Gadopiclenol

Vueway ® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (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) Vueway is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (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)

Gadopiclenol is a paramagnetic molecule (macrocyclic non-ionic complex of gadolinium) that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues.

The recommended dose for adult and pediatric patients, including term neonates, is 0.05 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered intravenously at approximately 2 mL/sec.

Vueway is contraindicated in patients with history of hypersensitivity reactions to Vueway. History of hypersensitivity reactions to Vueway

Boxed warning (risk associated with intrathecal use and nephrogenic systemic fibrosis): Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Vueway is not approved for intrathecal use. Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with GBCAs. Monitor patients closely for need of emergency cardiorespiratory support. Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs.

The following clinically significant adverse reactions are discussed elsewhere in labeling: Nephrogenic Systemic Fibrosis Hypersensitivity Reactions Most common adverse reactions (incidence >0.2%) are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, localized swelling, and erythema.

Store at 25°C (77°F), excursions permitted from 15°C to 30°C (59°F to 86°F). Do not freeze Pre-filled syringes.