Pronunciation:

gad-OX-e-tate dye-SOE-dee-um

Brand Names:

• Eovist

Dosage Forms:

• Solution

Warnings:

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs. Patients with chronic, severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)) or acute kidney injury are at greatest risk. NSF may lead to fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Avoid use of GBCAs in patients with impaired elimination unless use is essential and other modalities (eg, non-contrast enhanced MRI) are not available. Screen for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes), perform lab testing to estimate the GFR. For patients with the highest NSF risk, do not exceed the recommended dose and allow enough time for drug elimination prior to any readministration .

Classifications:

Therapeutic—

Diagnostic Agent

Uses of This Medicine:

Gadoxetate injection is a magnetic resonance imaging (MRI) contrast agent used to help create a clear picture of the body during MRI scans. MRI scans use magnets and computers to create images or “pictures” of certain areas of the body. Unlike x-rays, MRI scans do not involve radiation. Gadoxetate is a gadolinium-based contrast agent (GBCA) that is given by injection before an MRI to help diagnose problems in the liver.

This medicine is to be used only by or under the direct supervision of a doctor.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gadoxetate injection in children. Safety and efficacy have not been established in premature infants.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadoxetate injection 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 this medicine.

Breast-feeding—

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.

Other medicines—

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, or history of or
• Liver disease, severe—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.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine. This medicine is given through an IV catheter that is placed in 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 While Using This Medicine:

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 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, vomiting, unusual tiredness or weakness, dizziness, drowsiness, fever, headache, irritability, mood or mental changes, hallucinations, stiff neck, confusion, change or loss of consciousness, seizures, or death.

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 gadoxetate.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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 receiving the medicine.

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

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.

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

Side Effects of This Medicine:

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 or tightness

chills

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

trembling or shaking of the hands or feet

trouble breathing

Incidence not known

Cold, clammy skin

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, weak pulse

lightheadedness

restlessness

sneezing

stuffy or runny nose

sweating

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:

Rare

Back pain

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

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

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.