4.2.3 Duration of treatment

Patients with susceptibility to fluoroquinolones can be started on the BPaLM regimen for 6 months (26 weeks). In the case of resistance to fluoroquinolones, identified after treatment initiation, moxifloxacin may be discontinued and the regimen can be continued as BPaL. When the regimen is BPaL from the start or is changed to BPaL, it can be extended to a total of 9 months (39 weeks) (continuing from the start of the therapy with BPaLM/BPaL). This extension of the BPaL regimen can occur in cases where there is a lack of culture conversion or clinical response (based on the clinical judgement of the treating physician) between months 4 and 6. Treatment interruption up to 1 month can be added to the overall treatment duration if there is a need to make up the missed doses.

Temporary cessation of the full regimen is allowed for suspected drug-related toxicity. Reintroduction of the full regimen could be considered after a cessation of no more than 14 days of consecutive treatment interruption or up to a cumulative 4 weeks of nonconsecutive treatment interruption. Missed doses need to be made up and added to the treatment duration.

Individuals who switch from BPaLM to BPaL should consider their treatment start date the same as the date BPaLM was initiated, because the patient remained on treatment with three effective drugs during the entire treatment period.

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