Prohance

— THERAPEUTIC CATEGORIES —
  • Imaging agents

Prohance Generic Name & Formulations

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