Pretomanid Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Nov 25, 2024.

Pretomanid Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the 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 were observed in rats or rabbits at doses up to about 2 times the human exposure. There are no controlled data in human pregnancy.

Reduced fertility and/or testicular toxicity were observed in male rats and mice after oral dosing of this drug; 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

Pretomanid Breastfeeding Warnings

If this drug is required by the mother, it is not a reason to discontinue breastfeeding; however, until more data are available, an alternate agent may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.

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

Comments:
-No information is available on the use of this drug during breastfeeding.
-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 adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered. A risk to the child cannot be excluded.
-The manufacturer product information for bedaquiline and linezolid should be consulted; the lactation information for these drugs also applies to this combination regimen.

According to author estimation, based on a computed milk-to-plasma ratio of 0.89, a fully breastfed infant would receive 1.02 mcg/kg/day of this drug with a standard maternal dose (200 mg/day); however, a nonstandard milk volume was used in their calculation. Using the standard 150 mL/kg/day, the estimated infant dosage would be 0.83 mcg/kg/day.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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