Elucirem

Elucirem is a gadolinium-based contrast agent used in adults and children, including full-term newborns, with magnetic resonance imaging (MRI) to find and see lesions that have unusual blood flow in:

• The central nervous system (brain, spine, and related tissues)
• The body (head and neck, chest, abdomen, pelvis, and musculoskeletal system).

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

Elucirem can cause a serious condition in people with advanced kidney disease. Before getting this medicine, inform your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive this medicine. Also, let your doctor know if you have recently received any contrast agents similar to this medicine.

Elucirem can cause a serious condition in people with advanced kidney disease. Talk to your doctor about your personal risk.

Elucirem can remain in your body for months or years after you receive it. It is not known if this could lead to health issues in people with healthy kidneys. Inform your doctor if you have had multiple scans with a contrast agent, and provide the date of your most recent scan.

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

Tell your doctor if you have ever experienced:

• 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).

Notify your doctor 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 gadopiclenol may happen up to several days after the injection.

Elucirem 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.

Elucirem may cause serious side effects. Call your doctor immediately 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 of Elucirem 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.

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

You will be watched for a short time to make sure you do not have an allergic reaction.

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

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

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

Other drugs may affect Elucirem, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.