Patient Medication Information: uses, side effects, how to take - Gadovist 1.0
Serious warnings and precautions box
Nephrogenic Systemic Fibrosis (NSF) Gadolinium-based contrast agents (such as GADOVIST 1.0) increase the risk of a rare disease called Nephrogenic Systemic Fibrosis (NSF) in patients with:
These patients should avoid the use of GADOVIST 1.0 unless their healthcare professional believes the possible benefits outweigh the potential risks. Your healthcare professional will monitor your health before and after giving you GADOVIST 1.0 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 GADOVIST 1.0 can cause serious life-threatening side effects such as:
GADOVIST 1.0 is for intravenous (IV) use only. |
What GADOVIST 1.0 is used for:
- GADOVIST 1.0 is used during magnetic resonance imaging (MRI) of the brain, spine, blood vessels, breast and kidney. This helps with the diagnosis of various conditions.
How GADOVIST 1.0 works:
- MRI is a form of medical diagnostic imaging that creates detailed images of the organs and tissues inside your body.
- GADOVIST 1.0 makes certain areas appear brighter in your MRI. This helps your healthcare professional identify any potential issues.
The ingredients in GADOVIST 1.0 are:
Medicinal ingredients: gadobutrol
Non-medicinal ingredients: calcium sodium butrol, hydrochloric acid, trometamol, water for injection.
GADOVIST 1.0 comes in the following dosage forms:
GADOVIST 1.0 is a ready-to-use solution for rapid injection into a vein. It is supplied as 604.72 milligrams of gadobutrol per milliliter of solution (corresponding to 1.0 mmol/mL). It is packaged in glass vials.
Do not use GADOVIST 1.0 if:
- You are allergic (hypersensitive) to gadobutrol or to any of the other ingredients of GADOVIST 1.0 (see “The ingredients in GADOVIST 1.0 are:”, above),
- You have previously had a life-threatening reaction to GADOVIST 1.0.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take GADOVIST 1.0. Talk about any health conditions or problems you may have, including if you:
- have or have had a previous reaction to contrast media
- suffer or have suffered from an allergy (eg, hay fever, hives) or asthma
- suffer from brain conditions with seizures
- have kidney or liver problems. Your healthcare professional may take blood tests to decide if you should be given GADOVIST 1.0.
are pregnant or are planning to become pregnant, as it is not known if GADOVIST 1.0 may harm your unborn baby. GADOVIST 1.0 will only be given to you during pregnancy if your doctor decides it is absolutely necessary.
- are breast-feeding or intend to breast-feed since breast-feeding should be stopped for at least 24 hours following GADOVIST 1.0 administration
Other warnings you should know about:
Accumulation of Gadolinium in the Brain
Recent information shows that gadolinium (as in GADOVIST 1.0) 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
Nephrogenic Systemic Fibrosis
Receiving GADOVIST 1.0 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.
Patients with severe kidney disease should avoid the use of GADOVIST 1.0 unless their healthcare professional believes the possible benefits outweigh the potential risks.
Before you receive GADOVIST 1.0, your healthcare professional will evaluate your kidney function. This will help determine if you should be given GADOVIST 1.0.
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 GADOVIST 1.0, if you are considered to be at risk for developing NSF.
If you have poor kidney function, your healthcare professional will make sure that GADOVIST 1.0 has been eliminated from your body before you receive a second injection of GADOVIST 1.0.
GADOVIST 1.0 can be removed from the body by dialysis. If you are currently on dialysis, your healthcare professional will decide when you should receive your next dialysis.
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 GADOVIST 1.0.
How to take GADOVIST 1.0:
- GADOVIST 1.0 will be given to you by a healthcare professional before your MRI.
Usual dose:
Your healthcare professional will determine your dose based on your age, weight and the area that is being examined:
Adults: A single injection of 0.1 to 0.3 millilitres of GADOVIST 1.0 per kg of body weight. The maximum single dose of GADOVIST 1.0 is 0.3 millilitre per kg of body weight.
Children (including term newborns): A single injection of 0.1 millilitres of GADOVIST 1.0 per kg of body weight.
Overdose:
No overdosing has so far been reported. If overdosing does occur, your healthcare professional will treat any resulting symptoms and will check if your heart and kidneys are working normally.
If you have any further questions on the use of this product, ask your doctor or radiologist.
| If you think you, or a person you are caring for, have been given too much GADOVIST 1.0, 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. |
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Possible side effects from using GADOVIST 1.0:
These are not all the possible side effects you may have when taking GADOVIST 1.0. If you experience any side effects not listed here, tell your healthcare professional.
Like all medicines, GADOVIST 1.0 can cause side effects, although not everybody gets them.
Possible side effects are listed below by how likely they are.
Common (may affect up to 1 in 10 people)
- headache
- nausea (feeling sick)
Uncommon (may affect up to 1 in 100 people)
- dizziness, disturbed sense of taste (dysgeusia), pins and needles (parasthesia)
- vomiting
- redness of the skin (erythema)
- itching (pruritus (including generalized pruritus))
- rash (including generalized rash, macular rash [small flat red spots], papular rash [small, raised, circumscribed lesions], pruritic rash [itchy rash])
- various kinds of injection site reactions (eg leakage into the surrounding tissue, burning, coldness, warmth, reddening, rash, pain or bruising)
- feeling hot
Rare (may affect up to 1 in 1000 people)
- convulsion
- disturbed sense of smell (parosmia)
- rapid heart beat (tachycardia)
- palpitations (feeling of heart pounding)
- dry mouth
- generally feeling unwell (malaise)
- feeling cold
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Uncommon | |||
| Dyspnea (shortness of breath) | ✓ | ||
| Rare | |||
| Loss of consciousness | ✓ | ||
| Serious allergic reaction: swelling of the face, lips, tongue, eyes or throat, difficulty breathing, blueness in the lips, coughing, runny nose, low blood pressure, chest pain, rash / hives, and flushing (redness) or paleness in the skin. This can sometimes be fatal. Reactions may occur within 30 minutes but can also happen within hours or days after taking GADOVIST 1.0. | ✓ | ||
| Unknown frequency | |||
| Cardiac arrest (heart stops beating) | ✓ | ||
| Nephrogenic Systemic Fibrosis (NSF) (a disease mainly involving thickening of the skin and connective tissues): severe joint immobility, muscle weakness, or may affect the normal working of internal organs which may potentially be life-threatening. | ✓ | ||
| Acute Respiratory Distress Syndrome (ARDS): severe difficulty breathing, including shortness of breath at rest or with activity, rapid breathing, wheezing or cough | ✓ | ||
| Pulmonary edema (excess fluid in the lungs): difficulty breathing that worsens with activity or when lying down, extreme shortness of breath, wheezing or gasping for breath, cold clammy skin, irregular heartbeat, cough that produces frothy sputum, blue-tinged lips | ✓ | ||
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:
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:
GADOVIST 1.0 should be stored at temperatures between 15°C to 30°C. Do not freeze.
After the vial/bottle has been opened, GADOVIST 1.0 remains stable for 24 hours at 20°C to 25°C and must then be discarded.
If you want more information about GADOVIST 1.0:
- 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 |
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Date of Authorization: 2025-04-16
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