Prohance

Prohance is a contrast agent that has magnetic properties. It is used with magnetic resonance imaging (MRI) to help make blood vessels, organs, and other non-bony tissues more visible on the MRI.

Prohance is used to assist in diagnosing certain disorders of the head and neck, or brain and spine (central nervous system).

Prohance may also be used for reasons not mentioned in this medication guide.

Prohance can cause a serious condition in people with advanced kidney disease. Before getting this medicine, inform your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive this medicine. Also, let your doctor know if you have recently received any contrast agents similar to this medicine.

Prohance can lead to a serious condition in people with advanced kidney disease. Speak with your doctor about your personal risk.

Prohance can remain in your body for months or years after you are given it. It is not known if this could cause any health issues in people with normal kidney function. Inform your doctor if you have had multiple scans with a contrast agent and include the date of your last scan.

You should not receive Prohance if you are allergic to it.

Inform your doctor if you have ever experienced:

• any type of reaction to a contrast agent;
• diabetes;
• asthma, hay fever, food or drug allergies;
• high blood pressure; or
• kidney disease (or if you are on dialysis).

Let your doctor know if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects of gadoteridol may happen up to several days after the injection.

Prohance can cause a life-threatening condition in people with advanced kidney disease. Call your doctor right away if you have any symptoms of this condition, such as:

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

Prohance may cause serious side effects. Call your doctor immediately if you have:

• kidney problems—little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;
• a seizure (convulsions); or
• a light-headed feeling, like you might pass out.

Common side effects of Prohance may include:

• headache;
• nausea; or
• unusual or unpleasant taste in your mouth.

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.

Prohance is given as an infusion into a vein. A healthcare provider will give you this injection.

You will be watched for a short time to make sure you do not have an allergic reaction.

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose will be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Other drugs may interact with Prohance, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.