Naldebain Use In Pregnancy & Lactation

Pregnancy: Teratogenic Effects: Pregnancy Category B: Reproduction studies have been performed in rats by subcutaneous administration of nalbuphine up to 100 mg/kg/day, or 590 mg/m²/day which is approximately 6 times the MRHD (Maximum Recommended Human Dose), and in rabbits by intravenous administration of nalbuphine up to 32 mg/kg/day, or 378 mg/m²/day which is approximately 4 times the MRHD. The results did not reveal evidence of developmental toxicity, including teratogenicity, or harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, NALDEBAIN should be used during pregnancy only if clearly needed.
Non-teratogenic Effects: Neonatal body weight and survival rates were reduced at birth and during lactation when nalbuphine was subcutaneously administered to female and male rats prior to mating and throughout gestation and lactation or to pregnant rats during the last third of gestation and throughout lactation at doses approximately 4 times the maximum recommended human dose.
Labor and Delivery: See Use During Labor and Delivery under Precautions.
Nursing Mothers: Limited data suggest that nalbuphine (nalbuphine hydrochloride) is excreted in maternal milk but only in a small amount (less than 1% of the administered dose) and with a clinically insignificant effect. Caution should be exercised when NALDEBAIN is administered to a nursing woman.