Gadoxetate (Intravenous Route)

Contrast agents are 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 a€śpicturesa€ť of certain areas inside the body . Unlike x-rays, they do not involve ionizing radiation. Gadoxetate is a gadolinium-based contrast agent (GBCA).

Gadoxetate is given by injection before MRI to help diagnose problems in the liver .

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 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 have not been performed on the relationship of age to the effects of gadoxetate in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

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, history of or


• Kidney problems, severe (recent or long-term)a€”Use with caution. May cause side effects to become worse.

Proper Use

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have an MRI scan.

Precautions

Check with your doctor right away if you 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. Anaphylaxis can be life-threatening and requires immediate medical attention . Tell your doctor or nurse right away if you have cold clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection .

Make sure your doctor knows that you have used this medicine. This medicine may affect the results of certain medical tests (e.g., serum iron).

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

• Blurred vision


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Chest pain


• Chills


• Difficult or labored breathing


• Dizziness


• Fainting


• Fast, slow, or irregular heartbeat


• Feeling hot


• Headache


• Inability to sit still


• Need to keep moving


• Nervousness


• Pounding in the ears


• Restlessness


• Shakiness in the legs, arms, hands, or feet


• Shortness of breath


• Tightness in chest


• Trembling or shaking of hands or feet


• Troubled breathing


• Wheezing

Incidence not known

• Cold clammy skin


• Confusion


• Fast, weak pulse


• Lightheadedness


• Restlessness


• Sweating

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

• Back pain


• Bleeding, blistering, burning, coldness, discoloration of 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


• Change in sense of smell


• Change in taste


• Dry mouth


• Feeling of constant movement of self or surroundings


• Feeling of warmth


• General feeling of discomfort or illness


• Increased sweating


• Increased watering of the mouth


• Itching


• Loss of taste


• Nausea


• Rash with flat lesions or small raised lesions on the skin


• Redness of the face, neck, arms, and occasionally, upper chest


• Sensation of spinning


• Unusual tiredness or weakness


• 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.