Generic Name and Formulations:
Gadoteridol 279.3mg/mL; soln for IV inj; preservative-free.
Indications for PROHANCE:
For use in MRI in adults and children ≥2 years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. For use in MRI in adults to visualize lesions in the head and neck.
Give as rapid IV infusion (10–60mL/min) or bolus (>60mL/min). CNS: 0.1mmol/kg (0.2mL/kg); a second dose of 0.2mmol/kg (0.4mL/kg) may be given up to 30mins after the first in patients suspected of having poorly enhancing lesions. Extracranial/extraspinal tissues: 0.1mmol/kg (0.2mL/kg).
<2yrs: not established. Give as rapid IV infusion (10–60mL/min) or bolus (>60mL/min). ≥2yrs: CNS: 0.1mmol/kg (0.2mL/kg).
Nephrogenic systemic fibrosis (NSF).
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 respiratory disorders. Monitor for signs/symptoms of hypersensitivity reactions during and for several hours after administration; discontinue if occur. Sickle cell anemia and other hemoglobinopathies. Increased risk of gadolinium retention with multiple lifetime doses, in pregnant patients, children, and those with inflammatory conditions; minimize repetitive imaging studies. Grand mal seizure. Renal or hepatic impairment. Avoid extravasation. Elderly. Pregnancy. Nursing mothers.
Gadolinium-based contrast agent.
Nausea, taste perversion; acute kidney injury, hypersensitivity reactions.
Single-dose vials (5mL, 10mL, 15mL, 20mL)—5; Prefilled syringe (10mL, 17mL)—5