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Bedaquiline Dosage

Medically reviewed by Drugs.com. Last updated on Jan 10, 2020.

Applies to the following strengths: 100 mg

Usual Adult Dose for Tuberculosis - Resistant

Weeks 1 and 2: 400 mg orally once a day
Weeks 3 to 24: 200 mg orally 3 times a week, with at least 48 hours between doses
Duration of therapy: 24 weeks

Comments:
-Alcohol should be avoided during treatment.
-Treatment should be given by directly observed therapy (DOT).
-This drug was approved based on sputum culture conversion time in clinical trials; continued approval may be based upon verification and clinical benefit in confirmatory trials.
-Use of this drug should be limited to infections where effective treatment regimens cannot otherwise be provided.
-Treatment should be used with at least 3 other drugs to which the in-vitro multidrug resistant tuberculosis (MDR-TB) isolate has been shown to be susceptible OR with at least 4 other drugs to which the isolate is likely to be susceptible if in-vitro results are unavailable.

Use: Part of combination therapy in the treatment of pulmonary MDR-TB caused by Mycobacterium tuberculosis

Usual Pediatric Dose for Tuberculosis - Resistant

12 years and older:
30 kg and over:
-Weeks 1 and 2: 400 mg orally once a day
-Weeks 3 to 24: 200 mg orally 3 times a week, with at least 48 hours between doses
-Duration of therapy: 24 weeks

Comments:
-Alcohol should be avoided during treatment.
-Treatment should be given by DOT, and should be given in combination with other antimycobacterial agents.
-This drug was approved based on sputum culture conversion time in clinical trials; continued approval may be based upon verification and clinical benefit in confirmatory trials.
-Use of this drug should be limited to infections where effective treatment regimens cannot otherwise be provided.
-Treatment should be used with at least 3 other drugs to which the in-vitro MDR-TB isolate has been shown to be susceptible OR with at least 4 other drugs to which the isolate is likely to be susceptible if in-vitro results are unavailable.

Use: Part of combination therapy in the treatment of pulmonary MDR-TB caused by M tuberculosis

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction: Use with caution; frequent monitoring recommended.

Liver Dose Adjustments

All patients: Frequent liver function test and hepatotoxicity sign/symptom monitoring recommended.

Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: Use is recommended only if clearly needed and the benefit outweighs the risk. Frequent monitoring recommended.

New/worsening liver dysfunction: Patients should be tested for viral hepatitis, and other hepatotoxic medications should be discontinued.

Treatment Discontinuation:
This drug should be discontinued if the patient develops:
-AST elevations accompanied by total bilirubin elevations exceeding 2 times the upper limit of normal (2 x ULN)
-AST elevations greater than 8 x ULN
-AST elevations greater than 5 x ULN AND persisting longer than 2 weeks

Dose Adjustments

Missed Doses:
-Weeks 1 and 2: Skip the missed dose, then continue the daily dosing regimen; do not administer the missed dose the following day as a double dose.
-Weeks 3 to 24: Administer the missed dose as soon as possible, then resume the 3 times a week regimen.

Treatment Discontinuation:
This, and any other QT-prolonging agent(s), should be discontinued if the patient develops:
-Clinically significant ventricular arrhythmia
-QT interval of greater than 500 msec (confirmed with repeated ECG)

Precautions

CONTRAINDICATIONS:
-None.

US BOXED WARNINGS:
INCREASED MORTALITY:
-An increased risk of death was seen in the active component treatment group (11.4%) compared to the placebo treatment group (2.5%) in 1 placebo-controlled trial in adults.
Recommendation:
-This drug should be limited for use in patients 12 years of age and older when an effective treatment regimen cannot otherwise be provided.

QT PROLONGATION:
-QT prolongation can occur with use.
-Use with drugs that prolong the QT interval may cause additive prolongation.
Recommendations:
-Monitoring should include ECG.
-Use should be discontinued in patients who develop significant ventricular arrhythmias and/or in patients with significant QTcF interval prolongation (greater than 500 msec).

Safety and efficacy have not been established in patients younger than 12 years and/or weighing less than 30 kg.

Consult WARNINGS section for additional precautions.

Dialysis

End-stage renal disease (ESRD) requiring hemodialysis: Use with caution; frequent monitoring recommended.
ESRD requiring peritoneal dialysis: Use with caution; frequent monitoring recommended.

Other Comments

Administration advice:
-This drug should be taken with food.
-Doses should be swallowed whole with water.

Storage requirements:
-Protect from light.

General:
-Limitations of use: This drug should not be used in the treatment of drug-sensitive tuberculosis, extrapulmonary tuberculosis, infections caused by non-tuberculous mycobacteria, and/or latent infections due to M tuberculosis.
-There are limited safety and efficacy data for use in the treatment of MDR-TB in patients with HIV.

Monitoring:
-CARDIOVASCULAR: ECG at baseline, and regularly thereafter
-HEPATIC: Liver function tests and signs/symptoms of hepatotoxicity at baseline and regularly thereafter
-IMMUNOLOGIC: Susceptibility information for the background regimen (if possible)
-METABOLIC: Calcium, potassium, and magnesium levels at baseline and follow-up if QT prolongation occurs

Patient advice:
-Patients should be advised to avoid missing doses and to complete the entire course of therapy, even if they feel better.
-Patients should be told to report any unusual or severe side effects, including signs/symptoms of hepatotoxicity and/or QT prolongation.
-Patients should be instructed to tell their healthcare provider about all the medicines that they take, including prescription and non-prescription medicines.
-Inform patients that this drug may cause dizziness, and they should avoid driving or operating machinery if these side effects occur.
-Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.