Is Gadopiclenol approved by the FDA?

Gadopiclenol, known by its brand names Elucirem, Vueway, and Elucirem Prefilled Syringe, was approved by the FDA on September 21, 2022.It is an FDA-approved contrast agent used in magnetic resonance imaging (MRI). This contrast agent is utilized to enhance the visibility of blood vessels, organs, and other non-bony tissues during MRI scans, helping in the diagnosis of various disorders in the body and central nervous system.

What is Gadopiclenol? 

Gadopiclenol is a contrast agent with magnetic properties. It is injected into a vein, where it enhances the contrast of images obtained during an MRI. This helps in the clear visualization of blood vessels, organs, and other tissues, aiding in the accurate diagnosis of conditions affecting these structures.

Dosage and Administration:

• Usual Adult Dose for MRI: 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec.
• Usual Pediatric Dose for MRI: Same as the adult dose, 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec.

Gadopiclenol is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

Side Effects: 

Common side effects of gadopiclenol may include pain, bruising, swelling, or irritation at the injection site, dizziness, headache, and nausea. Serious side effects can include kidney problems, seizures, and symptoms of a life-threatening condition in people with advanced kidney disease such as burning, itching, swelling, scaling, tightening or hardening of the skin, muscle weakness, joint stiffness, pain, tiredness, and trouble moving.

Warnings:

• Kidney Disease: Gadopiclenol can cause a life-threatening condition in people with advanced kidney disease. Patients with kidney disease or those on dialysis may not be able to receive gadopiclenol. It is crucial to inform the doctor about any history of kidney disease.
• Retention in Body: Gadopiclenol can stay in the body for months or years after administration. The long-term health impact in people with normally functioning kidneys is unknown. Patients should inform their doctor about any previous scans with contrast agents and the dates of such scans.
• Allergies: Patients should not receive gadopiclenol if they are allergic to it. It is important to disclose any history of reactions to contrast agents, as well as any conditions like diabetes, asthma, hay fever, food or drug allergies, high blood pressure, or kidney disease.

Conclusion: 

Gadopiclenol (Elucirem, Vueway) is an FDA-approved contrast agent for use in MRI to enhance the visualization of lesions with abnormal vascularity. Approved on September 21, 2022, it plays a crucial role in improving diagnostic accuracy for various conditions affecting the central nervous system and other body regions. Patients should follow their healthcare provider's instructions carefully and be aware of the potential side effects and precautions associated with gadopiclenol. Regular monitoring and adherence to the prescribed dosage regimen are essential for safe and effective use of this contrast agent.

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