Natrecor: Uses, Side Effects and Dosage

What is a Notice of Compliance with Conditions (NOC/c)?

An NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada.

Products approved under Health Canada’s NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies. Health Canada has provided access to this product on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an agreed upon time frame.

^PrNATRECOR^®* nesiritide for Injection

This leaflet is Part III of a three-part "Product Monograph" published when NATRECOR^® was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about NATRECOR^®. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

NATRECOR^® is an intravenous medicine for use in the treatment of hospitalized patients with acute episodes of heart failure who did not respond to treatment with diuretic drugs for two hours.

What it does:

NATRECOR^® is a pharmaceutical form of a hormone which is naturally produced by the heart during heart failure in order to help the heart work more efficiently. NATRECOR^® will improve the heart's ability to function and will relieve symptoms of heart failure, including breathlessness.

When it should not be used:

You should not use NATRECOR^® if:

• you are allergic to any of the ingredients in

  NATRECOR^®;

• you are suffering from cardiogenic shock, i.e. your heart is unable to pump enough blood for the needs of your body;
• your systolic blood pressure (higher value of your blood pressure measurement) is continually below 100 mm Hg at the time of start of therapy.

What the medicinal ingredient is:

nesiritide

What the nonmedicinal ingredients are:

mannitol, citric acid monohydrate, and sodium citrate dihydrate

What dosage forms it comes in:

Each 5 mL vial contains 1.5 mg nesiritide (as citrate salt).

WARNINGS AND PRECAUTIONS

Administration of NATRECOR^® should be avoided if you are suspected of having, or known to have, low cardiac filling pressures.

NGBEFORE you use NATRECOR^® talk to your doctor or pharmacist if:

• you have or have ever had low blood pressure;
• you have or have ever had heart problems or heart disease;
• you are taking or have recently taken any other medicines, even those not prescribed, as some medicines that can lower your blood pressure may increase the risk of hypotension (a fall in blood pressure);
• you have or have ever had a problem with your liver or kidneys;

• you are pregnant or think you might be pregnant;

• you are breast-feeding;
• you have or have ever had any allergies.

There is no information available on the use of NATRECOR^® in patients under 18 years of age; therefore, its use in this age group is not recommended.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with NATRECOR^® include:

• ACE inhibitors.

Tell your doctor about all medications you are using, including those obtained without a prescription and any other remedies or dietary supplements.

It is especially important that your doctor know if you are taking high blood pressure medication.

PROPER USE OF THIS MEDICATION

Your doctor will decide the amount and duration of treatment with NATRECOR^® that is best for you. It depends on your body weight and the severity of your condition.

Before administration, NATRECOR^® powder will be made up into a solution which will be diluted to achieve the dose to be given.

Usual dose:

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

Overdose:

If you receive more NATRECOR^® than you should, this may result in a large drop in your blood pressure. Your doctor will decide either to reduce the dose or to discontinue treatment. If necessary, appropriate measures to increase your blood pressure will be taken.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, NATRECOR^® can have side effects. The most common effects with NATRECOR^® are:

• hypotension (fall in blood pressure) with or without

  symptoms (light-headedness, dizziness, feeling faint, blurred vision);

• nonsustained ventricular tachycardia (a rapid heart rate

  that occurs sporadically);

• headache;
• nausea.

Other possible side effects are:

• changes in the rate and regularity of the heartbeat:

  slowness of the heart, increase in the heartbeat, extra heartbeats, and palpitations;

• angina pectoris (specific type of pain in the chest caused

  by inadequate blood flow through the blood vessels of the heart muscle);

• dizziness, confusion;
• vomiting;
• shortness of breath;

• increased creatinine (can be an indicator of an

  abnormality in kidney function);

• sweating, pruritis (or itching) and rash;

  • hypersensitivity reactions.

Side effects may occur during treatment. If you notice any of these or any other effects not mentioned in this leaflet, either during treatment, after treatment has finished or after you have

been discharged from hospital, please inform your doctor. This is not a complete list of side effects. For any unexpected effects while taking NATRECOR^®, contact your doctor or pharmacist.

HOW TO STORE IT

Store NATRECOR^® at 2-25°C. Do not freeze. Store in the original package.

Keep the container in the outer carton in order to protect from light.

Do not use after the expiry date stated on the label and carton. Keep out of the reach of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

$ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full Product Monograph, prepared for health professionals can be found at: http://www.janssen.ca

or by contacting the sponsor, Janssen Inc., at: 1-800-567-3331

Janssen Inc.

Toronto, Ontario M3C 1L9

Last revised: January 2012

* All trademark rights used under license