Language selection

Government of Canada

Search

Details for: DOTAREM

Company: GUERBET

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02459329DOTAREMGADOTERATE MEGLUMINE376.9 MG / MLSOLUTIONINTRAVENOUS
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Basis of Decision
Regulatory Decision Summary
Regulatory Decision Summary
Summary Safety Review - Gadolinium based contrast agents - Assessing the risk of gadolinium build-up in the brain and potential brain and nervous system (neurological) side effects
Summary Safety Review - Gadolinium-Based Contrast Agents - Assessing the Potential Risks of Congenital Anomalies, Stillbirth and Neonatal Death

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

DOTAREM is a contrast agent used for magnetic resonance imaging (MRI) of the brain and spine in children and adults.

What it does

DOTAREM makes the tissues brighter and allows the doctor to see any abnormal tissues during MRI procedures.

When it should not be used
  • You have an allergy to gadoterate meglumine or to any other ingredient in DOTAREM (see “What are the ingredients in DOTAREM”).

DOTAREM should not be injected directly into the brain or spine.

What the medicinal ingredient is

Gadoterate meglumine.

What the non-medicinal ingredients are

Water.

What dosage form it comes in

DOTAREM is:

  • a ready-to-use solution for rapid injection into a vein,
  • supplied as 376.9 milligrams of gadoterate meglumine per milliliter of solution (corresponding to 0.5 mmol/mL),
  • packaged in glass vials and in prefilled syringes.
Warnings and precautions

Serious Warnings and Precautions

Your doctor may or may not use DOTAREM and will consider risks such as:

  • DOTAREM contains gadolinium.
  • Taking products with gadolinium can lead to Nephrogenic Systemic Fibrosis (NSF) in those with kidney problems.
  • If used, the doctor will watch your health before and after treatment if you are at risk. (See: “To help avoid side effects…”)

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

  • You suffer or have suffered from an allergy (eg, hay fever, hives) or asthma.
  • You are pregnant or plan to get pregnant.
  • You are breast-feeding or plan to breast-feed.
  • You have kidney disease.

After taking DOTAREM you may have allergic reactions with:

  • Heart problems.
  • Breathing difficulties.
  • Skin reactions.

Your doctor will observe you for side effects for a short time after your treatment.

Nephrogenic Systemic Fibrosis:

  • After taking gadolinium-based contrast agent (GBCA) such as DOTAREM you can develop a rare disease called Nephrogenic Systemic Fibrosis (NSF).
  • NSF is mostly observed in patients with severe kidney disease.
  • If you have kidney disease, your doctor will decide whether to use DOTAREM.

If you experience any of the symptoms of NSF listed here, contact your doctor:

Skin
  • Swelling, hardening, tightening.
  • Red or dark patches.
  • Burning or itching.
Eyes
  • Yellow spots on the white part of the eye.
Bone or muscle
  • Stiffness of joints.
  • Pain in hipbone or rubs.
  • Muscle weakness.

NSF may spread to other organs and even cause death.

After you receive DOTAREM, your doctor will monitor your health to check if you are at risk of developing NSF.

Accumulation of gadolinium in the brain:
Recent information shows that gadolinium (as in DOTAREM) 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

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 with DOTAREM.

Proper use of this medication

You will lie down on the MRI scanning bed and then will be given DOTAREM 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 DOTAREM injection.

Usual dose

The dose of DOTAREM depends on your body weight. Your doctor use your weight to decide your dose.

Overdose

If you think you have been given too much DOTAREM, 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

DOTAREM can have side effects in adults and children which:

  • are mostly mild to moderate,
  • occur mostly within half an hour of administration,
  • can be delayed hours or days after injection.

Common side effects can include:

  • nausea, headache,
  • injection site pain or coldness.

Uncommon side effects can include:

  • fatigue, dizziness, sleepiness,
  • bad taste in the mouth, rash, itching, burning sensation.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
VERY COMMON
Paresthesia (numbness, tingling, burning feeling in the skin) ✔    
COMMON
Pain at the injection site ✔   ✔
RARE
Severe allergic reactions with symptoms such as:
  • breathing difficulties
  • swollen face and throat
  • heart and vascular problems that may lead to collapse and death
  • skin reactions such as rash, itching
   ✔ ✔
Heartbeat which is slow, fast or irregular   ✔  
Blood circulation problems such as:
  • low or high blood pressure
  • dilated (expanded) blood vessels
  • pain and swelling of superficial veins
   ✔  
Feeling unwell   ✔  
Tremors, convulsion   ✔  
Loss of consciousness   ✔  

These are not all the possible side effects you may feel when taking DOTAREM. 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. Please also see the warnings in the “To help avoid side effects…” section.
How to store

DOTAREM should be stored at controlled room temperature between 15ºC and 30ºC.

Keep out of sight and reach of children.

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

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
  • 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, the importer’s website www.methapharm.com, or by calling 1-800-287-7686.

You may report any injury to a person's health that is suspected of being associated with the use of DOTAREM by calling toll free to 1-800-287-7686.

This leaflet was prepared by Guerbet.

Last revised: April 23, 2018

Date modified: