"By Megan Brooks
Medscape Medical News
The US Food and Drug Administration (FDA) will require makers of prescription testosterone products to clarify the approved uses of these medications on the product label and add information"...
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. The risk of hypotension may be increased by the concomitant use of NATRECOR® with drugs affecting the reninangiotensin system (i.e., angiotensin receptor blockers and/or angiotensin-converting enzyme inhibitors) or other afterload reducers. 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® (4%) and IV nitroglycerin (5%). When hypotension occurred, however, the duration of symptomatic hypotension was longer with NATRECOR® (mean duration was 2.2 hours) than with nitroglycerin (mean duration was 0.7 hours).
Administer NATRECOR® only in settings where blood pressure can be monitored closely and hypotension aggressively treated. Reduce the dose of or discontinue NATRECOR® in patients who develop hypotension [see DOSAGE AND ADMINISTRATION].
Avoid administration of NATRECOR® in patients suspected of having, or known to have, low cardiac filling pressures.
NATRECOR® 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].
Worsening of Renal Function
NATRECOR® may decrease renal function as judged by increases in serum creatinine. Monitor serum creatinine both during and after therapy has been completed. Monitor serum creatinine until values have stabilized. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin aldosterone system, treatment with NATRECOR® may be associated with azotemia. When NATRECOR® 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.
Serious hypersensitivity/allergic reactions following administration of NATRECOR® have been reported.
These reactions are more likely to occur in individuals with a history of sensitivity to recombinant peptides. Before therapy with NATRECOR® is instituted, careful inquiry should be made to determine whether the patient has had a previous hypersensitivity reaction to other recombinant peptides. If an allergic reaction to NATRECOR® occurs, discontinue the drug. Some serious hypersensitivity/allergic reactions may require treatment with epinephrine, oxygen, IV fluids, antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.
Carcinogenesis, Mutagenesis, and 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.
Use In Specific Populations
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.
It is not known whether this drug is excreted in human milk.
The safety and effectiveness of NATRECOR® in pediatric patients have not been established.
Of the total number of patients in clinical trials treated with NATRECOR® (n=4505), 52% were 65 years or older and 27% were 75 years or older. No overall differences in effectiveness were observed between these patients and younger patients, 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® than younger individuals.
Last reviewed on RxList: 9/4/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Natrecor Information
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