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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]. 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
- 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].
DOSAGE AND ADMINISTRATION
Important Administration Instructions
- Administer SIRTURO by directly observed therapy (DOT).
- Use SIRTURO only in combination with other anti-mycobacterial drugs [see Recommended Dosage in Combination Therapy].
- Emphasize the need for compliance with full course of therapy.
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 Recommended Dosage in Combination Therapy]
- ECG [see WARNINGS AND PRECAUTIONS]
- Serum potassium, calcium, and magnesium concentrations [see WARNINGS AND PRECAUTIONS]
- Liver enzymes [see WARNINGS AND PRECAUTIONS]
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.
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.
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.
SIRTURO is supplied as uncoated white to almost white round biconvex 100 mg tablets with debossing of “T” over “207” on one side and “100” on the other side. The tablets are packaged in white high density polyethylene (HDPE) bottles with child-resistant polypropylene (PP) closure with induction seal liner. Each bottle contains 188 tablets.
Storage And Handling
Keep out of reach of children.
Dispense in original container. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]
Finished Product Manufactured by: Kemwell Biopharma Pvt. Ltd., Bangalore, India Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP Titusville, NJ 08560. Revised: 05/2015
Last reviewed on RxList: 9/11/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Sirturo Information
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