Imaging agents:

Indications for PROHANCE:

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.

Adult Dosage:

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 Dosage:

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).

Boxed Warning:

Nephrogenic systemic fibrosis (NSF).

PROHANCE 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 Classification:

Gadolinium-based contrast agent.

Adverse Reactions:

Nausea, taste perversion; acute kidney injury, hypersensitivity reactions.

How Supplied:

Single-dose vials (5mL, 10mL, 15mL, 20mL)—5; Prefilled syringes (10mL, 17mL)—5