Vasovist

Vasovist 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.

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

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

Vasovist 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 Vasovist, tell your doctor if you have kidney disease. You may not be able to receive this medicine.

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.

Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions to Vasovist.

Vasovist 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 Vasovist, tell your doctor if you have kidney disease. You may not be able to receive an MRI using this medicine.

Before receiving Vasovist, 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 Vasovist, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. It is not known whether Vasovist is harmful to an unborn baby. Before you receive Vasovist, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether gadofosveset trisodium passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction to Vasovist: 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 Vasovist 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.

Vasovist 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.

Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.

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

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

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

There may be other drugs that can affect Vasovist. 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.