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Savene® is indicated for the treatment of anthracycline extravasation and is the only proven and licenced antidote to date. Savene® must be initiated immediately and no later than six hours after the first signs or suspicion of extravasation.

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Anthracycline extravasation

The possibility of anthracycline extravasation is often underestimated by clinicians due to its very low occurrence; yet extravasation can occur during any anthracycline infusion. A survey of published sources showed that 0.1% to 1,0% of all anthracycline treatments involve extravasation.

Clinical results

The efficacy of Savene® was demonstrated in preclinical studies as well as two clinical trials (TT01 and TT02), using doxorubicin, daunorubicin, epirubicin or idarubicin. The animal model of anthracycline extravasation showed that systemic dexrazoxane therapy reduced markedly the area of tissue lesions compared with standard treatments such as DMSO and hydrocortisone. The two prospective open-label clinical trials showed that in biopsy-verified anthracycline extravasation Savene® eliminated the need for surgery in 71 % of patients thus allowing continuation of chemotherapy as scheduled. In trial TT01 none of the 18 evaluable patients required surgical debridement, whereas in trial TT02 only one of the 36 evaluable patients required surgery. Savene® is well tolerated with minimal and transient side-effects that are largely attributable to the anthracycline therapy rather than Savene® alone. The overall results of both clinical trials show that Savene® is a highly effective and well-tolerated treatment for patients experiencing an anthracycline extravasation.

Savene® is made up of Savene® Powder (dexrazoxane) and Savene® Diluent, which are conveniently formulated and packaged as the Savene® Emergency Extravasation Kit. The quantities of one kit are adapted to one 3-day treatment. The kit should always be at hand at the site of anthracycline administration and become part of the treatment inventory of every anthracycline administration site. The Savene® Emergency Extravasation Kit is easy to use allowing for rapid intervention and user friendliness.

Regulatory status

Savene® was granted orphan-medicinal-product status by the European Commission in September 2001 and received a marketing authorization on 28 July 2006. It is indicated for the 'Treatment of anthracycline extravasation'. SpePharm is responsible for manufacturing and commercializing Savene® throughout Europe.