What determines eligibility for a BPALM (Bedaquiline, Pretomanid, Linezolid, Moxifloxacin) regimen in patients with multidrug-resistant tuberculosis (MDR-TB)?

Eligibility for BPaLM in Tuberculosis

BPaLM (bedaquiline, pretomanid, linezolid 600mg, moxifloxacin) is recommended for adults with MDR/RR-TB who are fluoroquinolone-susceptible, have no prior exposure (>30 days) to bedaquiline, pretomanid, or linezolid, and are not pregnant, breastfeeding, or under 14 years of age. 1

Primary Eligibility Criteria

Patients Who ARE Eligible:

• Adults with MDR/RR-TB (multidrug-resistant or rifampicin-resistant tuberculosis) who are fluoroquinolone-susceptible - this is the core indication for BPaLM 1

• People living with HIV - HIV status does not preclude BPaLM use 1

• Patients with extensive pulmonary TB - severe lung involvement is acceptable 1

• Most forms of extrapulmonary TB - BPaLM can be used for extrapulmonary disease 1

• Patients with cardiac disease or QTc-prolonging medications - eligible but require close monitoring 1

• Patients with low BMI (<17) - eligible but require close monitoring 1

Patients Who Are NOT Eligible:

• Age under 14 years - insufficient safety data in children 1

• Pregnant or breastfeeding women - limited pretomanid safety data in this population 1, 2

• CNS tuberculosis, miliary TB, or osteoarticular TB - no efficacy data for these specific sites 1

• Prior exposure >30 days to bedaquiline, pretomanid, or linezolid - unless resistance to these drugs is definitively ruled out 1

• Confirmed or suspected resistance to bedaquiline, linezolid, or pretomanid - these patients should receive longer individualized regimens 1

• Drug-sensitive TB or latent TB infection - BPaLM is only for drug-resistant disease 2

• Extensively drug-resistant TB (XDR-TB) - defined as resistance to both fluoroquinolones AND injectable agents; these patients are not eligible for BPaLM 1

Special Considerations for Fluoroquinolone Resistance

• If fluoroquinolone resistance is detected AFTER starting BPaLM, stop moxifloxacin and continue as BPaL (bedaquiline, pretomanid, linezolid only) for 9 months total 1

• Pre-extensively drug-resistant TB (fluoroquinolone-resistant but not XDR) should receive BPaL without moxifloxacin from the start, not BPaLM 1

• Drug susceptibility testing for fluoroquinolones is strongly encouraged but should not delay treatment initiation - start empirically and adjust if resistance is found 1

Conditional Eligibility Requiring Caution

Patients with hematologic abnormalities:

• Hemoglobin <7 g/dL or platelets <75,000/mm³ - BPaLM is possible but other regimens are preferred due to linezolid's myelosuppressive effects 1

Patients with pre-existing peripheral neuropathy:

• Grade III-IV peripheral neuropathy - BPaLM is possible but other regimens are preferred due to linezolid's neurotoxicity 1

Common Pitfalls to Avoid

• Do not use BPaLM for MDR-TB patients who can tolerate standard therapy - this regimen is specifically for those with additional resistance or treatment intolerance 2

• Do not delay treatment waiting for fluoroquinolone susceptibility results - start BPaLM empirically and switch to BPaL if resistance is documented 1

• Do not use BPaLM as monotherapy or in combinations other than the studied regimen - all four drugs (or three in BPaL) must be given together as prescribed 2

• **Do not assume prior brief exposure (<30 days) to component drugs is a contraindication** - only exposure >30 days requires ruling out resistance before proceeding 1

• Do not use BPaLM for patients with known resistance to any component drug - switch immediately to an 18-month individualized regimen 1