Gadobenate dimeglumine 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 on the MRI or MRA.

Gadobenate dimeglumine is used to help diagnose certain disorders of the brain and spine (central nervous system). This medication is also used to diagnose atherosclerosis (clogged arteries).

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

Gadobenate dimeglumine 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.

Gadobenate dimeglumine is given as an 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 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 mmol/kg (0.2 mL/kg) as a rapid bolus intravenous injection. 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 Magnetic Resonance Angiography:

MRA of renal and aorto-ilio-femoral vessels:

0.1 mmol/kg (0.2 mL/kg) as a rapid bolus intravenous injection followed by a saline flush of at least 20 mL either manually or using an automatic injector system.

Imaging may be started immediately after the administration of gadobenate meglumine, with scan delay calculated by test bolus or automatic bolus detection technique. If bolus timing is not determined by an automatic contrast detection pulse sequence, then a test bolus injection of 1-2 ml of gadobenate meglumine should be used to calculate the scan delay.

Usual Pediatric Dose for CNS Magnetic Resonance Imaging:

2 years and older:
0.1 mmol/kg (0.2 mL/kg) as a rapid bolus intravenous injection. To ensure complete injection of the medium, the injection should be followed by a saline flush of at least 5 mL.

Gadobenate dimeglumine 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.

Gadobenate dimeglumine can stay in your body for months or years after you receive gadobenate dimeglumine. 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 gadobenate dimeglumine if you are allergic to it.

Tell your doctor if you have ever had:

• kidney disease;

• 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 this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Since gadobenate dimeglumine is used only during your MRI, you will not be on a dosing schedule.

Since this medication 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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

Gadobenate dimeglumine 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;

• a seizure (convulsions);

• pounding heartbeats or fluttering in your chest;

• breathing problems; or

• pain, burning, swelling, blistering, or skin changes where the injection was given.

Common side effects of gadobenate dimeglumine 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.

Tell your doctor about all medicines you have recently used, especially cancer medicines, such as:

• cisplatin;

• daunorubicin, doxorubicin;

• etoposide;

• methotrexate;

• paclitaxel;

• tamoxifen; or

• vinblastine, vincristine.

This list is not complete. Other drugs may interact with gadobenate dimeglumine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.