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Information about Clofazimine

Clofazimine is a fat soluble, brick red dye that is used in combination with other agents in the therapy of leprosy.


Liver safety of Clofazimine

Clofazimine, by itself, has not been associated with serum aminotransferase elevations during therapy or to instances of clinically apparent acute liver injury.

Mechanism of action of Clofazimine

Clofazimine (kloe faz' i meen) is a fat soluble iminophenazine, brick red dye that has in vitro activity against several species of mycobacteria and was found to be very effective in the treatment of leprosy (Hansen disease). Clofazimine binds to mycobacterial DNA and was developed as a potential therapy of mycobacterium tuberculosis, but showed minimal activity. In contrast, it was found to be a valuable agent in treating leprosy; clinical trials demonstrating benefit both as monotherapy and when combined with dapsone and rifampin. Multidrug therapy using all three agents is now considered the first line of therapy for adults with leprosy and provides a high rate of ultimate cure after 1 to 3 years of therapy.

FDA approval information for Clofazimine

Clofazimine was approved for use in the United States in 1986, but was withdrawn in 2016 and is now only available under the auspices of the National Hansen's Disease (Leprosy) Program ( In other countries, clofazimine is available under the commercial name Lamprene in tablets of 50 mg, the recommended dose being 100 mg daily. Clofazimine also has immunosuppressive activity and it has been used experimentally to treat discoid lupus erythematosus and psoriasis. More recently, it has shown some activity in treating infectious with drug resistant non-tuberculosis Mycobacterium species including Mycobaterium avian complex and abscessus.

Side effects of Clofazimine

The major side effects of clofazimine include skin discoloration and gastrointestinal upset with pain, nausea and diarrhea. The skin discoloration is due to the reddish-orange color of clofazimine and results in a pinkish-brown discoloration of skin and bodily fluids in the majority of patients treated for more than a month. The discoloration fades with stopping the drug, but may persist for months or years. The gastrointestinal side effects of clofazimine can be severe and require dose modification or discontinuation. The symptoms appear to be due to crystallization of the clofazimine molecule in intestinal submucosa; these crystals can also be found in liver, lymph nodes and spleen. While clofazimine is rarely used in the United States, it is an important medication from a worldwide perspective and has played an essential role in public health efforts to eradicate leprosy.

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