DOTAREM

DOTAREM- gadoterate meglumine injection
Guerbet LLC

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

  • The risk for NSF appears highest among patients with:
    • Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2), or
    • Acute kidney injury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing (5.1).
  • For patients at highest risk for NSF, do not exceed the recommended DOTAREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (5.1)].

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.
  • When DOTAREM is to be injected using plastic disposable syringes, the contrast medium should be drawn into the syringe and used immediately.

Pharmacy Bulk Package Preparation:

  • Do not use the Pharmacy Bulk Package for direct intravenous infusion.
  • Perform the transfer of DOTAREM from the Pharmacy Bulk Package in an aseptic work area, such as laminar flow hood and using aseptic technique and suitable transfer device. Penetrate the closure only one time.
  • Once the container closure is punctured, do not remove the Pharmacy Bulk Package from the aseptic work area.
  • The Pharmacy Bulk Package is used as a multiple dose container with an appropriate transfer device for filling empty sterile syringes.
  • Use each individual dose of DOTAREM promptly following withdrawal from the Pharmacy Bulk Package.
  • Use the contents of the Pharmacy Bulk Package within 24 hours after initial puncture.

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