Optimark: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Optimark is used in magnetic resonance imaging (MRI) to help the doctor better see tissue abnormalities such as tumours in the brain, spine and liver.

What it does:

Optimark is an injectable solution of a contrast agent containing gadolinium. When viewed with MRI, this agent helps tissues appear brighter helping the clinician visualize the tissues and any abnormal conditions.

When it should not be used:

• Patients with severe kidney disease and newborns less than 4 weeks of age should not be given Optimark.
• If you have a history of allergy, or a reaction to the active ingredient, or any other ingredient in the formulation (see non-medicinal ingredients).

What the medicinal ingredient is:

The active ingredient is gadoversetamide.

What the important non-medicinal ingredients are:

• calcium chloride dihydrate
• calcium hydroxide
• versetamide

What dosage forms it comes in:

The product is one solution for intravenous injection.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Patients with severe kidney disease should not be given Optimark.
• Acute kidney injury requiring dialysis has occurred with the use of GBCAs in patients with chronically reduced kidney function. The risk of acute kidney injury may increase with an increased dose of the contrast agent.
• If you have a history of allergy or drug reaction, you will be observed for several hours after administration of Optimark.
• Serious, life-threatening and sometimes fatal allergic or cardiovascular (heart) reactions are considered possible (see below), particularly those with a history of allergic reactions (see Side Effects).
• The safety of repeat doses of Optimark has not been studied. Your doctor will determine if and how further doses can be administered if required. A period of at least 7 days should elapse if a repeat scan is considered.

Optimark 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 the 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 attention.

Before you use Optimark, talk with your doctor or pharmacist if you have any medical conditions, including:

• heart disease including irregular or low heartbeat
• stroke, brain hemorrhage
• a personal history of fainting spells
• family history of sudden cardiac death at < 50 years
• electrolyte disturbances (e.g. low blood potassium levels)
• an eating disorder or are following a strict diet
• diabetes, especially with associated nerve disorders
• kidney disease (if relevant to the elimination of the drug)

OR if:

• You are pregnant. Gadoversetamide has caused abnormalities in animal offspring but no studies have been done in pregnant women. Your doctor will discuss with you whether the benefit justifies the risk

• You are breastfeeding. Animal studies have shown transfer of gadoversdetamide to animal offspring via breast milk, but no studies have been done in breastfeeding women to determine whether this is excreted in human milk. It is recommended to discontinue breastfeeding for a period of 24 hours after gadoversetamide administration. Your doctor will discuss the issue with you.

BEFORE you use Optimark, be aware of the following information:

• Your doctor may recommend blood testing.
• When you receive this drug, you will be at the hospital or specialized clinic. Somebody will inform you about effects of the product and you will not have permission to return home alone.
• Your doctor will inform you on the procedure to follow regarding the examination. He will advise you of all precautions to follow during this process.
• Finally, your collaboration is essential for the best results and for minimized allergic reactions.

Accumulation of gadolinium in the brain:

Recent information shows that gadolinium (as in Optimark) may build up in the brain after multiple uses and:

• The effect on the brain is unknown right now.

• Your doctor will:

  • Carefully consider whether to use repeated doses
  • Use the lowest doses

INTERACTIONS WITH THIS MEDICATION

Your doctor will not give you other drugs during your examination. No formal studies examining drug-drug interactions have been done for Optimark. However, the following drugs, when used with Optimark, may increase the risk of heart rhythm problems. You should check with your doctor before taking any other medications with Optimark including:

• Class IA antiarrhythmics (e.g. quinidine, procainamide, dispyramide)
• Class III antiarrhythmics (e.g. amiodarone, sotalol, ibutilide)
• Class IC antiarrhythmics (e.g. flecanide, propafenone)
• antipsychotics (e.g. chlorpromazine, pimozide, haloperidol, droperidol)
• tricyclic/tetracyclic antidepressants (e.g. amitripyline, imipramine, maprotiline)
• fluoxetine
• venlafaxine
• methadone
• macrolide antibiotics and analogues (e.g. erythromycin, clarithromycin, telithromycin)
• fluoroquinolone antibiotics (e.g. moxifloxacin, gatifloxacin)
• pentamide
• antimalarials (e.g. halofantrine, quinine)
• azole antifungals (e.g. ketoconazole, fluconazole, voriconazole)
• domperidone
• 5-HT₃ antagonists (e.g. dolasetron, ondansetron)
• Tacrolimus

Optimark should be used with caution with drugs that can disrupt electrolyte levels, including, but not limited to, the following:

• loop, thiazide, and related diuretics
• amphotericin B
• high dose corticosteroids

PROPER USE OF THIS MEDICATION

Usual Adult Dose:

Optimark should be administered as an intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg). The solution contains 0.5 mmol/mL of Gadoversetamide.

Overdose:

Missed Dose:

Not applicable for this product.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The possibility of a reaction, including serious, life threatening situations can occur. You must inform your doctor about such reactions whether during the examination, after examination, or once you have returned home.

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 attention.

Less serious side effects include headache, taste perversion, nausea, vasodilation, paresthesia/abnormal sensation of burning.

For any unexpected effects while taking Optimark, contact your doctor or pharmacist.

HOW TO STORE IT

The doctor/healthcare professional will store this diagnostic agent.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals is included with the product or may be obtained by contacting the sponsor, Liebel-Flarsheim Canada Inc. at 1-844-208-7620.

Last revised: 15 June 2017

Liebel-Flarsheim Canada Inc.

Pointe-Claire, Quebec, H9R 5H8

CANADA

GBT 1177CA0417