Bedaquiline is a new antibacterial drug used to treat multidrug resistant tuberculosis (MDR-TB), which belongs to diarylquinoline compounds.

I. Drug name

1. Product Name: SIRTURO

2. Common name: Bedaquiline

II. Indications

SIRTURO is a diarylquinoline based anti tuberculosis drug used to treat tuberculosis caused by Mycobacterium tuberculosis, which is at least resistant to rifampicin and isoniazid, in adult and pediatric patients (2 years and older and weighing at least 8 kilograms) as part of a combination therapy.

III. Specifications

100mg tablets.

IV. Main components

Active ingredient: Bedaquiline Fumarate

V. Usage and dosage

1. Recommended dose for adults: 400mg per dose for the first 2 weeks, once daily; Subsequently, 200mg each time for 22 weeks, three times a week (with a minimum interval of 48 hours).

2. Recommended dosage for pediatric patients: based on weight adjustment, please refer to the doctor's prescription for specific instructions.

VI. Dose adjustment

1. Patients with severe liver dysfunction should use it with caution, only when the benefits outweigh the risks, and monitor for adverse reactions related to bedaquiline.

2. Patients with severe renal insufficiency should use it with caution.

VII. Medication precautions

1. Before and after meals: SIRTURO must be taken with food.

2. Missed dose: If missed in the first or second week, do not make up for it and continue with the next dose at the normal time; If missed in the third week or later, take it as soon as possible and resume the three times a week dosing regimen to ensure that the total dose within 7 days does not exceed the recommended weekly dose.

3. Vomiting: If vomiting occurs after taking the medication, there is no need to take it again. Continue with the next dose at the normal time.

VIII. Medication for special populations

1. Pregnancy: There is insufficient data to assess the risks of SIRTURO for pregnant women, and the decision to use it should be made after weighing the pros and cons.

2. Breastfeeding period: It is recommended that lactating women do not breastfeed unless infant formula is not available. If infants are exposed to bedaquiline, relevant adverse reactions should be monitored.

3. Pediatrics: The safety and efficacy of pediatric patients aged 2 years and above with a weight of at least 8 kilograms have been established.

4. Elderly: Insufficient research on differences in response among patients aged 65 and above.

IX. Adverse reactions

1. Common adverse reactions include nausea, joint pain, headache, vomiting blood, and chest pain.

2. Serious adverse reactions include QTc prolongation, increased risk of death, and liver toxicity.

X. Contraindications

There are no specific contraindications, but attention should be paid to drug interactions and medication safety for specific populations.

XI. Drug interactions

1. Avoid co administration with potent or moderate CYP3A4 inducers as it may lower the plasma concentration of bedaquiline.

2. The combination with CYP3A4 inhibitors may increase the plasma concentration of bedaquiline, and patient safety needs to be closely monitored.

3. Co administration with other drugs that prolong the QTc interval may further prolong the QTc interval, and ECG monitoring is necessary.

XII. Storage method

Distributed in the original container, if distributed to an external container, it must be stored in an opaque, tightly sealed container with a shelf life of no more than 3 months, kept away from light, kept tightly sealed, stored at 25 ° C (77 ° F), with a permissible range of 15 ° C to 30 ° C (59 ° F to 86 ° F).

Bedaquilineinformation