In 2001, Scios Inc. caught international attention with the successful US launch of NATRECOR®, the first new approved treatment for acute heart failure in more than a decade.
NATRECOR® is indicated for acutely decompensated heart failure (ADHF) patients who have dyspnea at rest or with minimal activity (such as talking, eating and bathing).
For more information about Scios, please visit www.sciosinc.com.
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
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®.
Please click here to see Full Prescribing Information for NATRECOR®.
© Scios Inc. 2009.
