DOTAREM Rx

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DOTAREM

Imaging agents
Only 4 drugs may be compared at once

Generic Name and Formulations:

Gadoterate meglumine 0.5mmol/mL (376.9mg/mL); soln for IV inj.

Company:

Guerbet LLC

Select therapeutic use:

Indications for DOTAREM:

For use in MRI to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity in brain (intracranial), spine and associated tissues.

Adults and Children:

<2yrs: not established. ≥2yrs: 0.1mmol/kg (0.2mL/kg) given as a IV bolus at a rate of 2mL/sec (adults) or 1–2mL/sec (children), followed by a normal saline flush (to ensure complete injection). Weight based dosing: see full labeling.

Warnings/Precautions:

Increased risk of nephrogenic systemic fibrosis among patients with chronic, severe renal impairment (GFR<30mL/min/1.73m2) or acute kidney injury. Screen for renal dysfunction and other conditions that may reduce renal function. Patients at risk for chronically reduced renal function (eg, >60yrs, diabetes mellitus, chronic hypertension), estimate the GFR by lab testing. Use lowest dose necessary. Do not exceed recommended dose; allow sufficient period of time for elimination prior to re-administration. History of a reaction to contrast media, bronchial asthma and/or allergic disorders. Have resuscitative equipment available. Monitor for signs/symptoms of hypersensitivity reactions. Avoid extravasation. Pregnancy (Cat.C). Nursing mothers.

Pharmacological Class:

Paramagnetic contrast agent (Gadolinium-based).

Adverse Reactions:

Nausea, headache, inj site pain, inj site coldness, burning sensation; hypersensitivity reactions.

How Supplied:

Single-dose vials (10mL, 15mL, 20mL)—10; Pre-filled syringes (10mL, 15mL, 20mL)—5