Patient Medication Information: uses, side effects, how to take - Multihance
Serious Warnings and Precautions
- Tell your healthcare professional if you have a condition called a hemolytic anemia including sickle cell anemia. If you have one of these conditions MultiHance could make your blood condition worse. This medication has not been studied in individuals with these conditions.
- As with other contrast medications similar to MultiHance, there is a possibility of allergic reactions. For those with a history of allergic reactions, asthma or allergic respiratory disorders, there is a possibility of a serious life threatening or fatal allergic reaction including heart reactions, with MultiHance treatment. You will be observed for at least one hour after administration of MultiHance. Serious allergic reactions can occur after you receive MultiHance. These reactions can be fatal. Get immediate medical help if you get any of the following symptoms: difficulty breathing, hives, itching, rash, runny nose, swelling of your face, tongue or throat or a very fast heartbeat. You may be observed by your healthcare professional for several hours after you receive MultiHance. This will be done if you have had an allergy or reaction to a medicine in the past.
If you have kidney problems, you could get a rare disease called Nephrogenic Systemic Fibrosis (NSF) after receiving medicines such as MultiHance. With NSF, the skin becomes thickened, coarse and hard, which makes bending of the joints difficult. NSF may spread to other parts of your body and even cause death. Patients with kidney problems should not use of MultiHance unless your healthcare professional believes the possible benefits outweigh the potential risks. Get immediate medical help if you get any of the following symptoms after receiving MultiHance:
- Swelling, hardening and tightening of your skin
- Red or dark patches on your skin
- Burning or itching of your skin
- Yellow spots on the whites of your eyes
- Stiffness in your joints, problems moving or straightening arms, hands, legs or feet
- Pain deep in your hip bone or ribs
- Muscle weakness
Your healthcare professional will monitor your health after administering MultiHance, if you are at risk for getting NSF. They might give you a lower dose and wait longer before giving you MultiHance again.
Not for Intrathecal Use.
If injected into the spinal canal (by intrathecal injection), gadolinium-based contrast agents such as MultiHance 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
MultiHance is for intravenous (IV) use only.
What is MultiHance used for?
MultiHance is a contrast agent used for magnetic resonance imaging (MRI).
In adults and children 2 years of age and older it is used for:
- MRI of the brain, spine and surrounding areas.
In adults it is also used for:
- magnetic resonance angiography (MRA) of blood vessels.
- MRI of the breast.
How does MultiHance work?
MultiHance makes your tissues brighter. This allows your healthcare professional to see any abnormal tissues during MRI or MRA procedures.
What are the ingredients in MultiHance?
Medicinal ingredients: gadobenate dimeglumine
Non-medicinal ingredients: water for injection
MultiHance comes in the following dosage forms:
MultiHance is supplied as a solution for injection containing gadobenate dimeglumine 529 mg/mL.
Do not use MultiHance if:
You are allergic to gadobenate dimeglumine, or to any of the non-medicinal ingredients in MultiHance.
MultiHance should not be used in children less than 2 years of age.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MultiHance. Talk about any health conditions or problems you may have, including if you:
- have a condition called a hemolytic anemia including sickle cell anemia
- have kidney problems
- have heart problems
- have had seizures in the past
- have had any brain disorder including a brain tumour in the past
- have asthma or an allergic respiratory disease
- have had allergies in the past
- have had an allergic reaction to a medicine in the past
are pregnant or are planning to become pregnant. MultiHance will only be given to you during pregnancy if your healthcare professional decides it is absolutely necessary. It is not known if MultiHance will harm your unborn baby.
- are breastfeeding or are planning to breastfeed
Other warnings you should know about:
Accumulation of gadolinium in the brain:
Recent information shows that gadolinium, the medicinal ingredient in MultiHance, 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
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with MultiHance:
- There are no known interactions with MultiHance.
How to take MultiHance:
- MultiHance will be given to you by a healthcare professional.
- It will be infused directly into your vein.
- It will be given to you before or during your MRI procedure.
- Follow all instructions given to you by your healthcare professional.
Usual dose:
- Your healthcare professional will decide how much MultiHance you will receive.
- The dose you receive will be based on the procedure you are getting and your weight.
- Your healthcare professional will use the lowest dose that is possible.
Overdose:
If you think you, or a person you are caring for, have received too much MultiHance, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
What are possible side effects from using MultiHance?
These are not all the possible side effects you may have when taking MultiHance. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- headache
- nausea
- injection site reactions
- altered sense of taste
- fever
- dizziness
- vomiting
- sweating
- feeling hot
- feeling flushed
- chills
- abdominal pain
- diarrhea
- constipation
- abnormal sensation in the skin (tingling, prickling or numbness)
- anxiety
- confusion
- thirst
- blurred vision
- ringing in ears
- decreased hearing
- feeling tired
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
| Serious allergic reactions that can be fatal: difficulty breathing, hives, itching, rash, runny nose, swelling of your face, tongue or throat, very fast heartbeat. | X | ||
| Low blood pressure: dizziness, fainting. | X | ||
| Nephrogenic systemic fibrosis (NSF) in patients with kidney disease: thick, hard skin (sometimes looks like orange peels), decreased movement and flexibility in arms or legs, muscle weakness, joint and muscle pain. | X | ||
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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
Storage:
MultiHance should be stored at room temperature (15 to 25°C) and protected from light. It should not be frozen. Throw away unused portions.
Keep out of reach and sight of children.
If you want more information about MultiHance:
- 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: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website http://www.braccoimaging.com, or by calling 1-800-465-5820.
