Vasovist: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

VASOVIST is an injectable solution used in magnetic resonance imaging (MRI) procedures to help detect changes in your blood vessels which are known or suspected to be abnormal.

What it does:

VASOVIST helps blood vessels viewed by MRI appear brighter to make it easier for the doctor to see any potential abnormalities.

When it should not be used:

If you have an allergy to any of the ingredients in VASOVIST (see below).

What the medicinal ingredient is:

The active substance is gadofosveset trisodium.

What the important nonmedicinal ingredients are:

The other ingredients are fosveset, sodium hydroxide, hydrochloric acid and water for injection.

What dosage forms it comes in:

VASOVIST is a ready-to-use solution for rapid injection into a vein. It is supplied in a strength of 244 milligrams of gadofosveset trisodium per millilitre of solution and is packaged in glass vials.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• If you have a history of allergy or drug reaction, you will be observed for at least one hour after administration of VASOVIST.

• You will need special medical attention if allergy-like

  reactions occur. Tell your doctor immediately if you notice itching or a feeling of mild swelling in your throat or tongue, which might be a first sign of an allergy-like reaction. Your doctor will watch for other signs as well.

• VASOVIST may have an effect on the electrical activity of the heart. This effect can be measured as a

  change in the electrocardiogram (ECG). In very rare cases, drugs with this effect on the ECG can lead to disturbances in heart rhythm

  (arrhythmias/dysrhythmias) that could result in fainting or death. These heart rhythm disturbances are more likely in patients with risk factors, such as heart disease, or in the presence of certain interacting drugs. Females and persons more than 65 years in age may be at higher risk.

  • If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of a rapid, pounding or irregular heartbeat), fainting, or seizures, seek immediate medical intention.

BEFORE you are given VASOVIST talk to your doctor if:

• you have a cardiac pacemaker or any ferromagnetic implant in your body.

• you are pregnant or could be pregnant (even if you are not sure). It has not been proven that VASOVIST is safe to use during pregnancy. Your doctor will consider this with you and decide whether VASOVIST is needed for the MRI examination.

• you suffer from allergy (eg, hay fever, hives) or asthma.
• you have had any reactions to previous injections of contrast media.
• you are breast-feeding.
• you have a disorder know as Long QT Syndrome.
• you have heart disease.
• you have a slow heart rate.
• you have had a stroke or brain hemorrhage.
• you have a personal history of fainting spells.
• you have a family history of sudden cardiac death at less than 50 years.
• you have electrolyte disturbances (eg, low blood potassium levels).
• you have an eating disorder or are following an extreme diet.
• you have diabetes, especially with associated nerve disorders.
• you have kidney disease.

If any of these apply to you, your doctor will decide whether the intended examination is possible or not.

The safety of VASOVIST in persons under 18 has not yet been tested.

Nephrogenic Systemic Fibrosis

There have been postmarket reports of a rare disease called Nephrogenic Systemic Fibrosis (NSF) following gadolinium-based contrast agent (GBCA) use.

NSF is a rare condition which has only been observed so far in patients with severe kidney disease. At present, there is no evidence that other patient groups are at risk of developing the

condition. Due to NSF the skin becomes thickened, coarse, and hard, which sometimes makes bending of the joints difficult. NSF may spread to other organs and even cause death.

Patients with severe kidney disease should avoid the use of VASOVIST unless the health care professional believes the possible benefits outweigh the potential risks. Those who have already had an MR imaging procedure and who have any of the following symptoms should seek medical attention as soon as possible:

• Swelling, hardening and tightening of the skin
• Reddened or darkened patches on the skin
• Burning or itching of the skin
• Yellow spots on the whites of the eyes

• Stiffness in the joints, problems moving or

  straightening arms, hands, legs or feet

• Pain deep in the hip bone or ribs
• Weakness of the muscles

Your doctor will monitor your health after administering VASOVIST, if you are considered to be at risk for developing NSF.

INTERACTIONS WITH THIS MEDICATION

Caution must be used if iodine-containing or gadolinium-based contrast agents are given the day before or the day after VASOVIST is given.

The following list includes some, but not all of the drugs that may increase the risk of heart rhythm problems while receiving VASOVIST. You should check with your doctor before taking any other medication with VASOVIST.

• Antiarrhythmics (drugs that stabilize heart rhythm, eg,

  quinidine, procainamide, dispyramide, amiodarone, sotalol, ibutilide, flecanide, propafenone)

• Antipsychotics (eg, chlorpromazine, pimozide, haloperidol,

  droperidol)

• Antidepressants (eg, amitripyline, imipramine, maprotiline,

  fluoxetine, venlafaxine)

• Certain antibiotics (eg, erythromycin, clarithromycin,

  telithromycin, moxifloxacin, gatifloxacin, pentamidine)

• Antimalarials (eg, halofantrine, quinine)

• Antifungals (eg, ketoconazole, fluconazole, voriconazole,

  amphotericin B)

• Certain antinausea drugs (eg, dolasetron, ondansetron)

• Diuretics (drugs that increase the flow of urine from the

  body)

• Methadone (a drug used to treat heroin addiction)

• Domperidone (a drug that helps the stomach empty more

  quickly)

• Tacrolimus or high dose corticosteroids (drugs that

  suppress the immune system)

PROPER USE OF THIS MEDICATION

Usual dose:

The dose of VASOVIST varies depending on your weight. The doctor will decide how much VASOVIST is needed for your examination.

You will be asked to lie down on the MRI scanning bed and then you will be given VASOVIST by injection into a vein. The usual injection site is in the back of your hand or the forearm. Scanning can start immediately after the VASOVIST injection. After the injection, you will be observed in case there are any initial side effects.

Overdose:

Overdose is highly unlikely, but your doctor will know what to do should it occur. If necessary, VASOVIST can be removed from the body by hemodialysis.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

VASOVIST can have side effects. Itching, tingling or numbness of the hands or feet, headache, nausea, warm feeling (vasodilatation), burning sensation, change of taste in the mouth (dysgeusia) and feeling cold are the most commonly reported side effects, based on clinical trials in 1321 patients. More than 1 in every 100 persons may experience these side effects.

Most of the side effects were mild to moderate in intensity, and most (80%) occurred within two hours. Delayed reactions may occur within hours or days after injection.

This is not a complete list of side effects. If you notice any side effects not mentioned in this leaflet, please inform your doctor, radiologist or hospital personnel.

HOW TO STORE IT

VASOVIST should be stored at controlled room temperature between 15ºC and 30ºC and protected from light.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada, through the Canada Vigilance Program, collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance by: toll-free telephone: (866) 234-2345

toll-free fax (866) 678-6789 on-line: www.healthcanada.gc.ca/medeffect email: CanadaVigilance@hc-sc.gc.ca

regular mail:

Canada Vigilance National Office

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Health Products and Food Branch

Health Canada

Tunney’s Pasture, AL 0701C

Ottawa, ON K1A 0K9

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. 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:

www.bayer.ca

or by contacting the sponsor, Bayer Inc., at: 1-800-265-7382.

Bayer Inc.

77 Belfield Road

Toronto, Ontario

M9W 1G6

Canada

Last revised: July 16, 2008

©2008, Bayer Inc.