US Prescribing Information

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> NATRECOR^® PI (June 2009)

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.

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^®.

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© Scios Inc. 2009.

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