Clofazimine: a review of its use in leprosy and Mycobacterium avium complex infection

This article reviews the chemistry, pharmacology, spectrum of activity, pharmacokinetics, clinical efficacy in leprosy and Mycobacterium avium complex (MAC) infection, adverse effects, drug interactions, and special considerations of clofazimine. The drug is active in vivo against M. leprae and in vitro against MAC. In addition, it possesses antiinflammatory and immunosuppressive properties. Clinical studies support the efficacy of clofazimine as a part of multidrug therapy in treating leprosy. It also appears to reduce the incidence and severity of erythema nodosum leprosum reactions that often occur during the treatment of leprosy. Efficacy in treating MAC infection in patients with AIDS is not well documented, despite the use of clofazimine in combination with other agents. A few patients have responded symptomatically and by clearing their mycobacteremia, although there is no evidence that mortality is reduced. Clofazimine is well tolerated, at least when doses less than or equal to 100 mg/d are used. Adverse reactions include discoloration of the skin, self-limiting gastrointestinal intolerance, severe and life-threatening abdominal pain and organ damage due to clofazimine crystal deposition, and asymptomatic discoloration of the eye. Clofazimine should be considered for formulary inclusion.