Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

1. Omniscan

Descriptions

Gadodiamide injection is a magnetic resonance imaging (MRI) contrast agent used to help create a clear picture of the body during an MRI scan. MRI scans use magnets and computers to create images of certain areas of the body. Unlike x-rays, MRI scans do not involve radiation. Gadodiamide is a gadolinium-based contrast agent (GBCA) that is given by injection before an MRI to help diagnose problems in the brain, spine, chest, stomach, hip area, and other parts of your body.

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 risk 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 an IV catheter that is 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.

This medicine should not be given intrathecally (injection given through the spinal canal). It may cause serious unwanted effects including agitation, back pain, blurred vision, change or loss of consciousness, confusion, death, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or metal changes, seizures, stiff neck, unusual tiredness or weakness, or vomiting when given intrathecally.

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 cause a serious 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, kidneys, liver, spleen) 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 gadodiamide 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, discomfort, or tightness
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. total body jerking
55. trembling or shaking of the hands or feet
56. unsteadiness, trembling, or other problems with muscle control or coordination
57. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
58. vomiting
59. 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.

Portions of this document last updated: March 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/gadodiamide-intravenous-route/precautions/drg-20074702