Gadoquatrane

AMBELVIST 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) AMBELVIST 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)

Gadoquatrane is a paramagnetic tetrameric 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 the signal intensity (brightness) of tissues.

Recommended dose for adult and pediatric patients, including term neonates, is 0.01 mmol/kg actual body weight (equivalent to an injection volume of 0.1 mL/kg). Administer the dose by intravenous injection, manually or by compatible power injector, at 1 mL/sec to 4 mL/sec followed by a flush of 0.9% sodium chloride injection, for pediatric patients, adjust the flow rate and flush volume based on age.

AMBELVIST is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST. History of severe hypersensitivity to AMBELVIST.

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. AMBELVIST 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 the labeling: Nephrogenic Systemic Fibrosis Hypersensitivity Reactions Most frequently observed adverse reactions (incidence ≥ 0.2%) were dizziness, headache, injection site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus.

Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).