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Natrecor

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Natrecor

Natrecor Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Natrecor (nesiritide) is indicated for the treatment of patients with acutely decompensated heart failure who have dyspnea at rest or with minimal activity. Natrecor works by lowering blood pressure. Common side effects of Natrecor are hypotension, nausea, back pain, headache, and dizziness.

The recommended dose of Natrecor is an IV bolus of 2 mcg/kg followed by a continuous infusion of 0.01 mcg/kg/min. Natrecor may interact with injectable formulations of heparin, insulin, ethacrynate sodium, bumetanide, enalaprilat, hydralazine, and furosemide. Natrecor should be used during pregnancy only if the potential benefit justifies any possible risk to the fetus. It is not known whether this drug is excreted in human milk. Consult your doctor before breastfeeding.

Our Natrecor (nesiritide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Natrecor in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have:

  • confusion, feeling light-headed, fainting;
  • fast, slow, or irregular heartbeats;
  • urinating less than usual;
  • chest pain; or
  • fever, unusual weakness or tiredness.

Other common side effects may include:

  • headache, mild dizziness;
  • nausea, vomiting;
  • back pain;
  • numbness or tingly feeling;
  • tremors; or
  • vision changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Natrecor (Nesiritide) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Natrecor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following are discussed in more detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A causal relationship for NATRECOR® cannot be reliably established in individual cases.

Adverse drug reactions that occurred at least ≥ 2% more frequently on NATRECOR® than on placebo during the first 24 hours of infusion (excluding the ASCEND-HF study) are shown in Table 3.

Table 3: Adverse Drug Reactions* Reported at ≥ 2% Frequency During the First 24 Hours After the Start of Infusion in Long Infusion Trials† of NATRECOR® at the Recommended Dose excluding ASCEND-HF Results

System Organ Class Adverse Reaction NATRECOR®
(N=331)
0.01 mcg/kg/min
% (n)‡
Placebo
(N=188)
% (n)§
Vascular Disorders
Hypotension 12 (41) 4 (7)
GI Disorders
Nausea 3 (11) 1 (2)
Musculoskeletal Disorders
Back pain 3 (11) 1 (2)
Nervous System Disorders
Headache 7 (24) 6 (11)
Dizziness 2 (8) 2 (3)
*Adverse drug reaction is defined as an adverse event with a frequency in the NATRECOR® group ≥ 2% and occurred at a higher frequency than in the placebo group.
† Trials in which NATRECOR® was administered as a continuous infusion for ≥ 12 hours.
‡704.339 [VMAC] and 704.341[PROACTION]
§704.311, 704.325 and 704.341 [PROACTION]

Laboratory adverse drug reactions that occurred in ≥ 2% of patients and collected during the first 14 days after the start of NATRECOR® infusion included: hypoglycemia.

Worsening Renal Function

In the ASCEND-HF trial, through Day 30, the incidence of renal impairment as measured by a > 25% decrease in glomerular filtration rate (calculated based on serum creatinine) was observed in 31.4% and 29.5% in the NATRECOR® and placebo groups, respectively. Other metrics of decompensated renal function such as an increase in creatinine of > 0.5 mg/dl, a 50% increase in creatinine or a value of ≥ 2 or 100% increase in creatinine were more frequent in the NATRECOR® group. At 30 days post enrollment, more subjects in the NATRECOR® group had elevated levels of creatinine of 50% greater than baseline compared to placebo 4.6% versus 3.3%. In the ASCEND-HF study there were relatively few subjects requiring either hemofiltration or dialysis.

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.

Neutral Effect on Mortality

A meta-analysis performed of seven clinical trials demonstrated NATRECOR® did not increase mortality in patients with acute decompensated heart failure (ADHF) at Day 30 or Day 180 (see Figures 1 and 2). Data from seven studies in which 30-day data were collected are presented in Figure 1. The data depict hazard ratios (HR) and confidence intervals (CI) of mortality data for randomized and treated patients with NATRECOR® relative to active or placebo controls through Day 30 for each of the seven individual studies along with the overall combined estimate (Studies 311, 325, 326, 329 [PRECEDENT], 339 [VMAC], 341 [PROACTION], and A093 [ASCEND-HF]).

Figure 1 (on logarithmic scale) also contains an estimate for the seven studies combined (n=8514). The results indicate that there is no increased mortality risk for NATRECOR® at Day 30 (seven studies pooled: HR=0.99; 95% CI: 0.80, 1.22). The percentages are the Kaplan-Meier estimates.

Figure 1 : 30-Day All-Cause Mortality Hazard Ratios

30-Day All-Cause Mortality Hazard Ratios - Illustration

*Studies 704.311, 704.325, 704.326, 704.329, 704.339, 704.341 and ASCEND-HF

Figure 2 presents 180-day mortality hazard ratios from all six individual studies where 180day data were collected (Studies 325, 326, 329, 339, 341 and A093 [ASCEND-HF]). The results indicate that with the addition of the ASCEND-HF data, there is no increased mortality risk for NATRECOR® at Day 180 (six studies pooled: HR=0.98; 95% CI: 0.88, 1.10).

Figure 2 : 180-Day All-Cause Mortality Hazard Ratios

180-Day All-Cause Mortality Hazard Ratios - Illustration

*Studies 704.325, 704.326, 704.329, 704.339, 704.341 and ASCEND-HF

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of NATRECOR®. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

  • Hypersensitivity reactions
  • Infusion site extravasation
  • Pruritus
  • Rash

Read the entire FDA prescribing information for Natrecor (Nesiritide) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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