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Sirturo Side Effects Center
Reviewed by Melissa Conrad Stöppler, MD
Sirturo (bedaquiline) is a prescription medicine used to treat adults with pulmonary multi-drug resistant tuberculosis (MDR-TB) when other alternatives are not available. Sirturo is the first drug approved to treat multi-drug resistant TB and should be used in combination with other drugs used to treat TB. Commonly reported side effects from the use of Sirturo may include nausea, joint pain, and headache.
The recommended dose for Sirturo is 400 mg once daily for 2 weeks followed by 200 mg 3 times per week for 22 weeks with food. Sirturo tablets should be swallowed whole with water. Some drugs that are CYP3A4 inhibitors such as Serzone, Sporanox, Nizoral, Vfend, Reyataz, Biaxan and Ketek are contraindicated with Sirturo. Before taking Situro, women should tell their healthcare providers if they are pregnant or planning to become pregrnant; or breastfeeding or planning to breastfeed. It is not known if Sirturo passes into breast milk. Patients and their healthcare providers should decide if the patient will take Sirturo or breastfeed. Patients should not do both.
Our Sirturo (bedaquiline) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Sirturo FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed elsewhere in the labeling:
- Increased mortality [see WARNINGS AND PRECAUTIONS]
- QT Prolongation [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Drug Interactions [see WARNINGS AND PRECAUTIONS]
Clinical 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.
Adverse drug reactions for SIRTURO were identified from the pooled safety data from 335 SIRTURO-exposed patients who received 8 weeks (Study 2) and 24 weeks (Studies 1 and 3) at the proposed dose. Studies 1 and 2 were randomized, double-blind, placebo-controlled trial in newly diagnosed patients with pulmonary MDR-TB. In both treatment arms, patients received SIRTURO or placebo in combination with other drugs used to treat MDR-TB. Study 3 was an open-label, noncomparative study with SIRTURO administered as part of an individualized pulmonary MDR-TB treatment regimen in previously treated patients.
In Study 1, 35% were Black, 17.5% were Hispanic, 12.5% were White, 9.4% were Asian, and 25.6% were of another race. Eight of 79 (10.1%) patients in the SIRTURO group and 16 of 81 (19.8%) 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.
Table 1: Select Adverse Reactions from Study 1 That
Occurred More Frequently Than Placebo During Treatment with SIRTURO
|Adverse Reactions||SIRTURO Treatment Group
|Placebo Treatment Group
|Nausea||30 (38)||26 (32)|
|Arthralgia||26 (33)||18 (22)|
|Headache||22 (28)||10 (12)|
|Hemoptysis||14 (18)||9 (11)|
|Chest Pain||9 (11)||6 (7)|
|Anorexia||7 (9)||3 (4)|
|Transaminases Increased*||7 (9)||1 (1)|
|Rash||6 (8)||3 (4)|
|Blood Amylase Increased||2 (3)||1 (1)|
|* Terms represented by 'transaminases increased' included transaminases increased, AST increased, ALT increased, hepatic enzyme increased, and hepatic function abnormal.|
No additional unique Adverse Reactions were identified from the uncontrolled Study 3.
In both Studies 1 and 2, aminotransferase elevations of at least 3 times the upper limit of normal developed more frequently in the SIRTURO treatment group (11/102 [10.8%] vs 6/105 [5.7%]) than in the placebo treatment group. In Study 3, 22/230 (9.6%) patients had alanine aminotransferase or aspartate aminotransferase greater than or equal to 3 times the upper limit of normal during the overall treatment period.
In Study 1, there was a statistically significant increased mortality risk by Week 120 in the SIRTURO treatment group compared to the placebo treatment group (9/79 (11.4%) versus 2/81 (2.5%), p-value=0.03, an exact 95% confidence interval of the difference [1.1%, 18.2%]). Five of the 9 SIRTURO deaths and the 2 placebo deaths were tuberculosis-related. One death occurred during the 24-week SIRTURO treatment period. The median time to death for the remaining eight subjects in the SIRTURO treatment group was 329 days after last intake of SIRTURO. The imbalance in deaths is unexplained; no discernible pattern between death and sputum conversion, relapse, sensitivity to other drugs used to treat tuberculosis, HIV status, and severity of disease was observed.
In the open-label Study 3, 6.9% (16/233) subjects died. The most common cause of death as reported by the investigator was TB (9 subjects). All but one subject who died of TB had not converted or had relapsed. The causes of death in the remaining subjects varied.
Read the entire FDA prescribing information for Sirturo (Bedaquiline Tablets)
Additional Sirturo Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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