Dexrazoxane: new indication. Anthracycline extravasation: continue using dimethyl sulfoxide. 2009


1) Anthracycline extravasation can provoke extensive tissue necrosis, sometimes with serious consequences. Topical dimethylsulfoxide (DMSO) is the main antidote known to prevent this necrosis. It is used off-licence in France, based on the results of non-comparative trials. Among nearly 150 patients treated with dimethylsulfoxide, only one required surgery and about 10% of patients had sequelae; 2) A product based on dexrazoxane, an iron chelator, also approved to prevent anthracycline cardiotoxicity, has now been authorized for intravenous treatment of anthracycline extravasation; 3) Clinical evaluation of dexrazoxane in this setting does not include any trials versus dimethylsulfoxide. The combination of dexrazoxane plus dimethylsulfoxide is contraindicated, based on the results of animal studies; 4) Clinical evaluation of dexrazoxane only includes one case of anthracycline extravasation from a central venous line; 5) In two non-comparative trials in a total of 54 patients, only one patient required surgery for tissue necrosis. About one-third of patients had local complications (sensory disorders, pain, cutaneous atrophy, or restricted movement); 6) The only known adverse effect of topical dimethylsulfoxide is local irritation. In contrast, 10% of patients who received intravenous dexrazoxane had an infection that the investigators considered possibly linked to dexrazoxane. In addition to the known haematological effects of dexrazoxane (leukopenia and thrombocytopenia), other serious adverse events observed in the two trials included a major increase in hepatic transaminase activity, elevated creatinine levels, and hyper- or hypokalaemia; 7) Based on an evaluation that is neither sufficiently thorough nor rigorous, the risk-benefit balance of intravenous dexrazoxane appears to be less favourable than that of local dimethylsulfoxide, which should therefore continue to be used in this setting. In the meantime, preventive measures should be strictly followed in order to prevent extravasation from occurring. The assessment of dexrazoxane in anthracycline extravasation from a central line also remains inadequate.

UI MeSH Term Description Entries
D007239 Infections Invasion of the host organism by microorganisms or their toxins or by parasites that can cause pathological conditions or diseases. Infection,Infection and Infestation,Infections and Infestations,Infestation and Infection,Infestations and Infections
D007262 Infusions, Intravenous The long-term (minutes to hours) administration of a fluid into the vein through venipuncture, either by letting the fluid flow by gravity or by pumping it. Drip Infusions,Intravenous Drip,Intravenous Infusions,Drip Infusion,Drip, Intravenous,Infusion, Drip,Infusion, Intravenous,Infusions, Drip,Intravenous Infusion
D011929 Razoxane An antimitotic agent with immunosuppressive properties. ICRF-159,ICRF-186,NSC-129943,Razoxane Mesylate, (R)-Isomer,Razoxane, (R)-Isomer,Razoxin,ICRF 159,ICRF 186,ICRF159,ICRF186,NSC 129943,NSC129943
D004121 Dimethyl Sulfoxide A highly polar organic liquid, that is used widely as a chemical solvent. Because of its ability to penetrate biological membranes, it is used as a vehicle for topical application of pharmaceuticals. It is also used to protect tissue during CRYOPRESERVATION. Dimethyl sulfoxide shows a range of pharmacological activity including analgesia and anti-inflammation. DMSO,Dimethyl Sulphoxide,Dimethylsulfoxide,Dimethylsulphinyl,Dimethylsulphoxide,Dimexide,Rheumabene,Rimso,Rimso 100,Rimso-50,Sclerosol,Sulfinylbis(methane),Rimso 50,Rimso50,Sulfoxide, Dimethyl,Sulphoxide, Dimethyl
D005119 Extravasation of Diagnostic and Therapeutic Materials The escape of diagnostic or therapeutic material from the vessel into which it is introduced into the surrounding tissue or body cavity. Extravasation of Contrast Media,Extravasation of Diagnostic, Therapeutic Materials,Contrast Media Extravasation
D005602 France A country in western Europe bordered by the Atlantic Ocean, the English Channel, the Mediterranean Sea, and the countries of Belgium, Germany, Italy, Spain, Switzerland, the principalities of Andorra and Monaco, and by the duchy of Luxembourg. Its capital is Paris. Corsica,Saint Pierre and Miquelon,Miquelon and Saint Pierre,Miquelon and St. Pierre,St. Pierre and Miquelon
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D017277 Drug Approval Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug. Drug Approval Process,New Drug Approval,Food and Drug Administration Drug Approval,Food and Drug Administration Drug Approval Process,New Drug Approval Process,Approval Process, Drug,Approval Processes, Drug,Approval, Drug,Approval, New Drug,Approvals, Drug,Approvals, New Drug,Drug Approval Processes,Drug Approval, New,Drug Approvals,Drug Approvals, New,New Drug Approvals,Process, Drug Approval,Processes, Drug Approval
D018943 Anthracyclines Organic compounds that have a tetrahydronaphthacenedione ring structure attached by a glycosidic linkage to the amino sugar daunosamine. Anthracycline

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