Gadopiclenol 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.

Gadopiclenol is used to help diagnose certain disorders of the body and central nervous system.

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

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

Gadopiclenol 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 gadopiclenol if you are allergic to it.

Tell your doctor if you have ever had:

• any type of reaction to a contrast agent;
• diabetes;
• asthma, hay fever, food or drug allergies;
• high blood pressure; or
• kidney disease (or if you are on dialysis).

Tell your doctor if you are pregnant or breastfeeding.

Use Elucirem Prefilled Syringe (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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 gadopiclenol may occur up to several days after injection.

Gadopiclenol 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 discoloration;
• muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• pain; or
• tiredness, trouble moving.

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); or
• a light-headed feeling, like you might pass out.

Common side effects may include:

• pain, bruising, swelling, or irritation where the medicine was injected;
• dizziness, headache; 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.

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