Sirturo Side Effects

Generic Name: bedaquiline

Note: This document contains side effect information about bedaquiline. Some of the dosage forms listed on this page may not apply to the brand name Sirturo.

Some side effects of Sirturo may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to bedaquiline: oral tablet

Along with its needed effects, bedaquiline (the active ingredient contained in Sirturo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking bedaquiline:

More common
  • Abdominal or stomach pain or tenderness
  • chest pain
  • coughing or spitting up blood
  • dark-colored urine
  • decreased appetite
  • fever
  • general feeling of tiredness or weakness
  • headache
  • itching
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • skin rash
  • swelling of the feet or lower legs
  • unusual tiredness or weakness
  • yellow eyes or skin
Incidence not known
  • Fainting
  • irregular heartbeat recurrent

Some side effects of bedaquiline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Difficulty with moving
  • muscle pain or stiffness
  • pain in the joints

For Healthcare Professionals

Applies to bedaquiline: oral tablet

General

In clinical studies, bedaquiline (the active ingredient contained in Sirturo) was given in combination with other drugs used to treat multi-drug resistant tuberculosis. The most frequent side effects during bedaquiline therapy in controlled trials were nausea, arthralgia, headache, hemoptysis, and chest pain. During Study 1, 8.9% of patients treated with bedaquiline and 7.4% of patients treated with placebo discontinued because of a side effect.

Other

Very common (10% or more): Increased mortality risk/death (11.4%), chest pain (11.4%)

In Study 1, there was a statistically significant increased mortality risk by Week 120 in the bedaquiline treatment group compared to the placebo treatment group (9/79 [11.4%] versus 2/81 [2.5%]). Five of the 9 bedaquiline deaths and the 2 placebo deaths were tuberculosis-related. One death occurred during the 24-week bedaquiline treatment period. The time to death for the remaining 8 patients in the bedaquiline treatment group averaged 329 days after the last bedaquiline dose. The imbalance in deaths is unexplained; no apparent pattern between death and sputum conversion, relapse, sensitivity to other drugs used to treat tuberculosis, HIV status, and severity of disease was observed.

Chest pain was reported with a greater incidence in the bedaquiline treatment group but was not identified as an adverse drug reaction.

Cardiovascular

Frequency not reported: QT prolongation

In Study 1, from the first week of therapy, increases in QTc (corrected using the Fridericia method) were greater in the bedaquiline treatment group (9.9 ms at Week 1) compared to the placebo treatment group (3.5 ms at Week 1). The greatest increase in QTc during the 24 weeks of bedaquiline treatment was 15.7 ms compared to 6.2 ms with placebo treatment (at Week 18). In the bedaquiline group, QT increases from baseline continued after bedaquiline was stopped. During the trial, there was no clear association of prior significant QT prolongation or clinically significant dysrhythmia in any of the patients that died.

In Study 3, where patients with no treatment options received other QT-prolonging drugs used to treat tuberculosis (including clofazimine), coadministration with bedaquiline resulted in additive QT prolongation, proportional to the number of QT prolonging drugs in the treatment regimen. Patients receiving bedaquiline alone with no other QT prolonging drug had a mean QTcF increase over baseline of 23.7 ms (with no QT interval exceeding 480 ms), while patients with at least 2 other QT prolonging drugs had a mean QTcF increase over baseline of 30.7 ms (with QTcF interval exceeding 500 ms in 1 patient).

Gastrointestinal

Very common (10% or more): Nausea (38%)
Common (1% to 10%): Increased blood amylase (2.5%)

Musculoskeletal

Very common (10% or more): Arthralgia (32.9%)

Nervous system

Very common (10% or more): Headache (27.8%)

Hepatic

Very common (10% or more): Reversible aminotransferase elevations (at least 3 times ULN; 10.8%)
Common (1% to 10%): Increased transaminases (terms included: increased transaminases, increased AST, increased ALT, increased hepatic enzyme, abnormal hepatic function; 8.9%)

Respiratory

Very common (10% or more): Hemoptysis (17.7%)

Hemoptysis was reported with a greater incidence in the bedaquiline treatment group but was not identified as an adverse drug reaction.

Metabolic

Anorexia was reported with a greater incidence in the bedaquiline (the active ingredient contained in Sirturo) treatment group but was not identified as an adverse drug reaction.

Common (1% to 10%): Anorexia (8.9%)

Dermatologic

Rash was reported with a greater incidence in the bedaquiline (the active ingredient contained in Sirturo) treatment group but was not identified as an adverse drug reaction.

Common (1% to 10%): Rash (7.6%)

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