Vasovist

What is gadofosveset trisodium?

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

Gadofosveset trisodium is used to help diagnose certain disorders of the heart and blood vessels.

Gadofosveset trisodium may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about gadofosveset trisodium?

Gadofosveset trisodium can cause a life-threatening condition in people with advanced kidney disease. 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 gadofosveset trisodium.

Tell your doctor if you have a heart rhythm disorder, a personal or family history of "Long QT Syndrome," liver disease, asthma or allergies, or if you are on dialysis.

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

Gadofosveset trisodium 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 gadofosveset trisodium.

Before receiving gadofosveset trisodium, tell your doctor if you have ever had any type of reaction to another contrast agent, or if you have:

• a heart rhythm disorder;

• a personal or family history of "Long QT Syndrome";

• liver disease;

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

• if you are on dialysis.

If you have any of these conditions, you may not be able to receive gadofosveset trisodium, or you may need a dose adjustment or special tests during treatment.

How is gadofosveset trisodium given?

Gadofosveset trisodium 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 MRA.

What happens if I miss a dose?

Since gadofosveset trisodium is used only during your MRA, 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 gadofosveset trisodium overdose are not known.

What should I avoid after receiving gadofosveset trisodium?

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

Gadofosveset trisodium 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. Call your doctor at once if you have any of these serious side effects:

• urinating more or less than usual, or not at all;

• feeling light-headed, fainting;

• skin changes where the injection was given; or

• fast, uneven heart rate.

Less serious side effects may include:

• mild itching;

• headache, dizziness;

• nausea, unusual or unpleasant taste in your mouth;

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

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

• numbness or tingling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect gadofosveset trisodium?

There may be other drugs that can affect gadofosveset trisodium. 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 can provide more information about gadofosveset trisodium.

• 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.