Patient Medication Information: uses, side effects, how to take - Vueway
Serious warnings and precautions box
What VUEWAY is used for:
VUEWAY is a contrast agent used for magnetic resonance imaging (MRI) of the body including the brain and spine. It is used in adults and in children 2 years of age and older.
How VUEWAY works:
MRI is a form of medical diagnostic imaging that creates detailed images of the organs and tissues inside your body.
Gadolinium-based contrast agents (such as VUEWAY) increase the risk of getting a rare and severe disease called Nephrogenic Systemic Fibrosis (NSF) in patients with:
- Chronic, severe kidney disease, or
- Acute kidney injury.
In NSF, the skin becomes thickened, coarse and hard, which makes bending of the joints difficult. NSF may spread to other parts of the body such as your muscles and organs and even cause death. Your healthcare professional will screen you for kidney problems before you are given VUEWAY. They will avoid giving VUEWAY to you if you have certain kidney problems unless it is absolutely necessary. They will make sure to give you the right dose and will wait longer before giving you VUEWAY again. See also “Other warnings you should know about”, further below, for more information.
- Not for Intrathecal Use.
If injected into the spinal canal (by intrathecal injection), gadolinium-based contrast agents such as VUEWAY can cause 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
VUEWAY is for intravenous (IV) use only.
VUEWAY is a gadolinium-based contrast agent that makes certain areas appear brighter in your MRI. This helps your healthcare professional see any abnormal tissues.
The ingredients in VUEWAY are:
Medicinal ingredient: Gadopiclenol
Non-medicinal ingredients: Hydrochloric acid and/or sodium hydroxide, tetraxetan, trometamol, and water for injection.
VUEWAY comes in the following dosage form:
Solution, 485.1 mg/mL (0.5 mmol/mL) gadopiclenol.
Do not use VUEWAY if:
- You are allergic to gadopiclenol or to any of the ingredients in VUEWAY.
- You are allergic to any part of the VUEWAY container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VUEWAY. Talk about any health conditions or problems you may have, including if you:
- You have or had an allergic reaction to a contrast agent in the past.
- You have or have had allergies such as hay fever in the past.
- You have or have had asthma in the past.
- You have had seizures in the past.
- You have kidney problems.
You are pregnant or are planning to become pregnant.
- You are breastfeeding or intend to breastfeed.
Other warnings you should know about:
Accumulation (Build-up) of Gadolinium in the Brain:
Gadolinium which is in VUEWAY may accumulate in the brain after multiple administrations. It is not known how this may affect the brain. Your healthcare professional will carefully consider whether to use repeat doses of VUEWAY and will use the lowest dose necessary.
Nephrogenic Systemic Fibrosis (NSF):
VUEWAY may cause NSF. This is a rare and severe disease which has only been observed so far in patients with severe kidney disease.
NSF causes the skin to become thickened, coarse and hard, which makes bending of the joints difficult. NSF may spread to other organs and even cause death. Your healthcare professional will screen you for kidney problems before you are given VUEWAY. Tell your healthcare professional before you receive VUEWAY if you know you have any kidney problems. You must get immediate medical help if you get any symptom of NSF after you receive VUEWAY. These include: skin changes including hardening, thickening, burning, itching, scaling, darkening, hardening and tightening of the skin, red or dark patches on the skin, stiffness in the joints with trouble moving, pain in the hip bones or ribs, severe pain, muscle weakness.
Also tell your healthcare professional if you have ever had symptoms of NSF after receiving MRI in the past.
Seizures:
Seizures have been reported after VUEWAY was used. It is not known if VUEWAY causes seizures, but people who have had seizures before may have a higher risk. Tell your healthcare professional if you have ever had a seizure in the past. Your healthcare professional will monitor you for seizures while you receive VUEWAY and for a period of time after you have received it.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take VUEWAY:
- VUEWAY will be given to you by a healthcare professional.
- It will be infused directly into your vein.
- It will be given to you before your MRI procedure.
- Follow all instructions given to you by your healthcare professional.
Usual dose:
Your healthcare professional will decide how much VUEWAY you will receive. The dose you receive will be based on your weight.
Overdose:
If you think you, or a person you are caring for, have taken too much VUEWAY, contact a 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 VUEWAY:
These are not all the possible side effects you may have when taking VUEWAY. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Pain, warmth, coldness, redness, swelling, or numbness where VUEWAY was injected into your body
- Dizziness, headache
- Nausea, vomiting, diarrhea
- Numb feeling in the mouth
- Feeling hot
- Change heartbeat taking longer than normal to reset between beats
- A metallic or bitter taste in the mouth
- Itching, rash
- Fatigue
- Skin redness or irritation
- Decreased appetite
- Swelling of eyelid
- Fever
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Rare | |||
| Serious allergic reaction that can be fatal: swelling of the face, tongue and throat, difficulty breathing, rash, hives. | √ | √ | |
| Nephrogenic Systemic Fibrosis (NSF) (a severe disease where skin becomes thickened, coarse and hard): skin changes including hardening, thickening, burning, itching, scaling, darkening, hardening and tightening of the skin, red or dark patches on the skin, stiffness in the joints with trouble moving, pain in the hip bones or ribs, severe pain, muscle weakness, effects on the normal working of internal organs which may potentially be life threatening. | √ | √ | |
| Acute Kidney Injury (sudden and rapid kidney problems): swelling in legs or feet, fluid retention, nausea, fatigue, decreased urine output, agitation or confusion. | √ | ||
| Seizures (a sudden, temporary change in how the brain works): shaking or jerking movements of the body, losing awareness or consciousness, or seeing flashing lights. | √ | ||
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:
Store between 15°C to 30°C. Discard any unused portion no later than 24 hours after initial puncture.
If you want more information about VUEWAY:
- 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 (Drug Product Database: Access the database); the manufacturer’s website https://www.bracco.com/; or by calling 1-800-465-5820.
Date of Authorization: 2026-04-10