Gadofosveset (Injection)

Gadofosveset is a contrast agent. It is used in magnetic resonance angiography (MRA) to help create a clear picture of the blood vessels (arteries). The MRA scan is a special type of diagnostic test. It uses magnets and computers to create images or “pictures” of the blood vessels in certain areas of the body. Gadofosveset is a gadolinium-based contrast agent (GBCA).

Gadofosveset is given by injection before MRA to help diagnose problems in the blood vessels (e.g., blockage of the arteries).

This medicine is to be used only by or under the direct supervision of a doctor.

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. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell 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.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it will provide. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done on how age affects the use of gadofosveset in children. Safety and effectiveness have not been established for this group.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the use of gadofosveset. However, older patients are more likely to have kidney problems related to age, which may require careful monitoring and an adjustment in the dose for those receiving gadofosveset.

Breast Feeding

There are no proper studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if interactions might happen. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional about any other prescription or nonprescription (over-the-counter [OTC]) medicines you are taking.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating or with certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Having other medical problems may affect how this medicine works for you. Make sure to inform your doctor about any other medical issues, especially:

• Asthma or allergies, history of
• Heart disease, history of
• Heart rhythm problems (e.g., QT prolongation)
• Severe kidney problems (recent or long-term)—Use with caution. May worsen side effects.

• Diabetes
• Hypertension (high blood pressure)—Use with caution. May raise the risk for kidney problems.

Along with its necessary effects, Gadofosveset (Injection) may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Cough
• Difficulty with swallowing
• Dizziness
• Fast heartbeat
• Hives
• Itching
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Shortness of breath
• Skin rash
• Tightness in the chest
• Unusual tiredness or weakness
• Wheezing

Less common

• Blurred vision
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Feeling faint, dizzy, or lightheaded
• Feeling of warmth or heat
• Flushing or redness of the skin, especially on the face and neck
• Headache
• Nervousness
• Pounding in the ears
• Slow or fast heartbeat
• Sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Gadofosveset. Also, your healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Change in taste
• Feeling cold
• Loss of taste
• Nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Ablavar

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.