged in single vial packs.

NDC 0013-8727-89
500 mg single dose vial with a blue flip-top seal, packaged in single vial packs.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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 Co, Division of Pfizer Inc, NY, NY 10017. Revised August 2011

Last reviewed on RxList: 7/16/2012
This monograph has been modified to include the generic and brand name in many instances.

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