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Bedaquiline: Drug information

Bedaquiline: Drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Bedaquiline: Patient drug information" and "Bedaquiline: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
QTc prolongation:

QTc prolongation can occur with bedaquiline. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue bedaquiline if significant ventricular arrhythmia or QTc interval >500 msec develops.

Brand Names: US
  • Sirturo
Pharmacologic Category
  • Antitubercular Agent
Dosing: Adult
Tuberculosis, multidrug resistant, pulmonary

Tuberculosis, multidrug resistant, pulmonary:

Note: Expert consultation for optimal regimen and duration of treatment is advised.

Oral: Directly observed therapy: 400 mg once daily for 2 weeks, followed by 200 mg 3 times weekly with doses spaced ≥48 hours apart; use as part of an appropriate combination regimen (Ref). Alternatively, a regimen of 200 mg once daily for 8 weeks, followed by 100 mg once daily for 18 weeks, has been studied in combination with linezolid and pretomanid (Ref).

Missed doses: 400 mg once daily for 2 weeks, followed by 200 mg 3 times weekly regimen: If a dose is missed during the first 2 weeks, do not make up the missed dose, and continue the usual dosing schedule. From week 3 onward, if a dose is missed, administer the missed dose as soon as possible, and resume the 3 times a week schedule; the total dose during a 7-day period should not exceed the recommended weekly dose of 600 mg (with ≥24 hours between doses).

Duration: Individualize based on rapidity of culture conversion, extent of disease, and patient-specific factors, including clinical response and toxicity (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Mild to moderate renal impairment: No dosage adjustment necessary.

Severe renal impairment: There are no dosage adjustments provided in the manufacturer's labeling; use with caution and monitor for adverse reactions.

End-stage renal disease (ESRD) on intermittent hemodialysis (IHD) or peritoneal dialysis (PD): There are no dosage adjustments provided in the manufacturer's labeling; use with caution and monitor for adverse reactions. Bedaquiline is highly protein bound and not likely to be removed by dialysis.

Dosing: Liver Impairment: Adult

Mild or moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution and monitor for adverse reactions.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Bedaquiline: Pediatric drug information")

Tuberculosis, pulmonary

Tuberculosis, pulmonary:

Note : Recommended only in patients with drug-resistant tuberculosis. Always administer as part of a combination regimen with at least 3 to 4 additional drugs active against the patient's M. tuberculosis isolate; see guidelines for details. Although the manufacturer recommends only 6 months of therapy in patients <16 years of age, longer durations may be necessary in consultation with experts and close monitoring (Ref). Administer as directly observed therapy (DOT).

Infants <3 months: Limited data available:

3 to <10 kg: Oral: 30 mg once daily for 2 weeks, then 10 mg 3 times weekly on Mondays, Wednesdays, and Fridays. For patients weighing <5 kg, use in consultation with an expert in pediatric drug-resistant tuberculosis whenever possible (Ref).

Infants 3 to <6 months: Limited data available:

3 to <16 kg: Oral: 60 mg once daily for 2 weeks, then 20 mg 3 times weekly on Mondays, Wednesdays, and Fridays. For patients weighing <5 kg, use in consultation with an expert in pediatric drug-resistant tuberculosis whenever possible (Ref).

Infants ≥6 months and Children <5 years: Limited data available:

3 to <7 kg: Oral: 60 mg once daily for 2 weeks, then 20 mg 3 times weekly on Mondays, Wednesdays, and Fridays. For patients weighing <5 kg, use in consultation with an expert in pediatric drug-resistant tuberculosis whenever possible (Ref).

7 to <10 kg: Oral: 80 mg once daily for 2 weeks, then 40 mg 3 times weekly on Mondays, Wednesdays, and Fridays (Ref).

10 to <16 kg: Oral: 120 mg once daily for 2 weeks, then 60 mg 3 times weekly on Mondays, Wednesdays, and Fridays (Ref).

16 to <30 kg: Oral: 200 mg once daily for 2 weeks, then 100 mg 3 times weekly on Mondays, Wednesdays, and Fridays (Ref).

30 to <46 kg: Oral: 400 mg once daily for 2 weeks, then 200 mg 3 times weekly on Mondays, Wednesdays, and Fridays (Ref).

Children ≥5 years and Adolescents:

15 to <30 kg: Oral: 200 mg once daily for 2 weeks, then 100 mg 3 times weekly with at least 48 hours between doses (eg, Monday, Wednesday, Friday) (Ref).

≥30 kg: Oral: 400 mg once daily for 2 weeks, then 200 mg 3 times weekly with at least 48 hours between doses (eg, Monday, Wednesday, Friday) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity: Children ≥5 years and Adolescents: Arrhythmia, QT prolongation: If clinically significant ventricular arrhythmia or QTc interval >500 msec (ECG confirmed): Discontinue therapy.

Dosing: Kidney Impairment: Pediatric

Children ≥5 years and Adolescents: Oral:

Mild to moderate renal impairment: No dosage adjustment necessary.

Severe renal impairment: There are no dosage adjustments provided in the manufacturer's labeling; use with caution and monitor for adverse reactions.

End-stage renal disease (ESRD) on intermittent hemodialysis (IHD) or peritoneal dialysis (PD): There are no dosage adjustments provided in the manufacturer's labeling; use with caution and monitor for adverse reactions. Bedaquiline is highly protein bound and not likely to be removed by dialysis.

Dosing: Liver Impairment: Pediatric

Children ≥5 years and Adolescents: Oral:

Baseline (at initiation of therapy):

Mild or moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution and monitor for adverse reactions.

Hepatotoxicity during therapy: Discontinue therapy if any of the following presents: Aminotransferase elevation and total bilirubin >2 times ULN, aminotransferase elevation >8 times ULN, or aminotransferase elevation >5 times ULN and for >2 weeks.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported with combination therapy in adults.

>10%:

Cardiovascular: Chest pain (11%)

Gastrointestinal: Nausea (38%)

Hepatic: Increased serum transaminases (9% to 11%)

Nervous system: Headache (28%)

Neuromuscular & skeletal: Arthralgia (33%)

Respiratory: Hemoptysis (18%)

1% to 10%:

Dermatologic: Skin rash (8%)

Gastrointestinal: Anorexia (9%), increased serum amylase (3%)

Frequency not defined:

Cardiovascular: Prolonged QT interval on ECG

Hepatic: Hepatotoxicity

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Hepatic effects: Increased risk of hepatic reactions; avoid alcohol intake and other known hepatotoxic drugs, especially in patients with impaired hepatic function. Test for viral hepatitis and discontinue other hepatotoxic medications if evidence of new or worsening hepatic disease occurs. Discontinue use if aminotransferase elevations are accompanied by total bilirubin elevation >2 times ULN, aminotransferase elevations are >8 times ULN, or aminotransferase elevations are >5 times ULN and continue for >2 weeks.

• Increased mortality: An increased risk of death was seen in the bedaquiline treatment group, compared to the placebo treatment group, in one placebo-controlled trial in adults. The imbalance in deaths is unexplained; no discernible pattern between death and sputum culture conversion, relapse, sensitivity to other drugs used to treat tuberculosis, HIV status, or severity of disease could be identified. In a subsequent active-controlled trial in adults, increased mortality was not observed.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Sirturo: 20 mg

Sirturo: 100 mg [contains corn starch]

Generic Equivalent Available: US

No

Pricing: US

Tablets (Sirturo Oral)

20 mg (per each): $38.30

100 mg (per each): $191.49

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Administer by directly observed therapy. For dosing week 3 and beyond, space doses at least 48 hours apart.

Oral: Tablet-specific administration information:

100 mg tablets: Administer with food; swallow whole.

20 mg tablets:

For patients who can swallow intact tablets: Administer whole or divided in half with food.

For patients who cannot swallow intact tablets, administer using one of the following methods:

• Method 1: In a cup, disperse up to 5 tablets in 5 mL of water; mix well until tablets are completely dispersed, and then either administer the contents of the cup, or if desired, the dispersed mixture in water can be further mixed with ≥5 mL of a beverage (eg, water, milk products, apple juice, orange juice, cranberry juice, carbonated beverage) or 1 teaspoonful of soft food (eg, yogurt, applesauce, mashed banana, porridge) and then administered. If the total dose requires >5 tablets, repeat the preparation steps with the appropriate number of additional tablets until the desired dose is reached. Rinse remaining tablet residue from the cup (with more beverage or soft food) and consume immediately. Food should be consumed following administration of the final desired dose.

• Method 2: In a container, crush tablets and mix with soft food (eg, yogurt, applesauce, mashed banana, porridge) then administer immediately. Rinse remaining tablet residue from the container (with more soft food) and consume immediately.

Feeding tube: Using the 20 mg tablets only, disperse up to 5 tablets in 50 mL of noncarbonated water and mix well (mixture should be white to almost white with visible particles); administer immediately through a feeding tube (≥8 French). If the total dose requires >5 tablets, repeat the preparation steps with the appropriate number of additional tablets until the desired dose is reached. Rinse and flush with 25 mL of additional water to remove any remaining tablet residue in the items used for preparation or the feeding tube. Food should be consumed following administration of the final desired dose.

Administration: Pediatric

Note: Administer as directly observed therapy (DOT). During weeks 3 to 24 of treatment (3-times-per-week dosing), doses should be separated by ≥48 hours.

Oral: Administration with a high-fat meal is preferred to improve exposure (Ref).

100 mg tablets : Administer with food; swallow tablets whole with water. When 20 mg dispersible tablets are not available, crushing and dissolving each 100 mg tablet in 10 mL of water has been described; use of 20 mg tablets is preferred for patients unable to swallow tablets whole (Ref).

20 mg tablets :

For patients who can swallow intact tablets: Administer with food; swallow tablets whole or divided in half with water.

For patients who cannot swallow intact tablets:

Method 1: In a cup, disperse up to 5 tablets in 5 mL of water; mix well until tablets are completely dispersed; administer the contents of the cup with food, or, if desired, the dispersed mixture in water can be further mixed with ≥5 mL of a beverage (eg, water, milk products, apple juice, orange juice, cranberry juice, carbonated beverage) or 1 teaspoonful of soft food (eg, yogurt, applesauce, mashed banana, porridge) and then administered. Rinse remaining tablet residue from the cup (with more beverage or soft food) and consume immediately. If the total dose requires >5 tablets, repeat the preparation steps with the appropriate number of additional tablets until the desired dose is reached. Food should be consumed following administration of the final desired dose.

Method 2: In a container, crush tablets and mix with soft food (eg, yogurt, applesauce, mashed banana, porridge) then administer immediately. Rinse remaining tablet residue from the container (with more soft food) and consume immediately.

Administration via feeding tube: Using the 20 mg tablets only, disperse up to 5 tablets in 50 mL of noncarbonated water and mix well (mixture should be white to almost white with visible particles); administer through a feeding tube (≥8 French). If the total dose requires >5 tablets, repeat the preparation steps with the appropriate number of additional tablets until the desired dose is reached. Rinse and flush with 25 mL of additional water to remove any remaining tablet residue in the items used for preparation or the feeding tube. Food should be consumed following administration of the final desired dose.

Missed doses:

Weeks 1 and 2 (once-daily dosing): If a dose is missed, do not make up the missed dose and continue the usual dosing schedule.

Weeks ≥3 (3-times-weekly dosing): If a dose is missed, administer the missed dose as soon as possible and resume the 3-times-weekly schedule.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204384s017lbl.pdf#page=27, must be dispensed with this medication.

Use: Labeled Indications

Tuberculosis, multidrug resistant, pulmonary: Treatment of pulmonary tuberculosis (TB) resistant to at least rifampin and isoniazid, as part of combination therapy, in pediatric patients ≥5 years of age (weighing ≥15 kg) and adults.

Limitations of use: Do not use for the treatment of extrapulmonary TB, TB infection (latent TB), drug-sensitive TB, or infections caused by non-tuberculous mycobacteria.

Metabolism/Transport Effects

Substrate of CYP2C19 (Minor), CYP2C8 (Minor), CYP3A4 (Major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Alcohol (Ethyl): May increase hepatotoxic effects of Bedaquiline. Risk X: Avoid

Amiodarone: QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Amiodarone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Amisulpride (Oral): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Amisulpride (Oral). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even greater risk. Risk D: Consider Therapy Modification

Arsenic Trioxide: QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Arsenic Trioxide. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Azithromycin (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Azithromycin (Systemic). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification

BCG (Intravesical): Antibiotics may decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid

BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor

Carbetocin: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Chloroquine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Chloroquine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid

Citalopram: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Citalopram. Risk X: Avoid

Clarithromycin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Clarithromycin. Risk X: Avoid

Clofazimine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Clofazimine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

ClomiPRAMINE: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

CloZAPine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of CloZAPine. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

CYP3A4 Inducers (Moderate): May decrease serum concentration of Bedaquiline. CYP3A4 Inducers (Moderate) may increase active metabolite exposure of Bedaquiline. Risk X: Avoid

CYP3A4 Inducers (Strong): May decrease serum concentration of Bedaquiline. CYP3A4 Inducers (Strong) may decrease active metabolite exposure of Bedaquiline. Risk X: Avoid

CYP3A4 Inhibitors (Moderate): May increase serum concentration of Bedaquiline. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Bedaquiline. Risk C: Monitor

CYP3A4 Inhibitors (Strong): May increase serum concentration of Bedaquiline. CYP3A4 Inhibitors (Strong) may increase active metabolite exposure of Bedaquiline. Risk C: Monitor

Dabrafenib: May increase QTc-prolonging effects of Bedaquiline. Dabrafenib may decrease active metabolite exposure of Bedaquiline. Dabrafenib may decrease serum concentration of Bedaquiline. Risk X: Avoid

Dasatinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Dasatinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Domperidone: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Domperidone. Risk X: Avoid

Doxepin-Containing Products: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Doxepin-Containing Products. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Dronedarone: QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Dronedarone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

DroPERidol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of DroPERidol. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Encorafenib: May increase QTc-prolonging effects of Bedaquiline. Encorafenib may decrease active metabolite exposure of Bedaquiline. Encorafenib may decrease serum concentration of Bedaquiline. Risk X: Avoid

Entrectinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk X: Avoid

Escitalopram: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Escitalopram. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Etelcalcetide: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid

Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid

Fexinidazole: May increase QTc-prolonging effects of Bedaquiline. Fexinidazole may decrease serum concentration of Bedaquiline. Fexinidazole may increase active metabolite exposure of Bedaquiline. Risk X: Avoid

Fingolimod: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias (including TdP) with a continuous overnight ECG when fingolimod is combined with QT prolonging drugs. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Flecainide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Flecainide. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Fluconazole: May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Fluconazole. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Fluorouracil Products: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Fluorouracil Products. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Flupentixol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Flupentixol. Risk X: Avoid

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Gadobenate Dimeglumine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Gadobenate Dimeglumine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Gemifloxacin: May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Gilteritinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. If use is necessary, monitor for QTc interval prolongation and arrhythmias. Risk D: Consider Therapy Modification

Grapefruit Juice: May increase serum concentration of Bedaquiline. Grapefruit Juice may increase active metabolite exposure of Bedaquiline. Risk C: Monitor

Halofantrine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Halofantrine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Haloperidol: QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Haloperidol. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

HydrOXYzine: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk C: Monitor

Imipramine: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Inotuzumab Ozogamicin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Inotuzumab Ozogamicin. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor

Lefamulin: May increase QTc-prolonging effects of QT-prolonging CYP3A4 Substrates. Management: Do not use lefamulin tablets with QT-prolonging CYP3A4 substrates. Lefamulin prescribing information lists this combination as contraindicated. Risk X: Avoid

Levofloxacin-Containing Products (Systemic): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Levoketoconazole: QT-prolonging CYP3A4 Substrates may increase QTc-prolonging effects of Levoketoconazole. Levoketoconazole may increase serum concentration of QT-prolonging CYP3A4 Substrates. Risk X: Avoid

Lofexidine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Lofexidine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Lopinavir: May increase serum concentration of Bedaquiline. Lopinavir may increase active metabolite exposure of Bedaquiline. Management: Consider alternatives to this combination. Concomitant use should only occur if the benefit of coadministration outweighs the risk. If combined, monitor for increased bedaquiline effects/toxicities (eg, QTc interval prolongation). Risk D: Consider Therapy Modification

Meglumine Antimoniate: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Methadone: May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Midostaurin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Midostaurin. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Moxifloxacin (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Moxifloxacin (Systemic). Risk X: Avoid

Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor

Nilotinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Nilotinib. Risk X: Avoid

OLANZapine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of OLANZapine. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Ondansetron: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Ondansetron. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Osimertinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Osimertinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Oxytocin: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

PAZOPanib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of PAZOPanib. Risk X: Avoid

Pentamidine (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pentamidine (Systemic). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Pilsicainide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pilsicainide. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Pimozide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pimozide. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk X: Avoid

Piperaquine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Piperaquine. Risk X: Avoid

Posaconazole: May increase serum concentration of QT-prolonging CYP3A4 Substrates. Such increases may lead to a greater risk for proarrhythmic effects and other similar toxicities. Risk X: Avoid

Probucol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Probucol. Risk X: Avoid

Propafenone: May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Propofol: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Agents (Indeterminate Risk - Avoid): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Agents (Indeterminate Risk - Caution): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Class IA Antiarrhythmics (Highest Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Class III Antiarrhythmics (Highest Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-Prolonging Inhalational Anesthetics (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Kinase Inhibitors (Highest Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Miscellaneous Agents (Highest Risk): May increase QTc-prolonging effects of Bedaquiline. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk) may increase serum concentration of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this combination. If combined, monitor for increased toxicities, including QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): May increase QTc-prolonging effects of Bedaquiline. QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase serum concentration of Bedaquiline. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QUEtiapine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of QUEtiapine. Risk X: Avoid

Quizartinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Ribociclib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Ribociclib. Risk X: Avoid

RisperiDONE: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of RisperiDONE. QT-prolonging Agents (Highest Risk) may increase CNS depressant effects of RisperiDONE. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Sertindole: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk X: Avoid

Sodium Picosulfate: Antibiotics may decrease therapeutic effects of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider Therapy Modification

Sparfloxacin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Sparfloxacin. Risk X: Avoid

SUNItinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of SUNItinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Terbutaline: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Thioridazine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Thioridazine. Risk X: Avoid

Toremifene: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Toremifene. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification

Vemurafenib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Vemurafenib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Food Interactions

Administration with a standard meal (~22 g fat; 558 calories) increases bioavailability by approximately twofold. Management: Administer with food.

Reproductive Considerations

Evaluate pregnancy status prior to treatment of multidrug-resistant tuberculosis in females of reproductive potential. Females of reproductive potential should use effective contraception during treatment for multidrug-resistant tuberculosis (Esmail 2018).

Pregnancy Considerations

Information related to bedaquiline use during pregnancy is limited. An increased risk of low birth weight infants was found following in utero bedaquiline exposure; however, this was found not to be clinically significant over time (Jaspard 2017; Loveday 2020; WHO 2020).

Tuberculosis (TB) disease (active TB) is associated with adverse fetal outcomes, including intrauterine growth restriction, low birth weight, preterm birth, and perinatal death (Esmail 2018; Miele 2020), as well as adverse maternal outcomes, including increased risks for anemia and cesarean delivery. Placental transmission may rarely occur with active maternal disease (Miele 2020).

Data are limited for use of second-line drugs during pregnancy (ie, bedaquiline). The treatment of multidrug-resistant tuberculosis in pregnant patients should be individualized; evidence to support a specific regimen is not available (ATS/CDC/ERS/IDSA [Nahid 2019]; WHO 2020). Bedaquiline should be reserved for use during pregnancy when an effective treatment regimen cannot otherwise be provided (CDC 2013).

Breastfeeding Considerations

Bedaquiline is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment and for 27.5 months after the last bedaquiline dose, unless infant formula is not available. Infants exposed to bedaquiline via breast milk should be monitored for adverse events, such as hepatotoxicity.

Monitoring Parameters

Susceptibility information for the background regimen against M. tuberculosis isolate should be obtained if possible. ECG should be obtained at baseline, after the initial 2 weeks, and monthly thereafter during therapy (ATS/CDC/ERS/IDSA [Nahid 2019]). Monitor ECG weekly with concurrent administration of other medications known to prolong the QTc interval (including fluoroquinolones, macrolide antibiotics, or clofazimine) or if the patient has ongoing or a history of conditions predisposing them to QTc prolongation (torsade de pointes, congenital long QT syndrome, hypothyroidism, uncompensated heart failure, bradyarrhythmias) (CDC 2013). If QTc prolongation is detected during therapy, monitor ECG frequently to confirm QTc return to baseline. Baseline potassium, calcium, and magnesium should be obtained and corrected, if abnormal, and monitored during therapy (ATS/CDC/ERS/IDSA [Nahid 2019]). Discontinue therapy (and all other QT prolonging drugs) if patient develops confirmed QTcF interval of >500 ms (confirmed by repeat ECG) or ventricular arrhythmia.

Monitor AST, ALT, alkaline phosphatase, and bilirubin, and symptoms of liver dysfunction (eg, fatigue, nausea, anorexia, jaundice, dark urine, liver tenderness, hepatomegaly) at baseline, monthly during treatment, and as needed. Monitor more frequently if patient has underlying hepatic disease or is receiving concomitant hepatotoxic drugs (CDC 2013). Further evaluate patients with evidence of liver dysfunction (AST/ALT and/or bilirubin elevations, and/or symptoms [eg fatigue, nausea, anorexia, hepatomegaly]). Discontinue if AST or ALT elevations are >5 times ULN and persist >2 weeks, are >8 times ULN, or if elevations also include total bilirubin >2 times ULN.

Monitor weekly for arthralgias, chest pain, headache, hemoptysis, nausea, and rash. Monitoring serum bedaquiline levels may be considered in patients with renal impairment. Sputum specimens should be evaluated monthly throughout treatment and at the end of treatment, even if cultures become negative. Specimens positive for M. tuberculosis (including pretreatment specimen) should be evaluated further by a laboratory (in conjunction with a state public health laboratory) that performs bedaquiline resistance testing (CDC 2013).

Mechanism of Action

As a diarylquinoline antimycobacterial, inhibits the proton transfer chain of mycobacterial ATP synthase required for energy generation in M. tuberculosis. It is not active against human ATP synthase.

Pharmacokinetics (Adult Data Unless Noted)

Note: Pharmacokinetic data in pediatric patients (age range: 5 to 17 years; weight: 14 to 75 kg) reported to be similar to in adults; may be variable in some patients.

Absorption: Significantly increased with food

Distribution: Vd: ~164 L

Protein binding: >99.9%

Metabolism: Hepatic via CYP3A4; forms N-monodesmethyl metabolite (M2) which has 4 to 6 times less antimycobacterial potency than parent drug

Half-life elimination: Terminal: ~5.5 months (bedaquiline and M2 metabolite)

Time to peak, serum: Oral: Adolescents: ~4 hours; Adults: ~5 hours

Excretion: Feces; urine (≤0.001%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: Mean exposure is ~20% lower in patients with moderate impairment (Child-Pugh class B).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Sirturo;
  • (AT) Austria: Sirturo;
  • (BE) Belgium: Sirturo;
  • (BG) Bulgaria: Sirturo;
  • (CL) Chile: Bedaquilina;
  • (CZ) Czech Republic: Sirturo;
  • (DE) Germany: Sirturo;
  • (EE) Estonia: Sirturo;
  • (EG) Egypt: Sirturo;
  • (ES) Spain: Sirturo;
  • (ET) Ethiopia: Sirturo;
  • (FI) Finland: Sirturo;
  • (FR) France: Sirturo;
  • (GB) United Kingdom: Sirturo;
  • (HK) Hong Kong: Sirturo;
  • (HU) Hungary: Sirturo;
  • (IE) Ireland: Sirturo;
  • (IT) Italy: Sirturo;
  • (JP) Japan: Sirturo;
  • (KR) Korea, Republic of: Sirturo;
  • (LT) Lithuania: Sirturo;
  • (MX) Mexico: Sirturo;
  • (MY) Malaysia: Sirturo;
  • (NL) Netherlands: Sirturo;
  • (NO) Norway: Sirturo;
  • (NZ) New Zealand: Sirturo;
  • (PE) Peru: Sirturo;
  • (PH) Philippines: Sirturo;
  • (PL) Poland: Sirturo;
  • (PR) Puerto Rico: Sirturo;
  • (PT) Portugal: Sirturo;
  • (RO) Romania: Sirturo;
  • (RU) Russian Federation: Sirturo;
  • (SA) Saudi Arabia: Sirturo;
  • (SE) Sweden: Sirturo;
  • (SI) Slovenia: Sirturo;
  • (SK) Slovakia: Sirturo;
  • (TR) Turkey: Sirturo;
  • (TW) Taiwan: Sirturo;
  • (UA) Ukraine: Sirturo;
  • (UG) Uganda: Sirturo;
  • (ZA) South Africa: Sirturo
  1. Centers for Disease Control and Prevention (CDC). Provisional CDC guidelines for the use and safety monitoring of bedaquiline fumarate (Sirturo) for the treatment of multidrug-resistant tuberculosis. MMWR Recomm Rep. 2013;62(RR-09):1-12. [PubMed 24157696]
  2. Centers for Disease Control and Prevention (CDC), “Treatment of Tuberculosis. American Thoracic Society, CDC, and Infectious Diseases Society of America,” 2003, MMWR Recomm Rep, 52(RR-11):3-5. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5211a1.htm [PubMed 12836625]
  3. Conradie F, Bagdasaryan TR, Borisov S, et al; ZeNix Trial Team. Bedaquiline-pretomanid-linezolid regimens for drug-resistant tuberculosis. N Engl J Med. 202;387(9):810-823. doi:10.1056/NEJMoa2119430 [PubMed 36053506]
  4. Conradie F, Diacon AH, Ngubane N, et al; Nix-TB Trial Team. Treatment of highly drug-resistant pulmonary tuberculosis. N Engl J Med. 2020;382(10):893-902. doi:10.1056/NEJMoa1901814 [PubMed 32130813]
  5. Diacon AH, Donald PR, Pym A, et al, “Randomized Pilot Trial of Eight Weeks of Bedaquiline (TMC207) Treatment for Multidrug-Resistant Tuberculosis: Long Term Outcome, Tolerability, and Effect on Emergence of Drug Resistance,” Antimicrob Agents Chemother, 2012, 56(6):3271-6. [PubMed 22391540]
  6. Diacon AH, Dawson R, von Groote-Bidlingmaier F, et al, “14-Day Bactericidal Activity of PA-824, Bedaquiline, Pyrazinamide and Moxifloxacin Combinations: A Randomised Trial,” Lancet, 2012, 380(9846):986-93. [PubMed 22828481]
  7. Diacon AH, Pym A, Grobusch M, et al, “The Diarylquinoline TMC207 for Multidrug-Resistant Tuberculosis,” N Engl J Med, 2009, 360(23):2397-405. [PubMed 19494215]
  8. Dooley KE, Park JG, Swindells S, et al, “Safety, Tolerability and Pharmacokinetic Interaction of the Antituberculous Agent TMC207 (Bedaquiline) With Efavirenz in Healthy Volunteers: AIDS Clinical Trials Group Study A5267,” J Acquir Immune Defic Syndr, 2012, 59(5):455-62. [PubMed 22126739]
  9. Esmail A, Sabur NF, Okpechi I, Dheda K. Management of drug-resistant tuberculosis in special sub-populations including those with HIV co-infection, pregnancy, diabetes, organ-specific dysfunction, and in the critically ill. J Thorac Dis. 2018;10(5):3102-3118. doi:10.21037/jtd.2018.05.11 [PubMed 29997980]
  10. Jaspard M, Elefant-Amoura E, Melonio I, De Montgolfier I, Veziris N, Caumes E. Bedaquiline and linezolid for extensively drug-resistant tuberculosis in pregnant woman. Emerg Infect Dis. 2017;23(10). [PubMed 28792382]
  11. Loveday M, Hughes J, Sunkari B, et al. Maternal and infant outcomes among pregnant women treated for multidrug/rifampicin-resistant tuberculosis in South Africa. Clin Infect Dis. Published online March 6, 2020. doi:10.1093/cid/ciaa189 [PubMed 32141495]
  12. Miele K, Bamrah Morris S, Tepper NK. Tuberculosis in pregnancy. Obstet Gynecol. 2020;135(6):1444-1453. doi:10.1097/AOG.0000000000003890 [PubMed 32459437]
  13. Nahid P, Dorman SE, Alipanah N, et al. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America clinical practice guidelines: treatment of drug-susceptible tuberculosis. Clin Infect Dis. 2016;63(7):e147-e195. doi:10.1093/cid/ciw376 [PubMed 27516382]
  14. Nahid P, Mase SR, Migliori GB, et al. Treatment of drug-resistant tuberculosis. An official ATS/CDC/ERS/IDSA clinical practice guideline. Am J Respir Crit Care Med. 2019;200(10):e93-e142. doi:10.1164/rccm.201909-1874ST [PubMed 31729908]
  15. Nyang'wa BT, Berry C, Kazounis E, et al. A 24-week, all-oral regimen for rifampin-resistant tuberculosis. N Engl J Med. 2022;387(25):2331-2343. doi:10.1056/NEJMoa2117166 [PubMed 36546625]
  16. Refer to manufacturer's labeling.
  17. Rustomjee R, Diacon AH, Allen J, et al, “Early Bactericidal Activity and Pharmacokinetics of Diarylquinoline TMC207 in Treatment of Pulmonary Tuberculosis,” Antimicrob Agents Chemother, 2008, 52(8):2831-5. [PubMed 18505852]
  18. Sirturo (bedaquiline) [prescribing information]. Horsham, PA: Janssen Products LP; June 2024.
  19. Svensson EM, du Bois J, Kitshoff R, et al. Relative bioavailability of bedaquiline tablets suspended in water: implications for dosing in children. Br J Clin Pharmacol. Published online June 27, 2018. doi:10.1111/bcp.13696 [PubMed 29952141]
  20. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV. https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection. Updated May 2, 2024. Accessed June 17, 2024.
  21. Villemagne B, Crauste C, Flipo M, et al, “Tuberculosis: The Drug Development Pipeline at a Glance,” Eur J Med Chem, 2012, 51:1-16. [PubMed 22421275]
  22. World Health Organization (WHO). WHO consolidated guidelines on tuberculosis. Module 4: treatment - drug-resistant tuberculosis treatment. https://www.who.int/publications/i/item/9789240007048. Published 2020.
  23. World Health Organization (WHO). WHO consolidated guidelines on tuberculosis. Module 4: treatment - drug-resistant tuberculosis treatment, 2022 update. https://www.who.int/publications/i/item/9789240063129. Published 2022. Accessed August 17, 2023. [PubMed 36630546]
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