SIRTURO- bedaquiline fumarate tablet
Janssen Products, LP
WARNINGS: INCREASED MORTALITY; QT PROLONGATION
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. Only use SIRTURO when an effective treatment regimen cannot otherwise be provided [see Indications and Usage (1) and Warnings and Precautions (5.1)].
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)].
1 INDICATIONS AND USAGE
SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adults (18 years and older) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. Administer SIRTURO by directly observed therapy (DOT).
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
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)].
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
Administer SIRTURO by directly observed therapy (DOT).
Use SIRTURO only in combination with other anti-mycobacterial drugs [see Dosage and Administration (2.3)].
Emphasize the need for compliance with full course of therapy.
2.2 Required Testing Prior to Administration
Prior to treatment with SIRTURO, obtain the following:
Susceptibility information for the background regimen against M. tuberculosis isolate if possible [see Dosage and Administration (2.3)]
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 (5.3)]
2.3 Recommended Dosage in Combination Therapy
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.
The recommended dosage of SIRTURO is 400 mg orally once daily for the first two weeks, followed by 200 mg orally three times per week (with at least 48 hours between doses) for 22 weeks (total duration of 24 weeks).
The SIRTURO tablet should be swallowed whole with water and taken 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 200 mg dose is missed, administer the missed dose as soon as possible, and then resume the 3 times a week dosing regimen.
3 DOSAGE FORMS AND STRENGTHS
SIRTURO tablets, 100 mg are uncoated white to almost white round biconvex with debossing of "T" over "207″ on one side and "100″ on the other side.