Nesiritide

Nesiritide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Overview

Nesiritide is a natriuretic peptide that is FDA approved for the {{{indicationType}}} of patients with acutely decompensated heart failure who have dyspnea at rest or with minimal activity. Common adverse reactions include hypotension, nausea, dizziness, headache, and elevated serum creatinine.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acute Decompensated Heart Failure

• NATRECOR® (nesiritide) is for intravenous (IV) use only. There is limited experience with administering NATRECOR® for longer than 96 hours. Monitor blood pressure closely during NATRECOR® administration.
• Dosing Information

• Recommended Dosage: IV bolus of 2 μg/kg followed by a continuous infusion of 0.01 μg/kg/min. Do not initiate NATRECOR® at a dose that is above the recommended dose.
• The loading dose may not be appropriate for those with low systolic blood pressure (SBP) <110 mm Hg or for patients recently treated with afterload reducers.
• The administration of the recommended dose of NATRECOR® is a two step process:

Step 1. Administration of the IV Bolus

• After preparation of the infusion bag, withdraw the bolus volume (see Table 1) from the NATRECOR® infusion bag, and administer it over approximately 60 seconds through an IV port in the tubing.

This image is provided by the National Library of Medicine.

Bolus Volume (mL) = Patient Weight (kg) / 3

Step 2. Administration of the Continuous Infusion

• Immediately following the administration of the bolus, infuse NATRECOR® at a flow rate of 0.1 mL/kg/hr. This will deliver a NATRECOR® infusion dose of 0.01 mcg/kg/min.
• To calculate the infusion flow rate to deliver a 0.01 mcg/kg/min dose, use the following formula (see Table 2):

Infusion Flow Rate (mL/hr) = Patient Weight (kg) × 0.1

This image is provided by the National Library of Medicine.

Dose Adjustments

• The dose-limiting side effect of NATRECOR® is hypotension. If hypotension occurs during the administration of NATRECOR®, reduce the dose of or discontinue NATRECOR® and initiate other measures to support blood pressure (IV fluids, changes in body position). When symptomatic hypotension occurs, discontinue NATRECOR®. Because hypotension caused by NATRECOR® may be prolonged (up to hours), a period of observation may be necessary before restarting the drug. NATRECOR® may be subsequently restarted at a dose that is reduced by 30% (with no bolus administration) once the patient has stabilized.

• Do not up-titrate NATRECOR® more frequently than every 3 hours. Use central hemodynamic monitoring and do not exceed 0.03 mcg/kg/min.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nesiritide in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nesiritide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

The safety and effectiveness of NATRECOR® in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nesiritide in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nesiritide in pediatric patients.

Contraindications

• Persistent systolic blood pressure <100 mm Hg prior to therapy because of an increased risk of symptomatic hypotension
• Hypersensitivity to any of its components
• Cardiogenic shock

Warnings

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Nesiritide in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Nesiritide in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nesiritide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nesiritide during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Nesiritide with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Nesiritide with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Nesiritide with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Nesiritide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nesiritide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Nesiritide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Nesiritide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nesiritide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nesiritide in patients who are immunocompromised.

Administration and Monitoring

Administration

• Intravenous

Monitoring

Preparation and Administration Instructions

• The NATRECOR® bolus must be drawn from the prepared infusion bag. Prime the IV tubing with 5 mL of the solution for infusion prior to connecting to the patient's vascular access port and prior to administering the bolus or starting the infusion.

1. Reconstitute one 1.5 mg vial of NATRECOR® by adding 5 mL of diluent removed from a pre-filled 250 mL plastic IV bag containing the diluent of choice. After reconstitution of the vial, each mL contains 0.32 mg of nesiritide. The following preservative-free diluents are recommended for reconstitution: 5% Dextrose Injection (D5W), USP; 0.9% Sodium Chloride Injection, USP; 5% Dextrose and 0.45% Sodium Chloride Injection, USP, or 5% Dextrose and 0.2% Sodium Chloride Injection, USP.
2. Do not shake the vial. Rock the vial gently so that all surfaces, including the stopper, are in contact with the diluent to ensure complete reconstitution. Use only a clear, essentially colorless solution.
3. Withdraw the entire contents of the reconstituted NATRECOR® vial and add to the 250 mL plastic IV bag. This will yield a solution with a concentration of NATRECOR® of approximately 6 mcg/mL. Invert the IV bag several times to ensure complete mixing of the solution.
4. Use the reconstituted solution within 24 hours, as NATRECOR® contains no antimicrobial preservative. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstituted vials of NATRECOR® may be stored at 2 to 25°C (36 to 77°F) for up to 24 hours.

IV Compatibility

There is limited information regarding IV Compatibility of Nesiritide in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Nesiritide in the drug label.

Pharmacology

Mechanism of Action

There is limited information regarding Nesiritide Mechanism of Action in the drug label.

Structure

There is limited information regarding Structure of Nesiritide in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Nesiritide in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Nesiritide in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Nesiritide in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Nesiritide in the drug label.

Condition1

Description

How Supplied

There is limited information regarding Nesiritide How Supplied in the drug label.

Storage

There is limited information regarding Nesiritide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Nesiritide in the drug label.

Precautions with Alcohol

Alcohol-Nesiritide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Natrecor®

Look-Alike Drug Names

• Natrecor® — Norcuron®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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