gadofosveset trisodium

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, scaling, and tightening or hardening of your skin;
• muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• deep bone pain in your ribs or your hips;
• trouble moving; or
• skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadofosveset trisodium.

Also tell your doctor if you have diabetes, high blood pressure, liver disease (or liver transplant), a heart rhythm disorder, a personal or family history of "Long QT Syndrome," asthma or allergies, if you are over 60 years old, if you have ever had a reaction to a contrast agent, or if you have recently had an injury, surgery, or severe infection.

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.

What is gadofosveset trisodium?

Gadofosveset trisodium is a contrast agent that 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 purposes not listed in this medication guide.

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. The symptoms of this condition include:

• burning, itching, swelling, scaling, and tightening or hardening of your skin;
• muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• deep bone pain in your ribs or your hips;
• trouble moving; or
• skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadofosveset trisodium.

To make sure you can safely receive this medication, tell your doctor if you have any of these other conditions:

• diabetes;
• high blood pressure;
• liver disease (or liver transplant);
• a heart rhythm disorder;
• a personal or family history of "Long QT Syndrome";
• asthma, hay fever, or a history of food or drug allergies;
• if you are over 60 years old;
• if you have ever had any type of reaction to a contrast agent; or
• if you have recently had an injury, surgery, or severe infection.

FDA pregnancy category C. It is not known whether gadofosveset trisodium will harm an unborn baby. Before you receive this medication, tell your doctor if you are pregnant.

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.

How is gadofosveset trisodium given?

Gadofosveset trisodium is injected into a vein through an IV. 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.

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?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving gadofosveset trisodium?

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

What are the possible side effects of gadofosveset trisodium?

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 a serious side effect such as:

• urinating less than usual or not at all;
• drowsiness, confusion, mood changes, increased thirst, loss of appetite;
• swelling, weight gain, feeling short of breath; 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?

This medication can harm the kidneys in certain people, and this effect may be increased if you also use other medicines harmful to the kidneys. Before you receive gadofosveset trisodium, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

There may be other drugs that can affect gadofosveset trisodium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about gadofosveset trisodium.