Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Magnevist

Descriptions


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

  1. Arm, back, or jaw pain
  2. bluish color of the fingernails, lips, skin, palms, or nail beds
  3. blurred vision
  4. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  5. changes in skin color
  6. chest pain, discomfort, tightness, or heaviness
  7. chills
  8. confusion
  9. cough
  10. difficult or labored breathing
  11. difficulty with swallowing
  12. dizziness
  13. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  14. fainting
  15. fast, pounding, or irregular heartbeat or pulse
  16. fever
  17. headache, severe and throbbing
  18. hives, itching, skin rash
  19. irritation of the throat
  20. loss of bladder control
  21. loss of consciousness
  22. nausea
  23. nervousness
  24. noisy breathing
  25. pain or swelling of the treated skin
  26. paleness of the skin
  27. pounding in the ears
  28. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  29. red or irritated eyes
  30. redness, tenderness, itching, burning, or peeling of the skin
  31. runny nose
  32. seizures
  33. slow heartbeat
  34. sneezing
  35. sore throat
  36. stuffy nose
  37. sweating
  38. swelling of the foot or leg
  39. swelling or puffiness of the face
  40. tenderness
  41. total body jerking
  42. unusual tiredness or weakness

Incidence not known

  1. Agitation
  2. blistering, peeling, or loosening of the skin
  3. burning or itching of the skin
  4. coughing that sometimes produces a pink frothy sputum
  5. decreased urine output
  6. depression
  7. diarrhea
  8. difficulty with speaking
  9. frequent strong or increased urge to urinate
  10. hoarseness
  11. hostility
  12. increased sweating
  13. irritability
  14. joint or muscle pain
  15. joint stiffness
  16. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  17. limited range of motion in the arms and legs
  18. muscle twitching or weakness
  19. no blood pressure or pulse
  20. no breathing
  21. pain that is deep in the hip bone or ribs
  22. pain, redness, or swelling in the arm or leg
  23. rapid weight gain
  24. red or dark patches on the skin
  25. shakiness in the legs, arms, hands, or feet
  26. skin swelling, hardening, or tightening
  27. slow or irregular breathing
  28. sores, ulcers, or white spots in the mouth or on the lips
  29. spots on your skin resembling a blister or pimple
  30. stopping of the heart
  31. swelling of the face, ankles, or hands
  32. tenderness
  33. tightness in the chest
  34. trembling or shaking of the hands or feet
  35. 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

  1. 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

  1. Bad, unusual, or unpleasant (after) taste
  2. burning, dry, or itching eyes
  3. change in taste
  4. continuing ringing or buzzing or other unexplained noise in the ears
  5. decrease or change in vision
  6. difficulty having a bowel movement
  7. discharge or excessive tearing
  8. double vision
  9. dry mouth
  10. ear pain
  11. eye pain
  12. feeling cold or warm
  13. hearing loss
  14. hyperventilation
  15. increased salivation
  16. lack or loss of strength
  17. loss of appetite
  18. nervousness
  19. pain in the tooth
  20. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  21. restlessness
  22. seeing double
  23. sleepiness or unusual drowsiness
  24. stomach pain or discomfort
  25. tearing of the eyes
  26. thirst
  27. trouble sleeping
  28. uncontrolled eye movements
  29. vomiting
  30. weight loss

Incidence not known

  1. Blurred or loss of vision
  2. change in sense of smell
  3. difficulty with moving
  4. disturbed color perception
  5. double vision
  6. halos around lights
  7. night blindness
  8. overbright appearance of lights
  9. poor hearing
  10. 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.