Inclusion and Exclusion Criteria for the Use of Bedaquiline

There are certain inclusion and exclusion criteria for the use of Bedaquiline (Bdq) in TB treatment.

Inclusion Criteria

• Adults and children aged 5 years to less than 18 years of age and weighing at least 15 kg, given their special needs, in consultation with a paediatrician.
• Patients with controlled stable arrhythmia can be considered after obtaining cardiac consultation.
• Pregnant & lactating women (with necessary precautions). ​

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Exclusion Criteria​

• Patients currently having uncontrolled cardiac arrhythmia that requires medication.
• Patients having the following corrected QT interval by Fridericia (QTcF) interval characteristics at screening:​
  • QTcF > 500 at baseline & normal electrolytes, Electrocardiogram (ECG) to be repeated after 6 hours and if both ECGs show QTcF > 500 then the patient should not be challenged with cardiotoxic drugs.​
• History of additional risk factors for Torsade de Pointes, e.g., heart failure, hypokalemia, family history of long QT syndrome.

If results of the serum chemistry panel, haematology or urinalysis are outside the normal reference range (including the above-listed parameters), the patient may still be considered based on the treating physician's judgement.

Hypokalemia, hypomagnesemia and hypocalcemia should be corrected prior to a patient receiving any corrected QT interval (QTc) prolonging drugs.

Resources
 

• Guidelines for Programmatic Management of Tuberculosis in India, 2021. 
• WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.
• The Use of Bedaquiline in the Treatment of Multidrug-resistant Tuberculosis: Interim Policy Guidance, 2013.

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