BEDAQUILINE

Background and Date of Approval

Bedaquiline is an antimycobacterial agent approved by the FDA in 2012 for treatment of multidrug-resistant tuberculosis (MDR-TB). A 2016 Phase 2 study evaluated the safety and efficacy of bedaquiline in patients with multidrug-resistant tuberculosis. The study demonstrated that bedaquiline combined with a background regimen led to improved treatment outcomes, establishing its role as a key component in the management of drug-resistant TB.

Uses

Bedaquiline is used as part of combination therapy to treat multidrug-resistant pulmonary tuberculosis in adults when other alternatives are not sufficient.

How is it administered?

Bedaquiline is administered orally, usually in combination with other TB medications. The dose and duration depend on the patient's condition and their response to treatment. It is essential to follow the prescribed regimen closely.

Side Effects

Common side effects include nausea, joint pain, headache, and dizziness. Serious effects like QT prolongation and liver toxicity can occur and need monitoring.

Warnings

Bedaquiline should not be used as monotherapy due to the risk of resistance. QT prolongation has been observed, and its use requires ECG monitoring.

Precautions

Bedaquiline should be used cautiously by patients with a history of heart conditions or those taking other drugs that affect heart rhythm.

Word of Advice

Bedaquiline should be taken with food to enhance absorption. Completing the entire course of therapy without missed doses is essential, as interruptions can result in treatment failure and resistance development. Alcohol should be avoided and liver function should be monitored throughout treatment.

References

https://pubchem.ncbi.nlm.nih.gov/compound/Bedaquiline https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/bedaquiline KD Tripathi, Essentials of Medical Pharmacology, Antiemetic, Prokinetic and Digestant Drugs, 7th edition, 2013, 669-670.

Frequently Asked Questions

Is Bedaquiline safe for long-term use?

Bedaquiline is usually prescribed for a specific treatment duration and not for long-term use.

Can Bedaquiline cause liver problems ?

Yes, liver function should be monitored as Bedaquiline may cause liver enzyme elevations.

Available Brands 1

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS