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IMPORTANT SAFETY INFORMATION

Important Safety Information

HYPOTENSION
NATRECOR® may cause hypotension and should be administered only in settings where blood pressure can be monitored closely. If hypotension occurs during administration of NATRECOR®, the dose should be reduced or discontinued. At the recommended dose of NATRECOR®, the incidence of symptomatic hypotension (4%) was similar to that of IV nitroglycerin (5%).
Asymptomatic hypotension occurred in 8% of patients treated with either drug. In some cases, hypotension that occurs with NATRECOR® may be prolonged. The mean duration of symptomatic hypotension was longer with NATRECOR® than IV nitroglycerin (2.2 versus 0.7 hours, respectively). NATRECOR® should not be used in patients with systolic blood pressure <90 mm Hg or as primary therapy in patients with cardiogenic shock. The rate of symptomatic hypotension may be increased in patients with a baseline blood pressure <100 mm Hg, and NATRECOR® should be used cautiously in these patients. In earlier trials, when NATRECOR® was initiated at doses higher than the 2 mcg/kg bolus followed by a 0.01 mcg/kg/min infusion, the frequency, intensity, and duration of hypotension were increased. The hypotensive episodes were also more often symptomatic and/or more likely to require medical intervention.

NATRECOR® is not recommended for patients for whom vasodilating agents are not appropriate and should be avoided in patients with low cardiac filling pressures.


RENAL

NATRECOR® 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® may be associated with azotemia. In the VMAC trial, through day 30, the incidence of elevations in creatinine to >0.5 mg/dL above baseline was 28% and 21% in the NATRECOR® and nitroglycerin groups, respectively. When NATRECOR® was initiated at doses higher than 0.01 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 were not increased.


MORTALITY

In 7 NATRECOR® clinical trials, through 30 days, 5.5% in the NATRECOR® treatment group died as compared with 4.3% in the group treated with other standard medications. In 5 clinical trials, through 180 days, 21.5% in the NATRECOR® treatment group died as compared with 20.7% in the group treated with other medications. There is not enough information to know if there is an increased risk of death after treatment with NATRECOR®.

Click here for additional Important Safety Information.

NATRECOR® for ADHF

The FDA approval in August 2001 of NATRECOR® (nesiritide) offered healthcare professionals a novel treatment option for patients with acute decompensated heart failure (ADHF). NATRECOR® is indicated for the intravenous treatment of ADHF patients who have dyspnea at rest or with minimal activity. In this population, NATRECOR® reduced pulmonary capillary wedge pressure and improved dyspnea.


The long road to FDA approval for NATRECOR® began 13 years earlier, when Scios began to investigate human B-type natriuretic peptide (hBNP) to treat heart failure. hBNP is normally produced primarily by the ventricular myocardium in response to the excessive stretching of the cardiomyocytes. Scios scientists chose hBNP because of its physiologic actions, including decreasing systemic vascular resistance and central venous pressure, as well as increasing natriuresis.


To learn more about the clinical efficacy, safety, and mechanism of action of NATRECOR® (nesiritide), view the video below.



Scios and NATRECOR®

In 2001, Scios Inc. caught international attention with the successful US launch of NATRECOR®, the first new approved treatment for acute heart failure in over a decade. NATRECOR® added to standard therapy is the only approved treatment for ADHF that has shown improvement in dyspnea and reduction of filling pressures in controlled clinical trials. NATRECOR® has been utilized in more than 3,800 hospitals in the US by a broad spectrum of healthcare professionals who manage ADHF patients.


In 1994 Scios began a clinical development program for the first recombinant form of hBNP. To date, NATRECOR® has been administered in 16 completed clinical trials to a total of 2,012 patients. Presently, Scios is sponsoring the first mega trial (>5000 patients) in ADHF known as ASCEND-HF (Acute Study of the Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). See below for more information.


Clinical Highlights


  • VMAC - Enrollment was completed in July 2000 for the pivotal Phase III VMAC (Vasodilation in the Management of Acute Decompensated Heart Failure) trial. The results from the VMAC study showed that NATRECOR® provided significant improvements in dyspnea and hemodynamics vs standard care, and served as the basis for the unanimous recommendation in June 2001 for approval of NATRECOR® by the Cardiovascular Advisory Panel of the FDA, followed by FDA approval in August 2001.

  • ADHERE® - In 2006, Scios completed a 5-year post -marketing observational study, ADHERE® (Acute Decompensated Heart Failure National Registry) designed to help the medical community better understand acute heart failure, improve its management, and enhance quality of care. By collecting observational data from across the US, ADHERE® characterized the clinical presentation and medical management of ADHF for 187,565 patients in the US. For more information on ADHERE®, please visit the About ADHERE®page

  • ASCEND-HF - In June 2007 Scios announced the enrollment of the first patient in ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). Involving approximately 600 sites worldwide, ASCEND-HF is being conducted by the Duke Clinical Research Institute (DCRI). This randomized, double-blind, placebo-controlled, parrallel-group, multicenter outcomes trial of approximately 7,000 ADHF patients is designed to assess in great depth the long-term clinical outcomes and benefits/risk profile of NATRECOR® (www.ClinicalTrials.gov To find information on the study enter the following in the Study ID field of the Advanced Search function option: NCT00475852).


Important Safety Information

HYPOTENSION

NATRECOR® may cause hypotension and should be administered only in settings where blood pressure can be monitored closely. If hypotension occurs during administration of NATRECOR®, the dose should be reduced or discontinued. At the recommended dose of NATRECOR®, the incidence of symptomatic hypotension (4%) was similar to that of IV nitroglycerin (5%). Asymptomatic hypotension occurred in 8% of patients treated with either drug. In some cases, hypotension that occurs with NATRECOR® may be prolonged. The mean duration of symptomatic hypotension was longer with NATRECOR® than IV nitroglycerin (2.2 versus 0.7 hours, respectively). NATRECOR® should not be used in patients with systolic blood pressure <90 mm Hg or as primary therapy in patients with cardiogenic shock. The rate of symptomatic hypotension may be increased in patients with a baseline blood pressure <100 mm Hg, and NATRECOR® should be used cautiously in these patients. In earlier trials, when NATRECOR® was initiated at doses higher than the 2 mcg/kg bolus followed by a 0.01 mcg/kg/min infusion, the frequency, intensity, and duration of hypotension were increased. The hypotensive episodes were also more often symptomatic and/or more likely to require medical intervention.

NATRECOR® is not recommended for patients for whom vasodilating agents are not appropriate and should be avoided in patients with low cardiac filling pressures.


RENAL

NATRECOR® 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® may be associated with azotemia. In the VMAC trial, through day 30, the incidence of elevations in creatinine to >0.5 mg/dL above baseline was 28% and 21% in the NATRECOR® and nitroglycerin groups, respectively. When NATRECOR® was initiated at doses higher than 0.01 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 were not increased.


MORTALITY

In 7 NATRECOR® clinical trials, through 30 days, 5.5% in the NATRECOR® treatment group died as compared with 4.3% in the group treated with other standard medications. In 5 clinical trials, through 180 days, 21.5% in the NATRECOR® treatment group died as compared with 20.7% in the group treated with other medications. There is not enough information to know if there is an increased risk of death after treatment with NATRECOR®.


Indication

NATRECOR® (nesiritide) is indicated for the intravenous treatment of patients with acutely decompensated heart failure who have dyspnea (difficulty breathing) at rest or with minimal activity.


Please click here to see Full Prescribing Information for NATRECOR®.