CARDIOXANE- dexrazoxane injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXRAZOXANE HYDROCHLORIDE (UNII: 5346058Q7S) (DEXRAZOXANE - UNII:048L81261F)

Available from:

Clinigen Healthcare Ltd

INN (International Name):

DEXRAZOXANE HYDROCHLORIDE

Composition:

DEXRAZOXANE 500 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Unapproved drug for use in drug shortage

Summary of Product characteristics

CARDIOXANE- DEXRAZOXANE INJECTION, POWDER, FOR SOLUTION
CLINIGEN HEALTHCARE LTD
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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CARDIOXANE 500 MG POWDER FOR SOLUTION FOR INFUSION
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