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Dexrazoxane Injection

Last Updated: July 6, 2018
Status: Current

Products Affected - Description
    • Zinecard injection, Pfizer, 250 mg, vial, 1 count, NDC 00013-8717-62
    • Zinecard injection, Pfizer, 500 mg, vial, 1 count, NDC 00013-8727-89
Reason for the Shortage
    • Cumberland Pharmaceuticals relaunched Totect in late-July 2017.
    • Mylan Institutional has dexrazoxane available.
    • Pfizer states manufacturing delay as the reason for the shortage.
    • West-Ward has dexrazoxane available.
Available Products
    • Totect kit, Cumberland Pharmaceuticals, 500 mg, vial, (only for extravasation injuries) 1 count, NDC 66220-0110-01
    • Dexrazoxane injection, Hikma, 250 mg, vial, 1 count, NDC 00143-9247-01
    • Dexrazoxane injection, Hikma, 500 mg, vial, 1 count, NDC 00143-9248-01
    • Dexrazoxane injection, Mylan Institutional, 250 mg, vial, 1 count, NDC 67457-0207-25
    • Dexrazoxane injection, Mylan Institutional, 500 mg, vial, 1 count, NDC 67457-0208-50

Estimated Resupply Dates

    • Pfizer has Zinecard 250 mg vials on allocation. The 500 mg vials are on back order and the company estimates a release date of September 2018.

Alternative Agents & Management

    • To help alleviate the dexrazoxane shortage, Clinigen Healthcare is coordinating with FDA to temporarily import Cardioxane (dexrazoxane) 500 mg powder for injection. This is manufactured by Cenexi Laboratories in Belgium for use in the United Kingdom. Orders can be placed through Clinigen's distributor, Cumberland Pharmaceuticals at 615-255-0068. Details on availability of the imported product can be found at the FDA shortage site: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Dexrazoxane%20Injection&st=c&tab=tabs-1
    • The main difference is reconstituted Cardioxane has a concentration of 20 mg/mL versus the US version of 10 mg/mL. Further dilution is usually 1.3 mg/mL to 3 mg/mL with Lactated Ringers solution for injection for use in the US. More details on this imported product can be found at the Dear Healthcare Professional letter posted on the FDA shortage site: https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM567098.pdf.

Updated

Updated July 6, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. Created November 30, 2011 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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