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NATRECOR® (nesiritide) is indicated for the treatment of patients with acutely decompensated heart failure who have dyspnea at rest or with minimal activity. In this population, the use of NATRECOR® reduced pulmonary capillary wedge pressure and improved short term (3 hours) symptoms of dyspnea.
DOSAGE AND ADMINISTRATION
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.
The recommended dose of NATRECOR® is an IV bolus of 2 mcg/kg followed by a continuous infusion of 0.01 mcg/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.
Bolus Volume (mL) = Patient Weight (kg) / 3
Table 1: NATRECOR® Weight-Adjusted
Bolus Volume Administered Over 60 Seconds (Final Concentration = 6 mcg/mL)
|Patient Weight (kg)||Volume of Bolus (mL=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) x 0.1
Table 2: NATRECOR® Weight-Adjusted Infusion
Flow Rate for a 0.01 mcg/kg/min Dose Following Bolus (Final Concentration = 6
|Patient Weight (kg)||Infusion Flow Rate (mL/hr)|
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 mg/kg/min.
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.
- 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.
- 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.
- 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.
- 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.
NATRECOR® is physically and/or chemically incompatible with injectable formulations of heparin, insulin, ethacrynate sodium, bumetanide, enalaprilat, hydralazine, and furosemide. Do not co-administer these drugs with NATRECOR® through the same IV catheter. The preservative sodium metabisulfite is incompatible with NATRECOR®. Do not administer injectable drugs that contain sodium metabisulfite in the same infusion line as NATRECOR®. Flush the catheter between administration of NATRECOR® and incompatible drugs.
NATRECOR® binds to heparin and therefore could bind to the heparin lining of a heparin-coated catheter, decreasing the amount of NATRECOR® delivered to the patient for some period of time. Therefore, do not administer NATRECOR® through a central heparin-coated catheter. Concomitant administration of a heparin infusion through a separate catheter is acceptable.
Dosage Forms And Strengths
NATRECOR® (nesiritide) is provided in a sterile, single-use vial. Each 1.5 mg vial contains a white- to off-white lyophilized powder for intravenous (IV) administration after reconstitution.
Storage And Handling
NATRECOR® (nesiritide) is provided as a sterile lyophilized powder in 1.5 mg, single-use vials. Each carton contains one vial and is available in the following package:
1 vial/carton (NDC 65847-205-25)
Store below 25°C. Do not freeze. Keep the vial in the outer carton in order to protect from light.
Manufactured for Scios Inc. Titusville, NJ 08560. Revised: 07/2012
Last reviewed on RxList: 9/4/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Natrecor Information
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