Make a stable choice with GE Healthcare
Web version

We understand changing from the status quo is hard, particularly in these uncertain times. We understand that you want stability in your supply and in your manufacturer, as well as in your GBCA.

Learn More

Make a stable choice:

MoleculeIn vitro data suggest gadoterate meglumine has the highest kinetic and thermodynamic stability of all GBCA molecules which may help to reduce the potential risk of gadolinium dissociation. The clinical significance of this is unknown.1,2

Supply – GE Healthcare has invested more than $240 million to increase manufacturing capacity to help ensure reliability of supply.3

Company – GE Healthcare has been meeting the contrast media needs of USA radiology departments for over 40 years, with a comprehensive portfolio across X-ray/CT, MRI and Ultrasound.

Latest updates!

Clariscan now has pre-filled syringes and Pharmacy Bulk Pack available to help with workflow and convenience

Clariscan is approved for patients aged 2 years and under to completely serve your pediatric population with the most stable molecule, and is now also available in 5mL glass vial

Stability. Reliability. Value.

Learn More

Clariscan

IMPORTANT SAFETY INFORMATION ABOUT CLARISCAN™ (gadoterate meglumine)

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. 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.

Please see additional Important Safety Information below.

Please see full Prescribing Information for Clariscan

References:
1. Port M et al. Biometals 2008; 21(4): 469-90.
2. Tweedle MF et al. App Radiol 2014;(Suppl.): 1-11.
3. Data on file. GE Healthcare Investment.

This email is intended for US healthcare professionals only.

CLARISCAN™ (gadoterate meglumine) injection for intravenous use

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 ABOUT CLARISCAN™

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 Clariscan, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of Clariscan 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 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 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 see Full Prescribing Information for Clariscan, including Boxed Warning and Medication Guide, for additional important safety information. Click here to access the Full Prescribing 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.

December 2020 JB00556US

 
 Do not reply to this email as it was sent from an unmonitored account.
 
Unsubscribe from the Breaking News.
 
Reset your password.
 
Contact AuntMinnie.com support.
 
AuntMinnie.com Privacy Policy
  
Email sent to: .

AuntMinnie.com, 1350 North Kolb Road, Suite 215, Tucson, AZ 85715 USA - (520) 298-1000