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Prohance Generic Name & Formulations
Legal Class
Rx
General Description
Gadoteridol 279.3mg/mL; soln for IV inj; preservative-free.
Pharmacological Class
Gadolinium-based contrast agent.
How Supplied
Single-dose vials (5mL, 10mL, 15mL, 20mL)—5; Prefilled syringes (10mL, 17mL)—5
Manufacturer
Prohance Indications
Indications
For use in MRI in adults, pediatrics including term neonates to visualize lesions with disrupted blood brain barrier and/or 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.
Prohance Dosage and Administration
Adult
See full labeling. Use lowest effective dose. Give as rapid IV infusion (10–60mL/min) or bolus (>60mL/min). CNS: 0.2mL/kg (0.1mmol/kg); a supplementary dose of 0.4mL/kg (0.2mmol/kg) may be given up to 30mins after the first dose in patients (with normal renal function) suspected of having poorly visualized lesions. Extracranial/extraspinal head and neck: 0.2mL/kg (0.1mmol/kg).
Children
See full labeling. Use lowest effective dose. Give as rapid IV infusion (10–60mL/min) or bolus (>60mL/min). CNS: 0.2mL/kg (0.1mmol/kg).
Prohance Contraindications
Not Applicable
Prohance Boxed Warnings
Boxed Warning
Nephrogenic systemic fibrosis (NSF).
Prohance Warnings/Precautions
Warnings/Precautions
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 trained personnel and medications readily available. History of asthma or other allergic disorders. Monitor for hypersensitivity reactions during and for up to 2hrs after administration; discontinue if occur and treat appropriately. Increased risk of gadolinium retention with multiple lifetime doses, in pregnant patients, children, and those with inflammatory conditions; minimize repetitive imaging studies. Renal impairment. Elderly. Pregnancy. Nursing mothers.
Prohance Pharmacokinetics
See Literature
Prohance Interactions
Prohance Adverse Reactions
Adverse Reactions
Nausea, taste perversion; acute kidney injury, hypersensitivity reactions.
Prohance Clinical Trials
See Literature
Prohance Note
Not Applicable
Prohance Patient Counseling
See Literature
