Rifabutin

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

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