Thrombate III Use In Pregnancy & Lactation

Pregnancy: Risk Summary: There are no data with THROMBATE III use in pregnant women to inform a drug-associated risk. However, there are clinical considerations (see Clinical Considerations). It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. THROMBATE III should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to THROMBATE III.
Clinical Considerations: Labor or Delivery: Suspend heparin (or low molecular weight heparin) administration and continue THROMBATE III administration during labor and delivery.
Lactation: Risk Summary: There is no information regarding the presence of THROMBATE III in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for THROMBATE III and any potential adverse effects on the breastfed infant from THROMBATE III or from the underlying maternal condition.