ELUCIREM

Elucirem Generic Name & Formulations

Legal Class

General Description

Gadopiclenol 485.1mg/mL (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

Guerbet LLC

Generic Availability

Elucirem 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.

Elucirem 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.

Elucirem Contraindications

Not Applicable

Elucirem Boxed Warnings

Boxed Warning

Nephrogenic systemic fibrosis.

Elucirem 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 for gadolinium retention with multiple lifetime doses, in pregnant patients, children, and those with inflammatory conditions; minimize repetitive imaging studies. Avoid extravasation. Interpreting Elucirem MRI scans without a companion non-contrast MRI. Renal impairment. Elderly. Pregnancy. Nursing mothers.

Elucirem 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.

Elucirem Interactions

Elucirem Adverse Reactions

Adverse Reactions

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

Elucirem Clinical Trials

See Literature

Elucirem Note