CLARISCAN- gadoterate meglumine injection, solution
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 m 2), 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.
|Pounds (lb)||Kilograms (kg)||Milliliters (mL)|
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.
Directions for Use of Clariscan (gadoterate meglumine) Injection
Aseptically draw up the contrast medium into a disposable syringe and use immediately.
Plastic pre-filled syringe:
- Holding the syringe vertically so the tip cap is pointed upward, aseptically remove the tip 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 Clariscan 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 Clariscan 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.
Plastic pre-filled syringe
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 and is available in vials and pre-filled syringes.
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 m 2) 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 m 2) and little, if any, for patients with chronic, mild kidney disease (GFR 60 — 89 mL/min/1.73 m 2). 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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