- Clariscan, approved in more than 55 countries globally with
over four million patient doses shipped, is now FDA-approved in the
U.S.
- Expands the GE Healthcare portfolio of contrast media
products
The U.S. Food and Drug Administration (FDA) has approved
Clariscan™, a macrocyclic, ionic, gadolinium-based, MRI contrast
agent, expanding the GE Healthcare portfolio for U.S. patients and
radiologists. 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 to detect and visualize areas with disruption of
the blood brain barrier (BBB) and/or abnormal vascularity.
Clariscan has been approved in more than 55 countries globally
and has had more than four million patient doses shipped in those
countries. It is the latest in a growing range of imaging agents
available in the U.S. from GE Healthcare. For more than 40 years,
GE agents have been routinely used across MRI, X-ray/CT and
ultrasound to enhance the image and support diagnosis.
“Demand for contrast media has significantly increased over the
past decade. The introduction of Clariscan increases our clinical
offering for U.S. radiologists, enhancing visualization to provide
better patient care. Our customers rely on our high-quality
products, first-rate supply network, and surrounding services to
support their day-to-day work,” explained Kevin O’Neill, President
& CEO Pharmaceutical Diagnostics at GE Healthcare.
“The FDA’s approval of this macrocyclic MR agent adds to the
range of contrast media options available here in the U.S. and as
radiologists we welcome this broader choice,” said Dr. Lawrence N
Tanenbaum, M.D., FACR.
GE Healthcare offers diagnostic imaging agents used in
approximately 90 million procedures per year globally, equivalent
to three patients every second. In the U.S., GE Healthcare has a
strong record of innovation in new contrast media products and
indications, with recent FDA approvals for Omnipaque™ (iohexol) in
CT of the abdomen and for Visipaque™ (iodixanol) in coronary CT
angiography. GE Healthcare has invested $240 million in its global
manufacturing and supply network over the past five years to
deliver imaging agents to hospitals and pharmacies globally.
Clariscan is manufactured in Norway using a proprietary
manufacturing process. As with all GE Healthcare contrast media
products, all stages of manufacturing, from development of the
active pharmaceutical ingredient (API) to finished product, are
managed entirely by GE Healthcare. Clariscan is available in single
dose vials of 10, 15 and 20 mL. The packaging contains a 2D data
matrix (barcode) on every Clariscan pack, which conveys key
information, including national drug code number, individual lot
number, and expiration date. This information can be easily scanned
and uploaded onto electronic medical systems, helping to reduce the
risk of manual data entry errors and helping workflow efficiencies
at medical centers.
ENDS
About GE Healthcare:
GE Healthcare is the $19.8 billion healthcare business of GE
(NYSE: GE). As a leading provider of medical imaging, monitoring,
biomanufacturing, and cell and gene therapy technologies, GE
Healthcare enables precision health in diagnostics, therapeutics
and monitoring through intelligent devices, data analytics,
applications and services. With over 100 years of experience in the
healthcare industry and more than 50,000 employees globally, the
company helps improve outcomes more efficiently for patients,
healthcare providers, researchers and life sciences companies
around the world. Follow us on Facebook, LinkedIn, Twitter and The
Pulse for latest news, or visit our website
https://corporate.gehealthcare.com/ for more information.
CLARISCANTM (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 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 CLARISCANTM
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 Boxed Warning and patient
Medication Guide, for additional important safety information
at:
https://www.gehealthcare.com/-/media/A4F1C1C8F50D489387BF91292DBA5629.pdf
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.
For additional safety information for Omnipaque™, please see
full Prescribing Information at
https://www.gehealthcare.com/-/jssmedia/c66966a70fe946afa829483a1d6c848c.pdf?la=en-us
For additional safety information for Visipaque™, please see
full Prescribing Information at
https://www.gehealthcare.com/-/jssmedia/1f0478f5573f47538b0e4bdcc619ac3c.pdf?la=en-us
November 2019 JB72654US
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191104005398/en/
Media Contact: Sophie White Communications +44
78255882977 sophie.white@ge.com
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