What is NOT considered Off-label use of an anti-TB drug?

The use of bedaquiline (Bdq) for a duration of 6 months is considered an approved use, aligning with established treatment guidelines for multidrug-resistant tuberculosis (MDR-TB). In contrast, off-label use refers to situations where drugs are utilized outside the indications approved by regulatory agencies.

When examining the other options, the extended use of Bdq or delamanid (Dlm) beyond 6 months may not be supported by clinical guidelines and could pose increased risks without clear evidence of benefit. The application of these drugs in extrapulmonary TB (EPTB) is also classified as off-label since most approvals are concentrated on pulmonary TB. Similarly, using Bdq in very young children or pregnant individuals raises safety concerns due to limited studies on these populations, making these practices off-label.

Thus, the 6-month use of Bdq aligns with regulatory standards and established treatment protocols, distinguishing it from the other scenarios that reflect off-label use.