Prohance

— THERAPEUTIC CATEGORIES —
  • Imaging agents
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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 or prefilled syringes (5mL, 10mL, 15mL, 20mL)—5

    Storage

    Store at 25°C (77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F).

    Protect from light. Do not freeze.

    Manufacturer

    Bracco Diagnostics

    Generic Availability

    NO

    Mechanism of Action

    Gadoteridol is a paramagnetic agent and, as such, develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment produced by the paramagnetic agent results in a relatively large local magnetic field, which can enhance the relaxation rates of water protons in the vicinity of the paramagnetic agent.

    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

    Risk associated with intrathecal use. Nephrogenic systemic fibrosis.

    Prohance Warnings/Precautions

    Warnings/Precautions

    Not approved for intrathecal use. 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. 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

    Distribution

    Volume of distribution: 204 ± 58 mL/kg.

    Elimination

    Renal. Half-life: 1.57 ± 0.08 hours.

    Prohance Interactions

    Not Applicable

    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

    • Latest News Your top articles for Wednesday

    • Haymarket Medical NetworkTop Picks

    • Loading...

      Continuing Medical Education (CME/CE) Courses

      Show More