Description
Gadobenate is a magnetic resonance imaging (MRI) contrast agent used to help create a clear picture of the body during MRI scans. MRI scans are a special kind of diagnostic procedure. They use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve ionizing radiation. Gadobenate is a gadolinium-based contrast agent (GBCA) that is given by injection before an MRI to help diagnose problems in the brain, spine, and other parts of your body.
This medicine is to be used only by or under the direct supervision of a 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 gadobenate injection in the pediatric population. However, safety and efficacy have not been established in preterm babies.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadobenate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving gadobenate.
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:
- Anemia or any other blood disorder or
- Asthma or allergies, history of or
- Heart disease, history of or
- Heart rhythm problems (eg, arrhythmia) or
- Kidney problems, severe (recent or long-term) or
- Liver disease or
- Patients who have recently received a GBCA or
- Seizures, history of—Use with caution. May cause side effects to become worse.
- Diabetes or
- Hypertension (high blood pressure)—Use with caution. May increase risk for more serious side effects.
- Dubin-Johnson syndrome (an inherited disorder)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A doctor or other trained health professional will give you this medicine. It is given through an IV catheter that is placed into one of your veins just before you have an MRI 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 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.
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. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.
This medicine contains a metal called gadolinium, which can stay in your body (including the brain, bones, skin, kidneys, liver, spleen) for a long time (several months to years). Talk to your doctor if you have concerns.
Tell your doctor right away if you or your child have mild, burning pain, feeling of warmth or coldness, or redness or swelling at the injection site.
This medicine can cause changes in heart rhythm, including QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have fainting or irregular heartbeat.
Before you have any medical tests, tell the medical doctor in charge that you or your child are receiving gadobenate. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
- Anxiety
- back pain
- black, tarry stools
- bladder pain
- bloody or cloudy urine
- blue lips and fingernails
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain, discomfort, or tightness
- chills
- confusion
- cough
- coughing that sometimes produces a pink frothy sputum
- dark urine
- decreased urination
- deep or fast breathing with dizziness
- difficult or labored breathing
- difficult, burning, or painful urination
- difficult, fast, or noisy breathing
- difficulty with breathing or swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- excessive muscle tone
- fainting
- fast, slow, or irregular heartbeat
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- headache
- hives, itching, skin rash
- inability to move the legs or arms
- increased sweating
- lower back or side pain
- muscle stiffness, tension, or tightness
- nausea
- nervousness
- numbness of the feet, hands, and around the mouth
- pain in the shoulders, arms, jaw, or neck
- pain or redness at the injection site
- pale skin at the injection site
- paralysis of one side of the body
- pounding heartbeat
- pounding in the ears
- problems with speech or speaking
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- reddening of the skin, especially around the ears
- seizures
- shakiness in the legs, arms, hands, or feet
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sugar in the urine
- sweating
- swelling in the legs and ankles
- swelling of the eyes, face, or inside of the nose
- swollen glands
- tiredness
- trembling or shaking of the hands or feet
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
Incidence not known
- Lack or loss of strength
- loss of consciousness
- peeling of the skin
- skin lesions
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
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, rash, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- feeling hot
Rare
- Bad, unusual, or unpleasant (after) taste
- belching
- blurred or loss of vision
- change in sense of smell
- change in taste
- continuing ringing or buzzing or other unexplained noise in the ears
- decreased awareness or responsiveness
- diarrhea
- difficulty having a bowel movement
- difficulty with moving
- disturbed color perception
- double vision
- dry mouth
- ear pain
- feeling unusually cold
- halos around lights
- hearing loss
- heartburn
- indigestion
- joint pain
- lack or loss of strength
- loss of bowel control
- muscle aches, spasms, or cramps
- night blindness
- overbright appearance of lights
- redness of the eye
- severe sleepiness
- shivering
- stomach discomfort or upset
- stuffy nose
- swollen joints
- tunnel vision
- 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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