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clofazimine (Rx)Brand and Other Names:Lamprene

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 50mg
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Leprosy

Indicated for treatment of lepromatous leprosy, including dapsone-resistant leprosy complicated by erythema nodosum leprosum

No longer commercially available in the United States; only available by obtaining an investigational new drug (IND), see Dosing Considerations

Preferably used in combination with 1 or more other antileprosy agents to prevent the emergence of drug resistance

Most patients today are treated with dapsone and rifampin, and, in multibacillary cases, clofazimine

Dapsone-sensitive multibacillary leprosy

  • 50 mg PO qDay 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

Dapsone-resistant leprosy

  • 100 mg PO qDay 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 Modifications

Erythema nodosum leprosum reactions

  • Treatment depends on the severity of symptoms
  • Basic antileprosy treatment should be continued, and if nerve injury or skin ulceration is threatened, corticosteroids should be given
  • Where prolonged corticosteroid therapy becomes necessary, clofazimine administered at dosages of 100 to 200 mg daily for up to 3 months may be useful in eliminating or reducing corticosteroid requirements
  • Dosages >200 mg/day are not recommended
  • Taper dose to 100 mg/day as quickly as possible after the reactive episode is controlled

Dosing Considerations

No longer commercially available in the United States

Clofazimine can be obtained by submitting an IND through the National Hansen’s Disease (Leprosy) Program (NHDP)

The prescriber is considered to be an investigator and must submit an FDA form 1572 and curriculum vitae to the National Hansen’s Disease Program from the U.S. Department of Health and Human Services

The institutional review board is provided by the Centers for Disease Control and Prevention Consent forms and other documents will be provided to the prescriber upon request

For more information, visit www.hrsa.gov/hansensdisease/ or call 1-800-642-2477

Tuberculosis (Orphan)

Orphan designation for treatment of active tuberculosis

Sponsor

  • Novartis Pharmaceuticals Corp; One Health Plaza, Bldg 135/409; East Hanover, NJ 07936-1080

Administration

Take with meals

Safety and efficacy not established; limit data are available from the National Hansen’s Disease (Leprosy) Program (NHDP)

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Interactions

Interaction Checker

clofazimine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Well tolerated when dose does not exceed 100 mg/day

            >10%

            Skin discoloration (75-100%)

            Gastrointestinal: Abdominal and epigastric pain, diarrhea, nausea, vomiting, GI intolerance (40%-50%)

            Ichthyosis and dry skin (8-28%)

            1-10%

            Rash and pruritus (1-5%)

            Ocular: Conjunctival and corneal pigmentation due to crystal deposits, dryness, burning, itching, irritation (>1%)

            Discoloration of urine, feces, sputum, sweat (>1%)

            Increased blood glucose (>1%) Increased ESR (>1%)

            <1%

            Skin: Phototoxicity, erythroderma, acneiform eruptions, monilial cheilosis

            Gastrointestinal: Bowel obstruction, GI bleeding, anorexia, constipation, weight loss, hepatitis, jaundice, eosinophilic enteritis, enlarged liver

            Ocular: Diminished vision

            Nervous: Dizziness, drowsiness, fatigue, headache, giddiness, neuralgia, taste disorder

            Psychiatric: Depression secondary to skin discoloration

            Laboratory: Elevated levels of albumin, serum bilirubin, and AST (SGOT), eosinophilia, hypokalemia

            Other: Splenic infarction, thromboembolism, anemia, cystitis, bone pain, edema, fever, lymphadenopathy, vascular pain

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            Warnings

            Contraindications

            None

            Cautions

            Skin dryness and ichthyosis may occur; apply oil to skin may relieve this effect

            Skin discoloration

            • Causes skin discoloration (pink-red to brownish-black) in most patients within a few weeks of treatment; this effect may result in depression (2 suicides reported)
            • Discoloration of the conjunctivae, lacrimal fluid, sweat, sputum, urine, and feces also reported
            • Skin discoloration, although reversible, may take several months or years to disappear after discontinuing clofazimine

            Severe gastrointestinal symptoms

            • Caution with GI problems (eg, abdominal pain and diarrhea)
            • Dosages >100 mg daily should be given for as short a period as possible 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
            • Autopsies have revealed crystalline deposits of clofazimine in various tissues including the intestinal mucosa, liver, spleen, and mesenteric lymph nodes
            • If patient complains of colicky or burning pain in the abdomen, nausea, vomiting, or diarrhea, the dose should be reduced and/or interval between doses should be increased, or the drug should be discontinued
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            Pregnancy & Lactation

            Pregnancy Category: C

            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 clearly indicated

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Exerts a slow bactericidal effect on Mycobacterium leprae (Hansen’s bacillus); inhibits mycobacterial growth and binds preferentially to mycobacterial DNA

            Also exerts anti-inflammatory properties in controlling erythema nodosum leprosum reactions; however, its precise mechanisms of action are unknown

            Absorption

            45-62% (PO): variable absorption rate in patients with leprosy

            Serum concentration: 0.7-1 mcg/mL (100-300 mg/day)

            Distribution

            Highly lipophilic and tends to be deposited predominantly in fatty tissue and in cells of the reticuloendothelial system; taken up by macrophages throughout the body

            Elimination

            Half-life: 70 days (at steady state)

            Excretion: Negligible in urine; small amount in feces and bile; small amount sputum, sebum, and sweat

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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