Clinical Information
Gen. Code and Des.
71377 gadoterate meglumine INTRAVEN VIAL 50MMOL/100
GCN and Des.
35143 gadoterate meglumine INTRAVEN VIAL 50MMOL/100
Strength
50MMOL
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
36680000 ROENTGENOGRAPHY AND OTHER IMAGING AGENTS
Active Ingredients
6172 gadoterate meglumine 92943936
These highlights do not include all the information needed to use CLARISCAN safely and effectively. See full prescribing information for CLARISCAN.
CLARISCAN™ (gadoterate meglumine) injection for intravenous use
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
Initial U.S. Approval: 2013
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
See full prescribing information for complete boxed warning
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.
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 (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing (5.1).
RECENT MAJOR CHANGES
Warnings and Precautions, Gadolinium Retention ( 5.3) 4/2018
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. ( 1)
DOSAGE AND ADMINISTRATION
Adult and pediatric patients: The recommended dose of Clariscan is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection at a flow rate of approximately 2 mL/second for adults and 1-2 mL/second for pediatric patients (including term neonates). The dose is delivered by manual or power injection. ( 2)
DOSAGE FORMS AND STRENGTHS
Clariscan Injection 0.5 mmol/mL contains 376.9 mg/mL of gadoterate meglumine. Clariscan Pharmacy Bulk Package is available in + PlusPak™ polymer bottles. ( 3)
CONTRAINDICATIONS
Clinically important hypersensitivity reactions to Clariscan. ( 4)
WARNINGS AND PRECAUTIONS
Nephrogenic Systemic Fibrosis has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeat dosing appear to increase the risk. ( 5.1)
Hypersensitivity: Anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred. Monitor patients closely for need of emergency cardiorespiratory support. ( 5.2)
Gadolinium is retained for months or years in brain, bone, and other organs. ( 5.3)
ADVERSE REACTIONS
The most frequent (≥ 0.2%) adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and rash. ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Use only if imaging is essential during pregnancy and cannot be delayed. ( 8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2020
