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Dear Doctor Letter (Rote-Hand-Brief) on Kybella® 10 mg/ml solution for injection (deoxycholic acid): risk of injection-site necrosis

Active substance: deoxycholic acid

Allergan Pharmaceuticals International Limited in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you of injection-site necrosis, including artery necrosis, around the submental treatment area which has been reported in patients treated with deoxycholic acid. Kybella should be injected midway into the preplatysmal subcutaneous fat tissue in the submental area. Intradermal, intramuscular or intravascular injection should be avoided. Incorrect injection technique may increase the risk of skin ulceration or necrosis. If injection-site ulceration or necrosis occurs, Kybella should never be re-administered.

Update 15.10.2020
The drug is now marketed in Germany.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 270KB, File is accessible

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