Clofazimine

Administration

• Type: Antibiotic
• Dosage Forms: CAP 50mg
• Routes of Administration: Oral
• Common Trade Names: Lamprene

Adult Dosing

Hansen's disease, multibacillary

• 50mg PO qd x 12mo in combination with rifampin and dapsone
  • Give 300mg PO qmo x 12mo in addition to daily dose

Erythema nodosum leprosum

• 100mg PO bid x12wk, then 100mg PO qd 12-24wk
  • Start 100mg PO tid x12wek

Pediatric Dosing

Hansen's disease, multibacillary

• 10-14 yo: 50mg PO qod AND 150mg PO qmo x12mo in combination with rifampin and dapsone
• >15 yo: 50mg PO qd AND 300mg PO qmo x 12mo in combination with rifampin and dapsone

Special Populations

• Pregnancy Rating: C
• Lactation risk: Caution advised
• Renal dosing: not defined
• Hepatic dosing: not defined

Contraindications

• Allergy to class/drug
• Caution:
  • Electrolyte abnormality
  • Congenital long QT syndrome, QT prolongation or family history of long QT
  • Torsades de pointes, ventricular arrhythmias
  • Bradycardia
  • Recent MI
  • CHF

Adverse Reactions

Serious

• Severe abdominal symptoms
• Hepatitis, Jaundice
• Intestinal obstruction
• GI Bleeding
• Splenic infarction
• Thromboembolism
• QT Prolongation, Torsades de pointes

Common

• Skin discoloration
• Nausea/Vomiting, diarrhea, abdominal/epigastric pain
• Ichthyosis/xeroderma
• Pruritus/rash
• Discolored urine/feces/sputum/sweat
• Ocular pigmentation, ocular irritation
• Hyperglycemia
• ESR elevated

Pharmacology

• Half-life: 70 days
• Metabolism: Unknown
• Excretion: Feces primarily

Mechanism of Action

• Bacteriostatic or bactericidal: Binds to mycobacterial DNA, inhibiting growth

See Also

• Hansen's disease

References

• Lexicomp
• Aronoff GR, Bennett WM, Berns JS, et al, Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children, 5th ed. Philadelphia, PA: American College of Physicians; 2007.
• FDA Safety Alert. Med Watch. Lamprene (Clofazimine). Food and Drug Administration website. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm514749.htm. Accessed November 11, 2016.
• Freerksen E, Seydel JK. Critical comments on the treatment of leprosy and other mycobacterial infections with clofazimine. Arzneimittelforschung. 1992;42(10):1243-5. Review. [PubMed 1472145]
• Health Resources and Services Administration (HRSA). National Hansen's Disease (Leprosy) Program: Recommended Treatment Regimens. http://www.hansensdisease/diagnosis/recommendedtreatment.html. Accessed on March 31, 2016.
• Holdiness MR. Clinical pharmacokinetics of clofazimine. A review. Clin Pharmacokinet. 1989;16(2):74-85. [PubMed 2656045]
• Lamprene (clofazimine) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals; January 2019.
• Legendre DP, Muzny CA, Swiatlo E. Hansen's disease (Leprosy): current and future pharmacotherapy and treatment of disease-related immunologic reactions. Pharmacotherapy. 2012;32(1):27-37. [PubMed 22392826]
• Szeto W, Garcia-Buitrago MT, Abbo L, Rosenblatt JD, Moshiree B, Morris MI. Clofazimine enteropathy: a rare and underrecognized complication of mycobacterial therapy. Open Forum Infect Dis. 2016;3(3):ofw004. [PubMed 27800519]
• World Health Organization. Drugs Used in Leprosy. http://apps.who.int/medicinedocs/pdf/h2988e/h2988e.pdf. Accessed April 6, 2016.
• World Health Organization. WHO Expert Committee on Leprosy. World Health Organ Tech Rep Ser. 2012;(968):1-61, 1 p following 61. [PubMed 22970604]

Authors:

Claire, Jonathan Fletcher, Jonathan Warren