rifabutin (Rx)

Brand and Other Names:Mycobutin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 150mg

oral solution

  • 10mg/mL
  • 20mg/mL

Mycobacterium avium Complex Prophylaxis

Indicated for prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection

300 mg PO qDay

Dosage Modifications

Nausea, vomiting, or GI upset: 150 mg PO BID with food

Renal impairment

  • Mild or moderate: No dose adjustment required
  • Severe (CrCl <30mL/min): Reduce dose by 50%

Hepatic impairment

  • Mild: No dose adjustment required
  • Moderate-to-severe: Not studied

Active Tuberculosis (off-label)

5 mg/kg PO qDay or 2-3x/week + other antitubercular agents, not to exceed 300 mg/dose

Mycobacterium avium Complex Treatment (Orphan)

Orphan designation for treatment of disseminated Mycobacterium avium complex disease

Sponsor

  • Pfizer, Inc; 235 East 42nd Street; New York, NY 10017

Dosage Forms & Strengths

capsule

  • 150mg

oral solution

  • 10mg/mL
  • 20mg/mL

Mycobacterium Avium Complex (Off-Label)

Treatment: 5-10 mg/kg PO qDay; not to exceed 300 mg/day

Prophylaxis: 1st episode in HIV/recurrence: 5 mg/kg PO qDay; not to exceed 300 mg/day

Active Tuberculosis with HIV (Off-label)

10-20 mg/kg PO qDay OR 2x/week + other antitubercular agents; not to exceed 300 mg/dose

Crohn Disease (Orphan)

Orphan designation for pediatric Crohn disease in combination with clarithromycin, rifabutin, and clofazimine

Sponsor

  • RedHill Biopharma Ltd; 42 Givati St; Israel
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Interactions

Interaction Checker

and rifabutin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Discoloration of urine (30%)

            Neutropenia (25%)

            Leukopenia (17%)

            Rash (11%)

            1-10%

            Incr AST/ALT (7-9%)

            Thrombocytopenia (5%)

            Abdominal pain (4%)

            Diarrhea (3%)

            Eructation (3%)

            Headache (3%)

            Nausea/vomiting (3%)

            Anorexia (2%)

            Flatulence (2%)

            Anemia

            Myalgia

            Postmarketing reports

            Blood and lymphatic system disorders: Agranulocytosis, lymphopenia, granulocytopenia, white blood cell count decreased, neutrophil count decreased), platelet count decreased

            Immune system disorders: Hypersensitivity, bronchospasm

            Gastrointestinal disorders: Clostridium difficile colitis/ Clostridium difficile associated diarrhea

            Pyrexia, rash and other hypersensitivity reactions such as eosinophilia, bronchospasm and shock might occur, as has been seen with other antibacterials; a limited number of skin discoloration have been reported

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            Warnings

            Contraindications

            Hypersensitivity to rifamycins

            Concomitant live bacterial vaccines

            Cautions

            Monitor hematologic status

            Eye pain, redness, loss of vision may indicate inflammatory ocular condition

            Joint stiffness, swelling, tenderness or paresthesia may indicate arthralgias or myositis

            May have brown-orange color of urine, feces, saliva, sputum, perspiration, tears, and skin

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            Pregnancy & Lactation

            Pregnancy

            Rifabutin crosses the placenta

            Animal studies

            • In rats and rabbit, doses up to 40 times the recommended human daily dose (RHDD) were not teratogenic
            • In rats, but fetal viability was decreased at the highest doses and at 8 times RHDD, fetal skeletal variation was observed
            • In rabbits, a dose of 16 times RHDD showed maternal toxicity

            Lactation

            No studies have examined if excreted in breast milk; however, women with HIV infection should not breastfeed

            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

            Inhibits DNA-dependent RNA polymerase

            Absorption

            Readily absorbed: 53%

            Bioavailability, absolute (HIV infected individual): 20%

            Peak plasma time: 2-4 hr

            Distribution

            Distributed in body tissues including the lungs, liver, spleen, eyes, & kidneys

            Vd: 9.32 L/kg

            Protein bound: 85%

            Metabolism

            Metabolized by hepatic CYP3A4 to active and inactive metabolites

            Elimination

            Half-life: 45 hr (range: 16-69 hr)

            Excretion

            • Urine: 10% as unchanged drug, 53% as metabolites
            • Feces: 10% as unchanged drug, 30% as metabolites
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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.