Gadobenate (Intravenous route)
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs (ie, chronic, severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)), or acute kidney injury. Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced MRI. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes), perform lab testing to estimate the GFR. For patients with the highest NSF risk, do not exceed recommended dose and allow a sufficient time period for elimination prior to readministration .
Radiological Ionic Contrast Media
Uses of This Medicine:
Gadobenate 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 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).
Gadobenate is given by injection before 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.
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 gadobenate solution 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 have not been performed on the relationship of age to the effects of gadobenate Multipack™ in the pediatric population. Safety and efficacy have not been established.
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.
|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:
- Anemia or any other blood disorder or
- Asthma or allergies, history of or
- Heart disease, history of or
- Heart rhythm problems (e.g., 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 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 right away if you or your child have burning or itching of the skin; red or dark patches on the skin; skin swelling, hardening, or tightening; joint stiffness; limited range of motion in the arms and legs; pain that is deep in the hip bone or ribs; or muscle weakness. 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 cold, clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.
Tell your doctor right away if you or your child have mild, burning pain; feeling of warmth or coldness; redness or swelling at the injection site.
This medicine can cause changes in the heart rhythm, such as a condition called 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 any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
Before you have any medical tests, tell the medical doctor in charge that you or your child are using 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 of This Medicine:
- Abdominal or stomach pain
- 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 or discomfort
- 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, sometimes with wheezing
- difficulty with breathing or swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- excessive muscle tone
- fast, slow, or irregular heartbeat
- frequent urge to urinate
- general feeling of discomfort or illness
- inability to move the legs or arms
- increased sweating
- lightheadedness, dizziness, or fainting
- lower back or side pain
- muscle stiffness
- muscle tension or tightness
- 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
- 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
- shakiness in the legs, arms, hands, or feet
- shortness of breath
- skin rash
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sudden shortness of breath or troubled breathing
- sugar in the urine
- swelling in the legs and ankles
- swelling of the eyes, face, or inside of the nose
- swollen glands
- tightness in the chest
- trembling or shaking of the hands or feet
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
- Less common
- 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
- feeling hot
- Acid or sour stomach
- bad, unusual, or unpleasant (after) taste
- 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
- difficulty having a bowel movement (stool)
- difficulty with moving
- disturbed color perception
- double vision
- dry mouth
- ear pain
- feeling unusually cold
- halos around lights
- hearing loss
- hives or welts
- joint pain
- lack or loss of strength
- loss of bowel control
- muscle aches or cramps
- muscle spasms
- night blindness
- overbright appearance of lights
- redness of the eye
- redness of the skin
- severe sleepiness
- stomach discomfort, upset, or pain
- stuffy nose
- swelling of the eyelid
- swollen joints
- tunnel vision
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