Gadobutrol (Intravenous route)
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF is greatest in patients with acute kidney injury or chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m(2). Evaluate patients for acute kidney injury or other conditions which may reduce renal function. Patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes) should have their estimate the glomerular filtration rate (GFR) determined through laboratory testing. Do not exceed the recommended gadobutrol dose in patients at highest risk for NSF. Allow sufficient time for the drug to be eliminated by the body prior to subsequent doses .
Diagnostic Agent, Radiological Contrast Media
Uses of This Medicine:
Gadobutrol injection is a magnetic resonance imaging (MRI) contrast agent. Contrast agents are used to help create a clear picture of the body during MRI scans. MRI scans are a special kind of procedure that let 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.
This medicine is to be used only by or under the direct supervision of a doctor.
Before Using This Medicine:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gadobutrol injection in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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 or
- Bronchial asthma, history of—Use with caution. May be at increased risk for an allergic reaction to this medicine.
- Kidney problems, severe (recent or long-term)—Should not be used in patients with this condition unless your doctor specifically tells you that it is necessary.
Proper Use of This Medicine:
A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have an MRI scan.
Precautions While Using This Medicine:
It is very important that your doctor check the progress of you or your child while you are receiving this medicine and during the MRI scan. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.
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 type of allergic reaction called anaphylaxis. Anaphylaxis 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 you receive the medicine.
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 with 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 of This Medicine:
- 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
- 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
- tightness in the chest
- 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
- deep bone pain
- difficulty with swallowing
- discharge or excessive tearing
- increased sweating
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle stiffness or weakness
- no blood pressure or pulse
- no breathing
- noisy breathing
- 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
- stiff joints or trouble moving
- stopping of the heart
- swelling of the mouth or throat
- Less common
- Change in sense of smell
- change in taste
- dry mouth
- feeling hot or cold
- loss of taste
- unusually warm skin
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:
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:
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.
Last Updated: 11/4/2014