Patient Medication Information: uses, side effects, how to take - Prohance
Serious Warnings and Precautions
If you have kidney problems, you could get a rare disease called Nephrogenic Systemic Fibrosis (NSF) after receiving medicines such as ProHance. 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 ProHance unless your health care professional believes the possible benefits outweigh the potential risks. Get immediate medical help if you get any of the following symptoms after receiving ProHance:
- 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 ProHance, if you are at risk for getting NSF. They might give you a lower dose and wait longer before giving you ProHance again.
Not for Intrathecal Use.
If injected into the spinal canal (by intrathecal injection), gadolinium-based contrast agents such as ProHance 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
ProHance is for intravenous (IV) use only.
What is ProHance used for?
ProHance is a contrast agent used for magnetic resonance imaging (MRI):
- In adults and children (including newborns), it is used for MRI of the brain, spine and surrounding tissues.
- In adults it is also used for MRI of the head and neck.
How does ProHance work?
ProHance makes your tissues brighter. This allows your healthcare professional to see any abnormal tissues during MRI procedures.
What are the ingredients in ProHance?
Medicinal ingredients: Gadoteridol
Non-medicinal ingredients: calteridol calcium, hydrochloric acid, tromethamine, sodium hydroxide, water for injection
ProHance comes in the following dosage forms:
ProHance is supplied as a solution for injection containing gadoteridol 279.3 mg/mL
Do not use ProHance if:
- You are allergic to gadoteridol or to any of the non-medicinal ingredients in ProHance.
ProHance should not be used in children less than 2 years of age for MRI of the head and neck.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ProHance. Talk about any health conditions or problems you may have, including if you:
- have had seizures in the past
- have kidney problems
- have had allergies or asthma in the past
- have had an allergic reaction to a medicine in the past
- have a condition called a hemolytic anemia including sickle cell anemia
are pregnant or are planning to become pregnant. ProHance will only be given to you during pregnancy if your doctor decides it is absolutely necessary. It is not known if ProHance will harm your unborn baby.
- are breastfeeding or are planning to breastfeed. Breastfeeding should be stopped for 24 hours after you are given ProHance.
Other warnings you should know about:
Accumulation of gadolinium in the brain:
Recent information shows that gadolinium (as in ProHance) 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.
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 ProHance:
- Drug interaction studies have not been performed with ProHance
How to take ProHance:
- ProHance 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 ProHance you will receive.
- The dose you receive will be based on the procedure you are getting and your weight.
- Your healthcare professional will carefully consider whether to use repeated doses.
- 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 ProHance, 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 ProHance?
These are not all the possible side effects you may have when taking ProHance. If you experience any side effects not listed here, tell your healthcare professional.
- altered sense of taste
- nausea
- pain, redness, and feeling hot or cold at the injection site
- feeling flushed
- facial swelling
- vomiting
- anxiety
- inflammation of the gums
- headache
- dizziness
- chest pain
- abnormal sensation in the skin (tingling, prickling or numbness)
- dry mouth and throat
- itching of the mouth
- Swollen tongue
- rash or hives
- abdominal pain
- decreased appetite
- fever
- Excessive sweating
- ear discomfort
- diarrhea
- ringing in the ears (tinnitus)
- temporary change in voice
- neck stiffness
- back pain
- Joint stiffness
- cough
- shaking
- fatigue
- feeling weak
- general pain
- pain and swelling of the throat
- sneezing
- eye redness
- itchy eyes
- Teary eyes
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| 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 | ||
| 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 | ||
Heart problems: including:
| X | ||
blood): sudden collapse, inability to breathe.
| |||
| Increased levels of liver enzymes (ALT, AST) in the blood: dark urine, fatigue, loss of appetite, yellowing of the skin or eyes. | X | ||
| Nervous system problems: loss of consciousness, coma, tremor, seizure, feeling lethargic, numbness. | X | ||
| UNKNOWN | |||
| Lung Problems: difficulty breathing, bluish skin colour, or excess fluid in the lungs which can cause difficulty breathing, wheezing, and an irregular heartbeat. | X | ||
| Acute renal failure (severe kidney problems): confusion; itchiness or rashes; puffiness in your face and hands; swelling in your feet or ankles; urinating less or not at all; weight gain. | 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:
ProHance should be stored at room temperature (15 to 30°C) and protected from light.
Keep out of reach and sight of children.
If you want more information about ProHance:
- 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.