Dotarem Generic Name & Formulations
Gadoterate meglumine 376.9mg/mL (0.5mmol/mL); soln for IV inj; preservative-free.
Gadolinium-based contrast agent.
Single-dose vials (5mL, 10mL, 15mL, 20mL)—10; Pre-filled syringes (10mL, 15mL, 20mL)—5
For use in MRI of the brain (intracranial), spine and associated tissues in adults and children (including term neonates) to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity.
Dotarem Dosage and Administration
Adults and Children
Preterm neonates: not established. Give by IV bolus inj at a rate of ~2mL/sec (adults) or 1–2mL/sec (neonates/children), manually or by power injector. 0.2mL/kg (0.1mmol/kg), followed by a normal saline flush to ensure complete injection.
Dotarem Boxed Warnings
Nephrogenic systemic fibrosis.
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 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. Elderly. Pregnancy. Nursing mothers.
Dotarem Adverse Reactions
Nausea, headache, inj site pain, inj site coldness, rash; hypersensitivity reactions.
Dotarem Clinical Trials
Dotarem Patient Counseling