Gadopiclenol

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

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

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

Gadopiclenol 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.

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

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

Gadopiclenol can remain in your body for months or years after you receive gadopiclenol. It is unclear 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 give the date of your last scan.

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

Notify your doctor if you have ever experienced:

• any kind 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).

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 gadopiclenol may happen up to several days after the injection.

Gadopiclenol can cause a life-threatening condition in people with advanced kidney disease. Call your doctor immediately 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.

Gadopiclenol may cause serious side effects. Call your doctor right away 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 gadopiclenol 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.

Usual Adult Dose for Magnetic Resonance Imaging:

Recommended dose: 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) IV bolus once, at approximately 2 mL/secComments:-Administration should be followed by a flush of 0.9% sodium chloride injection.Use: For use with MRI to detect and visualize lesions with abnormal vascularity in: -The central nervous system (brain, spine, and associated tissues)-The body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system

Usual Pediatric Dose for Magnetic Resonance Imaging:

Term Neonates to less than 18 years: 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) IV bolus once, at approximately 2 mL/secComments:-Administration should be followed by a flush of 0.9% sodium chloride injection-Adjust flow rate and flush volume based on age. Use: For use with MRI in pediatric patients (including term neonates), to detect and visualize lesions with abnormal vascularity in: -The central nervous system (brain, spine, and associated tissues)-The body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system

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 gadopiclenol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.