Gadobutrol

GADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) GADAVIST is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system…

Gadobutrol 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.

Recommended dose for adults and pediatric patients, including term neonates, is 0.1 mmol/kg actual body weight (equivalent to 0.1 mL/kg) administered by intravenous bolus injection. See Full Prescribing Information for administration, imaging, and handling.

GADAVIST is contraindicated in patients with history of severe hypersensitivity reactions to GADAVIST. History of severe hypersensitivity reaction to GADAVIST

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. GADAVIST is not approved for intrathecal use. Hypersensitivity Reactions: Anaphylactic and other hypersensitivity reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have occurred. Monitor patients closely during and after administration of GADAVIST. Acute Respiratory Distress Syndrome: For patients demonstrating respiratory distress after administration, assess oxygen requirement and monitor for worsening respiratory function. 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 Acute Respiratory Distress Syndrome Most common adverse reactions (incidence ≥ 0.5%) are headache, nausea, and dizziness.

Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). If solidification occurs due to cold exposure, bring GADAVIST to room temperature before use and inspect to ensure that the solution is clear and colorless to pale yellow.