Description
Gadopentetate injection is a magnetic resonance imaging (MRI) contrast agent that is used to help create a clear picture of the body during an MRI scan. MRI scans are a special kind of diagnostic procedure that use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve radiation. Gadopentetate is a gadolinium-based contrast agent (GBCA).
Gadopentetate is given by injection before MRI to help diagnose problems in the brain, spine, head, neck, tissues, and other parts of your body.
This medicine is to be given only by or under the direct supervision of your doctor.
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 gadopentetate 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
No information is available on the relationship of age to the effects of gadopentetate injection in geriatric patients.
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 prior reactions to contrast media—Use with caution. May increase your risk for having an allergic reaction.
- Diabetes or
- Hypertension (high blood pressure) or
- Infection, severe or—Use with caution. May increase your risk 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 disease, severe (acute or long-term)—Should not be used in patients with this condition unless your doctor specifically tells you that it is necessary.
Proper Use
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
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 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 or itching of the skin, red or dark patches on the skin, swelling, hardening, or tightening of 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 type of 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 cold, clammy skin, confusion, dizziness, lightheadedness, a skin rash, itching, sweating, swelling of the face, tongue, or throat, trouble with breathing, or chest pain after you receive 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 kidney failure. This is more likely if you or your child are receiving high doses of gadopentetate injection.
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
- Arm, back, or jaw pain
- bluish color of the fingernails, lips, skin, palms, or nail beds
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- changes in skin color
- chest pain, discomfort, tightness, or heaviness
- chills
- confusion
- cough
- difficult or labored breathing
- difficulty with swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fainting
- fast, pounding, or irregular heartbeat or pulse
- fever
- headache, severe and throbbing
- hives, itching, skin rash
- irritation of the throat
- loss of bladder control
- loss of consciousness
- nausea
- nervousness
- noisy breathing
- pain or swelling of the treated skin
- paleness of the skin
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red or irritated eyes
- redness, tenderness, itching, burning, or peeling of the skin
- runny nose
- seizures
- slow heartbeat
- sneezing
- sore throat
- stuffy nose
- sweating
- swelling of the foot or leg
- swelling or puffiness of the face
- tenderness
- total body jerking
- unusual tiredness or weakness
Incidence not known
- Agitation
- blistering, peeling, or loosening of the skin
- burning or itching of the skin
- coughing that sometimes produces a pink frothy sputum
- decreased urine output
- depression
- diarrhea
- difficulty with speaking
- frequent strong or increased urge to urinate
- hoarseness
- hostility
- increased sweating
- irritability
- joint or muscle pain
- joint stiffness
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- limited range of motion in the arms and legs
- muscle twitching or weakness
- no blood pressure or pulse
- no breathing
- pain that is deep in the hip bone or ribs
- pain, redness, or swelling in the arm or leg
- rapid weight gain
- red or dark patches on the skin
- shakiness in the legs, arms, hands, or feet
- skin swelling, hardening, or tightening
- slow or irregular breathing
- sores, ulcers, or white spots in the mouth or on the lips
- spots on your skin resembling a blister or pimple
- stopping of the heart
- swelling of the face, ankles, or hands
- tenderness
- tightness in the chest
- trembling or shaking of the hands or feet
- troubled breathing
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:
Less common
- 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
Rare
- Bad, unusual, or unpleasant (after) taste
- burning, dry, or itching eyes
- change in taste
- continuing ringing or buzzing or other unexplained noise in the ears
- decrease or change in vision
- difficulty having a bowel movement
- discharge or excessive tearing
- double vision
- dry mouth
- ear pain
- eye pain
- feeling cold or warm
- hearing loss
- hyperventilation
- increased salivation
- lack or loss of strength
- loss of appetite
- nervousness
- pain in the tooth
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- restlessness
- seeing double
- sleepiness or unusual drowsiness
- stomach pain or discomfort
- tearing of the eyes
- thirst
- trouble sleeping
- uncontrolled eye movements
- vomiting
- weight loss
Incidence not known
- Blurred or loss of vision
- change in sense of smell
- difficulty with moving
- disturbed color perception
- double vision
- halos around lights
- night blindness
- overbright appearance of lights
- poor hearing
- tunnel vision
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.
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