Dotarem

— THERAPEUTIC CATEGORIES —
  • Imaging agents
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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; Prefilled syringes (10mL, 15mL, 20mL)—5, 10

    Storage

    Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

    Prefilled syringes must not be frozen. Frozen syringes should be discarded.

    Manufacturer

    Guerbet LLC

    Generic Availability

    NO

    Mechanism of Action

    Gadoterate is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues.

    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

    Risk associated with intrathecal use. Nephrogenic systemic fibrosis.

    Dotarem Warnings/Precautions

    Warnings/Precautions

    Not approved for intrathecal use. 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 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

    Distribution

    Volume of distribution (at steady state): 179 ± 26 mL/kg (females); 211 ± 35 mL/kg (males).

    Elimination

    Renal. Half-life: 1.4 ± 0.2 hours (females); 2.0 ± 0.7 hours (males).

    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

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