Magnevist: Uses, Side Effects and Dosage

Serious warnings and precautions box

Nephrogenic Systemic Fibrosis (NSF)

Gadolinium-based contrast agents (such as MAGNEVIST) increase the risk of a rare disease called Nephrogenic Systemic Fibrosis (NSF) in patients with kidney disease. MAGNEVIST should not be used in:

• Patients with chronic, severe kidney disease
• Patients with acute kidney injury
• New-borns up to 4 weeks of age due to their developing kidneys

If you have mild to moderate kidney disease, you should only be given MAGNEVIST after a careful assessment by your healthcare professional.

MAGNEVIST should be used with caution in infants less than 1 year of age.

Your healthcare professional will monitor your health before and after giving you MAGNEVIST if you are at risk for developing NSF (see “Other warnings that you should know about”, below).

Not for Intrathecal use

If injected into the spinal canal (by intrathecal injection), gadolinium-based contrast agents such as MAGNEVIST can cause serious life-threatening side effects such as:

• Coma (prolonged loss of consciousness)
• Encephalopathy (changes in how your brain works)
• Seizures (temporary loss of consciousness and muscle control)
• Death

MAGNEVIST is for intravenous (IV) use only.

What MAGNEVIST is used for:

• MAGNEVIST is used during magnetic resonance imaging (MRI) of the head, neck and spine. This helps with the diagnosis of various conditions.

How MAGNEVIST works:

• MRI is a form of medical diagnostic imaging that creates detailed images of the organs and tissues inside your body.
• MAGNEVIST makes certain areas appear brighter in your MRI. This helps your healthcare professional identify any potential issues.

The ingredients in MAGNEVIST are:

Medicinal ingredient(s): gadopentetate dimeglumine

Non-medicinal ingredients: diethylenetriamine pentaacetic acid and meglumine

MAGNEVIST comes in the following dosage form:

MAGNEVIST is a ready-to-use solution (corresponding to 0.5 mmol/mL) for rapid injection into a vein.

Do not use MAGNEVIST if:

Gadolinium-based contrast agents (such as MAGNEVIST) increase the risk of a rare disease called Nephrogenic Systemic Fibrosis (NSF) in patients with kidney disease. MAGNEVIST should not be used in:

• Patients with chronic, severe kidney disease
• Patients with acute kidney injury
• New-borns up to 4 weeks of age due to their developing kidneys
• You are allergic (hypersensitive) to gadopentetate dimeglumine or to any of the other ingredients of MAGNEVIST (see “What are the ingredients in MAGNEVIST” section)
• You have previously had a life-threatening reaction to MAGNEVIST.

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

• You have or have had a previous reaction to contrast media
• You suffer or have suffered from an allergy (e.g., hay fever, hives) or asthma.
• You have very poor kidney function.
• You have recently had, or soon expect to have, a liver transplant.
• You have epilepsy or suffer from brain conditions with seizures.

• You are pregnant or are planning to become pregnant, as it is not known if MAGNEVIST may harm your unborn baby. MAGNEVIST will only be given to you during pregnancy if your doctor decides it is absolutely necessary. You are breast-feeding or intend to breast-feed. MAGNEVIST passes in breast milk.

• You suffer from heart or blood circulation problems. This is because in the rare event that you do have an allergic reaction, it is more likely to be serious or fatal.
• You have sickle cell anemia, hemolytic conditions (destruction of red blood cells), or related blood disorders of hemoglobin in the blood (hemoglobinopathies).
• You have heart problems, breathing difficulties, or skin reactions may occur with the use of MAGNEVIST. Severe reactions may occur. Most of these reactions occur within half an hour of administration. Therefore, your attending healthcare professional may observe you in this period. Delayed reactions may occur hours or even days later.

Other warnings you should know about:

MAGNEVIST may increase or decrease blood pressure and may make you feel dizzy or faint. See how you feel after you are given MAGNEVIST and before driving or operating machinery.

Accumulation of Gadolinium in the Brain

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

• The effect on the brain is unknown right now.

• Your healthcare professional will:

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

Kidney Impairment

Before you receive MAGNEVIST, your healthcare professional will check how well your kidneys are working. Patients with severe kidney disease should not be given MAGNEVIST (See Serious Warnings and Precautions). Patients with mild to moderate kidney disease should only be given MAGNEVIST after a careful assessment by their healthcare professional. Your doctor may decide to take a blood test to check this before making the decision to use MAGNEVIST.

If you have poor kidney function, your healthcare professional will make sure that MAGNEVIST has been eliminated from your body before you receive a second injection of MAGNEVIST.

MAGNEVIST can be removed from the body by dialysis. If you are already undergoing regular dialysis, your healthcare professional will decide if you should receive dialysis after you have been given MAGNEVIST.

Nephrogenic Systemic Fibrosis

Receiving MAGNEVIST may cause Nephrogenic Systemic Fibrosis (NSF). This is a rare condition which has only been observed so far in patients with severe kidney disease. NSF causes the skin to become thickened, coarse, and hard, which sometimes makes bending of the joints difficult. NSF may spread to other organs and even cause death.

Before you receive MAGNEVIST, your healthcare professional will evaluate your kidney function. This will help determine if you should be given MAGNEVIST.

If you have already had an imaging procedure and experience any of the following symptoms, you 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 healthcare professional will monitor your health after administering MAGNEVIST, if you are considered to be at risk for developing NSF.

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

Drug interaction studies have not been done for MAGNEVIST.

Before you have any blood tests, tell your healthcare professional you have been given MAGNEVIST. This is because some tests for iron levels in the blood may be affected for up to 24 hours after MAGNEVIST has been given.

How to take MAGNEVIST:

• MAGNEVIST will be given to you by a healthcare professional before your MRI.

Usual dose:

Your healthcare professional will determine your dose based on your body weight. The recommended dose of MAGNEVIST is 0.2 millilitres per kg body weight.

If you receive a bolus injection of MAGNEVIST (a large dose quickly) you may notice a temporary sweet taste in your mouth.

Overdose:

If you think you, or a person you are caring for, has been given too much MAGNEVIST, contact your healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Possible side effects from using MAGNEVIST:

These are not all the possible side effects you may have when taking MAGNEVIST. If you experience any side effects not listed here, tell your healthcare professional.

Like all medicines, MAGNEVIST can cause side effects, although not everybody gets them.

Common side effects observed in clinical trials (between 1 and 10 in every 100 patients are likely to get these):

• Headache (in some cases severe)
• Injection site discomfort
• Nausea (feeling sick)
• Pain (back, ear, eye, teeth)
• Dizziness
• Vomiting
• Paresthesia (“pins and needles”)

Serious side effects and what to do about them

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

Reporting side effects

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

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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

Storage:

MAGNEVIST should be stored at temperatures between 15°C to 30°C. MAGNEVIST is sensitive to light. Keep the container in the outer carton in order to protect from light.

Keep out of reach and sight of children.

If you want more information about MAGNEVIST:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.bayer.ca), or by calling Bayer Medical Information at 1-800-265-7382 or Canada.medinfo@bayer.com.

Bayer Inc. 2920 Matheson Boulevard East Mississauga, Ontario L4W 5R6

Date of Authorization: 2025-09-04

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