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Dotarem Generic Name & Formulations
Legal Class
Rx
General Description
Gadoterate meglumine 376.9mg/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; Pre-filled syringes (10mL, 15mL, 20mL)—5
Manufacturer
Generic Availability
NO
Dotarem Indications
Indications
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 Contraindications
Not Applicable
Dotarem Boxed Warnings
Boxed Warning
Nephrogenic systemic fibrosis.
Dotarem Warnings/Precautions
Warnings/Precautions
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 Pharmacokinetics
See Literature
Dotarem Interactions
Not Applicable
Dotarem Adverse Reactions
Adverse Reactions
Nausea, headache, inj site pain, inj site coldness, rash; hypersensitivity reactions.
Dotarem Clinical Trials
See Literature
Dotarem Note
Not Applicable
Dotarem Patient Counseling
See Literature
