BPaLM Regimen Composition for Drug-Resistant Tuberculosis
The BPaLM regimen consists of four drugs administered orally once daily for 26 weeks (6 months): Bedaquiline, Pretomanid 200 mg, Linezolid 600 mg, and Moxifloxacin. 1
Drug Components and Dosing Schedule
Pretomanid
- Dose: 200 mg orally once daily for 26 weeks 2
- Administered whole with water, with food 2
- For patients with swallowing difficulties, tablets can be crushed and suspended in water or soaked for 4-5 minutes then crushed 2
Bedaquiline
Two dosing options are available 2:
Option 1 (Traditional):
- 400 mg orally once daily for 2 weeks
- Then 200 mg three times per week (with at least 48 hours between doses) for 24 weeks
- Total duration: 26 weeks
Option 2 (Simplified):
- 200 mg orally once daily for 8 weeks
- Then 100 mg once daily for 18 weeks
- Total duration: 26 weeks
Linezolid
Preferred dosing: 600 mg orally once daily for 26 weeks 1, 2
Alternative: 1,200 mg orally once daily for 26 weeks (though associated with more adverse events) 2
Dose reduction option: 300 mg daily may be used if necessary to mitigate toxicity, though 600 mg daily throughout the regimen is preferable 1
Moxifloxacin
- Standard fluoroquinolone dose (typically 400 mg daily) for 26 weeks 1
- If fluoroquinolone resistance is documented after starting BPaLM, moxifloxacin should be stopped and the regimen continued as BPaL (without moxifloxacin) 1
Critical Administration Requirements
All three/four drugs must be administered together as a combination regimen - pretomanid is only indicated when used with bedaquiline and linezolid 2
Directly observed therapy (DOT) is required for the entire combination regimen 2
All medications must be taken with food 2
Missed doses: Doses of the combination regimen missed for safety reasons can be made up at the end of treatment; however, doses of linezolid alone missed due to linezolid adverse reactions should not be made up 2
Treatment completion: 26 weeks of prescribed doses should be completed within an overall period of 7 months to account for any necessary interruptions 1
Evidence Base and Superiority
The BPaLM regimen demonstrated superior outcomes compared to other BPaL-based regimens in the TB-PRACTECAL trial, with more treatment success, fewer failures or recurrences, and less emerging drug resistance with little difference in adverse events 1
The ZeNix trial data showed that linezolid 600 mg daily for 26 weeks was associated with higher treatment success, lower failure and recurrence rates, and fewer adverse events compared to 1,200 mg daily 1
Common Pitfalls to Avoid
Do not use pretomanid outside this specific combination - it is not indicated as monotherapy or with other drug combinations 2
Do not delay treatment initiation waiting for fluoroquinolone drug susceptibility testing, though testing is strongly encouraged 1
Do not permanently discontinue only one component - if bedaquiline and/or pretomanid are permanently discontinued, the entire combination regimen should be stopped 2
Avoid alcohol and hepatotoxic medications during treatment due to hepatotoxicity risk 2