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

Magnevist is used to help diagnose certain disorders of the brain, blood vessels, and spin (central nervous system).

Magnevist may also be used for purposes not listed in this medication guide.

Magnevist 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 Magnevist, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive this medicine. Also tell your doctor if you have recently received any contrast agent similar to Magnevist.

Also tell your doctor if you have diabetes, high blood pressure, liver disease, a heart rhythm disorder, 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.

Before taking this medicine

Magnevist can cause a life-threatening condition in people with advanced kidney disease. You should not receive this medication if you have kidney disease or if you are on dialysis.

Gadopentetate dimeglumine 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 whose kidneys work properly. 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 Magnevist if you are allergic to gadopentetate dimeglumine.

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

• kidney problems;

• 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 Magnevist will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether gadopentetate dimeglumine passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Magnevist is injected as an IV infusion into a vein. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Magnevist 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 mmol/kg (0.2 mL/kg) as a rapid bolus intravenous injection, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 pounds has not been studied. To ensure complete injection of the medium, the injection should be followed by a saline flush of at least 5 mL.

Usual Adult Dose for Vascular Magnetic Resonance Imaging:

0.1 mmol/kg (0.2 mL/kg) as a rapid bolus intravenous injection, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 pounds has not been studied. To ensure complete injection of the medium, the injection should be followed by a saline flush of at least 5 mL.

Usual Pediatric Dose for CNS Magnetic Resonance Imaging:

2 years to 18 years of age: 0.1 mmol/kg (0.2 mL/kg) as a rapid bolus intravenous injection, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 pounds has not been studied. To ensure complete injection of the medium, the injection should be followed by a saline flush of at least 5 mL.

Usual Pediatric Dose for Vascular Magnetic Resonance Imaging:

2 years to 18 years of age: 0.1 mmol/kg (0.2 mL/kg) as a rapid bolus intravenous injection, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 pounds has not been studied. To ensure complete injection of the medium, the injection should be followed by a saline flush of at least 5 mL.

Magnevist can cause a life-threatening condition in people with advanced kidney disease. You should not receive this medication if you have kidney disease or if you are on dialysis.

Gadopentetate dimeglumine 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 whose kidneys work properly. 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 Magnevist if you are allergic to gadopentetate dimeglumine.

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

• kidney problems;

• 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 Magnevist will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether gadopentetate dimeglumine passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Since Magnevist is used only during your MRI, 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 Magnevist: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

Magnevist 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; or

• swelling, bruising, redness, itching, burning, or skin changes where the injection was given.

Common Magnevist side effects may include:

• headache, dizziness;

• nausea;

• 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 gadopentetate dimeglumine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.