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

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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 June 2023

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Product indications and use

Clariscan™ (gadoterate meglumine) 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.

Important Safety Information

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.
  • 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

Nephrogenic Systemic Fibrosis (NSF):

  • • NSF has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeat dosing appear to increase the risk.
Hypersensitivity reactions:
  • • Anaphylactic and anaphylactoid reactions have been reported with gadoterate meglumine, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of gadoterate meglumine administration and resolved with prompt emergency treatment.
  • • 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.
  • • Administer Clariscan only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, including personnel trained in resuscitation.
Gadolinium retention:
  • • Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by brain, skin, kidney, liver and spleen. The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs.
  • • Consequences of gadolinium retention in the brain have not been established. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.
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. Pre-filled syringes must not be frozen. Frozen syringes should be discarded.

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.

Adverse reactions

  • • The most common adverse reactions (≥ 0.2%) associated with gadoterate meglumine in clinical trials were nausea, headache, injection site pain, injection site coldness and rash.
  • • Serious adverse reactions in the postmarketing experience have been reported with gadoterate meglumine. These serious adverse reactions include but are not limited to: arrhythmia, cardiac arrest, respiratory arrest, pharyngeal edema, laryngospasm, bronchospasm, coma and convulsion.

Use in specific populations

  • • Pregnancy: Because of the potential risks of gadolinium to the fetus, use Clariscan only if imaging is essential during pregnancy and cannot be delayed. Advise pregnant women of the potential risk of fetal exposure to GBCAs.
  • • Lactation: While no data is available for gadoterate meglumine, 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 and efficacy of gadoterate meglumine at a single dose of 0.1 mmol/kg have been established in pediatric patients from birth (term neonates ≥ 37 weeks gestational age) to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older, and clinical data in 52 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data. Safety of gadoterate meglumine has not been established in preterm neonates.

Please read the full Prescribing Information for Clariscan including Boxed Warning and the full Prescribing Information including Boxed Warning for Clariscan Pharmacy Bulk Package, which includes the patient Medication Guide for additional important safety information.

To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

*This pointer statement may change based on how the material is being presented

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