Dexrazoxane Hydrochloride 500 mg/50 mL, 250 mg/25 mL Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 500 mg/50 mL, 250 mg/25 mL

Reference Brands: Zinecard (USA), Cardioxane (EU)

Category: Oncology Cancer Care

Dexrazoxane hydrochloride powder for intravenous infusion, 250 mg and 500 mg vials, used against anthracycline cardiotoxicity and for extravasation. For hospital oncology pharmacies, importers and distributors.

Product Description:

Dexrazoxane protects the heart and tissues from anthracycline chemotherapy. It is a cyclic derivative of EDTA that opens inside cells into a chelating form, binding iron and limiting the iron-dependent free radical damage anthracyclines cause in heart muscle; it also acts on topoisomerase II. It is supplied as the hydrochloride, a sterile lyophilised powder in vials. The listed 250 mg/25 mL and 500 mg/50 mL describe the 10 mg/mL solution after reconstitution. It is given only by intravenous infusion.

There are two distinct uses. For cardioprotection it is infused shortly before each doxorubicin dose in patients who have already had a substantial cumulative anthracycline dose; the label sets the threshold and dose ratio. For anthracycline extravasation, a separate three-day regimen starts as soon as possible after the leak. It adds to chemotherapy myelosuppression, so blood counts are monitored, and the dose is reduced in renal impairment. Rules for children differ between regulators and have changed, so follow the current local label.

Sourcing notes. Cardioprotection and extravasation products carry different labels and pack sizes in some markets, so state which indication you need. A generic needs a CTD dossier for a sterile powder, with sterility, endotoxin and in-use stability data. Dexrazoxane is generally prepared with cytotoxic precautions, so closed-system preparation and cytotoxic labelling may apply. Unopened vials are usually stored at room temperature; check the label rather than assume a cold chain. Ask for a CoA per batch, a sterile-site GMP certificate and a CoPP. Give vial strength, diluent needs, quantity and destination.