SIRTURO (Bedaquiline) 20 mg
Diarylquinoline antimycobacterial for multidrug-resistant tuberculosis
Quick Facts About SIRTURO
Key Takeaways About SIRTURO
- Combination therapy only: SIRTURO must always be given together with at least three other antituberculosis medicines. Monotherapy is never appropriate and rapidly drives resistance.
- Heart rhythm risk: Bedaquiline prolongs the QT interval. ECG monitoring at baseline, week 2, 4, 8, 12 and 24 is standard, and any new palpitations or syncope must be reported immediately.
- Long half-life: Bedaquiline stays in the body for months after the last dose because it is slowly released from fatty tissue, so late side effects can still occur after treatment ends.
- Take with food: Food roughly doubles absorption. Missed doses and inconsistent food intake reduce blood levels and risk treatment failure.
- Paediatric use: The 20 mg dispersible tablet is specifically designed for children aged 5 years and older weighing 15 kg or more, using weight-banded dosing.
What Is SIRTURO and What Is It Used For?
SIRTURO (bedaquiline) is a prescription-only antibiotic used, together with other antituberculosis medicines, to treat pulmonary multidrug-resistant tuberculosis (MDR-TB) in adults and children aged 5 years and over who weigh at least 15 kg. It is used when the bacteria are resistant to at least isoniazid and rifampicin, the two most important first-line TB drugs.
SIRTURO is the trade name for bedaquiline, the first member of a novel antibiotic class called diarylquinolines. It was granted accelerated approval by the U.S. Food and Drug Administration in 2012 and conditional marketing authorisation by the European Medicines Agency in 2014 for multidrug-resistant tuberculosis, and represents the first genuinely new mechanism of action against TB in more than forty years. The 20 mg dispersible tablet was introduced later specifically to serve children and patients who cannot swallow the larger 100 mg film-coated tablet.
Multidrug-resistant tuberculosis is defined by the World Health Organization as tuberculosis caused by strains of Mycobacterium tuberculosis that are resistant to at least isoniazid and rifampicin, the two most effective first-line antituberculosis drugs. MDR-TB is far more difficult to cure than drug-sensitive tuberculosis, traditionally requiring 18 to 24 months of toxic, injectable-based therapy. The introduction of bedaquiline-based all-oral regimens (such as BPaL: bedaquiline, pretomanid, linezolid) has transformed the global management of MDR-TB, shortening treatment to six months in eligible patients with substantially better outcomes.
SIRTURO is indicated as part of an appropriate combination regimen in adults and paediatric patients (5 years of age and older weighing at least 15 kg) with pulmonary multidrug-resistant tuberculosis when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. It is prescribed and supervised by specialists in TB care, typically through a national tuberculosis programme, and its use is restricted to licensed indications because inappropriate use rapidly selects for bedaquiline-resistant strains.
How SIRTURO Works
Bedaquiline has a mechanism of action unique among tuberculosis drugs. It selectively inhibits mycobacterial ATP synthase, the enzyme responsible for producing adenosine triphosphate (ATP) — the energy currency that every living cell, including Mycobacterium tuberculosis, needs to survive. By binding to subunit c of this enzyme (encoded by the atpE gene), bedaquiline blocks the proton pump activity that generates ATP, effectively starving the bacterium of energy.
This mechanism gives bedaquiline two important clinical advantages. First, because ATP synthesis is essential even for dormant bacteria, bedaquiline is active against both actively replicating and non-replicating persister bacilli — the latter being a major reason why conventional TB treatment takes so long. Second, because the drug is highly specific for mycobacterial ATP synthase and has far lower affinity for the human enzyme, it spares the patient's own mitochondria at therapeutic concentrations.
Bedaquiline has a characteristically long terminal elimination half-life of approximately 5.5 months, reflecting slow release from peripheral tissues where it accumulates during treatment. This pharmacokinetic profile allows intermittent dosing after an initial intensive loading phase, but it also means that potential adverse effects — particularly QT prolongation — can persist for a prolonged period after the last dose has been taken.
SIRTURO 20 mg is a dispersible (water-soluble) tablet developed primarily for paediatric dosing and for adults who cannot swallow the 100 mg film-coated tablet whole. It can be swallowed intact with water, dispersed in approximately 5 mL of water, crushed and mixed with a small amount of water or soft food (such as yoghurt or apple puree), or administered via a nasogastric tube. All routes must still be taken with a full meal to achieve adequate absorption.
What Should You Know Before Taking SIRTURO?
Before starting SIRTURO, your doctor will perform an electrocardiogram (ECG), liver function tests, and measure your potassium, magnesium and calcium levels. You should not take SIRTURO if you are allergic to bedaquiline or any of its excipients, if you have a baseline QTcF interval greater than 500 milliseconds, a personal or family history of significant QT prolongation, or severe ventricular arrhythmia. SIRTURO must always be given alongside at least three other active antituberculosis medicines.
Because SIRTURO is a potent medicine with specific cardiac and hepatic risks, patients require careful screening and ongoing monitoring throughout treatment. The decisions about when to start, when to pause and when to stop SIRTURO are made by clinicians experienced in the management of drug-resistant tuberculosis, often within the framework of a national TB programme. Good adherence and full transparency about other medicines and medical history are essential for safe, effective treatment.
Contraindications
You must not take SIRTURO if:
- You are hypersensitive (allergic) to bedaquiline or to any of the other ingredients listed in the composition section
- You have a confirmed personal or family history of congenital long QT syndrome
- You have severe, symptomatic ventricular arrhythmias, including torsades de pointes
- Your baseline QT interval corrected using Fridericia's formula (QTcF) is greater than 500 milliseconds, confirmed on repeat ECG
- You have symptomatic or decompensated heart failure
- You have uncorrected hypokalaemia (low blood potassium) or hypomagnesaemia (low blood magnesium) — treatment should not begin until electrolytes are normalised
Warnings and Precautions
Talk to your doctor before taking SIRTURO if any of the following apply to you:
- Slow heart rate (bradycardia): A resting heart rate below 50 beats per minute may increase arrhythmia risk
- History of heart disease: Previous myocardial infarction, heart failure, cardiomyopathy, or known structural heart disease
- Liver disease: Pre-existing hepatitis, cirrhosis, elevated transaminases, or heavy alcohol use; baseline and regular liver function testing is required
- Kidney disease: Severe renal impairment (creatinine clearance below 30 mL/min) requires cautious use as data are limited
- HIV co-infection: Common among MDR-TB patients; interactions with antiretroviral therapy require specialist coordination
- Diabetes mellitus or thyroid disease: These conditions can amplify electrolyte disturbances
- Eating disorders or chronic vomiting/diarrhoea: These can deplete potassium and magnesium and increase arrhythmia risk
- Use of other QT-prolonging drugs: Including clofazimine, moxifloxacin, delamanid, levofloxacin, macrolides, and certain antifungals and antidepressants — see the interactions section
SIRTURO carries a boxed warning from the U.S. Food and Drug Administration. In one placebo-controlled trial, more deaths were reported in patients receiving bedaquiline than in those receiving placebo, even though bedaquiline-treated patients had higher rates of microbiological cure. The cause was not fully established. In addition, bedaquiline causes measurable QT interval prolongation, which can rarely progress to a life-threatening arrhythmia called torsades de pointes. SIRTURO should be prescribed only by clinicians experienced in the management of MDR-TB and used strictly according to international guidelines.
Pre-Treatment Assessments
Before your first dose of SIRTURO, your healthcare team will typically perform:
- A baseline 12-lead electrocardiogram, calculating QTcF
- Blood tests including full blood count, liver function (ALT, AST, alkaline phosphatase, bilirubin), kidney function (creatinine, urea), thyroid function (TSH), and electrolytes (potassium, magnesium, calcium)
- Drug susceptibility testing of your Mycobacterium tuberculosis strain to confirm resistance pattern and guide the companion drugs
- HIV testing and, where relevant, a pregnancy test in individuals of childbearing potential
- A review of all current medicines, including prescription, over-the-counter, herbal preparations and traditional remedies
Monitoring During Treatment
Because the risks of bedaquiline can evolve over time, regular monitoring continues throughout the course of therapy and typically beyond, given the long half-life. International guidelines recommend:
- ECGs at baseline, week 2, week 4, week 8, week 12 and week 24 (more frequently if QTcF is rising or other QT-prolonging drugs are added)
- Liver function tests monthly during treatment and when symptoms suggest hepatotoxicity (nausea, anorexia, fatigue, right upper-quadrant pain, jaundice, dark urine)
- Electrolyte checks monthly, and more frequently in patients with vomiting, diarrhoea or concomitant diuretic use
- Bacteriology: sputum smears and cultures to document clearance of tuberculosis bacteria
- Symptom review at each visit for palpitations, dizziness, syncope, chest pain, new rash or yellowing of skin/eyes
Pregnancy and Breastfeeding
Data on the use of bedaquiline in pregnant women are limited. Animal studies have not shown direct harmful effects on reproduction at clinically relevant doses, but human experience is incomplete. Because untreated active MDR-TB poses major risks to both the pregnant patient and the developing baby, the benefit of treatment usually outweighs the risk of withholding it. The decision should be made jointly by the patient, her TB physician and her obstetrician.
Bedaquiline is excreted into human breast milk at concentrations comparable to those in the mother's plasma, and its long half-life means exposure to the infant can be substantial. Given the theoretical risk of QT-related effects in the infant, most national guidelines recommend that mothers on SIRTURO use replacement feeding when culturally and socially feasible. Where breastfeeding must continue, close paediatric monitoring is required.
Children and Adolescents
SIRTURO is approved for use in paediatric patients from 5 years of age and weighing at least 15 kg. The 20 mg dispersible tablet was specifically developed for this age group, allowing accurate weight-banded dosing. Safety and efficacy in children younger than five or weighing less than 15 kg have not been established and bedaquiline should not be used in that population outside specialist research settings.
Driving and Using Machines
Bedaquiline itself has a minor to moderate influence on the ability to drive and use machines; dizziness and headache have been reported. Patients who experience these symptoms should avoid driving and operating heavy machinery until the symptoms resolve. In addition, symptoms of the underlying tuberculosis, concurrent medicines, and any episode of QT-related arrhythmia may all affect fitness to drive.
How Does SIRTURO Interact with Other Drugs?
SIRTURO is primarily metabolised by the liver enzyme CYP3A4. Strong inducers of CYP3A4 (such as rifampicin, phenytoin and efavirenz) markedly lower bedaquiline blood levels and should be avoided. Strong inhibitors (such as ketoconazole, itraconazole, ritonavir and clarithromycin) raise concentrations and must not be used for longer than 14 days. The most clinically important interaction is additive QT prolongation with other QT-prolonging drugs commonly used in MDR-TB regimens.
Interactions with bedaquiline fall into two main categories: metabolic interactions that change the blood level of bedaquiline itself, and pharmacodynamic interactions that combine with bedaquiline to increase toxicity (especially QT prolongation or hepatotoxicity). Because MDR-TB regimens inevitably contain several drugs, careful planning by a specialist is essential, and patients should never add or stop any medicine, including herbal supplements, without talking to their TB team.
Major Interactions
| Interacting Drug / Class | Effect | Recommendation |
|---|---|---|
| Rifampicin, rifapentine, rifabutin (strong CYP3A4 inducers) | Reduce bedaquiline plasma concentrations by roughly 50%, risking treatment failure | Avoid co-administration with rifampicin and rifapentine. If rifabutin is essential, monitor TB response closely. |
| Efavirenz (moderate CYP3A4 inducer) | Significantly lowers bedaquiline exposure | Prefer dolutegravir-based antiretroviral therapy in HIV-positive MDR-TB patients taking SIRTURO. |
| Ketoconazole, itraconazole, voriconazole (strong CYP3A4 inhibitors) | Increase bedaquiline exposure and risk of QT prolongation and hepatotoxicity | Do not co-administer for longer than 14 consecutive days unless benefit clearly outweighs risk; intensify ECG and liver monitoring. |
| Ritonavir, cobicistat (boosted antiretrovirals) | Substantial increase in bedaquiline levels | Use only with close ECG and liver monitoring; some regimens require dose adjustment. |
| Clofazimine, delamanid, pretomanid | Additive QT prolongation when combined in MDR-TB regimens | Combinations are widely used (e.g. BPaL) but require strict ECG and electrolyte monitoring per WHO guidance. |
| Fluoroquinolones (moxifloxacin, levofloxacin) | Additive QT prolongation, especially with moxifloxacin | Levofloxacin preferred over moxifloxacin where either would be appropriate; monitor ECG. |
| Macrolides (clarithromycin, erythromycin, azithromycin) | QT prolongation and CYP3A4 inhibition by clarithromycin/erythromycin | Avoid where possible; if needed, azithromycin is the preferred macrolide. |
| Class IA and III antiarrhythmics | Marked additive QT prolongation and arrhythmia risk | Use is strongly discouraged; seek specialist cardiology input if unavoidable. |
| Methadone, ondansetron, haloperidol, citalopram, escitalopram | Additive QT prolongation | Review necessity; choose safer alternatives where possible; intensify ECG monitoring if combined. |
| St John's Wort (herbal preparation) | Strong CYP3A4 induction, reducing bedaquiline levels | Avoid during SIRTURO treatment and for at least one month after stopping. |
Minor Interactions
Other interactions are generally less critical but still worth mentioning to your doctor:
- Paracetamol (acetaminophen): usually safe at standard doses, but heavy or chronic use increases the risk of additive liver injury.
- Non-steroidal anti-inflammatory drugs (NSAIDs): may worsen kidney function during prolonged MDR-TB treatment.
- Oral contraceptives: bedaquiline itself does not significantly reduce hormonal contraceptive efficacy, but some companion TB drugs can; discuss reliable contraception with your clinician.
- Calcium- or iron-containing antacids and supplements: may interfere with companion TB drugs (notably fluoroquinolones) rather than bedaquiline directly — space dosing as advised.
- Alcohol: increases the risk of hepatotoxicity and is best avoided throughout treatment.
Bring every medication you take to each clinic visit, including injections, patches, inhalers, eye drops, herbal teas, vitamins and traditional remedies. Interactions are one of the leading preventable causes of treatment failure and adverse events in MDR-TB, and your TB team can only help you if they know exactly what you are taking.
What Is the Correct Dosage of SIRTURO?
The standard adult SIRTURO regimen is 400 mg once daily for the first 14 days (loading phase), followed by 200 mg three times per week for 22 weeks (maintenance), giving a total treatment duration of 24 weeks. Paediatric doses are weight-banded. SIRTURO must always be taken with food and combined with at least three other active antituberculosis medicines.
SIRTURO dosing is built around the drug's unusual pharmacokinetics. The two-week loading phase achieves adequate tissue concentrations quickly; the thrice-weekly maintenance phase then sustains exposure while reducing pill burden. This fixed 24-week course is typically embedded in a longer MDR-TB regimen, and in some WHO-endorsed short regimens (such as BPaL and BPaLM) the whole treatment — bedaquiline included — lasts just six months. All dosing decisions should be made by a TB specialist or national TB programme.
Adults
Standard Adult Regimen (24 Weeks)
Weeks 1–2 (loading phase): 400 mg orally once daily, taken with food. Using the 20 mg dispersible tablet this is 20 tablets once daily, and in practice adults are more commonly given the 100 mg film-coated tablet. The 20 mg strength is the option for adults who cannot swallow tablets whole.
Weeks 3–24 (maintenance phase): 200 mg orally three times per week, with at least 48 hours between doses, taken with food. For example, doses may be scheduled Monday, Wednesday and Friday, giving a weekly total of 600 mg.
Children and Adolescents (5 Years and Older, ≥15 kg)
Paediatric Weight-Banded Dosing (using 20 mg dispersible tablets)
Paediatric dosing is weight-banded. The exact tablet count is determined by the prescriber, but the general structure mirrors the adult regimen with a daily loading phase for two weeks followed by a three-times-weekly maintenance phase for 22 weeks.
- 15–20 kg: 120 mg once daily for 14 days, then 60 mg three times per week for 22 weeks
- 20–30 kg: 200 mg once daily for 14 days, then 100 mg three times per week for 22 weeks
- 30–40 kg: 300 mg once daily for 14 days, then 150 mg three times per week for 22 weeks
- >40 kg: 400 mg once daily for 14 days, then 200 mg three times per week for 22 weeks (adult dose)
Tablets may be swallowed whole, dispersed in a small amount of water, or crushed and mixed with soft food. Each dose should be taken with food, and care should be taken to ensure the full dose is consumed.
Elderly
Clinical experience in patients aged 65 years and older is limited. No specific dose adjustment is recommended based on age alone. However, elderly patients are more likely to have reduced kidney or liver function, electrolyte disturbances, cardiovascular disease, and polypharmacy — all of which can amplify the risks of QT prolongation and hepatotoxicity. Extra vigilance and, where necessary, more frequent monitoring are prudent.
Renal and Hepatic Impairment
No dose adjustment is required for mild to moderate renal impairment. In severe renal impairment or end-stage renal disease (including patients on dialysis), use SIRTURO with caution as clinical data are limited. For patients with mild or moderate hepatic impairment, no dose adjustment is required but ALT/AST should be monitored closely. SIRTURO has not been studied in severe hepatic impairment and should generally be avoided in this group unless the benefit clearly outweighs the risk.
How to Take SIRTURO 20 mg
SIRTURO 20 mg dispersible tablets offer several administration options:
- Swallow whole with water, together with a meal
- Disperse in water: place the required number of tablets in at least 5 mL of drinking water per tablet, allow them to dissolve completely, stir briefly and drink immediately. Rinse the cup with a small amount of water and drink that too, to ensure the full dose is taken
- Crush and mix with soft food: yoghurt, apple puree, mashed banana or similar; the mixture should be taken immediately and in full
- Nasogastric tube administration: disperse in water and flush per standard tube-administration procedures
Whichever method is used, the dose should always be taken with food, because food roughly doubles the absorption of bedaquiline. Grapefruit juice is best avoided during treatment because of potential effects on drug metabolism.
Missed Dose
If you forget a dose during the loading phase (first two weeks), take the missed dose as soon as you remember on the same day, with food. Do not take a double dose to make up for a missed dose.
If you forget a dose during the maintenance phase (weeks 3 to 24), take the missed dose as soon as you remember, together with food. Afterwards, continue with your normal three-times-weekly schedule, but do not take two maintenance doses within 24 hours of each other. Tell your healthcare team about missed doses at your next visit.
Overdose
There is no specific antidote to bedaquiline overdose. Treatment is supportive and focuses on monitoring and correcting any ECG or electrolyte abnormalities (hypokalaemia, hypomagnesaemia, hypocalcaemia). Because bedaquiline is highly bound to plasma proteins, haemodialysis is unlikely to remove significant amounts. If overdose is suspected, contact your local poisons centre or emergency services immediately. Continuous cardiac monitoring and liver function testing are standard.
What Are the Side Effects of SIRTURO?
The most common side effects of SIRTURO are nausea, joint pain, headache, elevated liver enzymes, chest pain, loss of appetite, dizziness and QT prolongation on ECG. The most important serious side effect is prolongation of the QT interval, which can rarely cause a life-threatening arrhythmia called torsades de pointes. Hepatotoxicity is the other key serious risk. Seek urgent medical care for palpitations, fainting, severe chest pain, or yellowing of the skin or eyes.
Like all medicines, SIRTURO can cause side effects, although not everyone gets them. In clinical trials and real-world cohorts the overall tolerability of bedaquiline has been better than the injectable agents it often replaces, which is part of the reason bedaquiline-based regimens have rapidly become the standard of care for MDR-TB. However, a small number of adverse effects require active monitoring and prompt action, and every patient on SIRTURO should know the warning signs.
Contact your doctor or emergency services straight away if you experience: a rapid or irregular heartbeat, fainting or near-fainting, severe chest pain, breathlessness at rest, unexplained bruising, yellowing of the skin or eyes, dark urine, severe upper-right abdominal pain, extreme fatigue, a sudden severe rash, or seizures. These may be signs of serious QT-related or liver-related toxicity and require urgent assessment.
Side Effects by Frequency
The side effects below are grouped by how often they are reported in clinical trials and pharmacovigilance data. Many are also symptoms of MDR-TB itself or of other antituberculosis drugs in the regimen, so your healthcare team will work through them with you to identify the likely cause.
Very Common (affects more than 1 in 10 patients)
- Nausea
- Joint pain (arthralgia)
- Headache
- Increased transaminases (ALT/AST) on blood testing
- QT interval prolongation on electrocardiogram
- Dizziness
Common (affects up to 1 in 10 patients)
- Vomiting
- Diarrhoea
- Loss of appetite (anorexia)
- Chest pain
- Muscle pain (myalgia)
- Abdominal pain
- Rash
- Haemoptysis (coughing up blood) — often TB-related rather than drug-related
- Elevated blood amylase or mild pancreatic enzyme changes
Uncommon (affects up to 1 in 100 patients)
- Drug-induced hepatitis with clinically significant liver injury
- Clinically significant QTc prolongation (QTcF >500 ms or >60 ms rise from baseline) requiring dose interruption
- Pancreatitis
- Pruritus (itching) without rash
- Hypokalaemia (low potassium)
Rare (affects up to 1 in 1,000 patients)
- Ventricular tachycardia or torsades de pointes secondary to QT prolongation
- Hepatic failure requiring hospitalisation
- Severe cutaneous reactions such as Stevens-Johnson syndrome (reported very rarely in post-marketing data)
- Emergence of bedaquiline-resistant tuberculosis when the drug is used inappropriately (not a classical side effect but a critical clinical concern)
QT Prolongation Explained
The QT interval is a measurement on the electrocardiogram that reflects the time it takes for the heart's ventricles to recover between beats. When the QT becomes too long, the heart can enter a fast, chaotic rhythm called torsades de pointes, which can degenerate into ventricular fibrillation and sudden cardiac death. The corrected QT interval using Fridericia's formula (QTcF) above 500 milliseconds, or an increase of more than 60 milliseconds from baseline, are the usual thresholds for concern.
Bedaquiline alone prolongs QTcF modestly (mean increase of roughly 10–15 milliseconds). The risk becomes more clinically relevant when multiple QT-prolonging drugs are used together, or when potassium or magnesium is low. Regular ECGs, correction of electrolyte abnormalities, and careful selection of companion drugs are the cornerstones of managing this risk, and they allow the vast majority of patients to complete treatment safely.
Hepatotoxicity Explained
Liver enzyme elevations are common with bedaquiline, usually mild, and often occur in the first months of treatment. In most cases the enzymes normalise with continued therapy, but a small proportion of patients develop clinically significant drug-induced hepatitis. Warning signs include persistent nausea, loss of appetite, upper-right abdominal pain, dark urine, pale stools, and yellowing of the skin or whites of the eyes (jaundice). Your TB team will check liver function monthly and will pause or stop SIRTURO and other potentially hepatotoxic drugs if enzymes rise markedly.
Reporting Side Effects
Reporting suspected side effects helps regulatory agencies monitor the ongoing safety of SIRTURO. Patients in the European Economic Area can report to their national authority via the EudraVigilance system; in the United States, reports can be submitted to the FDA MedWatch programme; globally, the WHO Programme for International Drug Monitoring collates pharmacovigilance data. Always inform your healthcare provider first, and follow local reporting instructions.
How Should You Store SIRTURO?
Store SIRTURO 20 mg tablets below 30°C in the original container with the desiccant to protect them from moisture. Keep the container tightly closed and store the medicine out of the sight and reach of children. Do not use SIRTURO after the expiry date printed on the packaging, and dispose of unused medicine through your pharmacy rather than household waste.
Proper storage is particularly important for SIRTURO because the tablets are dispersible and therefore sensitive to moisture. Exposure to humidity can cause the tablets to degrade or become difficult to disperse, potentially reducing absorption. The moisture-absorbing desiccant that comes in the bottle is there for this reason and should never be removed or discarded while tablets remain in the container.
Storage Conditions
- Store below 30°C (86°F) in the original container
- Keep the bottle tightly closed to protect from moisture
- Do not remove the desiccant from the bottle
- Do not refrigerate or freeze unless specifically instructed by the pharmacist
- Protect from direct sunlight and heat sources such as radiators
- Keep out of the sight and reach of children at all times
Travel and Transport
If you travel while taking SIRTURO, keep the medicine in its original container with the patient information leaflet. Hand luggage is generally preferred over checked baggage to avoid extreme temperatures. Plan for any time-zone changes by asking your TB team how to adjust your dosing schedule. For international travel, carry a letter from your TB clinic describing your diagnosis and treatment, especially because tuberculosis therapy and injectable medicines can attract scrutiny at borders.
Disposal
Do not dispose of SIRTURO via wastewater or household waste. Return any unused or expired tablets to your pharmacy or national pharmaceutical take-back scheme. These measures protect the environment and, importantly, reduce the risk that unused bedaquiline is consumed inappropriately, which contributes to bedaquiline-resistant tuberculosis — a growing global concern.
What Does SIRTURO Contain?
Each SIRTURO 20 mg dispersible tablet contains 20 mg of bedaquiline (as fumarate). The tablets also contain inactive ingredients such as lactose, microcrystalline cellulose, croscarmellose sodium, hypromellose, polysorbate, colloidal silicon dioxide and magnesium stearate. The tablets are free of gluten but contain lactose, which may be relevant for patients with rare hereditary sugar intolerances.
Understanding what is in your medicine helps you and your healthcare provider identify potential allergies and tolerability issues. All ingredients in SIRTURO are pharmaceutical-grade and included at concentrations considered safe for the approved indications and patient populations. If you have ever had a reaction to a medicine, vaccine or food additive, tell your doctor before starting SIRTURO so that any overlap with the excipients below can be assessed.
Active Ingredient
The active substance is bedaquiline, supplied as bedaquiline fumarate. Each dispersible tablet contains 20 mg of bedaquiline (calculated as the free base). Bedaquiline is a diarylquinoline antimycobacterial agent with the chemical name (1R,2S)-1-(6-bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-(1-naphthyl)-1-phenylbutan-2-ol, molecular weight 555.5 g/mol (free base) or 671.6 g/mol (fumarate salt).
Excipients (Inactive Ingredients)
The 20 mg dispersible tablet formulation typically contains:
- Lactose monohydrate — diluent and tablet former
- Microcrystalline cellulose — binder and disintegration aid
- Hypromellose (HPMC) — film-former and stabiliser
- Croscarmellose sodium — super-disintegrant that enables rapid dispersion in water
- Polysorbate 20 or 80 — surfactant that improves wetting and dispersion
- Colloidal anhydrous silica (silicon dioxide) — glidant
- Magnesium stearate — tablet lubricant
- Sucralose — sweetener to improve paediatric palatability
- Flavouring agents (depending on batch)
The precise excipient list for the particular pack you receive is printed on the patient information leaflet. If you are unsure whether a specific ingredient is present, ask your pharmacist.
Important Composition Notes
- Contains lactose. Patients with the rare hereditary conditions of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take SIRTURO.
- Sodium content. Each tablet contains less than 1 mmol (23 mg) of sodium, so the product is considered essentially "sodium-free" and suitable for patients on a sodium-restricted diet.
- Sweetener. The paediatric dispersible formulation uses non-cariogenic sweeteners (such as sucralose), which do not contribute to tooth decay.
Appearance and Packaging
SIRTURO 20 mg dispersible tablets are typically white to off-white, round, uncoated tablets debossed with identifiers on one or both sides. They are supplied in high-density polyethylene (HDPE) bottles with a child-resistant closure and an integral desiccant canister. Pack sizes vary by country, reflecting the 24-week regimen and paediatric weight bands. Packaging details and imagery are provided in the country-specific patient information leaflet.
Frequently Asked Questions About SIRTURO
SIRTURO (bedaquiline) is used as part of combination therapy to treat pulmonary multidrug-resistant tuberculosis (MDR-TB) in adults and children aged 5 years and older weighing at least 15 kg when an effective regimen cannot otherwise be composed. The 20 mg dispersible tablet is primarily used for paediatric patients and for patients who cannot swallow whole film-coated tablets. SIRTURO is never used on its own and must always be given together with at least three other active antituberculosis medicines.
The most serious side effects of SIRTURO are prolongation of the QT interval on the electrocardiogram, which can lead to potentially life-threatening ventricular arrhythmias such as torsades de pointes, and hepatotoxicity, which can cause elevated liver enzymes and, rarely, serious liver injury. SIRTURO also carries a boxed warning about increased mortality observed in one placebo-controlled clinical trial. Regular ECG monitoring, liver function testing, and electrolyte monitoring are mandatory during treatment.
SIRTURO 20 mg dispersible tablets are taken by mouth with food to improve absorption. The tablets can be dispersed in water, or swallowed whole or crushed and mixed with soft food. The typical adult regimen consists of 400 mg once daily for the first two weeks (an intensive loading phase), followed by 200 mg three times per week for 22 weeks, with at least 48 hours between doses. Paediatric doses are weight-based. SIRTURO must always be taken as part of a combination regimen directed by a specialist in tuberculosis care.
SIRTURO should not be taken by people who are hypersensitive (allergic) to bedaquiline or to any of the excipients in the tablet. It must be used with extreme caution or avoided in patients with a personal or family history of congenital QT prolongation, a baseline corrected QT (QTcF) greater than 500 milliseconds, severe ventricular arrhythmia, symptomatic heart failure, or uncorrected hypokalaemia or hypomagnesaemia. It is not recommended during pregnancy unless the benefit clearly outweighs the risk, and is not used in children under 5 years or weighing less than 15 kg.
SIRTURO prolongs the QT interval on the electrocardiogram, which increases the risk of a dangerous heart rhythm called torsades de pointes. This risk is higher when bedaquiline is combined with other QT-prolonging medicines used in MDR-TB regimens, such as clofazimine, moxifloxacin, or delamanid. Current guidelines recommend performing an ECG before starting SIRTURO and at two, four, eight, twelve and 24 weeks, as well as whenever QT-prolonging medicines are added, and at any point where electrolyte abnormalities, syncope or palpitations occur.
SIRTURO should only be used during pregnancy when the potential benefit to the mother outweighs the potential risk to the foetus, as data in pregnant women are limited. Active multidrug-resistant tuberculosis itself poses serious risks to both mother and child, so treatment is often continued under specialist supervision. Bedaquiline is excreted in breast milk at concentrations comparable to those in maternal plasma, and because of the long half-life and the theoretical risk of QT effects in the infant, most guidelines recommend avoiding breastfeeding while on SIRTURO or using alternative infant feeding when feasible.
Bedaquiline has a very long terminal elimination half-life of around 5.5 months because it is slowly released from peripheral tissues where it accumulates during the first two weeks of daily dosing (the loading phase). Once adequate tissue concentrations are reached, three-times-weekly dosing is enough to maintain effective drug levels against tuberculosis bacteria. This reduces pill burden, lowers daily cost in programme settings and eases adherence without compromising efficacy.
References
- World Health Organization. WHO consolidated guidelines on tuberculosis. Module 4: Treatment — drug-resistant tuberculosis treatment, 2022 update. Geneva: WHO; 2022. Available at: who.int/publications/i/item/9789240063129. Accessed January 2026.
- European Medicines Agency (EMA). SIRTURO (bedaquiline) — Summary of Product Characteristics. Available at: ema.europa.eu/en/medicines/human/EPAR/sirturo. Accessed January 2026.
- U.S. Food and Drug Administration. SIRTURO (bedaquiline) — Highlights of Prescribing Information. Accelerated approval 2012; paediatric 20 mg dispersible tablet approval 2023.
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