Description
Gadoterate injection is used a magnetic resonance imaging (MRI) contrast agent used to help create a clear picture of the body during an MRI scan. MRI scans use magnets and computers to create images of certain areas of the body. Unlike x-rays, MRI scans do not involve radiation. Gadoterate is a gadolinium-based contrast agent (GBCA) that is given by injection before an MRI to help diagnose problems in the brain, spine, head, neck, and other parts of the body.
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 gadoterate injection in newborns to children 17 years of age. However, safety and efficacy have not been established in preterm newborns.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadoterate injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving gadoterate.
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:
- Asthma, history of or
- Patients who have had prior reactions to contrast media—Use with caution. May increase the likelihood of an allergic reaction.
- Diabetes or
- Hypertension (high blood pressure) or
- Infection, severe—Use with caution. May increase risk for kidney problems.
- Kidney disease, mild or moderate—Use with caution. May increase the risk for more serious side effects.
- Kidney problems, severe (acute or long-term)—Should not be used in patients with this condition.
Proper Use
A doctor or other trained health professional will give you or your child 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 you or your child's progress while you are receiving this medicine and during the MRI 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 metal 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 receiving the medicine.
This medicine contains a metal called gadolinium, which can stay in your body (including the brain, bones, skin) 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 requiring dialysis. This has occurred in patients with severe kidney problems, and the risk is increased with high doses of gadoterate injection. Talk to your doctor about this risk.
Tell your doctor right away if you or your child have mild, burning pain, feeling of warmth or coldness, peeling of the skin, 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
- Blurred vision
- dizziness
- fast, irregular, pounding, or racing heartbeat or pulse
- headache
- nervousness
- pounding in the ears
- slow or fast heartbeat
Incidence not known
- Areas of the skin that turned red or dark or feel tight
- bluish color of the fingernails, lips, skin, palms, or nail beds
- bone pain in the hips or ribs
- burning, dry, or itching eyes
- change in consciousness
- chest pain or discomfort
- cough
- decreased or uncontrolled urination
- difficulty with swallowing
- discharge or excessive tearing
- fainting
- fever
- hives or welts, itching, skin rash
- increased sweating
- lack or loss of strength
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness, or fainting
- loss of consciousness
- muscle weakness
- no blood pressure or pulse
- no breathing
- numbness, tingling, pain, or weakness in the hands or feet
- paralysis or severe weakness of the legs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- shakiness in the legs, arms, hands, or feet
- skin that burns or itches, swells, scales, or hardens
- stiff joints or muscles
- stopping of the heart
- trembling or shaking of the hands or feet
- trouble moving your arms or legs
- uncontrolled bowel movements
- uncontrolled movements of the body
- unusual tiredness or weakness
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:
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
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- discomfort in the throat
- fear
- loss of taste
- nausea
- pain in the arms or legs
- sleepiness or unusual drowsiness
- vomiting
Incidence not known
- Transient, mild, pleasant aromatic odor
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.
DRG-20060866
