BPaLM for Rifampicin-Resistant Extrapulmonary TB
Yes, you can use the 6-month BPaLM regimen for this patient with rifampicin-resistant extrapulmonary tuberculosis, provided the disease does not involve the central nervous system, osteoarticular sites, or disseminated (miliary) disease. 1, 2
Eligibility Confirmed
Your patient meets all WHO eligibility criteria for BPaLM:
- Age ≥14 years – BPaLM is approved for patients 14 years and older 1, 2
- Fluoroquinolone-susceptible – This is a mandatory requirement; the regimen cannot be used if fluoroquinolone resistance is present 1, 2
- Not pregnant – Pretomanid has no safety data in pregnancy and is an absolute contraindication 1, 2, 3
- Extrapulmonary TB (EPTB) without contraindicated sites – Most forms of EPTB are eligible for BPaLM 2
Critical Exclusions for EPTB
BPaLM is absolutely contraindicated in three specific EPTB forms: 1, 2
- Central nervous system TB (meningitis, tuberculoma)
- Osteoarticular TB (spine, joints, bone)
- Disseminated/miliary TB
For these three forms, you must use an 18-20 month individualized regimen instead. 1, 2
Acceptable EPTB Sites for BPaLM
All other extrapulmonary sites are eligible, including: 1, 2
- Lymph node TB (most common EPTB)
- Pleural TB
- Genitourinary TB
- Abdominal/peritoneal TB
- Pericardial TB (requires close cardiac monitoring due to QTc effects)
Regimen Composition and Duration
- Bedaquiline + Pretomanid + Linezolid 600 mg daily + Moxifloxacin 1, 2
- Duration: 6 months (26 weeks) – complete within 7 months to account for any missed doses 2
- No pyrazinamide or ethambutol – these are not part of BPaLM 1
- Must be given by directly observed therapy (DOT) 3
Mandatory Baseline Testing Before Starting
Before initiating BPaLM, obtain: 1
- Complete blood count (CBC)
- Liver function tests (AST, ALT, bilirubin, alkaline phosphatase)
- Renal function tests
- ECG with QTc calculation
- Electrolytes (potassium, magnesium, calcium) – critical for QTc risk
- Visual acuity testing
- Peripheral neuropathy assessment
- HIV status
- Pregnancy test
- Drug susceptibility testing for fluoroquinolones, bedaquiline, pretomanid, and linezolid
Critical Monitoring During Treatment
Cardiac monitoring (QTc prolongation risk): 1, 2
- ECG at baseline, weeks 2,4,8,12, then monthly
- Discontinue bedaquiline if QTcF >500 ms or clinically significant ventricular arrhythmia develops
Hematologic monitoring (linezolid myelosuppression): 1, 2
- Monthly CBC to detect anemia, thrombocytopenia, or leukopenia
Neurologic monitoring (linezolid toxicity): 1, 2
- Monthly assessment for peripheral neuropathy and optic neuropathy
- Prompt ophthalmologic evaluation if visual symptoms develop
- If Grade III-IV neuropathy develops, reduce linezolid to 300 mg daily or interrupt dosing
Hepatotoxicity monitoring: 2
- Monthly liver function tests
- More frequent if symptomatic or on other hepatotoxic medications
If Fluoroquinolone Resistance Detected After Starting
Switch immediately to BPaL (without moxifloxacin) and extend total duration to 9 months. 1, 2 Do not stop the entire regimen—bedaquiline, pretomanid, and linezolid remain highly effective. 1
Common Pitfalls to Avoid
- Do not delay treatment waiting for fluoroquinolone DST results – start BPaLM empirically if fluoroquinolone susceptibility is likely, then switch to BPaL if resistance is documented 2
- Do not modify the regimen by adding or removing drugs – BPaLM is studied as a fixed combination; alterations increase failure and resistance risk 1
- Do not use BPaLM for children <14 years – pretomanid has no pediatric safety data 1, 3
- Do not discontinue early even after culture conversion – complete the full 6 months 1
Why BPaLM Over Alternatives
BPaLM is superior to the 9-month all-oral regimen (with ethionamide or linezolid variations) due to higher treatment success, fewer failures/recurrences, and less emerging drug resistance. 2 It is also preferred over 18-month individualized regimens for eligible patients. 2