Antithrombin III use in specific populations
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1], Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]
Use in Specific Populations
Pregnancy Category B
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. It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.)(23)
Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants.(24,25) ATIII levels in premature infants may be much lower.(24,25) Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation.(18)[1]
References
- ↑ "THROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC]". Retrieved 7 March 2014.
Adapted from the FDA Package Insert.