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Administration of Natrecor (nesiritide) should be avoided in patients suspected of having, or known to have, low cardiac filling pressures.

General

Parenteral administration of protein pharmaceuticals or E. coli-derived products should be attended by appropriate precautions in case of an allergic or untoward reaction.

Natrecor (nesiritide) is not recommended for patients for whom vasodilating agents are not appropriate, such as patients with significant valvular stenosis, restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent upon venous return, or for patients suspected to have low cardiac filling pressures. (See CONTRAINDICATIONS.)

Renal

Natrecor (nesiritide) may affect renal function in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with Natrecor (nesiritide) may be associated with azotemia. When Natrecor (nesiritide) was initiated at doses higher than 0.01 mcg/kg/min (0.015 and 0.03 mcg/kg/min), there was an increased rate of elevated serum creatinine over baseline compared with standard therapies, although the rate of acute renal failure and need for dialysis was not increased. In the 30-day follow-up period in the VMAC trial, 5 patients in the nitroglycerin group (2%) and 9 patients in the Natrecor (nesiritide) group (3%) required first-time dialysis.

Cardiovascular

Natrecor (nesiritide) may cause hypotension. In the VMAC trial, in patients given the recommended dose (2 mcg/kg bolus followed by a 0.01 mcg/kg/min infusion) or the adjustable dose, the incidence of symptomatic hypotension in the first 24 hours was similar for Natrecor (nesiritide) (4%) and IV nitroglycerin (5%). When hypotension occurred, however, the duration of symptomatic hypotension was longer with Natrecor (nesiritide) (mean duration was 2.2 hours) than with nitroglycerin (mean duration was 0.7 hours). In earlier trials, when Natrecor (nesiritide) was initiated at doses higher than the 2 mcg/kg bolus followed by a 0.01 mcg/kg/min infusion (i.e., 0.015 and 0.03 mcg/kg/min preceded by a small bolus), there were more hypotensive episodes and these episodes were of greater intensity and duration. They were also more often symptomatic and/or more likely to require medical intervention (see ADVERSE REACTIONS). Natrecor (nesiritide) should be administered only in settings where blood pressure can be monitored closely, and the dose of Natrecor (nesiritide) should be reduced or the drug discontinued in patients who develop hypotension (see Dosing Instructions). The rate of symptomatic hypotension may be increased in patients with a blood pressure < 100 mm Hg at baseline, and Natrecor (nesiritide) should be used cautiously in these patients. The potential for hypotension may be increased by combining Natrecor (nesiritide) with other drugs that may cause hypotension. For example, in the VMAC trial in patients treated with either Natrecor (nesiritide) or nitroglycerin therapy, the frequency of symptomatic hypotension in patients who received an oral ACE inhibitor was 6%, compared to a frequency of symptomatic hypotension of 1% in patients who did not receive an oral ACE inhibitor.

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 (nesiritide) 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 (nesiritide) should be used during pregnancy only if the potential benefit justifies any possible risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Therefore, caution should be exercised when Natrecor (nesiritide) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Natrecor (nesiritide) in pediatric patients has not been established.

Geriatric Use

Of the total number of subjects in clinical trials treated with Natrecor (nesiritide) (n = 941), 38% were 65 years or older and 16% were 75 years or older. No overall differences in effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. Some older individuals may be more sensitive to the effect of Natrecor (nesiritide) than younger individuals.

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.