Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Prohance

Descriptions


Gadoteridol injection 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 procedure that let a doctor look at the inside of the body, such as the brain. They use magnets and computers to create images or “pictures” of the body. Unlike x-rays, MRI scans do not involve radiation. Gadoteridol is a gadolinium-based contrast agent (GBCA) that is given by injection before the MRI to help diagnose problems in the brain, spine, head, or neck.

This medicine is to be given only by or under the direct supervision of a 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 gadoteridol 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 gadoteridol injection in geriatric patients.

Pregnancy

Information about this gadoteridol-intravenous-route
Pregnancy Category Explanation
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.

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:

  • Anemia or
  • Asthma, history of or
  • Diabetes or
  • Hypertension (high blood pressure) or
  • Sickle cell anemia—Use with caution. May increase risk for side effects.
  • Kidney problems, severe, or history of or
  • Liver disease, history of or
  • Seizures (grand mal), history of—Use with caution. May cause side effects to become worse.

Proper Use

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

It is very important that your doctor check your or your child's progress 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.

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 increase your risk of having acute kidney injury (AKI). This has occurred in patients with severe kidney problems, and the risk is increased with high doses of gadoteridol.

This medicine may cause serious allergic reactions, including 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 chest pain, cold, clammy skin, confusion, dizziness, lightheadedness, a skin rash, itching, sweating, swelling of the face, tongue, and throat, or trouble breathing after you receive the medicine.

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. Bluish color of the fingernails, lips, skin, palms, or nail beds
  2. blurred vision
  3. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  4. chest pain or discomfort
  5. confusion
  6. cough
  7. decreased awareness or responsiveness
  8. difficult or labored breathing
  9. difficulty swallowing
  10. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  11. fainting
  12. feeling of warmth
  13. fever
  14. general feeling of discomfort or illness
  15. headache
  16. hives
  17. hoarseness
  18. increased salivation
  19. itching
  20. loss of bladder control
  21. loss of consciousness
  22. low blood pressure or pulse
  23. nervousness
  24. pounding in the ears
  25. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  26. redness of the face, neck, arms, and occasionally, upper chest
  27. seizures
  28. shakiness in the legs, arms, hands, or feet
  29. skin rash
  30. slow, fast, or irregular breathing
  31. spasm of the throat
  32. sweating
  33. tightness in the chest
  34. trembling or shaking of the hands or feet
  35. unconsciousness
  36. unusual tiredness or weakness

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. Bad, unusual, or unpleasant (after) taste
  2. nausea

Rare

  1. Abdominal or stomach cramps
  2. anxiety
  3. bleeding gums
  4. 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
  5. continuing ringing or buzzing or other unexplained noise in the ears
  6. diarrhea
  7. dry mouth
  8. hearing loss
  9. irritation in the mouth
  10. loss of coordination in the arms
  11. mouth ulcers
  12. rash with flat lesions or small raised lesions on the skin
  13. redness and swelling of the gums
  14. runny nose
  15. sneezing
  16. stuffy nose
  17. tingling sensation in the throat
  18. voice changes
  19. vomiting
  20. watery eyes

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.