Gadoxetate

What is gadoxetate?

Gadoxetate is a contrast agent. Gadoxetate produces magnetic effects. It is used in combination with magnetic resonance imaging (MRI) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRI.

Gadoxetate is used to help diagnose certain disorders of the liver.

Gadoxetate may also be used for other not those listed in this medication guide.

What is the most important information I should know about gadoxetate?

Gadoxetate can cause a life-threatening condition in people with advanced kidney disease who are undergoing an MRI. The symptoms of this condition include:

• burning, itching, swelling, and tightening or hardening of your skin;

• muscle weakness;

• pain or stiffness in your arms, hands, legs, or feet;

• deep bone pain in your ribs or your hips;

• yellow patches on the whites of your eyes; or

• skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease. You may not be able to receive an MRI with gadoxetate.

Also tell your doctor if you have liver disease, a bleeding or blood-clotting disorder, a history of stroke or blood clots, circulation problems, asthma or allergies, if you have had a liver transplant, or if you are on dialysis.

Some of the side effects of gadoxetate can occur up to several days after you have received the medication.

What should I discuss with my health care provider before receiving gadoxetate?

Gadoxetate can cause a life-threatening condition in people with advanced kidney disease who are undergoing an MRI. The symptoms of this condition include:

• burning, itching, swelling, and tightening or hardening of your skin;

• muscle weakness;

• pain or stiffness in your arms, hands, legs, or feet;

• deep bone pain in your ribs or your hips;

• yellow patches on the whites of your eyes; or

• skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease. You may not be able to receive an MRI with gadoxetate.

If you have certain other conditions, you may not be able to receive gadoxetate, or you may need a dose adjustment or special tests during treatment. Before receiving gadoxetate, tell your doctor if you have ever had any type of reaction to another contrast agent, or if you have:

• liver disease;

• a bleeding or blood-clotting disorder;

• a history of stroke, blood clots, or circulation problems;

• asthma, hay fever, or a history of food or drug allergies;

• if you have had a liver transplant; or

• if you are on dialysis.

How is gadoxetate used?

Gadoxetate is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting during your MRI.

Gadoxetate can cause you to have unusual results with certain medical tests for at least 24 hours after your MRI. Tell any doctor who treats you that you have received gadoxetate

What happens if I miss a dose?

Since gadoxetate is used only during your MRI, you will not be on a dosing schedule.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a gadoxetate overdose are not known.

What should I avoid after receiving gadoxetate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you receive gadoxetate.

Gadoxetate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some of the side effects of gadoxetate can occur up to several days after you have received the medication.

• trouble breathing;

• chest pain;

• fast or pounding heartbeats; or

• skin changes where the injection was given.

Less serious side effects may include:

• headache, tired feeling;

• dizziness, spinning sensation;

• nausea, vomiting;

• back pain;

• dry mouth, mouth pain or discomfort;

• decreased sense of taste or smell;

• increased sweating or salivation;

• warmth, redness, or tingly feeling under your skin;

• mild skin rash or itching;

• feeling unusually hot; or

• cold feeling, warmth, pain, or burning where the injection was given.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect gadoxetate?

Before you receive gadoxetate, tell your doctor if you are taking rifampin (Rifadin, Rifater, Rifamate). There may also be other drugs that can interact with gadoxetate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist has more information about gadoxetate written for health professionals that you may read.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.