Gadopentetate (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. 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:
Gadopentetate 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. 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, 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 gadopentetate 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 gadopentetate 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:
- 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)—Use with caution. May increase your likelihood of having 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. 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 the progress of you or your child 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.
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 use 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. 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.
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 (e.g., serum iron, bilirubin, or transaminase levels).
Side Effects of This Medicine:
- Arm, back, or jaw pain
- bluish color
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- changes in skin color
- chest pain or discomfort
- chest tightness or heaviness
- difficult or labored breathing
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- headache, severe and throbbing
- irritation of the throat
- loss of bladder control
- loss of consciousness
- 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
- shortness of breath
- skin rash
- slow or fast heartbeat
- sore throat
- stuffy nose
- swelling of the foot or leg
- swelling or puffiness of the face
- total body jerking
- unusual tiredness or weakness
- Incidence not known
- blistering, peeling, or loosening of the skin
- bluish color of the fingernails, lips, skin, palms, or nail beds
- burning or itching of the skin
- change in consciousness
- coughing that sometimes produces a pink frothy sputum
- decreased urine output
- difficult, fast, or noisy breathing, sometimes with wheezing
- difficulty with speaking
- frequent strong or increased urge to urinate
- increased sweating
- joint or muscle pain
- joint stiffness
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- 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 heart
- swelling of the face, ankles, or hands
- tightness in the chest
- trembling or shaking of the hands or feet
- troubled breathing
- 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
- Abdominal or stomach discomfort or pain
- 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 (stool)
- discharge or excessive tearing
- double vision
- dry mouth
- ear pain
- eye pain
- feeling cold or warm
- hearing loss
- hives or welts
- increased salivation
- lack or loss of strength
- loss of appetite
- pain in the tooth
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- seeing double
- skin rash
- sleepiness or unusual drowsiness
- tearing of the eyes
- trouble sleeping
- uncontrolled eye movements
- 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
- muscle pain or stiffness
- night blindness
- overbright appearance of lights
- poor hearing
- tunnel vision
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