Hemostatic
PREGNANCY RECOMMENDATION: Limited Human Data—Animal Data Suggest Low Risk
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports linking the use of aprotinin and congenital defects have been located. The drug crosses the placenta and decreases fibrinolytic activity in the newborn (1). The drug has been used safely in severe accidental hemorrhage with coagulation when labor was not established (2).
FETAL RISK SUMMARY
Aprotinin, a polypeptide, is a natural, broad-spectrum protease inhibitor obtained from bovine lung that is indicated for the prophylaxis of perioperative blood loss during cardiopulmonary bypass surgery. After IV administration, aprotinin undergoes rapid distribution into the total extracellular space and the plasma half-life, after the distribution phase, is about 150 minutes. The terminal half-life is about 10 hours (3).
Reproduction studies were conducted in rats with daily IV doses for 11 days up to 2.4 times the human dose based on body weight (HD-BW) or 0.37 times the human dose based on BSA (HD-BSA). Rabbits were given daily IV doses for 13 days up to 1.2 times the HD-BW or 0.36 times the HD-BSA. No effects on fertility or fetal harm were observed in either species (3).
BREASTFEEDING SUMMARY
No reports have been located describing the use of aprotinin during lactation. Because of the indication for this drug, the opportunity for breastfeeding following its use is probably nil. The oral absorption of this polypeptide is unknown, but most likely poor.
References
1.Hoffhauer H, Dobbeck P. Untersuchungen uber die plactapassage des kallikrein-inhibitors. Klin Wochenschr 1970;48:183–4.
2.Sher G. Trasylol in cases of accidental hemorrhage with coagulation disorder and associated uterine inertia. S Afr Med J 1974;48:1452–5.
3.Product information. Trasylol. Bayer, 2000.