Sirturo
Authorised
This medicine is authorised for use in the European Union
bedaquiline
MedicineHumanAuthorised
Overview
Sirturo is a tuberculosis medicine that contains the active substance bedaquiline. Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis.
Sirturo is used in combination with other tuberculosis medicines in adults and children (aged 5 years and older and weighing at least 15 kg) with tuberculosis in the lung that is resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines.
The medicine is available as tablets to be taken once a day for the first 2 weeks, and then 3 times a week for the next 22 weeks. In adults, treatment may be continued for up to 40 weeks. In children, the dose depends on the child’s weight. The tablets should be taken with food.
For more information about using Sirturo, see the package leaflet or contact your doctor or pharmacist.
The active substance in Sirturo, bedaquiline, blocks an enzyme inside the M. tuberculosis bacteria called ATP synthase, which the bacteria need to generate energy. Without the ability to generate energy, the bacteria die and the patient’s condition starts to improve.
In a main study in patients with multi-drug resistant tuberculosis affecting the lung, Sirturo was compared with placebo (a dummy treatment) when added to combination treatment with other standard tuberculosis medicines. The study showed that after 24 weeks, 79% of the patients given Sirturo (52 out of 66 patients) tested negative for M. tuberculosis in the sputum (phlegm) compared with 58% of patients given placebo (38 out of 66 patients). The average time it took to clear the bacteria from the sputum was also shorter for patients in the Sirturo group than for those in the placebo group (83 days versus 125 days).
The way Sirturo is handled in the body in children has been shown to be the same as in adults; it is therefore also expected to be effective at treating tuberculosis in children.
A follow-up study compared the benefits of Sirturo plus other tuberculosis medicines taken by mouth with another combination that included a tuberculosis medicine given by injection. The study showed that after 76 weeks, around 82% of the patients given the Sirturo combination (162 out of 196 patients) tested negative for M. tuberculosis in the sputum compared with 71% of patients given the combination with an injectable medicine (133 out of 187 patients).
For the full list of side effects and restrictions with Sirturo, see the package leaflet.
The most common side effects with Sirturo in adults (which may affect more than 1 in 10 people) are QT prolongation (abnormal electrical activity of the heart that affects its rhythm), nausea (feeling sick), vomiting, arthralgia (joint pain), increased blood levels of liver enzymes (a sign of possible liver problems), dizziness and headache. Overall, the side effects in adolescents are similar to those in adults. Blood tests showing increased liver enzymes and other effects on the liver occur in about 1 in 3 younger children.
The side effects in the Sirturo group in the main study were not markedly different from those in the placebo group, though there were higher levels of liver enzymes and some reports of alterations in the heart’s electrical activity (known as prolonged QT interval). Also, a higher number of deaths was reported in the Sirturo group. Although an analysis did not conclude that Sirturo caused these deaths, the company was asked provide more information from a long-term follow-up study to address any concerns.
The follow-up study confirmed the benefits of a Sirturo-containing regimen when compared with an injectable-containing regimen. The number of deaths in the Sirturo group was not higher than in the control group in this study and no new safety issues for Sirturo were identified. The known safety issues including liver toxicity and QT-prolongation were shown to be clinically manageable.
The European Medicines Agency therefore concluded that Sirturo’s benefits are greater than its risks and it can be authorised for use in the EU.
Sirturo was originally given ‘conditional authorisation’. The authorisation has now been switched to a standard authorisation as the company has provided the additional data requested by the Agency.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sirturo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sirturo are continuously monitored. Side effects reported with Sirturo are carefully evaluated and any necessary action taken to protect patients.
Sirturo received a conditional marketing authorisation valid throughout the EU on 5 March 2014. The conditional marketing authorisation was switched to a standard marketing authorisation on 17 June 2024.
Product information
Latest procedure affecting product information: II/0056
17/06/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Sirturo
- Active substance
- bedaquiline fumarate
- International non-proprietary name (INN) or common name
- bedaquiline
- Therapeutic area (MeSH)
- Tuberculosis, Multidrug-Resistant
- Anatomical therapeutic chemical (ATC) code
- J04AK05
Pharmacotherapeutic group
AntimycobacterialsTherapeutic indication
Sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (MDR TB) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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