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Elucirem Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
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
Mechanism of Action
Gadopiclenol is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues.
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
Risk associated with intrathecal use. Nephrogenic systemic fibrosis.
Elucirem Warnings/Precautions
Warnings/Precautions
Not approved for intrathecal use. 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 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
Mean (CV%) volume of distribution (at steady state): 13 (13%) L. Plasma protein bound: ≤1.8%.
Elimination
Renal (~98%). Half-life: 1.5 hours.
Elucirem Interactions
Not Applicable
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
Not Applicable
Elucirem Patient Counseling
See Literature
