Cardioxane 500 mg Powder for Solution for Infusion

Cardioxane 500 mg is indicated for reducing the incidence and severity of cardiomyopathy associated with anthracycline chemotherapy in adult patients. FDA approved brand name Cardioxane is not (yet) registered or available in India. The access to the drug is provided as per Name Patient Program respecting the regulatory framework as desired by local authorities.

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Cardioxane 500 mg Powder for Solution

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Cardioxane 500 mg Powder for Solution

Dexrazoxane is a cardioprotective agent used to reduce heart damage (cardiomyopathy) caused by anthracycline chemotherapy (e.g., doxorubicin) in breast cancer patients.

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.

In the U.S., the labelling for Dexrazoxane Injection (Zinecard) includes the following indication: 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.

The United States Food and Drug Administration has also approved a dexrazoxane for use as a treatment of extravasation resulting from IV anthracycline chemotherapy. Extravasation is an adverse event in which chemotherapies containing anthracylines leak out of the blood vessel and necrotize the surrounding tissue.

Drug (Brand / Generic): Cardioxane® 500 mg Powder for Solution for Infusion
Current Indication: cardiomyopathy
Approval Date: Cardioxane (dexrazoxane) 500 mg powder for solution for infusion has key regulatory dates in the EU and US. An EU-wide decision on its updated, restricted license was implemented on July 19, 2017. In the U.S., it was listed for import via FDA-authorized shortage distributors on July 28, 2017

Cardioxane® 500 mg Powder for Solution for Infusion
Dexrazoxane (as its hydrochloride salt) Intravenous use for short infusion.
Do not store above 25°C. Store in the original container. Protect from direct sunlight.

For more highlights of prescribing information regarding Indications and usage, dosage and administration, dosage forms and strengths, patient counseling information and medication guide. Click Here

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Our specialization lies in facilitating access to medicines, leveraging our expertise in sourcing and providing documentation assistance for programs such as Named Patient Program, Managed Access Program, and Early Access Program. We take pride in ensuring smooth and efficient access to medications for those who require them.

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