Recommended Treatment Regimen for Multi-Bacillary Leprosy Using Clofazimine
For multi-bacillary leprosy, clofazimine should be administered at a dosage of 50-100 mg daily as part of a multidrug therapy (MDT) regimen that includes rifampicin and dapsone. 1
Standard Multidrug Therapy Regimen for Multi-Bacillary Leprosy
- The World Health Organization (WHO) recommends a multidrug therapy regimen consisting of rifampicin, dapsone, and clofazimine for treating multi-bacillary leprosy 1, 2
- Clofazimine dosage should be 50-100 mg daily (self-administered) plus a supervised monthly dose of 300 mg 1, 3
- The standard duration of treatment for multi-bacillary leprosy is 12 months 2
- This regimen has been highly effective in reducing the global burden of leprosy, with significant decreases in registered cases since its implementation 2
Clofazimine Properties and Administration
- Clofazimine is a fat-soluble riminophenazine dye with both antimycobacterial and anti-inflammatory properties 4, 1
- It should be taken with meals or with milk to maximize absorption and reduce gastrointestinal adverse effects 4
- Available as 100 mg capsules (unlicensed medicine in some countries) 4
- Clofazimine has a long half-life of approximately 10 days, with higher bioavailability when taken with food 5
Monitoring During Treatment
- Regular clinical monitoring for treatment response is essential, with lesion flattening expected by 4-6 weeks after treatment initiation 1
- ECG monitoring is recommended at baseline, 2 weeks, and after addition of any new medication known to prolong QT interval 4, 1
- Routine laboratory monitoring (complete blood count, liver and kidney function) should be performed intermittently throughout treatment 4, 1
Common Adverse Effects and Management
- Skin discoloration: Pink to brownish-black skin pigmentation occurs in 75-100% of patients within 1-4 weeks; patients should be advised that this typically disappears within 6-12 months after stopping treatment 4, 3
- Dermatological effects: Ichthyosis and dry skin (8-38%), pruritus (5%), photosensitivity reactions 4
- Gastrointestinal effects: Abdominal pain, nausea, vomiting, diarrhea (up to 50% of patients) 4, 3
- Ocular effects: Conjunctival pigmentation (38-57%), subjective dimness of vision (12.3%), dry eyes and ocular irritation (24.6%) 4
Special Considerations
- QT interval prolongation: Monitor ECG when using clofazimine, especially when combined with other QT-prolonging medications 4, 1
- Potential cross-resistance with bedaquiline should be considered if treating concomitant tuberculosis 4
- Treatment should be continued during pregnancy as benefits outweigh risks, with close monitoring required 1
- For pediatric patients, the recommended dosage is 1-2 mg/kg/day (maximum 100 mg) 1
Alternative Regimens
- In cases of intolerance to standard MDT or relapses, alternative regimens containing minocycline, ofloxacin, and clofazimine have shown good tolerability and compliance 3
- Newer regimens with shorter duration (12 weeks) using multiple bactericidal drugs have been studied with promising results, but are not yet standard of care 6
- Pefloxacin and ofloxacin may be considered as adjunct drugs for increasing MDT efficacy in specific cases 7