Clofazimine (Cfz)

Update: August 2022

Forms and strengths

• 50 mg and 100 mg soft capsules or tablets

Dosage

• Child under 10 kg: doses are administered 3 times a week (Monday, Wednesday, Friday = M/W/F)

• Child 10 to 29 kg: 2 to 5 mg/kg once daily

• Child 30 kg and over and adult: 100 mg once daily

Contra-indications, adverse effects, precautions

• Do not administer to patients with hypersensitivity to clofazimine.
• Administer with caution to patients with severe hepatic impairment.
• May cause:
  • orange-brown discolouration of skin and body fluids;
  • strong QT prolongation;
  • gastrointestinal disturbances (nausea, vomiting, abdominal pain);
  • severe abdomen pain, bowel obstruction, intestinal bleeding;
  • eye and skin dryness and irritation, hypersensitivity reactions, photosensitivity.
• For the management of adverse effects, see Appendix 17.
• Avoid or use with caution and under close monitoring in patients taking other QT prolonging drugs (Appendix 19).
• Pregnancy: use only if the benefits outweigh the risks (safety is not established).
• Breast-feeding: avoid breastfeeding during treatment (safety not established). If used, may cause reversible breast milk discolouration and skin discolouration in breastfed infants.

Monitoring

• Symptomatic monitoring.
• ECG.

Patient instructions

• Take with food to improve gastrointestinal tolerance.
• Protect your skin from sun.
• Harmless orange-brown discoloration of the skin and body fluids (urine, sweat, saliva, sputum, tears, breast milk, etc.). It is reversible but may take months to disappear after stopping treatment.

Storage