Must-read for patients: Introduction to the instructions for bedaquiline

1. Name: Bedaquiline, Bedaquiline,

Product name: Sirui, Sirturo

2. Indications:

Bedaquiline (Bedaquiline) is a diarylquinoline antimycobacterial drug indicated for the combination treatment of adult and pediatric patients (5 years and above, weighing at least 15kg) with multidrug-resistant tuberculosis (MDR-TB). Reserve bedaquiline for use when effective treatment options are unavailable.

Limitations of use: Do not use bedaquiline in patients with latent infection caused by Mycobacterium tuberculosis, drug-sensitive tuberculosis, extrapulmonary tuberculosis, or infections caused by non-tuberculous mycobacteria. Due to limited clinical data, the safety and effectiveness of bedaquiline in treating multidrug-resistant tuberculosis in HIV-infected patients has not been established.

3. Usage and dosage:

1. Before treatment: Before treatment with bedaquiline , if possible, background protocol susceptibility information to Mycobacterium tuberculosis, electrocardiogram, serum potassium, calcium and magnesium concentrations, liver enzymes and other information. Administerbedaquiline via directly observed therapy (DOT).

2. Recommended dosage:

(1) Adults:The recommended dose of bedaquiline is 400 mg ((4 of 100 mg tablets or 20 of 20 mg tablets)) orally once daily for weeks 1 and 2, followed by From weeks 3 to 24, the recommended dose is 200 mg (2 of 100 mg tablets or 10 of 20 mg tablets) taken orally three times per week, separated by at least 48 hours and must be taken with food.

(2) Children: The recommended dose of bedaquiline is based on body weight, For patients under 15kg-30kg, the recommended dose is 200mg ((2 of 100mg tablets or 10 of 20mg tablets) orally once daily for weeks 1 and 2, followed by The recommended dose is 100 mg (1 of 100 mg tablets or 5 of 20 mg tablets) orally three times per week for weeks 3 to 24; for patients over 30 kg, the recommended dose is the same as for adults. Pediatric patients should receive bedaquiline for a total duration of 24 weeks, taken with food.

3. Medication management:

BedaquilineThe 20mg is a functionally scored tablet that can be divided into two equal portions of 10mg each at the score line to provide a dose of less than 20mg. Take the entire tablet with water. As an alternative method of administration, bedaquiline20 mg tablets may be administered by being dispersed in water, or dispersed in water and further mixed with a beverage or soft drink, or crushed and mixed with a soft drink, or administered through a feeding tube.

4. Adverse reactions:

In clinical studies of bedaquiline, common adverse reactions include nausea, arthralgia, headache, hemoptysis, chest pain, anorexia, elevated transaminases, rash, and elevated blood amylase.

5. Storage:

Bedaquiline is stored in original container. There is desiccant in the bottle. Do not discard the desiccant. Protect from light and moisture. Keep container tightly closed. Store25°C (77°F); excursions allowed between 15°C and 30°C (59°F and 86°F). Store tablets dispensed out of the original container in a sealed, light-proof container with an expiry date of no more than 3 months.

6. Special groups:

1. Females: Due to the potential for serious adverse reactions in breastfed infants, including hepatotoxicity, patients are advised not to breastfeed during treatment with bedaquiline and for 27.5 months (5 times the half-life) after the last dose, unless infant formula is unavailable.

2. Renal impairment: For patients with severe renal impairment or end-stage renal disease who require hemodialysis or peritoneal dialysis, bedaquiline should be used with caution, and adult and pediatric patients should be monitored for adverse reactions during drug treatment.

7. Mechanism of action:

Bedaquiline is a member of the diarylquinoline class of drugs with a unique mechanism of action that targets the adenosine triphosphate (ATP) synthase of Mycobacterium tuberculosis. ATP synthase is used in the process by which Mycobacterium tuberculosis generates its energy supply. It is active against Mycobacterium tuberculosis and the drug-resistant tuberculosis bacteria that cause multidrug-resistant tuberculosis. Laboratory tests and clinical trials show that it has strong bactericidal and disinfectant properties.

The drug is marketed and sold in China under the name of daquiline fumarate tablets and has been included in the scope of medical insurance. The price of a common specification of 100mg*24 tablets per box may be around RMB 10,000. The price of the Russian version of Bedaquiline sold overseas, Specifications100mg*188 tablets per box, may be around RMB 15,000 (the price may fluctuate due to the exchange rate). The pharmaceutical ingredients of Bedaquiline sold domestically and abroad are basically the same.