SIRTURO

Key points

Favourable opinion for reimbursement in the indication extension “treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) in 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”.

What therapeutic improvement ?

Therapeutic improvement in the care pathway for multidrug-resistant tuberculosis.

Role in the care pathway ?

The management of tuberculosis is well standardised and is the subject of national (HCSP) and international guidelines (WHO).

The treatment of adolescents is governed by the same principles and requires the same medicinal products as treatment in adults; however, the optimal treatment regimen durations are not known.

According to WHO guidelines, bedaquiline may be proposed as part of an anti-tuberculosis combination regimen in :

• pulmonary multidrug-resistant or at least rifampicin-resistant tuberculosis (exclusively oral short treatment regimen for 9 to 11 months or personalised long-term treatment regimen for 18 to 24 months),
• multidrug-resistant tuberculosis with resistance to fluoroquinolones (6 to 9-month treatment regimen including pretomanid, bedaquiline, linezolid).

The WHO recommends the use of bedaquiline from 6 years of age.

Role of the medicinal product in the care pathway

SIRTURO (bedaquiline) is a reference treatment option for the treatment of patients with pulmonary multidrug-resistant tuberculosis sensitive to bedaquiline.

The prescription of SIRTURO (bedaquiline) in adolescents must take into account a potential risk of increased occurrence of adverse effects (in particular, QT interval prolongation and increased transaminases) due to overexposure to drugs, particularly in adolescents weighing between 30 and 40 kg.

The Summary of Product Characteristics (SPC) and the Risk Management Plan (RMP) must be complied with.