Natrecor Side Effects

Generic Name: nesiritide

Please note - some side effects for Natrecor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Natrecor - for the Consumer

Natrecor

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Natrecor:

Anxiety; back pain; dizziness; headache; lightheadedness; nervousness; sleeplessness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; decreased urination; fainting; fast or slow heartbeat; interrupted breathing; nausea; severe dizziness; vomiting.

Natrecor Side Effects - for the Professional

Natrecor

Adverse events that occurred with at least a 3% frequency during the first 24 hours of Natrecor infusion are shown in the following table.

Adverse events that are not listed in the above table that occurred in at least 1% of patients who received any of the above Natrecor doses included: Tachycardia, atrial fibrillation, AV node conduction abnormalities, catheter pain, fever, injection site reaction, confusion, paresthesia, somnolence, tremor, increased cough, hemoptysis, apnea, increased creatinine, sweating, pruritus, rash, leg cramps, amblyopia, anemia. All reported events (at least 1%) are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population.

In placebo and active-controlled clinical trials, Natrecor has not been associated with an increase in atrial or ventricular tachyarrhythmias. In placebo-controlled trials, the incidence of VT in both Natrecor and placebo patients was 2%. In the PRECEDENT (Prospective Randomized Evaluation of Cardiac Ectopy with Dobutamine or Natrecor Therapy) trial, the effects of Natrecor (n = 163) and dobutamine (n = 83) on the provocation or aggravation of existing ventricular arrhythmias in patients with decompensated CHF was compared using Holter monitoring. Treatment with Natrecor (0.015 and 0.03 mcg/kg/min without an initial bolus) for 24 hours did not aggravate pre-existing VT or the frequency of premature ventricular beats, compared to a baseline 24-hour Holter tape.

Clinical Laboratory

In the PRECEDENT trial, the incidence of elevations in serum creatinine to > 0.5 mg/dL above baseline through day 14 was higher in the Natrecor 0.015 mcg/kg/min group (17%) and the Natrecor 0.03 mcg/kg/min group (19%) than with standard therapy (11%). 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 (2 mcg/kg bolus followed by 0.01 mcg/kg/min) and nitroglycerin groups, respectively.

Effect on Mortality

Data from all seven studies in which 30-day data were collected are presented in the chart below. The data depict hazard ratios and confidence intervals of mortality data for randomized and treated patients with Natrecor® relative to active controls through day 30 for each of the 7 individual studies (Studies 311, 325, 326, 329 [PRECEDENT], 339 [VMAC], 341 [PROACTION], and 348 [FUSION I]).

The figure (on logarithmic scale) also contains a plot for the six studies involving hospitalized or Emergency Department patients combined (n = 1507), and for all 7 studies combined (n = 1717). The percentage is the Kaplan-Meier estimate.

The figure below represents 180-day mortality hazard ratios for randomized and treated patients from all five individual studies where 180-day data were collected, 16 week hazard ratios for Study 348 (180-day data were not collected), and the five studies with 180-day data pooled (n = 1404).

There were few deaths in these studies, so the confidence limits around the hazard ratios for mortality are wide. The studies are also small, so some potentially important baseline imbalances exist among the treatment groups, the effects of which cannot be ascertained.

Side Effects by Body System

Cardiovascular

Cardiovascular side effects have included hypotension (11% to 35%), ventricular tachycardia (3% to 10%), ventricular extrasystoles (3% to 4%), angina pectoris (2% to 6%), and bradycardia (1% to 5%). Other side effects occurring in at least 1% of patients have included tachycardia, atrial fibrillation, and AV node conduction abnormalities.

The mean duration of symptomatic hypotension was 2.2 hours with nesiritide, compared to 0.7 hours with nitroglycerin.

Nesiritide was associated with a lower incidence of severe ventricular arrhythmias than dobutamine: sustained ventricular tachycardia (1% vs 7%), nonsustained ventricular tachycardia (11% vs 17%), cardiac arrest (0 vs 5%).

Nervous system

Nervous system side effects have included headache (7% to 9%), insomnia (2% to 6%), dizziness (3% to 6%), and anxiety (2% to 3%). Other side effects occurring in at least 1% of patients have included confusion, paresthesia, somnolence, and tremor.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (1% to 3%), nausea (4% to 13%), vomiting (1% to 4%), and hemoptysis (at least 1%).

Local

Local reactions reported in at least 1% of patients have included catheter pain and injection site reactions.

Respiratory

Respiratory side effects reported in at least 1% of patients have included increased cough and apnea.

Renal

Renal side effects reported have included increases in serum creatinine of greater than 0.5 mg/dL above baseline (17% in patients receiving 0.015 mcg/kg/min, 19% in patients receiving 0.03 mcg/kg/min, 28% in patients receiving a 2 mcg/kg bolus followed by 0.020 mcg/kg/min).

Other

Other side effects have included fever in at least 1% of patients.

Ocular

Ocular side effects have included amblyopia in at least 1% of patients.

Dermatologic

Dermatologic side effects have included pruritus and rash in at least 1% of patients.

Endocrine

Endocrine side effects have included sweating in at least 1% of patients.

Musculoskeletal

Musculoskeletal side effects have included back pain (1% to 4%) and leg cramps (at least 1%).

Hematologic

Hematologic side effects have included anemia in at least 1% of patients.

Metabolic

Metabolic side effects have included hypokalemia (3%) and hypomagnesemia (1% to 3%) in a trial with 103 CHF patients.

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