Gadavist is a contrast agent that has magnetic properties. It is used in combination with magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly.

Gadavist is used to help diagnose certain disorders of the brain and spine (central nervous system), or the blood vessels of the kidneys, and the heart. Gadavist is also used with MRI of the breast to help detect breast cancer.

Gadavist can cause a life-threatening condition in people with advanced kidney disease. Your doctor may check your kidney function before you receive this medicine.

Gadavist can stay in your body for months or years after you receive this medicine. It is not known whether this could cause any health problems in people with normal kidneys. Tell your doctor if you have had repeated scans with a contrast agent, and provide the date of your last scan.

Before taking this medicine

Gadavist can cause a life-threatening condition in people with advanced kidney disease. Your doctor may check your kidney function before you receive this medicine.

Gadobutrol can stay in your body for months or years after you receive this medicine. It is not known whether this could cause any health problems in people with normal kidneys. Tell your doctor if you have had repeated scans with a contrast agent, and provide the date of your last scan.

You should not receive Gadavist if you are allergic to gadobutrol.

To make sure Gadavist is safe for you, tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);

• any type of reaction to a contrast agent;

• diabetes;

• high blood pressure;

• liver disease;

• asthma, hay fever, food or drug allergies;

• an injury, surgery, or severe infection; or

• if you are over 60 years old.

It is not known whether Gadavist will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using gadobutrol. Ask your doctor about any risk.

Gadavist is given as an infusion into a vein. A healthcare provider will give you this injection in a clinic or hospital setting.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

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.

Usual Adult Dose for CNS Magnetic Resonance Imaging:

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injection
Comments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.

Use: Indicated for use with MRI to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

Usual Adult Dose for Diagnostic:

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injection
Comments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.

Use: Indicated for use with MRI to assess the presence and extent of malignant breast disease.

Usual Pediatric Dose for CNS Magnetic Resonance Imaging:

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injection
Comments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.

Use:
-Indicated for use with MRI to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

Gadavist can cause a life-threatening condition in people with advanced kidney disease. Your doctor may check your kidney function before you receive this medicine.

Gadobutrol can stay in your body for months or years after you receive this medicine. It is not known whether this could cause any health problems in people with normal kidneys. Tell your doctor if you have had repeated scans with a contrast agent, and provide the date of your last scan.

You should not receive Gadavist if you are allergic to gadobutrol.

To make sure Gadavist is safe for you, tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);

• any type of reaction to a contrast agent;

• diabetes;

• high blood pressure;

• liver disease;

• asthma, hay fever, food or drug allergies;

• an injury, surgery, or severe infection; or

• if you are over 60 years old.

It is not known whether Gadavist will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using gadobutrol. Ask your doctor about any risk.

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

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

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

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

Some side effects of Gadavist may occur up to several days after injection.

Gadobutrol 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;

• 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.

Also call your doctor at once 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.

Common Gadavist side effects may include:

• headache;

• dizziness;

• nausea;

• feeling hot;

• unusual or unpleasant taste in your mouth; or

• cold feeling, warmth, pain, or burning where the medicine was injected.

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.

Other drugs may interact with gadobutrol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.