Guideline for clinical use of thalidomide for management of erythema nodosum leprosum in Japan

Abstract

Treatment of erythema nodosum leprosum (ENL, type 2 lepra reaction) with thalidomide is an effective alternative to steroid therapy, but Ministry of Health, Labour and Welfare (Japan) has only approved thalidomide (Thaled® Capsule, Fujimoto Pharmaceutical Corp.) for the treatment of multiple myeloma under the Thalidomide Education and Risk Management System (TERMS®) 2008. Then thalidomide was approved for ENL in 2012 by Ministry of Health, Labour and Welfare. Use of thalidomide for patients with ENL has already been established by various studies in other countries, but limited experience in Japan has hindered application of this medication to domestic patients. This led us to devise a guideline on the usage of thalidomide to treat ENL in Japan. Based on TERMS®, we suggest that administration of thalidomide for ENL should be started at 50-100 mg/day p.o. before going to bed and then the dose should be adjusted according to the patient’s symptoms, while not exceeding the maximum recommended dose of 300 mg/day.