Description
Gadodiamide injection is 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. Gadodiamide is a gadolinium-based contrast agent (GBCA) that is given by injection before an 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 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 gadodiamide 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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadodiamide injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving gadodiamide.
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 or allergies, history of or
- Patients who have had previous 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 (recent 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 in a medical facility. 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. Check with your doctor or nurse right away if you or your child 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, kidneys, liver, spleen) 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 gadodiamide 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.
Make sure your doctor knows that you or your child have used this medicine. This medicine may affect the results of certain medical tests (eg, serum iron or calcium).
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
- Agitation
- 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, discomfort, or tightness
- clumsiness or unsteadiness
- confusion
- cough
- decreased awareness or responsiveness
- decreased urine output
- depression
- difficult or labored breathing
- difficulty controlling your bladder or bowels
- difficulty swallowing
- difficulty walking
- dilated neck veins
- dizziness
- extreme tiredness or weakness
- fainting
- fast, slow, or irregular heartbeat
- feeling of warmth or heat
- feeling sad or depressed
- feeling unusually cold
- flushing or redness of the skin, especially on the face and neck
- forgetful
- general feeling of discomfort or illness
- headache
- headache, severe and throbbing
- hives, itching, skin rash
- hostility
- irregular breathing
- irritability
- loss of bladder control
- loss of consciousness
- muscle cramps or twitching
- nausea
- 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
- seizures
- severe sleepiness
- shakiness and unsteady walk
- shakiness in the legs, arms, hands, or feet
- shivering
- slurred speech or problems swallowing
- sudden sweating
- sweating
- swelling of the face, fingers, feet, ankles, or lower legs
- tenderness
- total body jerking
- trembling or shaking of the hands or feet
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- vomiting
- weight gain
Incidence not known
- Burning or itching of the skin
- decreased or uncontrolled urination
- incoordination
- joint stiffness
- lack or loss of strength
- limited range of motion in the arms and legs
- muscle pain, spasms, stiffness, or weakness
- pain that is deep in the hip bone or ribs
- paralysis or severe weakness of the legs
- partial or slight paralysis
- red or dark patches on the skin
- skin swelling, hardening, or tightening
- small, abnormal patch or build-up
- stiffness of the arms or legs
- uncontrolled movements of the body
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
- Bad, unusual, or unpleasant (after) taste
- belching
- 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
- diarrhea
- difficulty with moving
- dry mouth
- excess air or gas in the stomach
- hearing loss
- increased sweating
- joint pain or swelling
- runny nose
- sneezing
- stomach pain
- stuffy nose
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-20074702
