Cardioxane Injection
Generic name: dexrazoxane
Dosage form: injection, powder, for solution
Drug class:Miscellaneous uncategorized agents
Medically reviewed by Drugs.com. Last updated on Jun 21, 2021.
IMPORTANT DRUG INFORMATION
Subject: Temporary Importation of Cardioxane 500 mg Powder for Solution for Infusion (dexrazoxane hydrochloride) to address drug shortage issues
Dear Healthcare Professional,
Important Reconstitution Note for Medication Error Prevention: Prescribers and pharmacists must be alert to the differences between the FDA-approved dexrazoxane products and Cardioxane’s presentation and reconstitution and dilution instructions in order to prevent medication errors. Appropriate quality assurance measures should be enacted to reduce the risk of medication errors. See comparison table below for more information. Cardioxane has a different vial capacity than FDA-approved dexrazoxane products, and, therefore must be reconstituted with a different volume of Water for Injection. Cardioxane 500 mg Powder for Solution for Infusion is provided in a vial with a capacity of 25 mL. To reconstitute, add 25 mL Water for Injection (USP) to the vial. The concentration of the resulting reconstitution solution will be 20 mg/mL – this solution should not be stored and must be further diluted before administration to the patient. Further dilute the reconstitution solution with Lactated Ringer's Injection, USP to a final concentration between 1.3 and 3 mg/mL. The diluted infusion solution should be used immediately or stored for a maximum of 4 hours under refrigeration. |
Due to the current critical shortage of Dexrazoxane for Injection, 250 mg/vial and 500 mg/vial in the United States (U.S.) market, Clinigen Healthcare Ltd is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of Dexrazoxane for Injection 500 mg/vial.
Clinigen Healthcare Ltd has initiated temporary importation into the U.S. of Cardioxane 500 mg Powder for Solution for Infusion (dexrazoxane hydrochloride), a non-FDA approved product, to help alleviate the shortage. The Cardioxane 500 mg Powder for Solution for Infusion was manufactured by Cenexi – Laboratoires Thissen S.A. in its FDA-inspected facility in Braine l’Alleud, Belgium and is licensed for sale in the United Kingdom. Clinigen Healthcare Ltd’s distributor for Cardioxane in the US is Cumberland Pharmaceuticals Inc.
At this time, no other entities except Clinigen Healthcare Ltd and its distributor Cumberland Pharmaceutical Inc. are authorized by the FDA to import or distribute Cardioxane 500 mg Powder for Solution for Infusion in the U.S. This does not constitute an FDA approval for the Cardioxane 500 mg Powder for Solution for Infusion being distributed in the U.S.
Cardioxane 500 mg Powder for Solution for Infusion contains the same active substance, dexrazoxane hydrochloride, as FDA-approved Zinecard. It is available as 500 mg/vial (no 250 mg/vial presentation is available). It is a clinically acceptable substitute for the out of stock U.S. Dexrazoxane for Injection products. Cardioxane is available only by prescription in the U.S.
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