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Optimark Generic Name & Formulations
Legal Class
Rx
General Description
Gadoversetamide 330.9mg/mL (0.5mmol/mL); soln for IV inj; preservative-free.
Pharmacological Class
Gadolinium-based contrast agent.
How Supplied
Single-dose vials (5mL, 10mL, 15mL, 20mL)—10; Syringes (10mL, 15mL, 20mL, 30mL)—10
Manufacturer
Optimark Indications
Indications
For use with MRI in patients with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues. For use with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver of patients who are highly suspect for liver structural abnormalities on computed tomography.
Optimark Dosage and Administration
Adult
Give as bolus peripheral IV inj at a rate of 1–2mL/sec, manually or by power injector. 0.2mL/kg (0.1mmol/kg), followed by 5mL normal saline flush to ensure complete injection.
Children
Not established.
Optimark Contraindications
Contraindications
Chronic, severe kidney disease (GFR <30mL/min/1.73m2). Acute kidney injury.
Optimark Boxed Warnings
Boxed Warning
Nephrogenic systemic fibrosis (NSF).
Optimark Warnings/Precautions
Warnings/Precautions
Increased risk of nephrogenic systemic fibrosis in chronic kidney disease or acute kidney injury (see Contraindications). 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 for several hrs after administration; discontinue if occur. Increased risk of gadolinium retention with multiple lifetime doses, in pregnant patients, children, and those with inflammatory conditions; minimize repetitive imaging studies. Renal impairment: use lowest effective dose. Avoid extravasation. Interpreting Optimark MRI scans without a companion non-contrast MRI. Elderly. Pregnancy. Nursing mothers: not recommended (discard breast milk up to 72hrs after inj).
Optimark Pharmacokinetics
See Literature
Optimark Interactions
Interactions
Interference in serum iron, copper, zinc, and calcium measurements.
Optimark Adverse Reactions
Adverse Reactions
Headache, vasodilation, taste perversion, dizziness, nausea, paresthesia; hypersensitivity reactions.
Optimark Clinical Trials
See Literature
Optimark Note
Not Applicable
Optimark Patient Counseling
See Literature
