SIRTURO- bedaquiline fumarate tablet
Janssen Products, LP
- An increased risk of death was seen in the SIRTURO treatment group (9/79, 11.4%) compared to the placebo treatment group (2/81, 2.5%) in one placebo-controlled trial in adults. Only use SIRTURO in patients 5 years of age and older when an effective treatment regimen cannot otherwise be provided [see Indications and Usage (1), Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
- QT prolongation can occur with SIRTURO. Use with drugs that prolong the QT interval may cause additive QT prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms develops [see Warnings and Precautions (5.2)].
SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided.
This indication is approved under accelerated approval based on time to sputum culture conversion [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Limitations of Use:
- Do not use SIRTURO for the treatment of:
- Latent infection due to Mycobacterium tuberculosis
- Drug-sensitive tuberculosis
- Extra-pulmonary tuberculosis
- Infections caused by non-tuberculous mycobacteria
- The safety and efficacy of SIRTURO in the treatment of HIV infected patients with MDR-TB have not been established as clinical data are limited [see Clinical Studies (14)].
- Administer SIRTURO by directly observed therapy (DOT).
- Only use SIRTURO in combination with at least 3 other drugs to which the patient’s MDR-TB isolate has been shown to be susceptible in vitro. If in vitro testing results are unavailable, SIRTURO treatment may be initiated in combination with at least 4 other drugs to which the patient’s MDR-TB isolate is likely to be susceptible. Refer to the prescribing information of the drugs used in combination with SIRTURO for further information.
- SIRTURO (20 mg and 100 mg) must be taken with food.
- SIRTURO 20 mg are functionally scored tablets which can be split at the scored lines into two equal halves of 10 mg each to provide doses less than 20 mg [see Dosage and Administration (2.6)].
- As an alternative method of administration, SIRTURO 20 mg tablets can be dispersed in water and administered or dispersed in water and further mixed with a beverage or soft food, or crushed and mixed with soft food, or administered through a nasogastric tube [see Dosage and Administration (2.6)].
- Emphasize the need for compliance with the full course of therapy.
Prior to treatment with SIRTURO, obtain the following:
- Susceptibility information for the background regimen against M. tuberculosis isolate if possible [see Dosage and Administration (2.1)]
- ECG [see Warnings and Precautions (5.2)]
- Serum potassium, calcium, and magnesium concentrations [see Warnings and Precautions (5.2)]
- Liver enzymes [see Warnings and Precautions (5.4)]
The recommended dosage of SIRTURO in adult patients is:
| Dosage Recommendation|
| Weeks 1 and 2||Weeks 3 to 24*|
| 400 mg (4 of the 100 mg tablets OR 20 of the 20 mg tablets) orally once daily||200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) orally three times per week|
Recommended dosage in pediatric patients are described in Table 2 below [See Dosage and Administration (2.4)].
The total duration of treatment with SIRTURO in adults is 24 weeks. Administer SIRTURO tablets with food.
The recommended dosage of SIRTURO in pediatric patients (5 years and older and weighing at least 15 kg) is based on body weight and shown in Table 2:
| Body Weight||Dosage Recommendation|
|Weeks 1 and 2||Weeks 3 to 24*|
| 15 kg to less than 30 kg||200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) orally once daily||100 mg (1 of the 100 mg tablets OR 5 of the 20 mg tablets) orally three times per week|
| Greater than or equal to 30 kg||400 mg (4 of the 100 mg tablets OR 20 of the 20 mg tablets) orally once daily||200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) orally three times per week|
The total duration of treatment with SIRTURO in pediatric patients is 24 weeks. Administer SIRTURO tablets with food.
If a dose is missed during the first 2 weeks of treatment, do not administer the missed dose (skip the dose and then continue the daily dosing regimen). From Week 3 onwards, if a dose is missed, administer the missed dose as soon as possible, and then resume the 3 times a week dosing regimen. The total dose of SIRTURO during a 7-day period should not exceed the recommended weekly dose (with at least 24 hours between each intake).
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