Clofazimine

What is clofazimine?

Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy. It is used in combination with rifampicin and dapsone for the treatment of the many forms of leprosy. In particular, it is used to treat erythema nodosum leprosum, the red lumps and thickened patches often seen in lepromatous leprosy.

Because of its anti-inflammatory effects, clofazimine is also sometimes used as a second or third line therapy for various skin conditions including:

• Pyoderma gangrenosum
• Lupus erythematosus
• Palmoplantar pustulosis.

Clofazimine is available as a 50 mg capsule. The trade name in New Zealand is Lamprene®.

How to use clofazimine

For the treatment of leprosy, clofazimine should always be given in combination with other specific antibiotics. Multidrug therapy is necessary to prevent the development of drug resistance.

To ensure maximum absorption clofazimine should be taken with food or with milk.

Precautions

Clofazimine should be not be used in the following patients. If clofazimine treatment is unavoidable, these patients should be monitored closely.

• Patients suffering repeatedly from abdominal pains and diarrhoea.
• Patients with liver damage.
• Patient with kidney damage.

If patients develop gastrointestinal symptoms such as diarrhoea or vomiting during treatment, the dosage should be reduced or the medication is taken less often. Failure to do this may result in accumulation of clofazimine in tissues that can lead to blockage of the intestines.

Clofazimine may be used in pregnant women with leprosy if the potential benefits justify the risk to the fetus. The World Health Organisation recommends that clofazimine is continued during pregnancy, as the symptoms of leprosy appear to worsen over this time. Clofazimine crosses the placenta, and skin discolouration has been seen in neonates.

Clofazimine also passes into breast milk resulting in skin discolouration in the infant.

What are the side effects of clofazimine?

Some side effects occur frequently (> 10%).

• Skin discolouration: reddish to brownish-black colour, particularly in fair-skinned patients at sites exposed to light. Discolouration of hair occurs in 75-100% of patients. It is reversible but may take several months to disappear after the end of treatment.
• Scaly and dry skin (acquired ichthyosis).
• Nausea, vomiting, diarrhoea and abdominal pain.
• Discolouration of the conjunctiva, cornea (eyes) and tears.
• Discolouration of sweat, sputum (spit), urine and faeces.

Side effects that occur rarely include:

• Dimness of vision: care required if driving or operating machinery
• Dry, irritated eyes
• Photosensitivity
• Weight loss and loss of appetite
• Depression, which may be due to skin discolouration.

Approved datasheets are the official source of information for medicines, including approved uses, doses, and safety information. Check the individual datasheet in your country for information about medicines.

We suggest you refer to your national drug approval agency such as the Australian Therapeutic Goods Administration (TGA), US Food and Drug Administration (FDA), UK Medicines and Healthcare products regulatory agency (MHRA) / emc, and NZ Medsafe, or a national or state-approved formulary eg, the New Zealand Formulary (NZF) and New Zealand Formulary for Children (NZFC) and the British National Formulary (BNF) and British National Formulary for Children (BNFC).