Consumer Information for: CORVERT

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

CORVERT is used to restore a normal heart rhythm in adults with certain types of abnormal heart rhythm (arrhythmias):

  • atrial fibrillation or
  • atrial flutter

It is unknown how safe or effective CORVERT is for use in children.

What it does

CORVERT works to restore a normal heart rhythm.

When it should not be used

Do not use CORVERT if:

  • you are allergic to any of the ingredients in CORVERT (see “What are the ingredients in CORVERT?” above).
What the medicinal ingredient is

Ibutilide fumarate

What the non-medicinal ingredients are

Sodium acetate trihydrate, sodium chloride, sodium hydroxide solution or hydrochloric acid solution (to adjust pH), and water for injection.

What dosage form it comes in

Solution for injection: 0.1 mg / mL.

Warnings and precautions

Serious Warnings and Precautions

CORVERT is intended for use only in patients with life-threatening irregular heartbeats (arrhythmias). Most anti-arrhythmic drugs have the potential to cause dangerous arrhythmias; some have been shown to be associated with an increase of sudden death. Your doctor will tell you about the risk and benefits of anti-arrhythmic therapy.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CORVERT. Talk about any health conditions or problems you may have, including if you:

  • have low levels of potassium.
  • have low levels of magnesium.
  • have problems with your liver.
  • have problems with your kidneys.
  • have other heart problems.
  • took a heart rhythm medication within 4 hours before you are going to be given CORVERT.

Other warnings you should know about:

Pregnancy, breastfeeding and women of childbearing age: You should not take CORVERT if you are:

  • pregnant or planning to become pregnant. Your doctor will decide whether the benefit of giving you CORVERT outweighs the risk to your unborn baby. Tell your doctor if you become pregnant.
  • breastfeeding or planning to breastfeed. CORVERT can pass into your breast milk.
  • of childbearing age and are not using an effective and reliable method of birth control.

Laboratory Tests: CORVERT can cause abnormal blood test results for:

  • Liver function tests
  • Blood, Urea and Nitrogen (BUN) test
  • Kidney function tests
  • Tests to measure blood magnesium, potassium and sodium levels
  • Tests to measure hemoglobin, platelets and white blood cell counts

Your doctor will decide when to perform blood tests and will interpret the results.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

The following may interact with CORVERT:

  • Other drugs used to treat abnormal heart rhythms, such as:
    • disopyramide,
    • quinidine,
    • procainamide,
    • amiodarone,
    • sotalol
  • Drugs that prolong the QT interval. These include:
    • Psychoactive drugs, such as:
      • Phenothiazines
      • Tricyclic antidepressants
      • Tetracyclic antidepressants
      • Pimozide
    • Drugs used to treat allergies (antihistamines) such as terfenadine and astemizole
    • Drugs used to treat infections, particularly when erythromycin given through your vein (intravenously)
    • Drugs to treat malaria (antimalarial) such as halofantrine
    • Drugs used to treat gastrointestinal problems such as cisapride.

Proper use of this medication

How CORVERT is given:

CORVERT will always be given to you:

  • by a doctor or nurse
  • as an injection into your vein as an infusion (intravenous infusion)
  • in a place where there is continuous ECG monitoring and the proper equipment available to the doctor or nurse during and after treatment with CORVERT.

Usual Dose

Your doctor will determine the right dose of CORVERT for you based on your weight.

Overdose

If you think you have been given too much CORVERT, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Side effects and what to do about them

These are not all the possible side effects you may feel when taking CORVERT. You will be watched closely to check for serious side effects. Tell your caregiver if you feel short of breath or like you might pass out. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • slow heart beat
  • high blood pressure
  • headache
  • constipation
  • bladder infection
  • fatigue
  • increase in white blood cells
  • leg cramps
  • difficulty sleeping
  • weakness
  • lack of energy
  • joint pain
  • muscle pain
  • itching
  • swelling
  • bruising
  • inflammation of the veins
  • difficulty urinating
  • nausea
  • vomiting
  • diarrhea
  • confusion
  • trouble with your vision

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
Allergic reaction: hives; difficulty breathing; swelling of face, lips, tongue, or throat     ✔
Chest pain, palpitations, irregular heartbeat   ✔  
Low blood pressure: fainting, dizziness     ✔
Tremor/abnormal involuntary movements     ✔

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

CORVERT will be stored by your healthcare professional.

Store:

  • At room temperature (15 -30°C).
  • In its original carton until it is used to protect it from light.

Keep out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about CORVERT:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website (http://www.pfizer.ca), Pfizer Canada ULC at 1-800-463-6001.

This leaflet was prepared by Pfizer Canada ULC

Last Revised: March 29, 2019

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