Gadopentetate (Intravenous)

Gadopentetate injection is a magnetic resonance imaging (MRI) contrast agent that helps 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.

It is very important for your doctor to monitor you or your child's progress while receiving this medicine and during the MRI scan to ensure it is working correctly. Blood and urine tests may be needed to check for unwanted effects.

The risk of a serious disease called nephrogenic systemic fibrosis (NSF) is higher in patients with severe kidney disease. Even if you have severe kidney issues, your doctor may still determine that receiving this medicine is necessary. Contact your doctor immediately if you or your child experience burning or itching of the skin, red or dark patches on the skin, swelling, hardening, or tightening of the skin, joint stiffness, limited movement in the arms and legs, deep pain in the hip bone or ribs, or muscle weakness. These may be signs of NSF.

This medicine may trigger a serious allergic reaction known as anaphylaxis, which can be life-threatening and requires immediate medical help. Contact your doctor or nurse right away if you or your child experience cold, clammy skin, confusion, dizziness, lightheadedness, a skin rash, itching, sweating, swelling of the face, tongue, or throat, difficulty breathing, or chest pain after receiving the medicine.

This medicine contains a metal called gadolinium, which can remain in your body (including the brain, bones, skin) for a long time (several months to years). Discuss any concerns with your doctor.

This medicine may increase your risk of kidney failure. This risk is higher if you or your child are receiving high doses of gadopentetate injection.

Notify your doctor immediately if you or your child experience mild, burning pain, a feeling of warmth or coldness, skin peeling, redness, or swelling at the injection site.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it may provide. The following points should be taken into account for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies conducted so far have not shown any specific problems in children 2 years of age and older that would limit the use of gadopentetate injection. However, safety and effectiveness have not been established in children younger than 2 years of age.

Geriatric

There is no information available about how age affects the effects of gadopentetate injection in older patients.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might happen. In such cases, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtime or with certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Asthma or allergies, history of or
• Prior reactions to contrast media—Use with caution. This may raise your risk of having an allergic reaction.

• Diabetes or
• Hypertension (high blood pressure) or
• Severe infection—Use with caution. This may increase your risk of having kidney issues (e.g., reduced kidney function).

• Mild or moderate kidney disease—Use with caution. This may raise the likelihood of serious side effects.

• Severe kidney disease (acute or long-term)—Should not be used in patients with this condition unless your doctor specifically states that it is necessary.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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
• severe and throbbing headache
• 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. Your health care professional may also 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.

In the U.S.

• Magnevist

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.