Gadoterate (Intravenous route)
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk for NSF appears highest among patients with chronic, severe kidney disease (GFR less than 30 mL/min/1.73m(2)), or acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, older than 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing .
Uses of This Medicine:
Gadoterate injection is used to help diagnose or find problems in the brain, spine, head, neck, and other parts of your body. It is a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) scans. Contrast agents are used to help create a clear picture of the different parts of the body during certain medical procedures, such as MRI scans. MRI scans use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve ionizing radiation.
This medicine is to be given only by or under the direct supervision of your 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 gadoterate injection in newborns to children 17 years of age. However, safety and efficacy have not been established in preterm newborns.
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.
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:
- Asthma or allergies, 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 your likelihood of having kidney problems (eg, reduced kidney function).
- Kidney disease, mild or moderate—Use with caution. May increase the likelihood of serious side effects.
- Kidney problems, severe (acute or long-term)—Should not be used in patients with this condition.
Proper Use of This Medicine:
A doctor or other trained health professional will give you or your child this medicine. It is given through a needle 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 While Using This Medicine:
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.
The risk of having a very serious disease called nephrogenic systemic fibrosis (NSF) is increased in patients with severe kidney disease. Even if you have severe kidney problems, your doctor may decide that it is still important to receive this medicine. Check with your doctor right away if you or your child have burning, itching, swelling, hardening, or tightening of the skin, red or dark patches on the skin, 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 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 is more likely in patients with a history of kidney problems or in patients receiving increasing 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 of This Medicine:
- Blurred vision
- fast, irregular, pounding, or racing heartbeat or pulse
- 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
- decreased or uncontrolled urination
- difficulty with swallowing
- discharge or excessive tearing
- 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
- 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
- loss of taste
- pain in the arms or legs
- sleepiness or unusual drowsiness
- Incidence not known
- Transient, mild, pleasant aromatic odor
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: 6/18/2019