When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to gadofosveset and other gadolinium-based contrast agents.

How to Use This Medicine:
Injectable

• A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have an MRA scan.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, asthma, diabetes, heart disease, heart rhythm problems (such as QT prolongation), high blood pressure, or a history of an allergic reaction to contrast agents or medicines.
• Tell your doctor if you have severe kidney disease. The risk of having a very serious side effect called nephrogenic systemic fibrosis (NSF) is increased in patients with severe kidney disease. Even if you have severe kidney problems, your doctor may decide that you should still use this medicine. Check with your doctor right away if you have burning or itching of the skin; red or dark patches on the skin; skin swelling, hardening, or tightening; joint stiffness; limited range of motion in the arms and legs; pain that is deep in the hip bone or ribs; or muscle weakness after you get the injection. These may be symptoms of nephrogenic systemic fibrosis.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you have cold, clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.
• This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
• Tell your doctor right away if you have mild, burning pain; feeling of warmth or coldness; or redness at the injection site.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fast, pounding, or uneven heartbeat.
• Muscle stiffness or weakness, stiff joints or trouble moving, or deep bone pain.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Shortness of breath.
• Skin rash, swelling, hardness, tightness, burning, itching, or red or dark patches.
• Warmth or redness in your face, neck, arms, or upper chest.

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste in your mouth.
• Headache or dizziness.
• Itching skin.
• Nausea.
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088