Description and Brand Names

US Brand Name

  1. Omniscan

Descriptions


Gadodiamide injection is used to help diagnose or find problems in the brain, spine, chest, stomach, hip area, and other parts of your body. It is a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) scans. Contrast agents are used to help create a clear picture of the different parts of the body during MRI scans. MRI scans use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve ionizing radiation.

This medicine is to be used only by or under the direct supervision of your 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 gadodiamide 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

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

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 previous reactions to contrast media—Use with caution. May increase the likelihood of an allergic reaction.
  • Diabetes or
  • Hypertension (high blood pressure) or
  • Infection, severe—Use with caution. May increase risk for kidney problems.
  • Kidney disease, mild or moderate—Use with caution. May increase the chance for more serious side effects.
  • Kidney problems, severe (recent or long-term)—Should not be used in patients with this condition.

Proper Use

A doctor or other trained health professional will give you or your child this medicine in a medical facility. 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 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 receive this medicine. Check with your doctor right away if you or your child have burning, swelling, tightening, or itching of the skin, red or dark patches on 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 a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving 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 acute kidney injury requiring dialysis. This is more likely in patients with a history of kidney problems or in patients receiving increasing doses of gadoterate injection. Talk to your doctor about this risk.

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 (eg, serum iron or calcium).

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. Agitation
  2. bloody, black, or tarry stools
  3. blurred vision
  4. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  5. change in consciousness
  6. changes in skin color
  7. chest pain or discomfort
  8. clumsiness or unsteadiness
  9. confusion
  10. cough
  11. decreased awareness or responsiveness
  12. decreased urine output
  13. depression
  14. difficult or labored breathing
  15. difficulty controlling your bladder or bowels
  16. difficulty swallowing
  17. difficulty walking
  18. dilated neck veins
  19. dizziness
  20. extreme tiredness or weakness
  21. fainting
  22. fast, slow, or irregular heartbeat
  23. feeling of warmth or heat
  24. feeling sad or depressed
  25. feeling unusually cold
  26. flushing or redness of the skin, especially on the face and neck
  27. forgetful
  28. general feeling of discomfort or illness
  29. headache
  30. headache, severe and throbbing
  31. hives, itching, skin rash
  32. hostility
  33. irregular breathing
  34. irritability
  35. loss of bladder control
  36. loss of consciousness
  37. muscle cramps or twitching
  38. nausea
  39. numbness or tingling in your arms, legs, or face
  40. pain or discomfort in the arms, jaw, back, or neck
  41. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  42. rapid weight gain
  43. redness of the face, neck, arms, and occasionally, upper chest
  44. seizures
  45. severe sleepiness
  46. shakiness and unsteady walk
  47. shakiness in the legs, arms, hands, or feet
  48. shivering
  49. slurred speech or problems swallowing
  50. sudden sweating
  51. sweating
  52. swelling of the face, fingers, feet, ankles, or lower legs
  53. tenderness
  54. tightness in the chest
  55. total body jerking
  56. trembling or shaking of the hands or feet
  57. unsteadiness, trembling, or other problems with muscle control or coordination
  58. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  59. vomiting
  60. weight gain

Incidence not known

  1. Burning or itching of the skin
  2. decreased or uncontrolled urination
  3. incoordination
  4. joint stiffness
  5. lack or loss of strength
  6. limited range of motion in the arms and legs
  7. muscle pain, spasms, stiffness, or weakness
  8. pain that is deep in the hip bone or ribs
  9. paralysis or severe weakness of the legs
  10. partial or slight paralysis
  11. red or dark patches on the skin
  12. skin swelling, hardening, or tightening
  13. small, abnormal patch or build-up
  14. stiffness of the arms or legs
  15. uncontrolled movements of the body

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:

Rare

  1. Bad, unusual, or unpleasant (after) taste
  2. belching
  3. 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
  4. bloated or full feeling
  5. change in taste
  6. changes in vision
  7. continuing ringing or buzzing or other unexplained noise in the ears
  8. diarrhea
  9. difficulty with moving
  10. dry mouth
  11. excess air or gas in the stomach
  12. hearing loss
  13. increased sweating
  14. joint pain or swelling
  15. runny nose
  16. sneezing
  17. stomach pain
  18. stuffy nose

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.