Bedaquiline

Dosing

Multidrug resistant tuberculosis, In combination with at least 3 other agents 400 mg PO once daily x2w, then 200 mg PO 3 times weekly for additional 22wNo renal dose adjustment

Multidrug resistant tuberculosis, In combination with at least 3 other agents

Age ≥5y BW ≥30 kg 400 mg PO once daily x2w, then 200 mg PO 3 times weekly for additional 22w

BW 15 to <30 kg 200 mg PO once daily x2w, then 100 mg PO 3 times weekly for 22wNo renal dose adjustment

Mild to moderate hepatic impairment No dose adjustment

Severe hepatic impairment Not recommended unless benefit outweighs risk

General Information

Multidrug resistant tuberculosis, in combination with at least 3 other agents.

Obtain sputum for mycobacterial culture and susceptibility testing prior to and during treatment.

Monitor liver function tests at baseline and during treatment.

Measure serum calcium, magnesium, and potassium at baseline.

Monitor ECG before initiation and during treatment.

Common

  • Chest pain

  • Abdominal pain

  • Nausea

  • Arthralgia

  • Headache

  • Hemoptysis

Serious

  • Prolonged QT interval

  • Increased liver enzymes

  • CYP3A4 inhibitors

  • CYP3A4 inducers

  • QTc prolongating drugs

  • Ethanol

Multiple drug-drug interactions

Antimicrobial class: Diarylquinoline

Pregnancy category: B

Average serum half life: 24-30 hours (effective) 4-5 months (terminal)

Precautions: Monitoring recommended and discontinue use with appearance of a clinically significant ventricular arrhythmia or a QTc interval of greater than 500 milliseconds (confirmed by repeat ECG).

Monitoring recommended and discontinue use if aminotransferase elevations are greater than 8 times ULN, or are greater than 5 times ULN and persist beyond 2 weeks, or are accompanied by total bilirubin greater than 2 times ULN.

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