Bedaquiline is a diarylquinoline based anti mycobacterial drug that exerts bactericidal effects by specifically inhibiting the c subunit of ATP synthase in Mycobacterium tuberculosis, blocking bacterial energy generation.

1、 Drug name

1. Common name: Bedaquiline

2. Product Name: SIRTURO ® (Snerry) ®)

2、 Indications

1. As part of the combination therapy, it is used to treat tuberculosis caused by Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid in adult and pediatric patients aged 2 years and above with a body weight of ≥ 8kg.

2. Not suitable for the treatment of latent tuberculosis, extrapulmonary tuberculosis, drug sensitive tuberculosis, or non tuberculous mycobacterial infections.

3、 Specifications 

100mg * 188 tablets/box.

4、 Main components

Active ingredient: Bedaquiline Fumarate (100mg Bedaquiline per 100mg tablet).

5、 Usage and dosage

1. Adult and ≥ 30kg pediatric patients: 400mg once daily for 1-2 weeks, 200mg three times a week for 3-24 weeks (with a minimum interval of 48 hours between each session).

2. Weight adjustment for pediatric patients: 8kg to<10kg: 80mg once a day for 1-2 weeks, 40mg three times a week for 3-24 weeks; 120mg once a day, 60mg three times a week for 10kg to<15kg; 200mg once a day, 100mg three times a week for 15kg to<30kg.

3. Usage: Must be taken with food. Tablets can be swallowed whole or dispersed and crushed according to instructions before taking.

6、 Dose adjustment

1. Liver and kidney dysfunction: Mild to moderate liver dysfunction requires dose adjustment, and severe cases should be used with caution; Mild to moderate renal insufficiency does not require dose adjustment, and severe or end-stage renal disease should be used with caution and monitored for adverse reactions.

2. Omission treatment: If missed in the first or second week, skip the dose and continue taking daily medication; Starting from the third week, if missed, take it as soon as possible and restore the three times a week regimen to ensure that the total dose within 7 days does not exceed the recommended weekly dose.

7、 Medication precautions

1. Must be taken with food to improve bioavailability.

2. Direct supervision medication (DOT) must be administered and the entire treatment process must be completed.

3. Electrocardiogram, electrolytes, and liver function should be monitored before and during medication.

4. Avoid drinking alcohol and using hepatotoxic drugs.

8、 Medication for special populations

1. Pregnant women: Due to limited data, it is necessary to weigh the pros and cons.

2. Breastfeeding period: It is not recommended to breastfeed unless infant formula cannot be obtained; If the baby is exposed through breast milk, adverse reactions such as liver toxicity should be monitored.

3. Children: The safety and efficacy of patients under 2 years old or weighing less than 8kg have not been established.

4. Elderly: Limited data, it is recommended to use with caution.

9、 Adverse reactions

1. Common adverse reactions include: QT interval prolongation, nausea, joint pain, vomiting, elevated transaminase levels, abdominal pain, rash, dizziness, headache, chest pain, insomnia, dry skin, palpitations, etc.

2. Serious adverse reactions include: QT interval prolongation leading to arrhythmia, increased risk of death, and liver toxicity.

10、 Contraindications

There are no clear contraindications.

11、 Drug interactions

1. Avoid co administration with potent or moderate CYP3A4 inducers (such as rifampicins and efavirenz), as it may reduce the efficacy of bedaquiline.

2. Be cautious when using CYP3A4 inhibitors in combination, as it may increase the risk of exposure to bedaquiline and adverse reactions.

3. Be cautious when using other drugs that prolong the QT interval, as it may increase the risk of arrhythmia.

12、 Storage method

Store in original packaging or sealed container away from light, stored at 15 ° C-30 ° C, and have a shelf life of no more than 3 months after opening.

Bedaquilineinformation