GE Healthcare’s Clariscan™ (gadoterate meglumine) Becomes Only FDA-Approved MRI Contrast Agent Available in Polymer Bottle
September 15 2020 - 7:30AM
Business Wire
- US FDA approves +PLUSPAK™ (polymer bottle) Pharmacy Bulk
Package for the gadolinium-based contrast agent, Clariscan™
(gadoterate meglumine)
- As the only polymer bottle for an MRI contrast agent, Clariscan
in +PLUSPAK offers the potential for increased workplace safety,
efficiency, convenience and environmental advantages
- Clariscan has been approved in more than 65 countries globally,
with more than six million patient doses shipped
GE Healthcare’s innovative shatterproof polymer +PLUSPAK
Pharmacy Bulk Package has been approved by the US FDA for use with
its macrocyclic gadolinium-based MRI contrast agent, Clariscan
(gadoterate meglumine). As the only FDA approved MRI contrast agent
in a polymer bottle, Clariscan in +PLUSPAK will offer MRI
departments a variety of ways in which they can improve safety and
workflow efficiency.
With its patented design and pharmaceutical grade polypropylene
composition, Clariscan’s +PLUSPAK Pharmacy Bulk Package reduces
risk of breakage and injury from broken glass, while its easy-open
cap helps avoid cuts from metal crimps. Injuries associated with
glass bottles make up an estimated 16 per cent of sharps injuries
in healthcare settings. Avoiding use of glass has the potential to
improve productivity by saving time spent treating sharps injuries
while also importantly helping to reduce the associated risk of
transmission of infectious blood-borne diseases.
The Pharmacy Bulk Package offers improved flexibility, with
Clariscan able to be transferred to sterile Syringes (using the
appropriate transfer device) for up to 24 hours after initial
puncture, for use in multiple patients and across work shifts.
Unlike single-use vials, the Pharmacy Bulk Package also enables
more efficient application of weight-based dosing, helping minimize
contrast waste. In addition to workflow efficiencies, +PLUSPAK also
offers certain environmental advantages, with the use of polymer
resulting in smaller and lighter packaging than glass. The bottle
is also fully recyclable.
Clariscan – now approved in over 65 countries globally - is
indicated for intravenous use with MRI in brain (intracranial),
spine and associated tissues in adult and pediatric patients (two
years and older) to detect and visualize areas with disruption of
the blood brain barrier (BBB) and/or abnormal vascularity. See
Important Safety Information including boxed warning and
instructions for use of the Pharmacy Bulk Packaging for Clariscan
below.
“Many radiology departments have already experienced the
benefits of +PLUSPAK with other GE Healthcare contrast media
products,” said Dr Mark Hibberd, Chief Medical Officer for GE
Healthcare’s Pharmaceutical Diagnostics unit. “This new addition to
the Clariscan portfolio helps improve operational workflow and
reduce disposal costs for MR departments, key focus areas
particularly in light of COVID-19.”
GE Healthcare’s Pharmaceutical Diagnostics unit develops and
supplies imaging agents used to support around 100 million
procedures per year globally, equivalent to three patients every
second. Clariscan, approved by U.S. FDA in November 2019, is the
latest in a growing range of imaging agents available in the U.S.
which are used across MRI, X-ray/CT and ultrasound to enhance the
image and support diagnosis.
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. Clariscan is available in single dose vials
of 10, 15 and 20 mL and now 100 mL Pharmacy Bulk Package in an
innovative +PLUSPAK polymer bottle.
ENDS
About GE Healthcare:
GE Healthcare is the $16.7 billion healthcare business of GE
(NYSE: GE). As a leading global medical technology and digital
solutions innovator, GE Healthcare enables clinicians to make
faster, more informed decisions through intelligent devices, data
analytics, applications and services, supported by its Edison
intelligence platform. With over 100 years of healthcare industry
experience and around 50,000 employees globally, the company
operates at the center of an ecosystem working toward precision
health, digitizing healthcare, helping to drive productivity and
improve outcomes for patients, providers, health systems and
researchers around the world. Follow us on Facebook, LinkedIn, Twitter and Insights , or
visit our website www.gehealthcare.com
for more information.
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 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 readministration.
Contraindications History of clinically important
hypersensitivity reactions to Clariscan.
Warnings and precautions
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.
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: 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 gadoterate
meglumine 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 gadoterate
meglumine or any other GBCA have been identified in pediatric
patients age 6 years and younger. The 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 involving Clariscan,
contact GE Healthcare at 800-654-0118 or the FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
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Media Contact: David Morris David.J.Morris@ge.com +44
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