SIRTURO Bedaquiline Fumarate 20 mg Tablet, 60-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Diarylquinoline Antimycobacterial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Sirturo always needs to be used alongside at least three other drugs that your TB bacteria are sensitive to. If you take it alone, the bacteria are much more likely to develop resi...
- Why do I have to take Sirturo with other TB medicines? Can't it work on its own?
- Sirturo affects the electrical activity in your heart in a way that can — in some people — lead to a dangerous irregular heartbeat. This is called QTc prolongation. It doesn't mean...
- Why do I need heart monitoring while I'm on this medication?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 7CV7WJK4UI
Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $32.06 | $1,923.41 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $32.34 | $1,940.50 / 60 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sirturo 20 mgthis 59676-0702-60 | Janssen | 60 tablets | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 7498343 ↗ | Drug substance | U-1321 | Dec 1, 2026 |
| US 8546428 ↗ | Drug substance | U-1321 | Mar 19, 2029 |
| US 8546428 ↗ | Drug substance | U-1321 | Mar 19, 2029 |
| US 7498343 ↗ | Drug substance | U-1321 | Dec 1, 2026 |
| Code | What it grants | Expires |
|---|---|---|
| M-306 | New indication / labeling change (3-year) | Jun 21, 2027 |
| ODE-251 | Orphan Drug Exclusivity (7-year) | Aug 9, 2026 |
| ODE-307 | Orphan Drug Exclusivity (7-year) | May 27, 2027 |
| M-306 | New indication / labeling change (3-year) | Jun 21, 2027 |
| ODE* | Orphan Drug Exclusivity (7-year) | Aug 9, 2026 |
| ODE-307 | Orphan Drug Exclusivity (7-year) | May 27, 2027 |
Is there a generic version of SIRTURO 20 MG TABLET?
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59676-0702-60 You're viewing this | 60 TABLET in 1 BOTTLE (59676-702-60) | 2020-05-27 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: QTc PROLONGATION QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs.
Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops [see Warnings and Precautions (5.1) ] . WARNING: QTc PROLONGATION See full prescribing information for complete boxed warning. QTc Prolongation QTc prolongation can occur with SIRTURO.
Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops.
( 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid.
( 1 ) Limitations of Use : Do not use SIRTURO for the treatment of latent, extra-pulmonary or drug-sensitive TB or for the treatment of infections caused by non-tuberculous mycobacteria. ( 1 ) Limitations of Use Do not use SIRTURO for the treatment of: Latent infection due to Mycobacterium tuberculosis ( M. tuberculosis ) Drug-sensitive pulmonary TB Extra-pulmonary TB Infections caused by non-tuberculous mycobacteria
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer SIRTURO by directly observed therapy (DOT). ( 2.1 ) Emphasize need for compliance with full course of therapy. ( 2.1 ) Prior to administration, obtain ECG, liver enzymes and electrolytes.
Obtain susceptibility information for the background regimen against Mycobacterium tuberculosis isolate if possible. ( 2.2 ) Only use SIRTURO in combination with at least 3 other drugs to which the patient's TB isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, may initiate SIRTURO in combination with at least 4 other drugs to which patient's TB isolate is likely to be susceptible.
( 2.1 ) Recommended dosage in adult patients: 400 mg (4 of the 100 mg tablets OR 20 of the 20 mg tablets) once daily for 2 weeks followed by 200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) 3 times per week (with at least 48 hours between doses) for 22 weeks. ( 2.3 ) Recommended dosage in pediatric patients (2 years and older and weighing at least 8 kg) is based on body weight. ( 2.4 ) Take SIRTURO tablets with food.
( 2.6 ) See full prescribing information for the different methods of administration of SIRTURO 20 mg tablet and administration of the 100 mg tablet.
2.1Important Administration Instructions Administer SIRTURO by directly observed therapy (DOT). Only use SIRTURO in combination with at least three other drugs to which the patient's TB isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, SIRTURO treatment may be initiated in combination with at least four other drugs to which the patient's TB isolate is likely to be susceptible.
Refer to the prescribing information of the drugs used in combination with SIRTURO for further information. SIRTURO (20 mg and 100 mg) must be taken with food. SIRTURO 20 mg are functionally scored tablets which can be split at the scored lines into two equal halves of 10 mg each to provide doses less than 20 mg [see Dosage and Administration (2.6) ].
As an alternative method of administration, SIRTURO 20 mg tablets can be dispersed in water and administered or dispersed in water and further mixed with a beverage or soft food, or crushed and mixed with soft food, or administered through a feeding tube [see Dosage and Administration (2.6) ]. Emphasize the need for compliance with the full course of therapy.
2.2Required Testing Prior to Administration Prior to treatment with SIRTURO, obtain the following: Susceptibility information for the background regimen against M. tuberculosis isolate if possible [see Dosage and Administration (2.1) ] ECG [see Warnings and Precautions (5.1) ] Serum potassium, calcium, and magnesium concentrations [see Warnings and Precautions (5.1) ] Liver enzymes [see Warnings and Precautions (5.4) ]
2.3Recommended Dosage in Adult Patients The recommended dosage of SIRTURO in adult patients is: Table 1: Recommended Dosage of SIRTURO in Adult Patients Dosage Recommendation Weeks 1 and 2 Weeks 3 to 24 At least 48 hours between doses 400 mg (4 of the 100 mg tablets OR 20 of the 20 mg tablets) orally once daily 200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) orally three times per week Recommended dosage in pediatric patients is described in Table 2 below [see Dosage and Administration (2.4) ]. Administer SIRTURO tablets with food.
The total duration of treatment with SIRTURO in adults is 24 weeks. When treatment with SIRTURO is considered necessary beyond 24 weeks, treatment may be continued at a dose of 200 mg three times per week [see Clinical Studies (14.1) ] .
2.4Recommended Dosage in Pediatric Patients (2 years and older and weighing at least 8 kg) The recommended dosage of SIRTURO in pediatric patients (2 years and older and weighing at least 8 kg) is based on body weight and shown in Table 2: Table 2: Recommended Dosage of SIRTURO in Pediatric Patients (2 years and older and weighing at least 8 kg) Body Weight Dosage Recommendation Weeks 1 and 2 Weeks 3…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS SIRTURO 20 mg tablet: uncoated, white to almost white oblong functionally scored tablet, with a score line on both sides, debossed with "2" and "0" on one side and plain on the other side. SIRTURO 100 mg tablet: uncoated, white to almost white round biconvex tablet with debossing of "T" over "207" on one side and "100" on the other side. Tablets: 20 mg, functionally scored ( 3 ) Tablets: 100 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS A mortality imbalance was seen in clinical trials in SIRTURO-treated patients with pulmonary TB due to Mycobacterium tuberculosis resistant to at least rifampin. ( 5.2 ) Hepatotoxicity may occur with use of SIRTURO. Monitor liver-related laboratory tests. Discontinue SIRTURO if evidence of liver injury occurs. ( 5.4 )
5.1QTc Prolongation SIRTURO prolongs the QTc interval [see Clinical Pharmacology (12.2) ] . Use with drugs that prolong the QTc interval may cause additive QTc prolongation [see Adverse Reactions (6) ] . In Study 4, where SIRTURO was administered with the QTc prolonging drugs clofazimine and levofloxacin, 5% of patients in the 40-week SIRTURO treatment group experienced a QTc ≥500 ms and 43% of patients experienced an increase in QTc ≥60 ms over baseline.
Of the clofazimine- and levofloxacin-treated patients in the 40-week control arm, 7% of patients experienced a QTc ≥500 ms and 39% experienced an increase in QTc ≥60 ms over baseline. Obtain an ECG before initiation of treatment, 2 weeks after initiation, during treatment, as clinically indicated and at the expected time of maximum increase in the QTc interval of the concomitantly administered QTc prolonging drugs (as applicable). Obtain electrolytes at baseline and during treatment and correct electrolytes as clinically indicated.
The following may increase the risk for QTc prolongation when patients are taking SIRTURO: use with other QTc prolonging drugs a history of Torsade de Pointes a history of congenital long QTc syndrome a history of or ongoing hypothyroidism a history of or ongoing bradyarrhythmias a history of uncompensated heart failure serum calcium, magnesium, or potassium levels below the lower limits of normal Discontinue SIRTURO if the patient develops: Clinically significant ventricular arrhythmia A QTc interval of greater than 500 ms (confirmed by repeat ECG) If syncope occurs, obtain an ECG to detect QTc prolongation.
5.2Mortality Imbalance in Clinical Trials An increased risk of death was seen in the SIRTURO treatment group (9/79, 11.4%) compared to the placebo treatment group (2/81, 2.5%) in one placebo-controlled trial in adults (Study 1; based on the 120 week visit window). One death occurred during the 24 weeks of administration of SIRTURO. 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 observed. In a subsequent active-controlled trial in adults (Study 4), deaths by Week 132 occurred in 11/211 (5.2%) patients in the 40-week SIRTURO treatment group, 8/202 (4%) patients in the active-control treatment group including four of 29 patients who received SIRTURO as part of a salvage treatment, and 2/143 (1.4%) patients in the 28-week SIRTURO treatment group [see Adverse Reactions (6.1) ] .
5.3Risk of Development of Resistance to Bedaquiline A potential for development of resistance to bedaquiline in M. tuberculosis exists [see Microbiology (12.4) ]. Bedaquiline must only be used in an appropriate combination regimen for the treatment of pulmonary TB due to M. tuberculosis resistant to at least rifampin and isoniazid, to reduce the risk of development of resistance to bedaquiline [see Indications and Usage (1) ] .
5.4Hepatotoxicity In clinical trials, more hepatic-related adverse reactions were reported in adults with the use of SIRTURO plus other drugs used to treat TB compared to other drugs used to treat TB without the addition of SIRTURO. Alcohol and other hepatotoxic drugs should be avoided while on SIRTURO, especially in patients with impaired hepatic function. Hepatic-related adverse reactions have also been reported in pediatric patients 5 years of age and older [see Adverse Reactions (6.1) ] .
Monitor symptoms (such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness and hepatomegaly) and laboratory tests (ALT, AST, alkaline…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: QTc Prolongation [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ] Mortality Imbalance in Clinical Trials [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Drug Interactions [see Warnings and Precautions (5.5) ] The most common adverse reactions reported in 10% or more adult patients treated with SIRTURO in Study 1 were nausea, arthralgia, headache, hemoptysis and chest pain.
( 6.1 ) The most common adverse reactions reported in 10% or more adult patients treated with SIRTURO (40-week arm) in Study 4 were QTc prolongation, nausea, vomiting, arthralgia, transaminases increased, abdominal pain, pruritus, dizziness, headache, chest pain, rash, insomnia, dry skin, and palpitations. ( 6.1 ) The most common adverse reactions reported in 10% or more of pediatric patients (12 years to less than 18 years of age) treated with SIRTURO were arthralgia, nausea and abdominal pain. ( 6.1 ) The most common adverse reaction reported in 10% or more of pediatric patients (5 years to less than 12 years of age) treated with SIRTURO was elevation in liver enzymes.
( 6.1 ) The most common adverse reaction reported in 10% or more of pediatric patients (2 years to less than 5 years of age) treated with SIRTURO was vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Therapeutics, Division of Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Refer to the prescribing information of the drugs used in combination with SIRTURO for their respective adverse reactions. Clinical Studies Experience in Adults Adverse reactions for SIRTURO were identified from safety data from 335 patients who received SIRTURO for eight weeks (Study 2) and 24 weeks (Studies 1 and 3), and 354 patients who received SIRTURO for 40 weeks or 28 weeks (Study 4).
In these studies, patients received SIRTURO in combination with other antimycobacterial drugs. Studies 1 and 2 were randomized, double-blind, placebo-controlled trials in newly diagnosed patients with pulmonary TB due to M. tuberculosis resistant to at least rifampin and isoniazid. Study 3 was an open-label, noncomparative study with SIRTURO administered as part of an individualized treatment regimen in previously treated patients with pulmonary TB due to M. tuberculosis resistant to at least rifampin and isoniazid, including patients resistant to second-line injectables and/or fluroquinolones.
In Study 1, 35% were Black, 17% were Hispanic, 13% were White, 9% were Asian, and 26% were of another race. Eight of 79 (10%) patients in the SIRTURO group and 16 of 81 (20%) patients in the placebo treatment group were HIV infected. Seven (8.9%) SIRTURO-treated patients and six (7.4%) placebo-treated patients discontinued Study 1 because of an adverse reaction.
Study 4 was an open-label, randomized, active-controlled trial in patients with pulmonary TB due to M. tuberculosis resistant to at least rifampin that evaluated a 40-week arm of SIRTURO in combination with other oral antimycobacterial drugs compared with a 40-week active control arm that included an injectable antimycobacterial drug in combination with other oral antimycobacterial drugs. A 28-week arm including SIRTURO, an injectable and other antimycobacterial drugs, was also evaluated in the trial, but recruitment was stopped early due to changes in the standard of care.
In the population treated in the two 40-week arms (N=413), the median age was 32.8 years, 61% were male, 46% were Asian, 36% were Black, 18% were White and 16% were HIV…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Avoid use of strong and moderate CYP3A4 inducers with SIRTURO. ( 7.1 ) Closely monitor patient safety (e.g., liver function) when SIRTURO is coadministered with CYP3A4 inhibitors. ( 5.4 , 7.1 )
7.1Effect of Other Drugs on SIRTURO Strong and Moderate CYP3A4 Inducers Coadministration of SIRTURO with moderate or strong CYP3A4 inducers may decrease systemic exposure of bedaquiline. Avoid coadministration of SIRTURO with strong or moderate CYP3A4 inducers [see Clinical Pharmacology (12.3) ] . CYP3A4 Inhibitors Coadministration of SIRTURO with CYP3A4 inhibitors increases the systemic exposure of bedaquiline which may increase the risk of adverse reactions.
Closely monitor patient safety (e.g., liver function) when SIRTURO is coadministered with CYP3A4 inhibitors. No dose adjustment of SIRTURO is needed when coadministered with CYP3A4 inhibitors [see Clinical Pharmacology (12.3) ] .
7.2Other Antimicrobial Medications No dose adjustment of isoniazid or pyrazinamide is required during coadministration with SIRTURO. In a placebo-controlled clinical trial in adult patients, no major impact of coadministration of SIRTURO on the pharmacokinetics of ethambutol, kanamycin, pyrazinamide, ofloxacin or cycloserine was observed.
7.3QTc Interval Prolonging Drugs In clinical trials of adult patients, additional QTc interval prolongation was observed during combination treatment with SIRTURO and other QTc prolonging drugs. In Study 3, concurrent use of clofazimine with SIRTURO resulted in QTc prolongation: mean increases in QTc were larger in the 17 adult patients who were taking clofazimine with bedaquiline at Week 24 (mean change from Day-1 of 32 ms) than in patients who were not taking clofazimine with bedaquiline at Week 24 (mean change from Day-1 of 12 ms).
Monitor ECGs if SIRTURO is coadministered to patients receiving other drugs that prolong the QTc interval, and discontinue SIRTURO if there is evidence of serious ventricular arrhythmia or QTc interval greater than 500 ms [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ] . ECG monitoring should be performed prior to initiation and at the expected time of maximum increase in the QTc interval of the concomitantly administered QTc prolonging drugs.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended unless infant formula is not available. If an infant is exposed to bedaquiline through breast milk, monitor for signs of bedaquiline-related adverse reactions, such as hepatotoxicity. ( 6 , 8.2 ) Pediatrics: The safety and effectiveness of SIRTURO in pediatric patients less than 2 years of age and/or weighing less than 8 kg have not been established.
( 8.4 ) Use with caution in patients with severe hepatic impairment and only when the benefits outweigh the risks. Monitor for SIRTURO-related adverse reactions. ( 8.6 ) Use with caution in patients with severe renal impairment.
( 8.7 )
8.1Pregnancy Risk Summary Available data from published literature of SIRTURO use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks associated with active TB during pregnancy (see Clinical Considerations ) . Reproduction studies performed in rats and rabbits have revealed no evidence of harm to the fetus due to oral administration of bedaquiline to pregnant rats and rabbits during organogenesis at exposures up to 6 times the clinical dose based on AUC comparisons (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Active TB in pregnancy is associated with adverse maternal and neonatal outcomes including maternal anemia, caesarean delivery, preterm birth, low birth weight, birth asphyxia, and perinatal infant death. Data Animal Data Pregnant rats were treated with bedaquiline at 5, 15 and 45 mg/kg (approximately 0.7, 2 and 6 times the clinical dose based on AUC comparisons) during the period of organogenesis (gestational Days 6 to 17, inclusive). Pregnant rabbits were treated with bedaquiline at 10, 30 and 100 mg/kg (approximately 0.05, 0.2 and 1.5 times the clinical dose based on AUC comparisons) during the period of organogenesis (gestational Days 6 to 19, inclusive).
No embryotoxic effects were found in rats or rabbits at dose exposures up to 6 times the clinical dose exposures based on AUC comparisons.
8.2Lactation Risk Summary Data from a published clinical lactation study demonstrate higher bedaquiline concentrations in breast milk compared to maternal plasma, suggesting that bedaquiline accumulates in breast milk (see Data ) . Data are insufficient to determine effects of the drug on the breastfed infants. No data are available on the effects of the drug on milk production.
Because of the potential for serious adverse reactions in a breastfed infant, including hepatotoxicity, advise patients that breastfeeding is not recommended during treatment with SIRTURO and for 27.5 months (5 times the half-life) after the last dose unless infant formula is not available. Clinical Considerations If an infant is exposed to bedaquiline through breast milk, monitor for signs of bedaquiline-related adverse reactions, such as hepatotoxicity [see Adverse Reactions (6) ]. Data A clinical lactation study was conducted in two lactating women who were approximately 7 weeks' postpartum.
Bedaquiline and M2, its active metabolite, levels were measured between approximately 27 and 48 hours after the last bedaquiline dose, and concentrations of bedaquiline and M2 ranged from 2.61 to 8.11 mg/L and 0.27 to 0.81 mg/L, respectively. The milk:plasma ratios for bedaquiline and M2 at 27 to 48 hours after the last dose of bedaquiline ranged from approximately 19 to 29 and 4 to 6, respectively.
8.4Pediatric Use The safety and effectiveness of SIRTURO have been established in pediatri…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from published literature of SIRTURO use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks associated with active TB during pregnancy (see Clinical Considerations ) . Reproduction studies performed in rats and rabbits have revealed no evidence of harm to the fetus due to oral administration of bedaquiline to pregnant rats and rabbits during organogenesis at exposures up to 6 times the clinical dose based on AUC comparisons (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Active TB in pregnancy is associated with adverse maternal and neonatal outcomes including maternal anemia, caesarean delivery, preterm birth, low birth weight, birth asphyxia, and perinatal infant death. Data Animal Data Pregnant rats were treated with bedaquiline at 5, 15 and 45 mg/kg (approximately 0.7, 2 and 6 times the clinical dose based on AUC comparisons) during the period of organogenesis (gestational Days 6 to 17, inclusive). Pregnant rabbits were treated with bedaquiline at 10, 30 and 100 mg/kg (approximately 0.05, 0.2 and 1.5 times the clinical dose based on AUC comparisons) during the period of organogenesis (gestational Days 6 to 19, inclusive).
No embryotoxic effects were found in rats or rabbits at dose exposures up to 6 times the clinical dose exposures based on AUC comparisons.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of SIRTURO have been established in pediatric patients 2 years and older weighing at least 8 kg. The use of SIRTURO in this pediatric population is supported by evidence from the study of SIRTURO in adults together with additional pharmacokinetic and safety data from the single-arm, open-label, multi-cohort trial that enrolled 45 pediatric patients 2 years to less than 18 years of age with confirmed or probable pulmonary TB caused by M. tuberculosis resistant to at least rifampin who were treated with SIRTURO for 24 weeks in combination with a background regimen [see Dosage and Administration (2.4) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) and Clinical Studies (14.2) ] .
The safety, effectiveness and dosage of SIRTURO in pediatric patients less than 2 years of age and/or weighing less than 8 kg have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of SIRTURO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients [see Clinical Pharmacology (12.3) ] .
🆘 Overdosage ▾
10 OVERDOSAGE There is no experience with the treatment of acute overdose with SIRTURO. Take general measures to support basic vital functions including monitoring of vital signs and ECG (QTc interval) in case of deliberate or accidental overdose. It is advisable to contact a poison control center to obtain the latest recommendations for the management of an overdose.
Since bedaquiline is highly protein-bound, dialysis is not likely to significantly remove bedaquiline from plasma.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Bedaquiline is a diarylquinoline antimycobacterial drug [see Microbiology (12.4) ] .
12.2Pharmacodynamics Bedaquiline has activity against M. tuberculosis . The major metabolite, M2 is not thought to contribute significantly to clinical efficacy given its lower average exposure (23% to 31%) in humans and lower antimycobacterial activity (3-fold to 6-fold lower) compared to the parent compound. However, M2 plasma concentrations are correlated with QTc prolongation.
Cardiac Electrophysiology In Study 1, the largest mean increase in QTc during the 24 weeks of SIRTURO treatment was 16 ms compared to 6 ms with placebo treatment (at Week 18). After SIRTURO treatment ended, the QTc gradually decreased, and the mean value was similar to that in the placebo group by study Week 60. In Study 4, the mean change from baseline in QTc for the SIRTURO-containing arm was 22 ms (95% CI: 19; 24) at Week 2 (i.e., the end of the 2-week SIRTURO loading period), and 8 ms (95% CI: 2; 13) in the levofloxacin-containing control arm subgroup.
In Study 4, the mean QTc increased from baseline over the first 12 weeks for both SIRTURO and the non-SIRTURO containing control arm, when a plateau was reached. The largest mean QTc increase from baseline was 35 ms (95% CI: 32 to 38 ms) for the SIRTURO-containing arm and 28 ms (95% CI: 21 to 34 ms) for the levofloxacin-containing control arm subgroup [see Warnings and Precautions (5.1) and Drug Interactions (7.3) ].
12.3Pharmacokinetics Pharmacokinetics (PK) parameters The pharmacokinetic properties of bedaquiline are summarized in Table 5 as mean (SD) in adult patients. Table 5: Model-Derived Pharmacokinetic Parameters of Bedaquiline and M2 (mean [SD]) after Multiple Doses of SIRTURO at the Recommended Dosing Regimen Pharmacokinetic Parameters Bedaquiline SD=Standard Deviation Absorption Food effect High fat meal (22 grams of fat, 558 total Kcal) increased C max and AUC by 2-fold. SIRTURO should be taken with food to enhance its oral bioavailability.
T max Around 5 hours after single oral dose administration of SIRTURO C max of bedaquiline Week 2: 3060 (1124) ng/mL Week 24: 1838 (684) ng/mL Week 40: 1787 (666) ng/mL C max of M2 Week 2: 326 (135) ng/mL Week 24: 234 (85) ng/mL Week 40: 246 (103) ng/mL Exposure AUC 168h of bedaquiline (AUC 24h for Week 2) Week 2: 41510 (15064) ng.h/mL Week 24: 163924 (55710) (ng.h/mL) Week 40: 168376 (74476) ng.h/mL AUC 168h of M2 (AUC 24h for Week 2) Week 2: 7267 (3029) ng.h/mL Week 24: 37255 (13998) ng.h/mL Week 40: 39540 (17220) ng.h/mL Distribution Percent bound to human plasma protein greater than 99.9%. apparent central volume of distribution approximately 117 Liters.
Proportionality C max and AUC increased proportionally up 700 mg (1.75 times the 400 mg loading dose). Elimination After reaching C max , bedaquiline concentrations decline tri-exponentially. Apparent clearance of bedaquiline
2.62 L/h Apparent clearance of M2
4.95L/h Terminal half-life ~ 5.5 months for both bedaquiline and N monodesmethyl metabolite (M2) Metabolism Metabolized to the M2 by CYP3A4; Relative exposure M2 versus bedaquiline: 23%~31% Excretion Major route of excretion Fecal excretion is the major route of elimination %Excreted unchanged in urine less than or equal to 0.001% of the dose in clinical studies Specific Populations Patients with Hepatic Impairment: After single-dose administration of 400 mg SIRTURO to 8 adult patients with moderate hepatic impairment (Child-Pugh B), mean exposure to bedaquiline and M2 (AUC 672h ) was approximately 20% lower compared to healthy adults.
SIRTURO has not been studied in patients with severe hepatic impairment [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6) ]. Patients with Renal Impairment: SIRTURO has mainly been studied in adult patients with normal renal function. Renal excretion of unchanged bedaquiline is not substantial (less than or equal to 0.001%).
In a population pharmacoki…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Bedaquiline is a diarylquinoline antimycobacterial drug [see Microbiology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied SIRTURO ® 20 mg tablets are supplied as uncoated white to almost white oblong functionally scored tablets with a score line on both sides, debossed with "2" and "0" on one side and plain on the other side. SIRTURO ® 100 mg tablets are supplied as uncoated white to almost white round biconvex 100 mg tablets with debossing of "T" over "207" on one side and "100" on the other side. SIRTURO tablets are packaged in white high-density polyethylene (HDPE) bottles with child-resistant polypropylene (PP) closure with induction seal liner in the following configurations: 20 mg tablets – bottles of 60 tablets.
Each bottle contains silica gel desiccant (NDC 59676-702-60) 100 mg tablets – bottles of 188 tablets (NDC 59676-701-01).
16.2Storage and Handling SIRTURO 20 mg Tablet Store in original container. Bottle contains desiccant. Do not discard desiccant.
Protect from light and moisture. Keep the container tightly closed. Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
SIRTURO 100 mg Tablet Dispense in original container. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months. Protect from light.
Keep the container tightly closed. Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
16.2Storage and Handling SIRTURO 20 mg Tablet Store in original container. Bottle contains desiccant. Do not discard desiccant.
Protect from light and moisture. Keep the container tightly closed. Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
SIRTURO 100 mg Tablet Dispense in original container. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months. Protect from light.
Keep the container tightly closed. Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION SIRTURO ® contains bedaquiline fumarate, a diarylquinoline antimycobacterial drug for oral administration. Each SIRTURO 20 mg tablet contains 20 mg of bedaquiline (equivalent to 24.18 mg of bedaquiline fumarate). Each SIRTURO 100 mg tablet contains 100 mg of bedaquiline (equivalent to 120.89 mg of bedaquiline fumarate).
Bedaquiline fumarate is a white to almost white powder and is practically insoluble in aqueous media. The chemical name of bedaquiline fumarate is (1 R , 2 S )-1-(6-bromo-2-methoxy-3-quinolinyl)-4-(dimethylamino)-2-(1-naphthalenyl)-1-phenyl-2-butanol compound with fumaric acid (1:1). It has a molecular formula of C 32 H 31 BrN 2 O 2 ∙C 4 H 4 O 4 and a molecular weight of 671.58 (555.50 + 116.07).
The molecular structure of bedaquiline fumarate is the following: SIRTURO 20 mg tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose 2910 5 mPa.s, polysorbate 20, purified water (removed during processing), silicified microcrystalline cellulose and sodium stearyl fumarate. SIRTURO 100 mg tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose 2910 15 mPa.s, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, purified water (removed during processing).
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Medication Guide). Serious Adverse Reactions Advise patients that the following serious side effects can occur with SIRTURO: heart rhythm abnormalities, death and/or hepatitis. In addition, advise patients about other potential side effects: nausea, vomiting, joint pain, increased transaminases, dizziness, headache, myalgia, diarrhea, increased blood amylase, hemoptysis, chest pain, anorexia, rash, and/or abdominal pain.
Additional testing may be needed to monitor or reduce the likelihood of adverse effects. Compliance with Treatment Advise patients to take SIRTURO in combination with other antimycobacterial drugs as prescribed. Emphasize compliance with the full course of therapy.
Advise patients that skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the treatment and (2) increase the likelihood that their mycobacterium may develop resistance and the disease will not be treatable by SIRTURO or other antimycobacterial drugs in the future. If a dose is missed during the first 2 weeks of treatment, advise patients not to make up the missed dose but to continue the usual dosing schedule. From Week 3 onwards, if a dose is missed, advise patients to take the missed dose as soon as possible, and then resume the 3 times a week regimen.
Ensure that the total dose of SIRTURO during a 7-day period does not exceed the recommended weekly dose (with at least 24 hours between each intake). Administration Instructions Advise patients to take SIRTURO with food. Advise patients who have difficulty swallowing tablets that SIRTURO 20 mg tablet can be administered by the following methods: Dispersed in water and the mixture administered immediately.
To aid with administration, the dispersed mixture in water can be further mixed with a beverage (e.g., water, milk products, apple juice, orange juice, cranberry juice or carbonated beverage) or soft food (e.g., yogurt, apple sauce, mashed banana or porridge) and then administered immediately, Crushed and mixed with soft food and the mixture administered immediately, Administered through a feeding tube [see Dosage and Administration (2.6) ] . Use with Alcohol and other Medications Instruct patients to abstain from alcohol, hepatotoxic medications or herbal products.
Advise patients to discuss with their physician the other medications they are taking and other medical conditions before starting treatment with SIRTURO. Lactation Advise patients not to breastfeed during treatment with SIRTURO and for 27.5 months after the last dose unless infant formula is not available. If an infant is exposed to bedaquiline through breast milk, advise caregivers to monitor the infant for signs of bedaquiline-related adverse reactions, such as hepatotoxicity (yellowing of the eyes and changes in the color of the urine or stool) [see Adverse Reactions (6) and Use in Specific Populations (8.2) ] .
💬 Medication Guide ▾
MEDICATION GUIDE SIRTURO ® (ser toor' oh) (bedaquiline) tablets, for oral use This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 7/2025 Read this Medication Guide before you start taking SIRTURO and each time you get a refill. There may be new information.
This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about SIRTURO? SIRTURO can cause serious side effects, including: A serious heart rhythm problem called QTc prolongation.
This condition can cause an abnormal heartbeat in people who take SIRTURO. Your healthcare provider should check your heart and do blood tests before and during treament with SIRTURO. Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat) or if you feel dizzy or faint.
What is SIRTURO? SIRTURO is a diarylquinoline antibiotic prescription medicine used as a part of combination therapy in adults and children (2 years of age and older and weighing at least 17.6 pounds) with pulmonary tuberculosis (TB) of the lungs that is resistant to at least rifampin and isoniazid. It is not known if SIRTURO is safe and effective in: people who have a tuberculosis (TB) infection, but do not show symptoms of TB (also known as latent TB). people who have TB of the lungs that is not resistant to antibiotics. people who have types of TB other than TB of the lungs. people who have an infection caused by bacteria other than TB. children under 2 years of age or weighing less than 17.6 pounds (8 kg).
Before you take SIRTURO, tell your healthcare provider about all your medical conditions including, if you: take any medicines for your heart. have had an abnormal heart rhythm (ECG) or other heart problems. have a family history of a heart problem called "congenital long QTc syndrome" or heart failure. have decreased thyroid gland function (hypothyroidism). have liver or kidney problems. have HIV infection. are pregnant or plan to become pregnant. It is not known if SIRTURO will harm your unborn baby. are breastfeeding or plan to breastfeed.
Do not breastfeed while taking SIRTURO, and for 27.5 months (2 years 3 months and 2 weeks) after your last dose, unless formula is not available. SIRTURO passes into breast milk. Talk to your healthcare provider about the best way to feed your baby while taking SIRTURO.
If you have to breastfeed because formula is not available, tell your healthcare provider right away if your baby has : yellowing of their eyes. darker than usual urine color. lighter than usual stool color or stool that is pale or light brown. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. You should not take certain liver medicines or herbal supplements while taking SIRTURO.
How should I take SIRTURO? Take SIRTURO exactly as your healthcare provider tells you to take it. You will take SIRTURO for a total of 24 weeks.
You may need to take your other TB medicines for longer than 24 weeks. If you are not sure, you should talk with your healthcare provider. SIRTURO must always be taken with other medicines to treat TB.
Your healthcare provider will decide which other medicines you should take with SIRTURO. It is important that you complete the full course of treatment with SIRTURO and not skip doses. Skipping doses may decrease the effectiveness of the treatment and increase the chances that your TB will not be treatable by SIRTURO or other medicines.
Week 1 and Week 2: Take your prescribed dose 1 time each day. Week 3 to Week 24: Take your prescribed dose 3 times a week . Take SIRTURO doses at least 48 hours apart.
For example, you may take SIRTURO on Monday, Wednesday and Friday every week from week 3 to week 24. Do not skip SIRTURO doses. If you skip doses, or do not complete the total 24 weeks of SIRT…