Drug-resistant tuberculosis treatment

Pregnant and lactating women were excluded from the Nix-TB study; therefore, no analysis 
specific to this subgroup of patients could be performed. For pregnant and lactating women, 
a longer regimen should be individualized to include components with a safety profile that is better 
established. Where this is the case, the outcomes of treatment and pregnancy (including infant 
characteristics), and postpartum surveillance for congenital anomalies should be documented to 
help inform future recommendations for MDR-TB treatment during pregnancy. The use of 
bedaquiline in pregnancy has been shown to be associated with infants born with a lower mean 
birth weight, when compared with infants whose mothers did not take bedaquiline; however, this 
did not appear to be a clinically significant finding when infants were followed up over time (see 
Section 3.2
).
Breastfeeding is not recommended for women taking BPaL (94). 
Extrapulmonary TB. Patients with extrapulmonary TB were excluded from the Nix-TB study; therefore, 
no analysis specific to this subgroup of patients could be performed. The WHO recommendations 
on MDR-TB regimens apply to patients with extrapulmonary disease, including for those with TB 
meningitis. There are few data on the CNS penetration of bedaquiline or
pretomanid.
Patients with very limited treatment options. In some instances, patients will have extensive 
drug-resistance profiles that may make it difficult (or impossible) to construct a regimen based on 
existing WHO recommendations. In such situations, the patient’s life may be endangered. Therefore, 
for individual patients for whom it is not possible to design an effective regimen based on existing 
recommendations,
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the BPaL regimen may be considered as a last resort under prevailing ethical 
standards. In such patients, the use of BPaL should be accompanied by individual patient informed 
consent, adequate counselling on the potential benefits and harms, and active monitoring and 
management of adverse events. Patients should also be advised that reproductive toxicities have 
been observed in animal studies, and that the potential effects on human male fertility have not been 
adequately evaluated at this
time.