INS cites FDA-approved Totect antidote for anthracycline extravasations

Dec 15 2009

The third edition of Infusion Nursing: An Evidence-Based Approach, published by the Infusion Nurses Society (INS), includes Totect(®), the only FDA-approved treatment for anthracycline extravasation. Anthracyclines are a group of chemotherapy medications including daunorubicin, doxorubicin, idarubicin and epirubicin that have been used in the treatment of various types of cancer since the early 1970s.

According to the INS publication: "In September 2007, the FDA approved the first anthracycline extravasation treatment, Totect (dexrazoxane for injection), which has a 98% efficacy in diminishing tissue damage and allows the majority of patients to continue with scheduled chemotherapy."

"In addition to ensuring the availability of Totect in the clinic, all nurses should be aware that it is critical to administer the antidote as soon as possible, and at least within six hours of the anthracycline extravasation," said Linda Person, RN, MSN, AOCN, Advanced Practice Nurse, Ambulatory, USC/Norris Cancer Hospital. "The growing number of Totect citations in the literature is supported by strong clinical data and the absence of Totect in the hospital or clinic could be considered a liability risk."

In addition to this INS citation, ASCO/ONS Chemotherapy Administration Safety Standards, published in 2009 in the Journal of Clinical Oncology, defines extravasation management procedures and references the third edition of the Chemotherapy and Biotherapy Guidelines and Recommendations for Practice published by the Oncology Nursing Society, citing Totect® as the only FDA-approved treatment for anthracycline extravasation.

During a patient's chemotherapy treatment, whether peripheral or central venous catheter, anthracyclines can leak out of the vein or central line into surrounding healthy tissue causing a serious complication known as extravasation. Anthracycline extravasations cause extreme damage to skin and tissue if left untreated. Approximately 500,000 doses of anthracycline are administered intravenously each year in the U.S.

"We are pleased that the INS, a group of professionals on the front lines of patient care, has clearly and accurately cited Totect(®), the only FDA-approved antidote for anthracycline extravasations," said John L. Parsons, Jr. President of TopoTarget USA, Inc. "This is the third major evidence-based publication to underscore the importance for healthcare institutions providing infusion services to have Totect available on site."