Patient Medication Information: uses, side effects, how to take - Ablavar

ABOUT THIS MEDICATION

What the medication is used for:

ABLAVAR 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:

ABLAVAR 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 ABLAVAR (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:

ABLAVAR 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 ABLAVAR.
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.
ABLAVAR 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.
Gadolinium-based contrast agents (GBCAs) increase the risk for Nephrogenic Systemic Fibrosis (NSF) in patients with chronic severe renal insufficiency or acute renal failure / acute kidney injury.

BEFORE you are given ABLAVAR 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 ABLAVAR is safe to use during pregnancy. Your doctor will consider this with you and decide whether ABLAVAR 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 ABLAVAR 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 ABLAVAR 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 ABLAVAR, 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 ABLAVAR is given.

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

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

You will be asked to lie down on the MRI scanning bed and then you will be given ABLAVAR 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 ABLAVAR 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, ABLAVAR can be removed from the body by hemodialysis.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

ABLAVAR 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.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect	Talk with your doctor
Only if severe	In all cases
Rare
Allergy-like (anaphylactoid) reaction (for example: skin reactions, breathing difficulties, and/or decreased heart rate)
✓
Rare
Possible heart rhythm disturbance (dizziness, palpitations/rapid, pounding or irregular heartbeat, fainting or seizures)
✓

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

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

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 0701C
  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TMCanada 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 obtained by contacting the sponsor, Lantheus MI Canada, Inc., at: 1-800-561-6871.

DIN	02333236
Schedule(s)	ETHICAL
Active ingredient(s)	Gadofosveset trisodium 244 MG
Dosage form(s)	Solution
Route(s) of administration	Intravenous
Drug class (WHO ATC)	V Various drug classes V08 Contrast media V08C Magnetic resonance imaging contrast media V08CA Paramagnetic contrast media V08CA11 Gadofosveset
Company	LANTHEUS MI CANADA INC
Current status	Cancelled Post Market
Current status date	March 7, 2016

Ablavar: Uses, Side Effects and Dosage