NATRECOR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NATRECOR (NATRECOR).
Nesiritide is a recombinant B-type natriuretic peptide that binds to guanylyl cyclase receptors on vascular smooth muscle and endothelial cells, increasing cGMP levels, leading to vasodilation, natriuresis, and diuresis. It also suppresses renin-angiotensin-aldosterone and sympathetic nervous systems.
| Metabolism | Primarily degraded by neutral endopeptidase (neprilysin) and by proteolysis in vascular and renal tissues; no significant hepatic metabolism. |
| Excretion | Primarily renal elimination via proteolysis and peptidase degradation; <2% excreted unchanged in urine. |
| Half-life | Terminal elimination half-life is approximately 18 minutes; clinical effects (e.g., reduction in pulmonary capillary wedge pressure) persist significantly longer (up to several hours) due to prolonged receptor binding. |
| Protein binding | Approximately 60–70% bound to plasma proteins (primarily albumin and other proteins). |
| Volume of Distribution | Vd is approximately 0.2 L/kg, indicating minimal distribution into tissues and confinement primarily to the vascular space. |
| Bioavailability | Only available intravenously; oral bioavailability is negligible due to extensive first-pass metabolism and polypeptide degradation. |
| Onset of Action | Intravenous: Onset within 15 minutes; maximum hemodynamic effect observed at approximately 1 hour. |
| Duration of Action | Duration of hemodynamic effects (e.g., afterload reduction, increased cardiac output) is 2–4 hours post-infusion, but clinical effects on symptoms may extend to 12 hours. |
Intravenous bolus of 2 mcg/kg followed by continuous IV infusion of 0.01 mcg/kg/min.
| Dosage form | FOR SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment, as drug is not renally eliminated. |
| Liver impairment | No specific Child-Pugh based dose adjustments; use with caution in severe hepatic impairment. |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No specific dose adjustment recommended; monitor for hypotension as elderly may be more sensitive. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NATRECOR (NATRECOR).
| Breastfeeding | It is not known whether nesiritide is excreted in human milk. Caution should be exercised when administered to a nursing woman. The M/P ratio is unknown. Due to potential serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. |
| Teratogenic Risk | Nesiritide is a recombinant human B-type natriuretic peptide. There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, no evidence of fetal harm was observed at doses up to 10 times the human dose. However, because animal studies are not always predictive of human response, nesiritide should be used during pregnancy only if clearly needed. Potential risks include hypotension and reduced uteroplacental perfusion due to vasodilation. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to nesiritide or any component","Cardiogenic shock","Systolic blood pressure < 90 mmHg","Low cardiac output states"]
| Precautions | ["Hypotension (especially symptomatic or requiring intervention)","Renal impairment (may worsen in some patients)","Cardiogenic shock or low cardiac output states","Use caution with concurrent vasodilators or diuretics"] |
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| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and renal function. Assess for signs of hypotension, especially during administration. Monitor fetal heart rate and uterine activity if used in labor. Continuous electrocardiographic monitoring is recommended due to risk of arrhythmias. Assess serum potassium and creatinine periodically. |
| Fertility Effects | No studies on fertility have been conducted. No impairment of fertility was observed in animal studies at doses up to 10 times the human dose. The effect on human fertility is unknown. |