Fact Sheet - Conditional Marketing Authorization of NATRECOR*

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What is NATRECOR?

NATRECOR (nesiritide) is a pharmaceutical form of a hormone which is naturally produced by the heart. NATRECOR is a sterile, purified preparation of human B-type natriuretic peptide (hBNP), and is manufactured from the bacterium E. coli using recombinant DNA technology.

NATRECOR, indicated for the treatment of hospitalized patients with acute episodes of heart failure (HF) who did not respond to treatment with diuretic drugs for two hours, has been authorized for sale in Canada by Health Canada under the Notice of Compliance with Conditions (NOC/c) policy. This authorization reflects the promising nature of the clinical evidence, which must be verified with further data. Products authorized under Health Canada's NOC/c policy have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment.

What is NATRECOR used for?

NATRECOR is a medicine to be administered intravenously (I.V.) for the treatment of hospitalized patients with acute, decompensated heart failure (ADHF) who did not respond to treatment with diuretic drugs for two hours. Diuretics, sometimes called "water pills" or "water tablets", are medications used to remove water from the body by increasing the amount of urine produced by the kidneys.

What is acute decompensated heart failure?

Heart failure is a serious illness in which the heart doesn't efficiently pump blood through the body. The heart still beats, but it pumps less nutrient- and oxygen-rich blood to the rest of the body. Because of this, heart failure can make patients feel tired or weak. Heart failure can also cause swelling and fluid build-up in the legs, feet, and the lungs. Fluid build-up in the lungs is often referred to as "congestion," hence the term "congestive heart failure (CHF)."

When a congestive heart failure patient's condition worsens to the point that a visit to the hospital may be required, the patient is described as having experienced acute heart failure (AHF) or acutely decompensated heart failure (ADHF).

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How does NATRECOR work?

The mechanism of action of NATRECOR results in vasodilatation (increase in the diameter of the blood vessels). It improves the heart's ability to function and may relieve symptoms of heart failure, including shortness of breath.

What other treatments have been used to treat Heart Failure?

Commonly used treatments include diuretics, vasodilators (nitroglycerin) and inotropes (dobutamine, milrinone). I.V. diuretics such as furosemide and torasemide, often administered in combination with oxygen and intravenous morphine, are used to improve ADHF symptoms.

What are the advantages of NATRECOR over other therapies?

Existing therapies that assist in managing ADHF have some limitations. Cardiac inotropes strengthen the contractility of the heart, but increase the incidence of cardiac arrhythmias (irregular heartbeats). Intravenously administered nitroglycerin requires careful monitoring and slow dosage increases in small increments, resulting in delays in attaining positive responses in acutely ill patients.

NATRECOR provides a new option for hospitalized ADHF patients who did not respond to treatment with diuretic drugs for 2 hours.

What do patients or family members need to know when receiving NATRECOR?

BEFORE using NATRECOR, patients or family members are advised to talk to their doctor, particularly if they have ever had low blood pressure, heart problems or heart disease, problems with their liver or kidneys, are taking or have recently taken any other medicines (especially high blood pressure medication, and medications that are not prescribed), are pregnant or think that they might be pregnant or are breast-feeding.

Drugs that may interact with NATRECOR include Angiotensin Converting Enzyme (ACE) inhibitors (medications used to lower the blood pressure). Special caution is advised in patients who also receive other high blood pressure medication(s).

What are the side effects and how serious are they?

The most common side effects include hypotension (fall in blood pressure) with or without symptoms (light-headedness, dizziness, feeling faint, blurred vision); non-sustained ventricular tachycardia (a rapid heart rate that occurs sporadically); headache; nausea.

NATRECOR may cause other possible side effects, including changes in the rate and regularity of the heartbeat; slowness of the heart, increase in the heartbeat, extra heartbeats and palpitations; angina pectoris (chest pain due to a heart condition); dizziness, confusion; vomiting; shortness of breath; increased creatinine (can be an indicator of an abnormality in kidney function); sweating.

The above is not a complete list of side effects reported with NATRECOR. For more information refer to the NATRECOR Product Monograph. Patients should inform their doctor if they notice any of these or any other effects, either during treatment, after treatment has finished or after they have been discharged from hospital.

Who can be treated with NATRECOR?

NATRECOR has been authorized for the treatment of hospitalized patients with acute episodes of heart failure who did not respond to treatment with diuretic drugs for two hours.

Who should not be treated with NATRECOR?

NATRECOR should not be used in patients who are allergic to any of the ingredients in NATRECOR, who suffer from cardiogenic shock (decreased pumping ability of the heart that causes a shock-like state), or whose systolic blood pressure (top number) is less than 90 mm Hg.

How is NATRECOR taken?

The prescribing physician will decide the amount and duration of treatment with NATRECOR that is best for each patient, which depends on the patient's body weight and the severity of the patient's condition.

Before administration, NATRECOR powder will be made up into a solution which will be diluted and mixed into an I.V. bag. NATRECOR will be administered I.V.

The usual dose is an I.V. bolus of 2 µg/kg followed by an infusion (continuous I.V. infusion over a longer period of time) at a dose of 0.01 µg/kg/min. If necessary, the doctor may decide to increase the dose. This will be done by administration of an I.V. injection of 1 µg/kg plus an increase of 0.005 µg/kg/min in the infusions dose. An increase in dose will not happen more often than every 3 hours and up to a maximum dose of 0.03 µg/kg/min.

Where can I learn more about NATRECOR?

Contact the Janssen-Ortho Medical Information Department at
1-800-567-3331 or visit the Web site http://www.janssen-ortho.com