Gadobenate dimeglumine

Gadobenate dimeglumine is a contrast agent that has magnetic properties. It is used with magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) to help see blood vessels, organs, and other soft tissues more clearly on MRI or MRA.

Gadobenate dimeglumine is used to help diagnose certain disorders of the brain and spine (central nervous system).

Gadobenate dimeglumine is also used in adults to diagnose atherosclerosis (clogged arteries).

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

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

You will be monitored for a short time to ensure you do not have an allergic reaction.

Gadobenate dimeglumine can lead to a serious condition in people with severe kidney disease. Before getting gadobenate dimeglumine, inform your doctor if you have kidney disease or if you are on dialysis. You might not be able to receive gadobenate dimeglumine. Also, let your doctor know if you have recently received any contrast agents similar to gadobenate dimeglumine.

Gadobenate dimeglumine can cause a life-threatening condition in people with advanced kidney disease. Ask your doctor about your individual risk.

Gadobenate dimeglumine can remain in your body for months or years after you receive gadobenate dimeglumine. It is not known if this could lead to any health problems in people whose kidneys function normally. Inform your doctor if you have had multiple 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:

• Dubin Johnson syndrome;
• any type of reaction to a contrast agent;
• diabetes;
• asthma, hay fever, food or drug allergies;
• heart rhythm disorder, high blood pressure; or
• liver or kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

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

Some side effects of gadobenate dimeglumine can happen up to several days after the injection.

Gadobenate dimeglumine can cause a serious condition in people with advanced kidney disease. Contact your doctor immediately if you experience 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, difficulty moving.

Gadobenate dimeglumine may lead to serious side effects. Contact your doctor right away if you have:

• kidney issues—little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;
• a seizure (convulsions);
• rapid heartbeats or fluttering in your chest; or
• pain, burning, swelling, blistering, or skin changes at the injection site.

Common side effects of gadobenate dimeglumine may include:

• headache;
• feeling hot;
• nausea; or
• burning around the IV needle.

This is not a complete list of side effects, and others may happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

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.

In a medical setting, you are unlikely to miss a dose.

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

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

Tell your doctor about all your other medicines, especially:

• cisplatin;
• daunorubicin, doxorubicin;
• etoposide;
• methotrexate;
• paclitaxel;
• tamoxifen; or
• vinblastine, vincristine.

This list is not complete. Other drugs may affect gadobenate dimeglumine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.