Clofazimine

Clofazimine is a prescription medicine used to treat the symptoms of leprosy.

• Clofazimine is available under the following different brand names: Lamprene

Adult dosage

Capsule

• 50mg

Leprosy

Adult dosage

• Dapsone-sensitive multibacillary leprosy
• 50 mg orally once daily in combination with dapsone 100 mg/day and rifampicin 600 mg/day
• Administer for at least 2 years and continued, if possible, until negative skin smears are obtained
• At this time, monotherapy with an appropriate antileprosy drug can be instituted
• Well tolerated when dose does not exceed 100 mg/day
• Dapsone-resistant leprosy
• 100 mg orally once daily in combination with 1 or more other antileprosy drugs for 3 years, followed by monotherapy with 100 mg of clofazimine daily
• Clinical improvement usually can be detected within 1-3 months of treatment and is usually clearly evident by the 6 months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Clofazimine include:

• loss of appetite,
• diarrhea,
• nausea,
• vomiting,
• dry skin,
• discoloration (from pink to brownish-black) of skin, stools, urine, saliva, sweat, tears, or lining of the eyelids,
• changes in taste,
• dry eyes,
• irritated eyes,
• headaches,
• fever,
• increased blood sugar, and
• increased sensitivity to sunlight.

Serious side effects of Clofazimine include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• black or bloody stools,
• severe stomach pain,
• yellowing of the skin or eyes (jaundice),
• unusual weakness, and
• depression.

Rare side effects of Clofazimine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Clofazimine has severe interactions with the following drugs:
  • ceritinib
  • clarithromycin
• Clofazimine has serious interactions with the following drugs:
  • entrectinib
  • fexinidazole
  • glasdegib
  • hydroxychloroquine sulfate
  • ivosidenib
  • lefamulin
  • macimorelin
  • mobocertinib
  • pitolisant
  • ribociclib
• Clofazimine has moderate interactions with at least 24 other drugs.
• Clofazimine has minor interactions with the following drug: 
  • rifampin

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Contraindicated in patients with known hypersensitivity to clofazimine or any of the excipients of clofazimine

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Clofazimine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Clofazimine?”

Cautions

• Skin dryness and ichthyosis may occur; applying oil to the skin may relieve this effect
• Skin discoloration
  • Causes orange-pink to brownish-black discoloration of the skin, as well as discoloration of conjunctivae, tears, sweat, sputum, urine, and feces in 75-100% of patients; advise patients that skin discoloration is likely to occur and may take several months or years to reverse after the conclusion of therapy; other skin reactions associated with therapy include ichthyosis, dry skin, and pruritus
  • Advise patients regarding skin discoloration and monitor for depression or suicidal ideation during therapy (2 suicides reported)
• Severe gastrointestinal symptoms
  • Caution with GI problems (eg, abdominal pain and diarrhea)
  • Dosages more than 100 mg daily should be given for as short a period as possible (less than 3 months) and only under close medical supervision
  • Severe abdominal symptoms have necessitated exploratory laparotomies; rare reports have included splenic infarction, bowel obstruction, and GI bleeding; deaths reported with severe abdominal symptoms
  • May accumulate in various organs as crystals, including mesenteric lymph nodes and histiocytes at lamina propria of the intestinal mucosa, spleen, and liver; deposition in intestinal mucosa may lead to the intestinal obstruction that may necessitate exploratory laparotomy; splenic infarction, gastrointestinal bleeding, and death reported; doses more than 100 mg daily should be given for a short period as possible less than 3 months) and only under close medical supervision
  • If a patient complains of pain in the abdomen, nausea, vomiting, or diarrhea, initiate appropriate medical assessment and reduce daily dose, increase dosing interval, or discontinue therapy
• QT Prolongation
  • Cases of Torsades de Pointes with QT prolongation were reported in patients receiving dosage regimens containing more than 100 mg daily or in combination with QT-prolonging medications; for QT prolongation and Torsades de Pointes cases, the patient must remain under medical surveillance; monitor electrocardiograms (ECGs) for QT prolongation and cardiac rhythm disturbances
  • QT prolongation was reported in patients receiving therapy in combination with bedaquiline at recommended dosage regimen for each drug; monitor ECGs if coadministered to patients receiving bedaquiline, and discontinue therapy if clinically significant ventricular arrhythmia noted or if QTcF interval is 500 ms or greater; if syncope occurs, obtain ECG to detect QT prolongation

Pregnancy and Lactation

• Use with caution if benefits outweigh risks during pregnancy
• Crosses the human placenta; the skin of infants born to women who had received the drug during pregnancy was found to be deeply pigmented at birth
• Lactation
  • Distributed in human breast milk; do not administer to breastfeeding women unless indicated