Natrecor (Nesiritide) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility of nesiritide. Nesiritide did not increase the frequency of mutations when used in an in vitro bacterial cell assay (Ames test). No other genotoxicity studies were performed.

Pregnancy

Category C

It is not known whether Natrecor can cause fetal harm when administered to pregnant women or if it can affect reproductive capacity. A developmental reproductive toxicology study was conducted in pregnant rabbits using doses up to 1440 mcg/kg/day given by constant infusion for 13 days. At this level of exposure (based on AUC, approximately 70 — human exposure at the recommended dose) no adverse effects on live births or fetal development were observed. Natrecor should be used during pregnancy only if the potential benefit justifies any possible risk to the fetus.

OVERDOSAGE

Overdose with Natrecor therapy has been reported and is primarily the result of either a miscalculated Natrecor dose or a mechanical error such as an infusion-pump malfunction or an infusion-pump programming error. The most frequently reported adverse event reported with Natrecor overdose is hypotension, which may be asymptomatic and most often resolves with drug stoppage, although in some cases hypotension may persist for several hours beyond discontinuation. Treatment of Natrecor overdose should include drug discontinuation and the administration of supportive measures (see PRECAUTIONS — Cardiovascular).

CONTRAINDICATIONS

Natrecor is contraindicated in patients who are hypersensitive to any of its components. Natrecor should not be used as primary therapy for patients with cardiogenic shock or in patients with a systolic blood pressure < 90 mm Hg.