"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
DOSAGE AND ADMINISTRATION
For adult and pediatric patients (2 years and older), the recommended dose of DOTAREM is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1-2 mL/second for pediatric patients. Table 1 provides weight-adjusted dose volumes.
Table 1: Volumes of DOTAREM Injection by Body Weight
|Body Weight||Volume Milliliters (mL)|
|Pounds (lb)||Kilograms (kg)|
To ensure complete injection of DOTAREM the injection may be followed by normal saline flush. Contrast MRI can begin immediately following DOTAREM injection.
Visually inspect DOTAREM for particulate matter prior to administration. Do not use the solution if particulate matter is present or if the container appears damaged. DOTAREM should be a clear, colorless to yellow solution.
Do not mix with other drugs or parenteral nutrition. Discard any unused portions of the drug.
When DOTAREM is to be injected using plastic disposable syringes, the contrast medium should be drawn into the syringe and used immediately.
Dosage Forms And Strengths
DOTAREM 0.5 mmol/mL is a sterile, clear, colorless to yellow, aqueous solution for intravenous injection containing 376.9 mg/mL gadoterate meglumine and is available in vials and pre-filled syringes.
Storage And Handling
DOTAREM Injection is a clear, colorless to yellow solution containing 0.5 mmol/mL of gadoterate meglumine. It is supplied in vials and prefilled syringes.
- DOTAREM Injection is supplied in 10 mL vials containing 10 mL of solution, in 20 mL vials containing 15 mL or 20 mL of solution.
Each single dose vial is closed with a rubber stopper and sealed with an aluminum cap and the contents are sterile. Vials are individually packaged in a shrink wrapped package of 10, in the following configurations:
10 mL in glass vial (NDC 67684-200-01)
15 mL in glass vial (NDC 67684-200-02)
20 mL in glass vial (NDC 67684-200-03)
DOTAREM Injection is supplied in 10 mL pre-filled syringes containing 10 mL of solution and 20 mL pre-filled syringes containing 15 mL or 20 mL of solution.
Each syringe is sealed with rubber closures and the contents are sterile. Syringes, including plunger rod, are packaged in a shrink wrapped package of 5, in the following configurations:
10 mL in glass pre-filled syringe (NDC 67684-300-01)
15 mL in glass pre-filled syringe (NDC 67684-300-02)
20 mL in glass pre-filled syringe (NDC 67684-300-03)
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature (CRT)].
Pre-filled syringes must not be frozen. Frozen syringes should be discarded.
Should solidification occur in the vial because of exposure to the cold, DOTAREM should be brought to room temperature before use. If allowed to stand at room temperature for a minimum of 90 minutes, DOTAREM should return to a clear, colorless to yellow solution. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. Should solids persist, discard the vial.
Directions for Use of the DOTAREM (gadoterate meglumine) Injection glass pre-filled syringe
- Screw the threaded tip of the plunger rod clockwise into the cartridge plunger and push forward a few millimeters to break any friction between the cartridge plunger and syringe barrel.
- Holding the syringe vertically so the rubber cap is
pointed upward, aseptically remove the rubber cap from the tip of the syringe
and attach either a sterile, disposable needle or compatible needleless luer
lock tubing set using a push-twist action. At this point, the tubing set is not
attached to a patient's intravenous connection.
- If using a needleless luer lock tubing set, check the connection between the syringe and the tubing as the fluid flows. Ensure that the connection is successful before administration of Dotarem Injection.
- If using a needle, hold the syringe vertically and push plunger forward until all of the air is evacuated and fluid either appears at the tip of the needle or the tubing is filled. Following the usual venous blood aspiration procedure, complete the DOTAREM injection.
- To ensure complete delivery of the contrast medium, the injection may be followed by a normal saline flush.
- Properly dispose of the syringe and any other materials used.
Guerbet LLC, 1185 West 2nd street, Bloomington, IN 47403, Pre-filled syringes manufactured by Catalent, Belgium for Guerbet, Vials manufactured by Recipharm, France for Guerbet. Revised: 3/2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/5/2013
Additional Dotarem Information
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