• Imaging agents

Dotarem Generic Name & Formulations

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


Generic Availability


Dotarem 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


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