Skip directly to site content Skip directly to search


Centers for Disease Control and Prevention. CDC twenty four seven. Saving Lives, Protecting People
 Search

		Submit


Tuberculosis (TB)


Facebook
        Twitter
        LinkedIn
        Syndicate





Treatment of Multidrug-Resistant TB: Bedaquiline Fact Sheet										Related Pages
										**Treatment of Multidrug-Resistant Tuberculosis: Bedaquiline**
**Introduction**
Bedaquiline fumarate (SirturoTM) is approved by the U.S. Food and Drug Administration (FDA) for use as part of a combination therapy in adults with pulmonary multidrug-resistant tuberculosis (MDR TB) when an effective treatment regimen cannot otherwise be provided.
The effectiveness and safety of this drug in different patient populations is unknown at this time. For more detailed information, refer to the *Provisional CDC Guidelines for the Use and Safety Monitoring of Bedaquiline Fumarate (SirturoTM) for the Treatment of Multidrug-Resistant Tuberculosis*.
**Dosage and Administration**
Due to the potential for serious adverse events, bedaquiline is not recommended for all MDR TB patients. Patients treated with bedaquiline should be managed by, or in close consultation with, local health departments and experts in the management of drug-resistant TB.
Bedaquiline may be used to treat adults (≥ 18 years) with a confirmed diagnosis of pulmonary MDR TB.
CAUTION: Bedaquiline may be considered for children, HIV-infected persons, pregnant women, persons with extrapulmonary TB, and persons with co-morbid conditions on concomitant medications when an effective treatment regimen cannot otherwise be provided. Further study is required before general use of bedaquiline can be recommended in these populations.
**Expert Clinical Consultation**
Medical consultation is available through some state TB programs or CDC’s TB Regional Training and Medical Consultation Centers (RTMCCs).
**Recommended Dose**
The recommended dose of bedaquiline for the treatment of pulmonary MDR in adults is:
Weeks 1 – 2: 400 mg (4 tablets of 100 mg) given orally, once daily
Weeks 3 – 24: 200 mg (2 tablets of 100 mg) three times per week, for a total dose of 600 mg per week**Initiation and Discontinuation**
Bedaquiline is to be used for a period of 24 weeks.
Bedaquiline may be used on a case-by-case basis for durations longer than 24 weeks when treatment options are limited.This drug has a half-life of 4-5 months. Consider discontinuing bedaquiline 4–5 months prior to discontinuing other drugs in the treatment regimen to reduce or avoid an extended period of exposure to low levels of bedaquiline as a single drug and subsequent acquired resistance.
**Administration**
All doses should be used in combination with at least three other anti-TB drugs to which the patient’s MDR TB isolate has been shown to be susceptible through laboratory testing.
Each dose should only be given by directly observed therapy (DOT) and with case management strategies to ensure treatment adherence. Each dose should be taken with food to maximize drug absorption.
**Missed Doses**
If a dose is missed during the first 2 weeks of treatment, patients should not be given the missed dose but should continue the usual dosing schedule. From Week 3 onwards, if a 200 mg dose is missed, patients should be given the missed dose as soon as possible, and then resume the 3 times a week regimen. Do not exceed 600 mg in a 7-day period of time.
**Adverse Reactions**
To date, adverse drug reactions associated with bedaquiline include:
Nausea / Vomiting
Dizziness
Headache
Hemoptysis
Increased blood amylase
Increased serum transaminases
Rash
Arthralgia (joint pain) / Myalgia (muscle pain)
Chest pain
Anorexia, fatigue, dark or cola-colored urine, jaundice**Patient Counseling**
Patients should be advised:
To eat food before taking bedaquiline
To abstain from alcohol and other hepatotoxic drugs
To report any signs and symptoms of adverse drug reactions to their health care provider
Of the potential benefits and harms of bedaquiline
That treatment non-adherence could result in treatment failure, relapse, or acquired drug resistance**Drug Interactions**
Bedaquiline is metabolized through the cytochrome P450 (CYP) system. Co-administration with rifamycins (e.g., rifampin, rifapentine, and rifabutin) or other strong CYP3A4 inducers should be avoided. Among the limited studies to date, no significant pharmacokinetic interactions have been observed between bedaquiline and the anti-TB drugs isoniazid, pyrazinamide, ethambutol, kanamycin, ofloxacin, or cycloserine.
**Patient Monitoring**
**Monitoring for Cardiac Toxicity**
Bedaquiline can affect the heart’s electrical activity, which could lead to an abnormal and potentially fatal heart rhythm. Patients should be monitored for symptoms of cardiac toxicity and by electrocardiogram (ECG).
Serum potassium, calcium, and magnesium should be obtained at baseline and whenever clinically indicated, especially if QTcF prolongation is detected.
ECG should be obtained at baseline and repeated at least 2, 12, and 24 weeks after treatment is started.
Weekly ECGs are recommended for persons prescribed bedaquiline and (1) other QTcF prolonging drugs including fluorquinolones, macrolide antibacterial drugs, and clofazimine; (2) have a history of Torsade de Pointes, congenital long QTcF syndrome, hypothyroidism and bradyarrhythmias, or uncompensated heart failure; or (3) have serum calcium, magnesium, or potassium levels below the lower limits of normal.
If syncope occurs, obtain an ECG to evaluate for QTcF prolongation.**Monitoring for Hepatotoxicity**
Hepatic-related adverse drug reactions have been reported with the use of bedaquiline. Patients’ aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, and alkaline phosphatase should be tested at baseline, monthly, and if symptomatic.
**Monitoring for Renal Toxicity**
Bedaquiline does not require dosage adjustment in patients with mild to moderate renal impairment (not requiring dialysis). Use caution when administering bedaquiline to patients with severe renal impairment requiring dialysis. Serum drug levels in patients with renal impairment should be considered.
**Therapeutic Drug Monitoring**
If bedaquiline is given with rifamycins or any other drugs that induce or suppress CYP3A4, monitoring of serum drug levels should be performed to ensure adequate therapy and minimize the risk of acquired drug resistance.
**Microbiologic Monitoring**
Treatment should be accompanied by microbiologic monitoring with one sputum specimen submitted for culture monthly throughout and at the end of treatment, even after conversion to negative culture.
**Monitoring for Additional Side Effects**
Patients should also be assessed weekly for nausea, headache, hemoptysis, chest pain, arthralgia, and rash. Monitoring for additional side effects should be tailored to the other drugs used to treat the patient’s MDR TB.
**Patient Registry and Surveillance of Drug Resistance**
As required by the FDA, a registry for persons treated with bedaquiline will be maintained by Janssen Therapeutics to track patient outcomes, adverse reactions, laboratory testing results, use of concomitant medications, and presence of other comorbid conditions. This registry will collect data prospectively on all patients started on bedaquiline.
Any monthly specimen that grows *M. tuberculosis*, including one before treatment initiation with bedaquiline, should be referred to a laboratory for surveillance of bedaquiline resistance in consultation with the state public health laboratory. CDC will assist in identifying a laboratory that can perform bedaquiline susceptibility testing.
Suspected adverse reactions (i.e., any adverse event for which there is a reasonable possibility that the drug caused the adverse event) and serious adverse events (i.e., any adverse event which results in death, hospitalization, permanent disability, or a life-threatening situation) should be reported to Janssen Therapeutics (1.800.526.7736), the FDA (1.800.332.1088 or http://www.fda.gov/Safety/MedWatch/default.htm), and to CDC’s Emergency Operations Center (1.770.488.7100).

**Additional Information**
Provisional CDC Guidelines for the Use and Safety Monitoring of Bedaquiline Fumarate (Sirturo TM) for the Treatment of Multidrug-Resistant Tuberculosis. *MMWR* 2013; 62 (No. 9). https://www.cdc.gov/mmwr/PDF/rr/rr6209.pdf [pdf 411K]
Janssen Therapeutics. SirturoTM Webpage http://www.sirturo.com/
U.S. Food and Drug Administration. SIRTUROTM (bedaquiline) Tablets label. US Food and Drug Administration website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204384s000lbl.pdf [pdf 505K].
					View Page In:PDF [215K]		
					
						Page last reviewed:  May 4, 2016					Content source: 	Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention homeTuberculosisBasic TB Factsplus iconHow TB SpreadsLatent TB Infection and TB DiseaseSigns & SymptomsTB Risk FactorsExposure to TBTB PreventionVaccinesTB & HIV CoinfectionTB and DiabetesTB TermsPersonal StoriesTesting & Diagnosisplus iconWho Should be TestedTesting for TB InfectionTesting in BCG-Vaccinated PersonsTB Screening and Testing of Health Care PersonnelTesting During PregnancyDiagnosing latent TB infection and TB diseaseTreatmentplus iconDeciding When to Treat Latent TB InfectionTreatment Regimens for Latent TB Infection (LTBI)Treatment for TB DiseaseAdverse EventsTB Treatment of Persons Living with HIVTB Treatment and PregnancyTB Treatment for ChildrenFrequently Asked QuestionsDrug-Resistant TBResearchplus iconTB Epidemiologic Studies Consortiumplus iconResearch ProjectsPublicationsTB Trials Consortiumplus iconStudy DescriptionsBackgroundBehavioral & Social Science ResearchHealth Care Settingsplus iconTB Infection Control in Health Care SettingsResources for TB Screening and Testing of Health Care Personnelplus iconFrequently Asked QuestionsTB in Specific Populationsplus iconHealth DisparitiesAsian PersonsBlack or African American PersonsHispanic or Latino PersonsChildrenPregnancyCorrectional FacilitiesPeople Experiencing HomelessnessInternational TravelersLaboratory Informationplus iconDrug Susceptibility TestingFalse-Positive Investigation ToolkitInterim Laboratory Biosafety Guidance for XDR  tuberculosis strainsModel Performance Evaluation Program (MPEP)Rapid Molecular Testing to Detect Drug-Resistant TB in the USplus iconExecutive SummaryIntroductionBackground on Tests for Molecular Detection of DRGeneral Considerations and Principles for a Molecular DR Testing ServicePossible Scenarios and Scope of Testing for a Molecular DR Testing ServiceResearch NeedsGeneral Recommendations of the Expert PanelCommunication Plan for the ReportRecommendationsReferencesPanel Members and CDC ParticipantsAppendix 1Appendix 2Appendix 3The Uses of Nucleic Acid Amplification Tests for the Diagnosis of TBplus iconGeneral ConsiderationsGeneral Recommendations of the Expert PanelRecommendations to ACET, CDC, DTBEData & Statisticsplus iconTB Incidence in the United StatesReported TB in the US, 2022 Surveillance Reportplus iconNational DataReporting Area DataRisk FactorsDemographicsTB Treatment and Case OutcomesDrug-Resistant TBMolecular SurveillanceTuberculosis in the United States, 2022 (Slide Set)Archived Surveillance Reports and Slide Sets2021 State and City ReportArchived State and City ReportsProfessional Resources & Toolsplus iconTools for Healthcare ProvidersResources for TB Programsplus iconStrengthening Civil Surgeons’ Capacity to Improve LTBI Surveillance and Outcomes Among Status AdjustersNotice of Funding Opportunity (NOFO)Program EvaluationTB Centers of ExcellenceTB Elimination AllianceTB Genotypingplus iconConventional TB GenotypingWhole Genome SequencingTB GIMSAnalytic ToolsLatent Tuberculosis Infection ResourcesPublications & Productsplus iconPatient and Public MaterialsFact SheetsGuidelinesplus iconControl & EliminationDrug-Resistant TBInfection Control & PreventionLaboratory & GenotypingTB & HIVTB in Specific PopulationsTesting & DiagnosisTreatmentVaccines & ImmunizationsArchived TB GuidelinesGuides & Toolkitsplus iconAggregate ReportsCDC TB Surveillance TrainingCore CurriculumEffective TB Interviewing for Contact InvestigationEthnographic GuidesFalse-Positive Investigation ToolkitForging Partnerships to Eliminate TuberculosisGuide to Application of GenotypingLTBI: A Guide for Primary Health Care ProvidersMantoux Tuberculin Skin Testing ProductsReport of Verified Case of Tuberculosis (RVCT)Self-Study ModulesTB Contact Investigation Interviewing Skills CourseTB eDOT ToolkitUnderstanding the TB Cohort Review ProcessNewslettersplus iconTB Notes, No. 4, 2023TB Notes, No. 3, 2023TB Notes. No. 2, 2023TB Notes. No. 1, 2023TB Notes, No. 4, 2022TB Notes, No. 3, 2022TB Notes, No. 2, 2022TB Notes, No. 1, 2022TB Notes, No. 4, 2021TB Notes, No. 3, 2021TB Notes, No. 2, 2021TB Notes, No. 1, 2021Pamphlets, Brochures, Bookletsplus iconQuestions and AnswersPatient Education SeriesTuberculosis - Get the FactsTuberculosis - The Connection between TB and HIV12-Dose Regimen for Latent TB Infection-Patient Education BrochurePostersplus iconMantoux Tuberculin Skin Test Wall ChartWorld TB DayThink TBStop TBTake on TBReports & Articlesplus iconDTBE Authored Journal ArticlesTuberculosis Laboratory Aggregate ReportsSlide Setsplus iconIntroduction to TuberculosisEpidemiology of Tuberculosis Among Non-U.S.​–Born Persons in the United States, 1993–2016Self-Study Modules on Tuberculosis, 1-5 Slide SetsThe Tuberculosis (TB) in Correctional Settingsplus iconFacilitator GuideIntroduction to TB GenotypingEpidemiology of Tuberculosis in Correctional Facilities, United States, 1993-2017Prevention and Control of Tuberculosis in Correctional and Detention FacilitiesGuidelines for Preventing the Transmission of M. TB in Health care SettingsInvestigation of Contacts of Persons with Infectious TBEpidemiology of Pediatric Tuberculosis in the United StatesTargeted Tuberculosis Testing and Treatment of Latent Tuberculosis InfectionElectronic Tools & ResourcesWeb-Based Courses & Webinarsplus iconTB 101 for Health Care WorkersContent SyndicationInfographicsplus iconSocial Media GraphicsCustomizable Take on TB Infographic with InstructionsEventsWorld TB Dayplus iconU.S. TB ChampionsHistoryFeaturesplus iconTB Risk FactorsTreating Latent TB Infection with Short-Course RegimensWorld Tuberculosis (TB) Day 2021World Tuberculosis (TB) Day 2020Linksplus iconState TB Control OfficesAbout Usplus iconMission Statement and Activitiesplus iconDTBE Strategic PlanNational TB Program ObjectivesOrganization ChartAdvisory Groupsplus iconFederal TB Task Force To receive email updates about this page, enter your email address: Email Address			What's this?				Submit


About CDC
					Contact Us
					800-232-4636
 Facebook Twitter Instagram LinkedIn Youtube Pinterest Snapchat
 CONTACT CDC
				Contact Us
							Call 800-232-4636
							Email Us
			ABOUT CDC
				About CDC
							Jobs
							Funding
			POLICIES
				Accessibility
							External Links
							Privacy
							Policies
							No Fear Act
							FOIA
							OIG
							Nondiscrimination
							Vulnerability Disclosure Policy
			CONNECT WITH US
				Facebook
								Twitter
								Instagram
								LinkedIn
							Youtube
								Pinterest
								Snapchat
								Email
			LANGUAGES
				Español
							繁體中文
							Tiếng Việt
							한국어
							Tagalog
							Русский
							العربية
							Kreyòl Ayisyen
							Français
							Polski
							Português
							Italiano
							Deutsch
							日本語
							فارسی
							English


U.S. Department of Health & Human Services
			Accessibility
			External Links
			Privacy
			Policies
			No Fear Act
			FOIA
			Nondiscrimination
			OIG
			Vulnerability Disclosure Policy
			USA.gov


Exit Notification / Disclaimer Policy Close
 Links with this icon  indicate that you are leaving the CDC website. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website.
				Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website.
				You will be subject to the destination website's privacy policy when you follow the link.
				CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Website Disclaimers
 Cancel Continue