The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-The manufacturer product information for bedaquiline and linezolid should be consulted; the pregnancy information for these drugs also applies to this combination regimen.

Animal studies have failed to reveal evidence of embryofetal toxicity but have revealed evidence of increased postimplantation loss at maternotoxic doses. Increased postimplantation loss was observed in rats with maternal toxicity (including reduced body weight and feed consumption) at oral doses of 100 mg/kg/day (about 4 times the human exposure for a 200 mg dose based on AUC); no adverse embryofetal effects observed in rats or rabbits doses up to about 2 times the human exposure. There are no controlled data in human pregnancy.

Reduced fertility and/or testicular toxicity observed in male rats and mice after oral administration; such effects were associated with hormonal changes (including deceased serum inhibin B, increased serum follicle stimulating hormone, increased luteinizing hormone) in rodents. Reduced fertility and testicular toxicity could not be definitively ruled out in male humans at this time.

Active tuberculosis during pregnancy is associated with adverse maternal and neonatal outcomes (including maternal anemia, caesarean delivery, preterm birth, low birth weight, birth asphyxia, perinatal infant death).

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-The manufacturer product information for bedaquiline and linezolid should be consulted; the lactation information for these drugs also applies to this combination regimen.

See references