Use of clofazimine for treating ENL reactions in leprosy
Most of the existing production of clofazimine by Novartis is donated through WHO for the supply of multidrug therapy (MDT) packs for the treatment of leprosy (WHO supplies close to 100% of global needs as part of its leprosy elimination project).
Since 2003, a smaller and limited amount of loose clofazimine has also been made available by Novartis under a separate donation, again through WHO, specifically for the treatment of severe erythema nodosum leprosum (ENL) reactions in leprosy and only on official request from Ministries of Health and recognised institutions.
The availability of loose clofazimine is limited to the treatment of severe ENL reactions only. The “off-label” use of clofazimine is actively discouraged by WHO because it is a first line drug for the treatment of leprosy, and its indiscriminate use must be guarded against to prevent resistance. Pharmaceutical agencies that previously supplied this product, such as IDA Netherlands and Action Medor (Germany) no longer do so, and refer enquiries from potential customers to WHO, which then contacts the countries of agencies or institutes direct. A free supply is only made available by WHO when it is clear that the intended use of the drug is for the treatment of severe ENL reactions in leprosy.
Some countries have started using the drug in the treatment of multi-drug resistant tuberculosis (MDR TB) and in mycobacterium avium complex (MAC) infections in acquired immune deficiency syndome (AIDS), but WHO has found no evidence of its effectiveness for these forms of treatment. However, if the intended use is for MDR-TB the request is refered to TB colleagues at WHO for their appraisal and possible approval, on a named patient basis. It should be noted that approval is only made on an exceptional basis
If the intended use is not for leprosy, nor for MDR-TB, supplies of Lamprene can be obtained on a commercial basis from: Victoria Pharmacy Attention Dr. C. Egloff, Bahnhofstrasse 71 Zurich 8021 Switzerland Tel: +41 44 211 2432 Fax: +41 44 221 23 22 Email: firstname.lastname@example.org Website: www.pharmaworld.com