Gadodiamide

Gadodiamide is a contrast agent with magnetic properties. It is used along with magnetic resonance imaging (MRI) to make blood vessels, organs, and other non-bony tissues clearer on the MRI.

Gadodiamide is used in adults and children who are at least 2 years old to help diagnose certain disorders of the brain and spine (central nervous system), as well as the stomach, chest, and pelvic areas.

Gadodiamide may also be used for reasons not mentioned in this medication guide.

Gadodiamide 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.

Gadodiamide can cause a serious and potentially life-threatening condition in people who have advanced kidney disease. Before you receive gadodiamide, inform your doctor if you have kidney disease or if you are undergoing dialysis. You might not be able to receive gadodiamide. Additionally, let your doctor know if you have recently received any contrast agents similar to gadodiamide.

Gadodiamide can lead to a serious condition in people with advanced kidney disease. Ask your doctor about your specific risk.

Gadodiamide can remain in your body for months or years after you receive it. It is not known if this could lead to any health issues in people with normal kidney function. Inform your doctor if you have had multiple scans with a contrast agent, and share the date of your last scan.

You should not receive gadodiamide if you are allergic to it.

Inform your doctor if you have ever had:

• any kind of reaction to a contrast agent;
• asthma, hay fever, food or drug allergies;
• diabetes;
• high blood pressure; or
• liver or kidney disease.

Let your doctor know if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty 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;
• skin redness or dark patches;
• tiredness, muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• pain; or
• trouble moving.

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;
• a seizure (convulsions); 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.

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.

In a medical setting, it is unlikely that you will miss a dose.

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

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

Other drugs may affect gadodiamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.