Gadodiamide (Intravenous route)
Gadodiamide is not for intrathecal use. Inadvertent intrathecal use has caused convulsions, coma, and sensory and motor neurologic deficits. 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 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. Do not administer to patients with chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m(2)) or acute kidney injury. 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:
Gadodiamide 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. Gadodiamide is a gadolinium-based contrast agent (GBCA).
Gadodiamide is given by injection before MRI to help diagnose problems in the brain, spine, chest, stomach, hip area, 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 gadodiamide 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 performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadodiamide 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 gadodiamide.
|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:
- Asthma or allergies, history of or
- Infection, severe or
- Kidney problems, mild to moderate 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 kidney problems.
- Kidney problems, severe (recent 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 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:
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.
Make sure your doctor knows that you or your child have used this medicine. This medicine may affect the results of certain medical tests (e.g., serum iron or calcium).
Side Effects of This Medicine:
- Less common or rare
- bloody, black, or tarry stools
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in consciousness
- changes in skin color
- chest pain or discomfort
- clumsiness or unsteadiness
- decreased urine output
- difficult or labored breathing
- difficulty controlling your bladder or bowels
- difficulty swallowing
- difficulty walking
- dilated neck veins
- extreme fatigue
- fast, slow, or irregular heartbeat
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- feeling sad or depressed
- feeling unusually cold
- flushing or redness of the skin, especially on the face and neck
- general feeling of discomfort or illness
- headache, severe and throbbing
- irregular breathing
- loss of bladder control
- loss of consciousness
- muscle cramps
- muscle twitching
- numbness or tingling in your arms, legs, or face
- pain or discomfort in the arms, jaw, back, or neck
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- redness of the face, neck, arms, and occasionally, upper chest
- shakiness and unsteady walk
- shakiness in the legs, arms, hands, or feet
- shortness of breath
- skin rash
- slurred speech or problems swallowing
- sudden sweating
- swelling of the face, fingers, feet, ankles, or lower legs
- tightness in the chest
- total body jerking
- trembling or shaking of the hands or feet
- troubled breathing
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual tiredness or weakness
- weight gain
- Incidence not known
- Burning or itching of the skin
- joint stiffness
- limited range of motion in the arms and legs
- muscle weakness
- pain that is deep in the hip bone or ribs
- partial or slight paralysis
- red or dark patches on the skin
- skin swelling, hardening, or tightening
- Less common or rare
- Abdominal or stomach pain
- bad, unusual, or unpleasant (after) taste
- 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
- bloated or full feeling
- change in taste
- changes in vision
- continuing ringing or buzzing or other unexplained noise in the ears
- difficulty with moving
- dry mouth
- excess air or gas in the stomach
- hearing loss
- hives or welts
- increased sweating
- joint pain
- muscle pains or stiffness
- redness of the skin
- runny nose
- stuffy nose
- swollen joints
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