DOTAREM

DOTAREM- gadoterate meglumine injection
Guerbet LLC

1 INDICATIONS AND USAGE

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 (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Guidelines

For adult and pediatric patients (including term neonates), 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
Pounds (lb)	Kilograms (kg)	Milliliters (mL)
5.5	2.5	0.5
11	5	1
22	10	2
44	20	4
66	30	6
88	40	8
110	50	10
132	60	12
154	70	14
176	80	16
198	90	18
220	100	20
242	110	22
264	120	24
286	130	26
308	140	28
330	150	30

To ensure complete injection of DOTAREM the injection may be followed by normal saline flush. Contrast MRI can begin immediately following DOTAREM injection.

2.2 Drug Handling

• 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.

Directions for Use of the DOTAREM (gadoterate meglumine) Injection

Glass vial:

Aseptically draw up the contrast medium into a disposable syringe and use immediately.

Glass or plastic pre-filled syringe:

1) Holding the syringe barrel firmly, screw the threaded tip of the plunger rod clockwise into the cartridge plunger.

• For glass pre-filled syringe: Push forward a few millimeters to break any friction between the cartridge plunger and syringe barrel.
• For plastic pre-filled syringe: After screwing the push rod into the syringe cartridge plunger, turn the push rod clockwise an additional ½ turn so that the cartridge plunger rotates freely.

2) 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.

3) To ensure complete delivery of the contrast medium, the injection may be followed by a normal saline flush.

4) Properly dispose of the syringe and any other materials used.