Web version

 
     
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 to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
 
Additional pediatric use information is approved for Guerbet LLC’s Dotarem (gadoterate meglumine injection). However, due to Guerbet LLC’s marketing exclusivity, this drug product is not labeled with that pediatric information.
 
IMPORTANT SAFETY INFORMATION ABOUT CLARISCAN™
 
     
     
     
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/1.73m2) 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.
 
 
 
 
Please see additional Important Safety Information at the end of this email and full Prescribing Information and patient Medication Guide.
 
 
     
Expanding your contrast media options from GE Healthcare
 
  Clariscan, approved in more than 55 countries globally with over four million patient doses shipped in those countries, is now FDA‑approved in the U.S.1,2
 
Two options available to order Clariscan™
 
    Direct from GE Healthcare online   click here
 
    Through our dedicated Customer Service team at 800 292 8514
 
 
Find out more
 
  Visit the Clariscan product website   click here
 
  For more information about Clariscan, speak with your GE Healthcare Account Manager
 
FDA, U.S. Food & Drug Administration.
 
     
We are at RSNA 2019 – Come and talk to us at booth #4133
 
 
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 to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
 
Additional pediatric use information is approved for Guerbet LLC’s Dotarem (gadoterate meglumine injection). However, due to Guerbet LLC’s marketing exclusivity, this drug product is not labeled with that pediatric information.
 
IMPORTANT SAFETY INFORMATION ABOUT CLARISCAN™
 
     
     
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.
 
 
 
 
Contraindications
 
History of clinically important hypersensitivity reactions to Clariscan.
 
Warnings and precautions
 
    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.
 
Adverse reactions
 
    The most common adverse reactions (≥ 0.2%) associated with Clariscan 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 Clariscan. 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: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive. 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: 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 and efficacy of Clariscan at a single dose of 0.1 mmol/kg has been established in pediatric patients from 2 to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older. Adverse reactions in pediatric patients were similar to those reported in adults. No dosage adjustment according to age is necessary in pediatric patients. No cases of NSF associated with Clariscan or any other GBCA have been identified in pediatric patients age 6 years and younger. The safety of Clariscan has not been established in preterm neonates.
 
Additional pediatric use information is approved for Guerbet, LLC’s Dotarem (gadoterate meglumine injection). However, due to Guerbet LLC’s marketing exclusivity, this drug product is not labeled with that pediatric information.
 
Prior to Clariscan administration please read the full Prescribing Information, including the Black Box Warning and 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.
 
Reference:
1. Data on File. GE Healthcare Safety Profile of Clariscan; 2019. 2. Clariscan [prescribing information]. Marlborough, MA: GE Healthcare; 2019.
 
© 2019 General Electric Company.
GE and the GE Monogram are trademarks of General Electric Company
Any third-party trademarks are the property of their respective owners.
December 2019 JB69034USa
     
GE Healthcare | Privacy Policy | Terms of Use | Contact Us
2019 Copyright General Electric Company
9900 W Innovation Dr | Wauwatosa, WI 53226
 
 
 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