Gadoteridol (Intravenous route)
Gadolinium-based contrast agents (GBCAs) 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 Non-Ionic Contrast Media
Uses of This Medicine:
Gadoteridol 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. Gadoteridol is a gadolinium-based contrast agent (GBCA) that is given by injection before the MRI to help diagnose problems in the brain, spine, head, or neck.
This medicine is to be given 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 gadoteridol 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.
No information is available on the relationship of age to the effects of gadoteridol injection in geriatric patients.
|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
- Asthma, history of or
- Diabetes or
- Hypertension (high blood pressure) or
- Sickle cell anemia—Use with caution. May increase risk for side effects.
- Kidney problems, severe, or history of or
- Liver disease, history of or
- Seizures (grand mal), history of—Use with caution. May cause side effects to become worse.
Proper Use of This Medicine:
A doctor or other trained health professional will give you or your child 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 your or your child's progress 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 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 gadoteridol.
This medicine may cause serious allergic reactions, including 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 breathing after you receive the medicine.
Side Effects of This Medicine:
- Bluish color of the fingernails, lips, skin, palms, or nail beds
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- decreased awareness or responsiveness
- difficult or labored breathing
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of warmth
- general feeling of discomfort or illness
- increased salivation
- loss of bladder control
- loss of consciousness
- low blood pressure or pulse
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the face, neck, arms, and occasionally, upper chest
- shakiness in the legs, arms, hands, or feet
- skin rash
- slow, fast, or irregular breathing
- spasm of the throat
- tightness in the chest
- trembling or shaking of the hands or feet
- unusual tiredness or weakness
- Less common
- Bad, unusual, or unpleasant (after) taste
- Abdominal or stomach cramps
- bleeding gums
- 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
- continuing ringing or buzzing or other unexplained noise in the ears
- dry mouth
- hearing loss
- irritation in the mouth
- loss of coordination in the arms
- mouth ulcers
- rash with flat lesions or small raised lesions on the skin
- redness and swelling of the gums
- runny nose
- stuffy nose
- tingling sensation in the throat
- voice changes
- watery eyes
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