Skip to Content

Dexrazoxane Injection

Last Updated: January 16, 2018
Status: Current

Dexrazoxane Injection

Products Affected - Description
  • Zinecard injection, Pfizer

250 mg, vial, 1 count (NDC 00013-8717-62)
500 mg, vial, 1 count (NDC 00013-8727-89)
 
Dexrazoxane injection, Mylan Institutional
250 mg, vial, 1 count (NDC 67457-0207-25)
500 mg, vial, 1 count (NDC 67457-0208-50)
Reason for the Shortage
    • Cumberland Pharmaceuticals relaunched Totect in late-July 2017.
    • Mylan Institutional did not provide a reason for the shortage.
    • Pfizer states manufacturing delay as the reason for the shortage.
    • West-Ward is not actively marketing dexrazoxane injection at this time.
Available Products
  • Totect kit, Cumberland Pharmaceuticals
    500 mg, vial, (only for extravasation injuries) 1 count (NDC 66220-0110-01)

Estimated Resupply Dates

    • Pfizer has Zinecard 250 mg and 500 mg vials on back order and the company estimates a release date of March 2018 for the 250 mg vials and September 2018 for the 500 mg vials.
    • Mylan has dexrazoxane 250 mg and 500 mg vials on intermittent back order and the company is releasing product as it becomes available.

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.
    • 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.

Updated

January 16, 2018; December 6, September 30, August 8 and 1, July 26, 13 and 3, January 11, 2017; October 21, July 26, 15 and 7, June 22 and 2, March 23, February 25 and 2, 2016; October 29, August 26 and 5, July 1, May 14, March 9, January 21, 2015; November 20, October 13, August 8, June 2, April 3, 2014; December 23, October 28, September 23, August 29 and 6, July 25 and 15, May 28, April 17, February 26 and 22, 2013; December 17, November 30, September 14, July 26, June 5, May 25, April 17, March 8, January 13 and 11, 2012; December 15, November 30, 2011, University of Utah, Drug Information Service. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

Hide