BEDAQUILINE FUMARATE (SIRTURO) Nursing Considerations

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What is the Generic Name

BEDAQUILINE FUMARATE

What is the Trade Name for BEDAQUILINE FUMARATE

SIRTURO

What is the Indication for BEDAQUILINE FUMARATE

  • 1 INDICATIONS AND USAGE 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. SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in 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. ( 1 ) This indication is approved under accelerated approval based on time to sputum culture conversion. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. ( 1 , 14 ) Limitations of Use : Do not use SIRTURO for the treatment of latent, extra-pulmonary or drug-sensitive tuberculosis or for the treatment of infections caused by non-tuberculous mycobacteria ( 1 ). Safety and efficacy of SIRTURO in HIV-infected patients with MDR-TB have not been established, as clinical data are limited. ( 14 ) 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) ] .

 

 

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References: https://open.fda.gov/

 

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