Gadodiamide 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.

Gadodiamide is used to help diagnose certain disorders of the brain and spine (central nervous system), or the stomach and chest areas.

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

Gadodiamide 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.

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

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.

Gadodiamide can cause unusual results with certain medical for 12 to 24 hours after your MRI. Tell any doctor who treats you that you have received gadodiamide.

Usual Adult Dose for CNS Magnetic Resonance Imaging:

To visualize lesions with abnormal vascularity in the brain, spine, and associated tissues:
0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.

Usual Adult Dose for Vascular Magnetic Resonance Imaging:

To facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space:

Kidney: 0.1 mL/kg (0.05 mmol/kg) administered as a bolus intravenous injection.
Intrathoracic, intra-abdominal, and pelvic cavities: 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.

Usual Pediatric Dose for CNS Magnetic Resonance Imaging:

To visualize lesions with abnormal vascularity in the brain, spine, and associated tissues:
2 years and older:
0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.

Usual Pediatric Dose for Vascular Magnetic Resonance Imaging:

To facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space:

2 years and older:
Kidney: 0.1 mL/kg (0.05 mmol/kg) administered as a bolus intravenous injection.
Intrathoracic, intra-abdominal, and pelvic cavities: 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.

Gadodiamide 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.

Gadodiamide can stay in your body for months or years after you receive gadodiamide. 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 gadodiamide if you are allergic to it.

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.

Tell your doctor if you are pregnant or breastfeeding.

Since gadodiamide 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 gadodiamide may occur up to several days after injection.

Gadodiamide 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;

• tiredness, 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 dark patches.

Also call your doctor at once if you have:

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or

• chest pain or pressure, pain spreading to your jaw or shoulder.

Common side effects of gadodiamide may include:

• headache;

• dizziness; or

• nausea.

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 affect gadodiamide, 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.