Nesiritide

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nesiritide falls into category C. There are no well-controlled studies that have been done in pregnant women. Nesiritide should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Receive nesiritide exactly as prescribed.

Nesiritide is available in an injectable form that is given directly into a vein (IV) by a healthcare professional.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your blood pressure
• your weight
• your response to Natrecor

The recommended dose of Natrecor (nesiritide) is a bolus of 2 mcg/kg followed by a continuous infusion of 0.01 mcg/kg/min. 

You should not use this medicine if you have very low blood pressure.

Tell your doctor about any heart problems you currently have or have had in the past. There are certain heart conditions that could make it dangerous for you to receive nesiritide.

Since nesiritide is given by a healthcare professional in a medical setting, you are not likely to miss a dose.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

• If you have an allergy to nesiritide or any other part of nesiritide.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have low blood pressure.
• If you have heart problems.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take nesiritide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach.
• Back pain.
• Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

No dosage adjustment necessary. Use cautiously in patients with renal impairment or those patients who rely on the renin-angiotensin-aldosterone system for renal perfusion. Monitor renal function closely.

Blood pressure, hemodynamic responses (PCWP, RAP, CI), BUN, creatinine; urine output; consult individual institutional policies and procedures

Applies to nesiritide: intravenous powder for injection

General

The most frequently reported side effects were hypotension, headache, nausea, renal impairment, and back pain.[Ref]

Cardiovascular

Very common (10% or more): Hypotension (12%)[Ref]

Renal

Very common (10% or more): GFR decreased (up to 31.4%), serum creatinine increased (up to 28%)[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness[Ref]

Dermatologic

Postmarketing reports: Pruritus, rash[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Metabolic

Common (1% to 10%): Hypoglycemia[Ref]

Gastrointestinal

Common (1% to 10%): Nausea[Ref]

Local

Postmarketing reports: Infusion site extravasation[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reaction[Ref]

Some side effects of nesiritide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Initial dose: 2 mcg/kg IV bolus, followed by 0.01 mcg/kg/min via continuous IV infusion; not to be titrated more frequently than every 3 hours to a maximum of 0.03 mcg/kg/min

Comments:
-This drug should not be initiated at a dose higher than the initial recommended dose.
-The loading dose may not be appropriate for those with systolic blood pressure less than 110 mmHg or for patients recently treated with afterload reducers.
-There is limited experience with administering this drug for longer than 96 hours; monitor blood pressure closely during administration.

Use: For the treatment of acutely decompensated heart failure in patients who have dyspnea at rest or with minimal activity

Administration advice:
-For IV use only
-Following preparation of infusion bag, withdraw the bolus and administer over about 60 seconds via IV port; begin continuous infusion immediately following the bolus at a flow rate of 0.1 mL/kg/hr.
-Consult manufacturer product information for appropriate volume of bolus and infusion flow rate.
-Flush the catheter between administration of this drug and incompatible drugs.
-Do not administer through a central heparin-coated catheter.

Storage requirements:
-Vials: Store below 25C (77F); do not freeze; keep in outer carton to protect from light.
-Reconstituted solution: Use within 24 hours
-Reconstituted vials: May store at 2C to 25C (36F to 77F) for up to 24 hours.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

IV compatibility:
-Compatible with 5% dextrose injection (D5W), 0.9% sodium chloride injection, 5% dextrose and 0.45% sodium chloride injection, and 5% dextrose and 0.2% sodium chloride injection.
-Incompatible with injectable formulations of heparin, insulin, ethacrynate sodium, bumetanide, enalaprilat, hydralazine, and furosemide; do not coadminister these drugs with nesiritide through same IV catheter.
-Do not administer injectable drugs that contain sodium metabisulfite in the same infusion line as nesiritide.

General:
-This drug has been shown to reduce pulmonary capillary wedge pressure and improve short term (3 hours) symptoms of dyspnea.

Monitoring:
-Cardiovascular: Monitor blood pressure closely during administration.
-Renal: Monitor serum creatinine both during and after therapy has completed.

Patient advice:
-Advise patients to notify their physician or healthcare professional if they have symptoms of hypotension.