US FDA Approves Guerbet's Optiray®
(Ioversol Injection) Imaging BulkPackage

NEWS PROVIDED BYGuerbet LLC USA 
Dec 03, 2020, 18:00 ET

PRINCETON, N.J., Dec. 3, 2020 /PRNewswire/ -- Guerbet (GBT), a global leader in medical
imaging, announced today that it received US Food and Drug Administration approval for thecommercial sale of the Optiray® Imaging Bulk Package (IBP) in the United States, as well as
FDA clearance of the LF IBP Transfer Set.

Guerbet's Optiray IBP has the capability to ll sterile single-use syringes when used with apower injector and a cleared contrast media transfer set, Guerbet's Optiray IBP presentation isan ef cient option because it can reduce the number of single dose vials opened without
requiring preparation in a laminar ow hood or pharmacy facility.

The Optiray IBP will be available in 500mL bottles in 2021 for the Optiray 320 and Optiray 350
concentrations"Guerbet's new Optiray IBP offers our customers the exibility they seek in the CT suite, with alabeled maximum use time of 12 hours once pierced – presently the longest among iodinatedcontrast IBPs available in the US. Our innovative product portfolio continues to provide ef cientsolutions for healthcare providers and their patients," said Thomas McLaughlin, VP, Guerbet
North America.
/Customers with questions are encouraged to contact Guerbet's Customer Service Department
via phone at (877) 729-6679, or via email at customer.service-us@guerbet.com

Important Safety Information1

WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTATIONFOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY.
Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure,
cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

INDICATIONS AND USAGE
Intra-arterial use in adults:

Optiray 300: cerebral arteriography, and peripheral arteriography
Optiray 320: cerebral arteriography, peripheral arteriography, visceral and renalarteriography, aortography, coronary arteriography, and left ventriculography
Optiray 350: peripheral arteriography, coronary arteriography, and left ventriculography

Intra-arterial use in pediatric patients

Optiray 320 and Optiray 350: angiocardiography

Intra-venous use in adults

Optiray 300: CT imaging of the head and body, venography, and intravenous excretoryurography
Optiray 320: CT imaging of the head and body, venography, and intravenous excretoryurography
Optiray 350: CT imaging of the head and body, venography, intravenous excretoryurography, and intravenous digital subtraction angiography (IV-DSA)

Intra-venous use in pediatric patients

Optiray 320: CT imaging of the head and body, and intravenous excretory urography/Contraindications
Optiray is contraindicated in patients with symptomatic hyperthyroidism.

Warnings and Precautions/Optiray can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis
and anaphylactic shock.
There is an increased risk in patients with a history of a previous reaction to contrast agent,and known allergies (i.e., bronchial asthma, drug, or food allergies), and otherhypersensitivities.
Acute kidney injury, including renal failure, may occur after Optiray administration.
Optiray increases the circulatory osmotic load and may induce acute or delayed
hemodynamic disturbances in patients with congestive heart failure, severely impaired
renal function, combined renal and hepatic disease, combined renal and cardiac disease,particularly when repetitive or large doses are administered.
Life-threatening or fatal cardiovascular reactions have occurred with the use of Optiray,including cardiac arrest, hypotensive collapse, and shock.
Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction canoccur during coronary arteriography and ventriculography.
Serious, fatal, thromboembolic events causing myocardial infarction and stroke can occur
during angiographic procedures with Optiray.
Extravasation can occur with Optiray administration, particularly in patients with severe
arterial or venous disease and can be associated with pain, hemorrhage and necrosis.
Thyroid storm has occurred following the intravascular use of iodinated radiopaqueagents in patients with hyperthyroidism or with an autonomously functioning thyroid
nodule.
Hypertensive crisis has occurred after the use of iodinated radiopaque contrast agents inpatient with pheochromocytoma.
Iodinated contrast agents may promote sickling in individuals who are homozygous for
sickle cell disease.
Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after
intravascular contrast agent administration. These reactions include Stevens-Johnson
syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous
pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS).
Reaction severity may increase and time to onset may decrease with repeat
administration of a contrast agent; prophylactic medications may not prevent or mitigate
severe cutaneous adverse reactions.

Adverse Reactions/The most common reaction in adults is nausea, occurring at a rate of 1 percent.
In pediatric patients, adverse reactions reported were similar in quality and frequency tothe adverse events reported by adults.
The following adverse reactions have been reported during post-approval use of Optiray.
These adverse reactions include but are not limited to: fatal anaphylactic shock, coronary
artery spasm, arrhythmia, temporary blindness, tongue edema, seizures, respiratory arrest,
bronchospasm, laryngeal spasm and obstruction, and thrombosis.

Use in Speci c Populations

Pregnancy: Postmarketing data with Optiray use in pregnant women are insuf cient todetermine if there is a risk of drug-associated adverse developmental outcomes.
Lactation: There is no information about the presence of ioversol in human or animal milk,
the effects of the drug on the breastfed infant, or the effects of the drug on milk
production. However, iodinated contrast agents are excreted unchanged in human milk invery low amounts with poor absorption from the gastrointestinal tract of the breastfedinfant.
Pediatric Use: Safety and effectiveness in pediatric patients have been established for theuse of Optiray 350 and Optiray 320 in angiocardiography; and for Optiray 320 incomputed tomographic imaging of the head and body, and intravenous excretoryurography. Safety and effectiveness of Optiray 350 and Optiray 320 have not been
established in pediatric patients less than 1 month of age. Safety and effectiveness ofOptiray 300 has not been established in pediatric patients.
Geriatric Use: Optiray is substantially excreted by the kidney, and the risk of adverse
reactions to Optiray may be greater in patients with impaired renal function.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

References
1 OptiRay Imaging Bulk Pack [package insert]. Raleigh, NC: Liebel-Flarsheim Company LLC; Nov

2020

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About Guerbet
Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceuticalproducts, medical devices, digital and AI solutions for diagnostic and interventional imaging, toimprove the diagnosis and treatment of patients. A pioneer since more than 90 years in theeld of contrast media with over 2,800 people globally, Guerbet is continuously innovatingwith 9% of revenue dedicated to Research & Development and four centers in France, Israel
and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) andgenerated €817 million in revenue in 2019. For more information about Guerbet, please visit
www.guerbet.com.

SOURCE Guerbet LLC USA

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