Vasodilator
PREGNANCY RECOMMENDATION: No Human Data—Animal Data Suggest Low Risk
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports describing the use of nesiritide in human pregnancy have been located. The animal data suggest low risk, but the absence of human pregnancy experience prevents an accurate assessment of the embryo–fetal risk. However, nesiritide is a recombinant formulation of human B-type natriuretic peptide, a naturally occurring peptide produced in the ventricular myocardium. Although the indication suggests that use in pregnancy will be uncommon; if indicated, it should not be withheld because of pregnancy.
FETAL RISK SUMMARY
Nesiritide is indicated for the IV treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity. Nesiritide is metabolized to inactive metabolites and the terminal elimination half-life is about 18 minutes (1).
Reproduction studies have been conducted in rabbits. In this species, no adverse effects on live births or fetal development were observed at a dose given by continuous infusion for 13 days, producing exposures that were about 70 times higher than the human exposure at the recommended dose (1).
Studies of carcinogenicity or effects on fertility have not been conducted. The drug was not mutagenic in an in vitro assay (1).
It is not known if nesiritide crosses the human placenta. The relatively high molecular weight (3464) and very short terminal elimination half-life suggest that exposure of the embryo and/or fetus will be minimal.
BREASTFEEDING SUMMARY
No reports describing the use of nesiritide during human lactation have been located. The relatively high molecular weight (3464) and very short terminal elimination half-life (about 18 minutes) suggest that the peptide will not be excreted into breast milk in clinically significant amounts. Moreover, as a peptide, any amounts in milk probably will be digested in the infant’s gut.
Reference
1.Product information. Natrecor. Scios, 2009.