Description
Gadobutrol injection is a magnetic resonance imaging (MRI) contrast agent that is used to help create a clear picture of the body during an MRI scan. MRI scans are a special kind of procedure that lets a doctor look at the inside of the body, such as the brain. They use magnets and computers to create images or “pictures” of the body. Unlike x-rays, MRI scans do not involve radiation. Gadobutrol is a gadolinium-based contrast agent (GBCA) that is given by injection before the MRI to help diagnose problems in the brain, spine, breast, and other parts of your body.
Gadobutrol injection is also used for magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adults and children. It is also used to assess how well blood flows through your heart (myocardial perfusion) and late gadolinium enhancement in adult patients with coronary artery disease (CAD).
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gadobutrol injection in children. However, safety and efficacy have not been established in premature infants.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadobutrol injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving gadobutrol.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergic disorders, history of or
- Bronchial asthma, history of—Use with caution. May increase your risk for an allergic reaction to this medicine.
- Diabetes or
- Hypertension (high blood pressure) or
- Infection, severe or—Use with caution. May increase risk for kidney problems.
Proper Use
A doctor or other trained health professional will give you or your child this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins just before you have an MRI or MRA scan.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Precautions
It is very important that your doctor check your or your child's progress while you are receiving this medicine and during the MRI or MRA scan to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine should not be given intrathecally (injection given through the spinal canal). It may cause serious unwanted effects including agitation, back pain, blurred vision, change or loss of consciousness, confusion, death, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or mental changes, seizures, stiff neck, unusual tiredness or weakness, or vomiting when given intrathecally.
Check with your doctor or nurse right away if you or your child have burning or itching of the skin, deep bone pain in the hips or ribs, joint stiffness, a limited range of motion in the arms and legs, muscle weakness, red or dark patches on the skin of the arms or legs, or skin swelling, hardening, or tightening within the first few days or weeks after you receive this medicine. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).
This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have chest pain, cold, clammy skin, confusion, dizziness, lightheadedness, a skin rash, itching, sweating, swelling of the face, tongue, and throat, or trouble with breathing after receiving the medicine.
This medicine contains a metal called gadolinium, which can stay in your body (including the brain, bones, skin, liver, kidney, spleen) for a long time (several months to years). Talk to your doctor if you have concerns.
This medicine may increase your risk of having acute kidney injury (AKI). This has occurred in patients with severe kidney problems, and the risk is increased if you or your child are receiving high doses of gadobutrol.
Tell your doctor right away if you or your child have burning pain, feeling of warmth or coldness, redness or swelling at the injection site.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Rare
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest tightness
- confusion
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- feeling of warmth
- general feeling of discomfort or illness
- hives or welts, itching, or skin rash
- loss of consciousness
- paleness of the skin
- redness of the face, neck, arms, and occasionally, upper chest
- redness of the skin
- seizures
- sweating
- unusual tiredness or weakness
Incidence not known
- Bluish color of the fingernails, lips, skin, palms, or nail beds
- burning sensation
- burning, dry, or itching eyes
- chest pain
- cough
- decreased or uncontrolled urination
- deep bone pain
- difficulty with swallowing
- discharge or excessive tearing
- hoarseness
- increased sweating
- lack or loss of strength
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- muscle stiffness or weakness
- no blood pressure or pulse
- no breathing
- noisy breathing
- numbness, tingling, pain, or weakness in the hands or feet
- paralysis or severe weakness of the legs
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- skin rash, swelling, hardness, tightness, burning, itching, or red or dark patches
- slow or irregular breathing
- sneezing
- stiff joints or trouble moving
- stopping of the heart
- swelling of the mouth or throat
- uncontrolled bowel movements
- uncontrolled movements of the body
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Headache
- nausea
Rare
- Change in sense of smell
- change in taste
- dizziness
- dry mouth
- feeling hot or cold
- loss of taste
- unusually warm skin
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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