Label Changes for:
Natrecor (nesiritide) for Injection
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
- Natrecor may cause hypotension. In the ASCEND-HF trial, the incidence of symptomatic hypotension was 7.1% in Natrecor-treated patients compared to 4.0% in placebo-treated patients on a background of standard care.
Worsening Renal Function
- In the ASCEND-HF trial, through Day 30, the incidence of renal impairment as measured by a >25% decrease in glomerular filtration rate (calculated based on serum creatinine) was observed in 31.4% and 29.5% in the Natrecor and placebo groups, respectively.
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 x 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.
- The following adverse reactions have been identified during post-approval use of Natrecor. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency: hypersensitivity reactions.
- 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