Generic Name and Formulations:
Gadobutrol 604.72mg/mL (1mmol/mL); soln for IV inj; preservative-free.
Indications for GADAVIST:
For use in MRI of the CNS in adults and children (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity. MRI of the breast to assess the presence and extent of malignant breast disease. For use in magnetic resonance angiography (MRA) in adults and children (including term neonates) to evaluate known or suspected supra-aortic or renal artery disease.
Adults and Children:
Premature infants: not established. Give by IV inj manually or by power injector (see full labeling). 0.1mL/kg (0.1mmol/kg), followed by a normal saline flush to ensure complete injection. MRI of CNS: at a rate of ~2mL/sec. MRA (adults): at a rate of ~1.5mL/sec, followed by 30mL saline flush at the same rate.
Nephrogenic systemic fibrosis.
Increased risk of nephrogenic systemic fibrosis in chronic kidney disease or acute kidney injury; avoid use. Screen for renal dysfunction. Do not exceed recommended dose and allow sufficient time for drug elimination before re-administration. Have emergency resuscitative equipment available. History of asthma or other allergic disorders. Monitor for signs/symptoms of hypersensitivity reactions during and after administration. Increased risk of gadolinium retention with multiple lifetime doses, in pregnant patients, children, and those with inflammatory conditions; minimize repetitive imaging studies. Gadavist MRI may overestimate extent of malignancy in the diseased breast up to 50% of patients. Low sensitivity for significant arterial stenosis. Avoid extravasation. Elderly. Pregnancy. Nursing mothers: consider interrupting nursing and pumping/discarding breast milk for up to 18hrs after inj.
Gadolinium-based contrast agent.
Headache, nausea, dizziness; hypersensitivity reactions.
Single-dose vials (2mL)—15; (7.5mL, 10mL, 15mL)—20; Single-use prefilled syringes (7.5mL, 10mL, 15mL)—5