CLARISCAN

CLARISCAN- gadoterate meglumine injection, solution
GE Healthcare

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 Clariscan 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

Clariscan 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 Clariscan 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 Clariscan 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 Clariscan, the injection may be followed by normal saline flush. Contrast MRI can begin immediately following Clariscan injection.

2.2 Drug Handling

  • Visually inspect Clariscan for particulate matter prior to administration. Do not use the solution if particulate matter is present or if the container appears damaged. Clariscan 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 Clariscan 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.
  • Do not use if tamper-evident ring is broken or missing.
  • Perform the transfer of Clariscan 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 Clariscan promptly following withdrawal from the Pharmacy Bulk Package.
  • Use the contents of the Pharmacy Bulk Package within 24 hours after initial puncture.

3 DOSAGE FORMS AND STRENGTHS

Clariscan 0.5 mmol/mL is a sterile, clear, colorless to yellow, aqueous solution for intravenous injection containing 376.9 mg/mL gadoterate meglumine.

Clariscan Pharmacy Bulk Package is available in +Plus Pak™ polymer bottles.

4 CONTRAINDICATIONS

History of clinically important hypersensitivity reactions to Clariscan [see Warnings and Precautions (5.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Nephrogenic Systemic Fibrosis

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2) as well as patients with acute kidney injury.

The risk appears lower for patients with chronic, moderate kidney disease (GFR 30 — 59 mL/min/1.73 m2) and little, if any, for patients with chronic, mild kidney disease (GFR 60 — 89 mL/min/1.73 m2). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.

Report any diagnosis of NSF following Clariscan administration to GE Healthcare at (1-800-654-0118) or FDA at (1-800-FDA-1088 or www.fda.gov/medwatch).

Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days), and usually reversible, decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronically reduced renal function (e.g., age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing.

The factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA, and the degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended Clariscan dose and allow a sufficient period of time for elimination of the drug prior to re-administration. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a GBCA in order to enhance the contrast agent’s elimination. The usefulness of hemodialysis in the prevention of NSF is unknown [see Dosage and Administration (2) and Clinical Pharmacology (12)].

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