Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Multihance

Descriptions


Gadobenate is a magnetic resonance imaging (MRI) contrast agent 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. Gadobenate is a gadolinium-based contrast agent (GBCA).

Gadobenate is given by injection before an MRI scan to help find problems in the brain, spine, and other parts of your body.

This medicine is to be used 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 diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, 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 gadobenate injection in the pediatric population. However, safety and efficacy have not been established in preterm babies.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadobenate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving gadobenate.

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 diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia or any other blood disorder or
  • Asthma or allergies, history of or
  • Heart disease, history of or
  • Heart rhythm problems (eg, arrhythmia) or
  • Kidney problems, severe (recent or long-term) or
  • Liver disease or
  • Patients who have recently received a GBCA or
  • Seizures, history of—Use with caution. May cause side effects to become worse.
  • Diabetes or
  • Hypertension (high blood pressure)—Use with caution. May increase risk for more serious side effects.
  • Dubin-Johnson syndrome (an inherited disorder)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

A doctor or other trained health professional will give you 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 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.

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, skin swelling, hardening, or tightening, 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 a very serious disease called nephrogenic systemic fibrosis (NSF).

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

This medicine is a gadolinium-based contrast agent. Gadolinium may be stored in the brain, bone, skin, and other organs of the body in patients with a normal kidney function. Talk to your doctor if you have concerns.

Tell your doctor right away if you or your child have mild, burning pain, feeling of warmth or coldness, or redness or swelling at the injection site.

This medicine can cause changes in heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as a fast, pounding, or irregular heartbeat.

Before you have any medical tests, tell the medical doctor in charge that you or your child are receiving gadobenate. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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. Anxiety
  2. back pain
  3. black, tarry stools
  4. bladder pain
  5. bloody or cloudy urine
  6. blue lips and fingernails
  7. blurred vision
  8. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  9. chest pain or discomfort
  10. chills
  11. confusion
  12. cough
  13. coughing that sometimes produces a pink frothy sputum
  14. dark urine
  15. decreased urination
  16. deep or fast breathing with dizziness
  17. difficult or labored breathing
  18. difficult, burning, or painful urination
  19. difficult, fast, or noisy breathing
  20. difficulty with breathing or swallowing
  21. dizziness
  22. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  23. excessive muscle tone
  24. fainting
  25. fast, slow, or irregular heartbeat
  26. fever
  27. frequent urge to urinate
  28. general feeling of discomfort or illness
  29. headache
  30. hives, itching, skin rash
  31. inability to move the legs or arms
  32. increased sweating
  33. lower back or side pain
  34. muscle stiffness, tension, or tightness
  35. nausea
  36. nervousness
  37. numbness of the feet, hands, and around the mouth
  38. pain in the shoulders, arms, jaw, or neck
  39. pain or redness at the injection site
  40. pale skin at the injection site
  41. paralysis of one side of the body
  42. pounding heartbeat
  43. pounding in the ears
  44. problems with speech or speaking
  45. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  46. reddening of the skin, especially around the ears
  47. seizures
  48. shakiness in the legs, arms, hands, or feet
  49. sore throat
  50. sores, ulcers, or white spots on the lips or in the mouth
  51. sugar in the urine
  52. sweating
  53. swelling in the legs and ankles
  54. swelling of the eyes, face, or inside of the nose
  55. swollen glands
  56. tightness in the chest
  57. tiredness
  58. trembling or shaking of the hands or feet
  59. unusual bleeding or bruising
  60. unusual tiredness or weakness
  61. yellow eyes or skin

Incidence not known

  1. Lack or loss of strength
  2. loss of consciousness
  3. peeling of the skin
  4. skin lesions

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, rash, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  2. feeling hot

Rare

  1. Bad, unusual, or unpleasant (after) taste
  2. belching
  3. blurred or loss of vision
  4. change in sense of smell
  5. change in taste
  6. continuing ringing or buzzing or other unexplained noise in the ears
  7. decreased awareness or responsiveness
  8. diarrhea
  9. difficulty having a bowel movement
  10. difficulty with moving
  11. disturbed color perception
  12. double vision
  13. dry mouth
  14. ear pain
  15. feeling unusually cold
  16. halos around lights
  17. hearing loss
  18. heartburn
  19. indigestion
  20. joint pain
  21. lack or loss of strength
  22. loss of bowel control
  23. muscle aches, spasms, or cramps
  24. night blindness
  25. overbright appearance of lights
  26. redness of the eye
  27. severe sleepiness
  28. shivering
  29. stomach discomfort or upset
  30. stuffy nose
  31. swollen joints
  32. tunnel vision
  33. vomiting

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.