| Status: Recommended | ||
Bedaquiline (Sirturo®) is recommended as an option for use within NHS Wales as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adults and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. |
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Medicine details |
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| Medicine name | bedaquiline (Sirturo®) | |
| Formulation | 100 mg tablet, 20 mg tablet (20mg tablet not yet available) | |
| Reference number | 4860 | |
| Indication | As part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability |
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| Company | Janssen-Cilag Ltd | |
| BNF chapter | Infections | |
| Submission type | Licence extension for paediatric use | |
| Status | Recommended | |
| Advice number | 2222 | |
| AWMSG meeting date | 18/10/22 | |
| Date of issue | 07/11/22 | |
| Further information AWMSG considered bedaquiline (Sirturo®) as an ultra-orphan medicine according to the criteria in the AWMSG appraisal process for a medicine for a rare disease. This advice incorporates and replaces the existing AWMSG recommendation on bedaquiline (Sirturo®) for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis in adult and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (Advice number 0820, originally published September 2020). |
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