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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.

About Heart Failure

About Heart Failure and Congestive Heart Failure (CHF)


The term “heart failure” denotes a complex clinical syndrome that represents a final common pathway for many cardiovascular diseases. Either systolic or diastolic left ventricular dysfunction initiates the pathophysiology of the syndrome, which includes multi-faceted neurohormonal and circulatory responses. Ventricular hypertrophy and remodeling occur both in response to the initial insult, for example hypertension or coronary disease, and as a manifestation of the neurohormonal changes of heart failure. For example, increases in aldosterone appear critically important in driving fibrosis after injury.


In addition to the direct impact on the heart, activation of the renin-angiotensin-aldosterone-sympathetic nervous systems (RAAS) in the heart failure syndrome results in a cardio-renal syndrome characterized by elevated peripheral vascular resistance, elevated ventricular filling pressures, and salt and water retention. When filling pressures rise, the physiologic stimulus for production of RAAS counter-regulatory natriuretic hormones, including B-type natriuretic peptide (BNP), occurs. Importantly, new research supports the hypothesis that, in heart failure, BNP processing is disturbed and the elevated immunoreactive BNP levels in heart failure do not reflect physiologically active hormone.


Clinically, neurohormonal blocking agents, including ACE-inhibitors, ARBs, beta blockers, and anti-aldosterone agents, when used in a comprehensive management program along with dietary and lifestyle measures, provide the most effective approach to long-term chronic heart failure management with the goal of keeping patients compensated. Despite this, many heart failure patients experience episodes of acute salt and water retention with subsequent pulmonary congestion that results in urgent presentation for emergency care of acute decompensated heart failure (ADHF).


Comorbidities such as hypertension, diabetes, chronic obstructive lung disease, chronic kidney disease, and atrial fibrillation frequently complicate acute and chronic heart failure management. We now realize that older women with hypertension and mild to moderate renal dysfunction represent a substantial subset of ADHF patients.


Treating patients with ADHF is challenging. With this constellation of presentation characteristics, the first-line goals of ADHF treatment are symptom relief and hemodynamic stabilization. Almost no randomized clinical trial data exist to support the use of most of the “standard” therapies for ADHF, most commonly intravenous diuretics. In contrast, data from a series of trials including over 1500 patients and clinical experience in over 3800 hospitals support the use of NATRECOR® for prompt, significant relief of dyspnea and reduction of left ventricular filling pressure in patients who have dyspnea at rest or with minimal activity, and whose systolic blood pressure is >90 mmHg.


This Web site offers HCPs many resources to support the management of patients with heart failure as part of our commitment to cardiovascular medicine. To download a slide set titled: HF-Disease State and Acute Treatment Overview click on the following link:

 


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®.