Which situation is not considered off-label use for Bdq and Dlm?

The correct situation that is not considered off-label use for Bdq (Bedaquiline) and Dlm (Delamanid) is when an extrapulmonary tuberculosis (EPTB) patient is taking Lfx (Levofloxacin).

Bedaquiline and Delamanid are primarily approved for the treatment of multidrug-resistant tuberculosis (MDR-TB), often indicated as part of a combination therapy regimen. Their use in EPTB patients falls within the broader guidelines for treating tuberculosis when those drugs are indicated. Levofloxacin is part of the class of fluoroquinolone antibiotics, which are often included in MDR-TB treatment regimens. Therefore, using Lfx in an EPTB scenario does not represent off-label use, as it aligns with established recommendations for treating resistant TB forms.

In contrast, the other situations listed involve using Bdq and Dlm in contexts that do not align with their approved indications. For instance, administering Bdq to a pregnant patient raises safety and efficacy concerns due to insufficient data regarding its effects in pregnancy. Similarly, using Dlm in a young child (4 years old) is also not supported by sufficient safety and efficacy data for that age group. Additionally, the initiation of Regimen