Vueway

— THERAPEUTIC CATEGORIES —
  • Imaging agents

Vueway Generic Name & Formulations

General Description

Gadopiclenol 0.5mmol/mL; soln for IV inj.

Pharmacological Class

Gadolinium-based contrast agent.

How Supplied

Single-dose vials (3mL, 7.5mL, 10mL, 15mL)—1, 10; Single-dose prefilled syringes (7.5mL, 10mL, 15mL)—1, 10

Manufacturer

Generic Availability

NO

Vueway Indications

Indications

For use in MRI of the CNS (brain, spine, and associated tissues) and the body (head, neck, thorax, abdomen, pelvis, and musculoskeletal system) in adults and children to detect and visualize lesions with abnormal vascularity.

Vueway Dosage and Administration

Adults and Children

<2yrs: not established. Give by IV bolus inj at a rate of ~2mL/sec manually or by compatible power injector. ≥2yrs: 0.05mmol/kg (0.1mL/kg), followed by a normal saline IV flush. 

Vueway Contraindications

Not Applicable

Vueway Boxed Warnings

Boxed Warning

Nephrogenic systemic fibrosis.

Vueway Warnings/Precautions

Warnings/Precautions

Increased risk for 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 disorders. Monitor for signs/symptoms of hypersensitivity reactions during and after administration. Increased risk of gadolinium retention with multiple lifetime doses, in pregnant patients, children, and those with inflammatory conditions; minimize repetitive imaging studies. Avoid extravasation. Interpreting Vueway MRI scans without a companion non-contrast MRI. Renal impairment. Elderly. Pregnancy. Nursing mothers.

Vueway Pharmacokinetics

Distribution

The mean (CV%) volume of distribution at steady state is 13 (13%) L. 

Plasma protein bound ≤1.8%.

Elimination

Renal (~98%). Half-life: 1.5 hours.

Vueway Interactions

Not Applicable

Vueway Adverse Reactions

Adverse Reactions

Inj site pain, headache, nausea, inj site warmth and coldness, dizziness, localized swelling.

Vueway Clinical Trials

See Literature

Vueway Note

Not Applicable

Vueway Patient Counseling

See Literature