Zinecard
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2)].
History
There is currently no drug history available for this drug.
Other Information
ZINECARD (dexrazoxane for injection), a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration.
Chemically, dexrazoxane is (S)-4,4'-(1-methyl-1,2-ethanediyl)bis-2,6-piperazinedione. The structural formula is as follows:
C11H16N4O4 M.W. 268.28
Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a whitish crystalline powder that melts at 191° to 197°C. It is sparingly soluble in water and 0.1 N HCl, slightly soluble in ethanol and methanol, and practically insoluble in nonpolar organic solvents. The pKa is 2.1. Dexrazoxane has an octanol/water partition coefficient of 0.025 and degrades rapidly above a pH of 7.0.
Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 25 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0.
Each 500 mg vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 50 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0.
The reconstituted ZINECARD solutions prepared from Sterile Water for Injection, USP, are intended for further dilution with Lactated Ringer's Injection, USP, for rapid intravenous drip infusion. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH [see Dosage and Administration (2.1, 2.3)].
Sources
Zinecard Manufacturers
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Pharmacia And Upjohn Company
![Zinecard (Dexrazoxane) Injection, Powder, Lyophilized, For Solution [Pharmacia And Upjohn Company]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zinecard | Pharmacia And Upjohn Company
2.1 Recommended DoseAdminister ZINECARD Injection via intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH.
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. Administer doxorubicin within 30 minutes after the completion of ZINECARD infusion.
2.2 Dose ModificationsDosing in Patients with Renal Impairment
Reduce ZINECARD dosage in patients with moderate to severe renal impairment (creatinine clearance values less than 40 mL/min) by 50% (ZINECARD to doxorubicin ratio reduced to 5:1; such as 250 mg/m2 ZINECARD to 50 mg/m2 doxorubicin) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Dosing in Patients with Hepatic Impairment
Since a doxorubicin dose reduction is recommended in the presence of hyperbilirubinemia, reduce the ZINECARD dosage proportionately (maintaining the 10:1 ratio) in patients with hepatic impairment.
2.3 Preparation and AdministrationPreparation and Handling of Infusion Solution
Reconstitute ZINECARD with Sterile Water for Injection, USP. Reconstitute with 25 mL for a ZINECARD 250 mg vial and 50 mL for a ZINECARD 500 mg vial to give a concentration of 10 mg/mL. Dilute the reconstituted solution further with Lactated Ringer's Injection, USP to a concentration of 1.3 to 3.0 mg/mL in intravenous infusion bags for intravenous infusion.
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 diluted 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). The infusion solutions have a pH of 3.5 to 5.5. DISCARD UNUSED SOLUTIONS.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Solutions containing a precipitate should be discarded.
Use caution when handling and preparing the reconstituted solution. The use of gloves is recommended. If ZINECARD powder or solutions contact the skin or mucosae, wash exposed area immediately and thoroughly with soap and water. Follow special handling and disposal procedures.1
Administration
Do not mix ZINECARD with other drugs.
Administer the final diluted solution of ZINECARD by intravenous infusion over 15 minutes before the administration of doxorubicin. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. Administer doxorubicin within 30 minutes after the completion of ZINECARD infusion.
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