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Rifabutin

    Brands

    DEA Class; Rx

    Common Brand Names; Mycobutin

    • Antitubercular Agents

    Antimycobacterial agent; alternative to clarithromycin or azithromycin for MAC prophylaxis; alternative to rifampin for TB prophylaxis or treatment.

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

    Hypersensitivity to rifamycins

    Concomitant live bacterial vaccines

    • Discoloration of urine (30%)
    • Neutropenia (25%)
    • Leukopenia (17%)
    • Rash (11%)
    • 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

    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

    Severe Cutaneous Adverse Reactions

    • Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) reported
    • Closely monitor patients that develop a skin rash; discontinue therapy if lesions progress
    • Specifically, for DRESS, a multi-system potential life-threatening SCAR, time to onset of first symptoms may be prolonged; DRESS is a clinical diagnosis, and its clinical presentation remains the basis for decision making; an early withdrawal of therapy is essential because of the syndrome’s mortality and visceral involvement (eg, liver, bone marrow or kidney)

    Rifabutin crosses the placenta

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

    Adults

    300 mg/day PO is the FDA-approved maximum dosage; 450 mg/day PO has been used off-label.

    Geriatric

    300 mg/day PO is the FDA-approved maximum dosage; 450 mg/day PO has been used off-label.

    Adolescents

    Safety and efficacy have not been established; 5 mg/kg/day (Max: 300 mg/day) PO has been used off-label.

    Children

    Safety and efficacy have not been established; 20 mg/kg/day (Max: 300 mg/day) PO has been used off-label.

    Infants

    Safety and efficacy have not been established; 20 mg/kg/day PO has been used off-label.

    Neonates

    Safety and efficacy have not been established.

    Rifabutin

    capsule

    • 150mg

    oral solution

    • 10mg/mL
    • 20mg/mL