APROTININ

Fetal Risk Summary

Aprotinin, a polypeptide, is a broad spectrum protease inhibitor indicated for the prophylaxis of perioperative blood loss during cardiopulmonary bypass surgery. Reproduction studies were conducted in rats with IV doses up to 200,000 KIU/kg/day for 11 days (2.4 times the human dose on a mg/kg basis and 0.37 times the human dose on a mg/m2 basis) and in rabbits with IV doses up to 100,000 KIU/kg/day for 13 days (1.2 times the human dose on a mg/kg basis and 0.36 times the human dose on a mg/m2 basis) (1). No effects on fertility or fetal harm were observed in either species.

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 (2). The drug has been used safely in severe accidental hemorrhage with coagulation when labor was not established (3).

Breast Feeding Summary

No reports have been located describing the use of aprotinin during lactation. Because of the indication for this drug, the opportunity for breast feeding following its use is probably nil. The oral absorption of this polypeptide is unknown, but most likely poor.

References

1. Product information. Trasylol. Bayer, 2000.
2. Hoffhauer H, Dobbeck P. Untersuchungen uber die plactapassage des kallikrein-inhibitors. Klin Wochenschr 1970;48:183–4.
3. Sher G. Trasylol in cases of accidental hemorrhage with coagulation disorder and associated uterine inertia. S Afr Med J 1974;48:1452–5.