Clariscan™ (gadoterate meglumine) injection for intravenous use

Clariscan™ ( gadoterate meglumine) is a macrocyclic gadolinium-based contrast agent, expertly manufactured by GE HealthCare, used to enhance visualization in MRI procedures across a range of indications
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At a glance

Macrocyclic structure

Macrocyclic, ionic chelate provides high kinetic and themodynamic stability1

Expertly manufactured

Quality manufacture and delivery, expertly managed by GE HealthCare for greatest control

Established tolerability

Over 20 million patient administrations, with low levels of adverse events2,3

Convenient packaging options

Vials, prefilled syringes and +PLUSPAK bottles in a range of volumes
ABOUT CLARISCAN

As part of our comprehensive MR product portfolio, GE HealthCare is proud to offer Clariscan (gadoterate meglumine), the generic equivalent of Dotarem®. Clariscan is a macrocyclic, general-purpose GBCA used to enhance over 20 million MRI procedures globally since launch.

Clariscan is available in a range of packaging options, has a well-established tolerability profile, and is manufactured in-house by GE HealthCare. Enhanced confidence in continuity of supply and in product availability is further supported by GE HealthCare’s vertically integrated Clariscan manufacturing process.
STRUCTURE

Gadoterate Meglumine: the only macrocylic, ionic molecule

Stability refers to how tightly the gadolinium ion is bound to the chelating molecule and how likely it is to dissociate. Gadoterate meglumine is the only macrocyclic, ionic molecule across all gadoliunium-based contrast agents. In vitro data suggest that combining a macrocyclic structure for high kinetic stability, with ionicity for thermodynamic stability, may help to reduce the potential risk of gadolinium dissociation.1
USAGE

A broad range of indications and well-established tolerability profile3

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.

Clariscan has been approved in more than 85 countries with over 20 million doses shipped globally. There are no signals to suggest that the safety profile of Clariscan is different to that established for the reference product, Dotarem®.2
PACKAGING

Meeting procedural needs, with packaging that prioritizes your workplace safety and efficiency

Clariscan offers a range of packaging:
  • • Glass vials: 5, 10, 15, and 20 mL
  • • Clear plastic prefilled syringes: 10, 15, and 20 mL
  • • +PLUSPAK polymer bottles: 100 mL
Our unique +PLUSPAK packaging reduces hazard and downtime:
  • • No more broken bottles, glass or ring-pull injuries4
It also reduces costs and environmental impact:
  • • Less storage space, lower disposal costs, reduced environmental impact4-6
COMMITMENT

Keeping production of Clariscan in-house, so you can be assured standards are maintained from start to finish

GE HealthCare invested $80 million to increase Clariscan manufacturing output at the Oslo, Norway plant. Enhanced confidence in continuity of supply and in product availability is further supported by GE HealthCare's vertically integrated Clariscan manufacturing process. All our manufacturing sites are cGMP-accredited and we work closely with regulatory agencies globally to ensure quality supply.7

Additional resources to support you

Access additional information to support you and your radiology team in the MRI department

Case studies

Case studies using macrocyclic Clariscan™ (gadoterate meglumine) demonstrate the potential utility of Clariscan in CNS brain and spine MRI scans for diagnosis and treatment.

REFERENCES
  1. 1. Port M et al. Biometals. 2008;21(4):469-490.
  2. 2. GE HealthCare Data on File, Safety Profile Clariscan March 2023
  3. 3. Clariscan [prescribing information]. Marlborough, MA GE HealthCare; 2020
  4. 4. Marshall G. Radiography 2008; 14: 128-34
  5. 5. Gricar J et al. Radiol Manage 2007; SEP/OCT: 34-42
  6. 6. Dhaliwal H et al. Int J Life Cycle Assess 2014; 19: 1965-73.
  7. 7. GE Healthcare Data on File, Investment 2021.
Dotarem is a trademark of Guerbet LLC.

JB07847US July 2024

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IMPORTANT SAFETY INFORMATION ABOUT CLARISCAN™ (GADOTERATE MEGLUMINE)

PRODUCT INDICATIONS AND USE:

Clariscan™ (gadoterate meglumine) is a prescription 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.

WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Risk Associated with Intrathecal Use
 Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Clariscan is not approved for intrathecal use.

Nephrogenic Systemic Fibrosis

GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of Clariscan in these patients unless the diagnostic information is essential and not available with noncontrasted 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/1.73m²), 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. 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.

CONTRAINDICATIONS
History of clinically important hypersensitivity reactions to Clariscan.

WARNINGS AND PRECAUTIONS

  • Risk Associated with Intrathecal Use: Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures. The safety and effectiveness of Clariscan have not been established with intrathecal use. Clariscan is not approved for intrathecal use.
  • Nephrogenic Systemic Fibrosis: GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of Clariscan among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.
  • Hypersensitivity Reactions: Anaphylactic and anaphylactoid reactions have been reported with Clariscan, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died.
  • Before Clariscan administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to Clariscan.
  • Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver and spleen). While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible.
  • Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging
  • Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Clariscan. Extravasation into tissues during Clariscan administration may result in tissue irritation

 

ADVERSE REACTIONS

  • In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received Clariscan included: nausea, headache, injection site pain, injection site coldness and rash.
  • Serious adverse reactions in the postmarketing experience have been reported with Clariscan. Serious adverse reactions include but are not limited to arrhythmia, cardiac arrest, respiratory arrest, pharyngeal edema, laryngospasm, bronchospasm, coma, convulsion, and acute pancreatitis with onset within 48 hours post GBCA administration.

 

USE IN SPECIFIC POPULATIONS

  • Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. Use only if imaging is essential during pregnancy and cannot be delayed
  • Lactation: There are no data on the presence of gadoterate in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk.
  • Pediatric Use:The safety of Clariscan has not been established in preterm neonates. No dosage adjustment according to age is necessary in pediatric patients.
  • Geriatric Use: The use of Clariscan in elderly patients should be cautious, reflecting the greater frequency of impaired renal function and concomitant disease or other drug therapy. No age-related dosage adjustment is necessary.
  • Renal Impairment: No Clariscan dosage adjustment is recommended for patients with renal impairment.

 

To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or by email at gpv.drugsafety@gehealthcare.com  or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see CLARISCAN full Prescribing Information, including the Medication Guide, for additional important safety information.

JB07847US July 2024