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.