Patient Medication Information: uses, side effects, how to take - Gadopentetate Dimeglumine Injection
ABOUT THIS MEDICATION
What the medication is used for:
GADOPENTETATE DIMEGLUMINE INJECTION is a contrast medium for magnetic resonance imaging (MRI) of the head, neck and spine.
MRI is a form of medical imaging that uses a complex system of magnets and radiowaves to obtain pictures of normal and abnormal tissues.
What it does:
GADOPENTETATE DIMEGLUMINE INJECTION helps tissues viewed by MRI appear brighter to make it easier for the healthcare professional to see any potential abnormalities.
When it should not be used:
Gadolinium-based contrast agents (such as GADOPENTETATE DIMEGLUMINE INJECTION) increase the risk of a rare disease called Nephrogenic Systemic Fibrosis (NSF) in patients with kidney disease. GADOPENTETATE DIMEGLUMINE INJECTION should not be used in:
- Patients with chronic, severe kidney disease
- Patients with acute kidney injury
- New-borns up to 4 weeks of age due to their developing kidneys
If you are hypersensitive (experience allergy-like reactions) to gadopentetate dimeglumine or to any of the other ingredients of GADOPENTETATE DIMEGLUMINE INJECTION (see below).
What the medicinal ingredient is:
gadopentetate dimeglumine
What the nonmedicinal ingredients are:
meglumine and pentetic acid
What dosage forms it comes in:
GADOPENTETATE DIMEGLUMINE INJECTION is a ready-to-use solution (corresponding to 0.5 mmol/mL) for rapid injection into a vein.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Gadolinium-based contrast agents (such as GADOPENTETATE DIMEGLUMINE INJECTION) increase the risk of a rare disease called Nephrogenic Systemic Fibrosis (NSF) in patients with kidney disease. GADOPENTETATE DIMEGLUMINE INJECTION should not be used in:
- Patients with chronic, severe kidney disease
- Patients with acute kidney injury
- New-borns up to 4 weeks of age due to their developing kidneys
Patients with mild to moderate kidney disease should only be given GADOPENTETATE DIMEGLUMINE INJECTION after a careful assessment by your physician.
GADOPENTETATE DIMEGLUMINE INJECTION should be used with caution in infants less than 1 year of age.
Your doctor will monitor your health before and after administration of GADOPENTETATE DIMEGLUMINE INJECTION if you are considered to be at risk for developing NSF (for details see Nephrogenic Systemic Fibrosis).
BEFORE you are given GADOPENTETATE DIMEGLUMINE INJECTION talk to your doctor if any of the following situations apply to you. The doctor will decide whether the intended examination is possible or not:
- You have or have had a previous reaction to contrast media
- You suffer or have suffered from an allergy (eg, hay fever, hives) or asthma.
- You have very poor kidney function.
- You have recently had, or soon expect to have, a liver transplant.
- You have epilepsy or suffer from brain conditions with seizures.
- You are pregnant or could be pregnant (even if you are not sure), since GADOPENTETATE DIMEGLUMINE INJECTION should not be used under such circumstances unless it is considered absolutely necessary.
- You suffer from heart or blood circulation problems. This is because in the rare event that you do have an allergic reaction, it is more likely to be serious or fatal.
- You have sickle cell anemia, hemolytic conditions (destruction of red blood cells), or related blood disorders of hemoglobin in the blood
- (hemoglobinopathies).
- Heart problems, breathing difficulties, or skin reactions may occur with the use of GADOPENTETATE DIMEGLUMINE INJECTION. Severe reactions may occur. Most of these reactions occur within half an hour of administration. Therefore, your attending healthcare professional may observe you in this period. Delayed reactions may occur hours or even days later.
GADOPENTETATE DIMEGLUMINE INJECTION may increase or decrease blood pressure, so caution must be used when driving or operating machinery.
Accumulation of Gadolinium in the Brain
Recent information shows that gadolinium (as in GADOPENTETATE DIMEGLUMINE INJECTION) 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 dose
Kidney Impairment
Before you receive GADOPENTETATE DIMEGLUMINE INJECTION, your healthcare professional will check how well your kidneys are working. Patients with severe kidney disease should not be given GADOPENTETATE DIMEGLUMINE INJECTION (See WARNINGS AND PRECAUTIONS – Serious Warnings and Precautions). Patients with mild to moderate kidney disease should only be given GADOPENTETATE DIMEGLUMINE INJECTION after a careful assessment by your physician. Your doctor may decide to take a blood test to check this before making the decision to use GADOPENTETATE DIMEGLUMINE INJECTION.
If you have poor kidney function, your healthcare professional will make sure that GADOPENTETATE DIMEGLUMINE INJECTION has been eliminated from your body before you receive a second injection of GADOPENTETATE DIMEGLUMINE INJECTION.
GADOPENTETATE DIMEGLUMINE INJECTION can be removed from the body by dialysis. If you are already undergoing regular dialysis, your healthcare professional will decide if you should receive dialysis after you have been given GADOPENTETATE DIMEGLUMINE INJECTION.
Breastfeeding
GADOPENTETATE DIMEGLUMINE INJECTION is excreted in human breast milk. Discuss with your doctor.
Nephrogenic Systemic Fibrosis
There have been postmarket reports of a rare disease called Nephrogenic Systemic Fibrosis (NSF) following gadolinium-based contrast agent (GBCA) use.
NSF is a rare condition which has only been observed so far in patients with severe kidney disease. At present, there is no evidence that other patient groups are at risk of developing the condition. Due to NSF, the skin becomes 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 GADOPENTETATE DIMEGLUMINE INJECTION unless the health care professional believes the possible benefits outweigh the potential risks. Those who have already had an MR imaging procedure and who have any of the following symptoms 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 GADOPENTETATE DIMEGLUMINE INJECTION, if you are considered to be at risk for developing NSF.
INTERACTIONS WITH THIS MEDICATION
Drug interaction studies have not been done for gadopentetate dimeglumine.
Interference with Diagnostic Tests:
Before you have any blood tests, tell your healthcare professional you have been given GADOPENTETATE DIMEGLUMINE INJECTION. This is because some tests for iron levels in the blood may be affected for up to 24 hours after GADOPENTETATE DIMEGLUMINE INJECTION has been given.
Tell your healthcare professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
PROPER USE OF THIS MEDICATION
Usual dose:
GADOPENTETATE DIMEGLUMINE INJECTION is injected by a healthcare professional via a needle or catheter into a vein. The recommended dose of GADOPENTETATE DIMEGLUMINE INJECTION is 0.2 millilitres per kg body weight. The actual dosage (volume) of GADOPENTETATE DIMEGLUMINE INJECTION that is right for you will depend on your body weight.
If you receive a bolus injection of GADOPENTETATE DIMEGLUMINE INJECTION (a large dose quickly) you may notice a temporary sweet taste in your mouth.
Overdose:
| If you think you have taken too much GADOPENTETATE DIMEGLUMINE INJECTION, 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
Like all medicines, GADOPENTETATE DIMEGLUMINE INJECTION can cause side effects, although not everybody gets them.
Common side effects observed in clinical trials (between 1 and 10 in every 100 patients are likely to get these):
- Headache (in some cases severe)
- Injection site discomfort
- Nausea (feeling sick)
- Pain (back, ear, eye, teeth)
- Hypersensitivity (allergic-like reactions) such as rash, hives, and swelling of the skin and mucous membranes (eg, mouth, throat, lips)
- Dizziness
- Vomiting
- Paresthesia (“pins and needles”)
The most serious side effects in patients receiving GADOPENTETATE DIMEGLUMINE INJECTION are Nephrogenic Systemic Fibrosis (NSF) and anaphylactoid reactions (allergy-like reactions) including severe reactions such as shock.
In rare cases (1 to 10 in 10 000 patients), serious allergy-like reactions may occur including severe reactions such as shock that may need immediate medical intervention. If you notice mild swelling of the face, lips, tongue or throat, coughing or sneezing, difficulty in breathing, stopped breathing, itching, runny nose, hives, throat tightness, voice box spasm, blue lips, or lose consciousness, tell your healthcare professional immediately. These may be the first signs that a severe reaction is happening. Your investigation may need to be stopped, and you may need further treatment.
Delayed reactions hours to several days after the administration of GADOPENTETATE DIMEGLUMINE INJECTION, have been observed in rare cases. If this should happen to you tell your healthcare professional.
The following side effects have been life-threatening or fatal in some cases:
- Fainting
- Heart rhythm disturbances: slow heartbeat, fast heartbeat, irregular heartbeat, or chest pain
- Heart stopping (cardiac arrest)
- Fits or seizures
- Unresponsiveness
- Coma
Fluid in the lungs
- Nephrogenic systemic fibrosis (NSF)
- Acute kidney failure
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN 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 allergy-like reactions, sometimes fatal, with symptoms such as swelling of the mouth and throat, difficulty in breathing, rash. | ✓ | ||||
This is not a complete list of side effects. For any unexpected effects while taking GADOPENTETATE DIMEGLUMINE INJECTION, contact your doctor or pharmacist.
HOW TO STORE IT
GADOPENTETATE DIMEGLUMINE INJECTION should be stored at temperatures between 15°C to 30°C. Do not freeze. GADOPENTETATE DIMEGLUMINE INJECTION is sensitive to light. Keep the container in the outer carton in order to protect from light. Keep out of the reach and sight of children.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
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
If you want more information about GADOPENTETATE DIMEGLUMINE INJECTION:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.avirpharma.com, or by calling 1-800-363-7988.
AVIR Pharma Inc.
660 Industriel Blvd
Blainville, Quebec, Canada
J7C 3V4
www.avirpharma.com
Date prepared: April 3, 2020