With 30 years of demonstrated safety and image quality, Optiray® provides the confidence clinicians demand.

  • Performance and flexibility in prefilled syringes, glass vials or pharmacy bulk packages
  • In an observational cohort study of more than 101,000 cases, imaging quality with Optiray® was described as excellent, good or adequate in 99.9% of all examinations1
  • High hydrophilic, low osmolar, non-ionic, monomeric X-ray contrast medium has a low incidence of acute adverse reactions2
  • Designed as prefilled syringes to work with L-F contrast delivery systems, to help streamline your workflow and optimize confidence
  • More than 230 million doses of Optiray® have been sold globally since 19893
  • See the Full Prescribing Information

Physical Characteristics

 

Ioversol content (mg/mL)

 Iodine content (mg l/mL) Osmolality (mOsm/kg water) Viscosity (cps) at 25˚C Viscosity (cps) at 37˚C Specific Gravity at 37˚C
Optiray 320 678 320 702 9.9 5.8 1.371
Optiray 350 741 350 792 14.3 9.0 1.405

OptiRay 350

Glass Plastic RFID-Tagged Syringes*
  • 25x50 mL bottles (NDC 0019-1333-06)
  • 12x100 mL bottles (NDC 0019-1333-11)
  • 12x150 mL bottles (NDC 0019-1333-16)
  • 12x200 mL fill/250 mL bottles (NDC 0019-1333-21)
  • 6x500 mL fill/500 mL bottle (NDC 0019-1333-61)
  • 20x50 mL hand held syringes (NDC 0019-1333-78)
  • 20x75 mL fill/125 mL power injector syringes (NDC 0019-1333-95)
  • 20x100 mL fill/125 mL power injector syringes (NDC 0019-1333-90)
  • 20x125 mL power injector syringes (NDC 0019-1333-87)
  • 20x100 mL fill/125 mL power injector syringes (NDC 0019-1333-00)
  • 20x125 mL power injector syringes (NDC 0019-1333-27)

OptiRay 320

Glass Plastic RFID-Tagged Syringes*
  • 25x20 mL vials (NDC 0019-1323-02)
  • 25X50 mL bottles (NDC 0019-1323-06)
  • 12x100 mL fill/250 mL bottles (NDC 0019-1323-21)
  • 6x500 mL fill/500 mL bottles (NDC 0019-1323-61)
  • 20x50 mL hand held syringes (NDC 0019-1323-78)
  • 20X50 mL fill/125 mL power injector syringes (NDC 0019-1323-52)
  • 20x75 mL fill/125 mL power injector syringes (NDC 0019-1323-95)
  • 20x100 mL fill/125 mL power injector syringes (NDC 0019-1323-90)
  • 20x125 mL power injector syringes (NDC 0019-1323-87)
  • 20x75 mL fill/125 mL power injector syringes ((NDC 0019-1323-85)
  • 20x100 mL fill/125 mL power injector syringes (NDC 0019-1323-00)
  • 20x125 mL power injector syringes (NDC 0019-1323-27)

*Radio Frequency Identification (RFID) Technology

Optiray® is a registered trademark of Guerbet LLC or its affiliates, and is available by prescription only.

References

1. Fichtner B. Observational Cohort Study to ascertain the tolerance to and clinical safety of the non-ionic, monomeric X-ray contrast medium OPTIRAY. 1999 p. 1-19.
2. Gomi T, Nagamoto M, Hasegawa M, Katoh A, Sugiyama M, Murata N et al. Are there any differences in acute adverse reactions among five low-osmolar non-ionic iodinated contrast media?. European Radiology. 2009;20(7):1631-1635.
3. Optiray [package insert]. Princeton NJ: Guerbet LLC; 2023.

 

GU02250005

Important Safety Information

Optiray (ioversol) Injection Important Safety Information

WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION

FOR 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. (5.1)

INDICATIONS AND USAGE

Intra-arterial use in adults:

Optiray 300: cerebral arteriography, peripheral arteriography

Optiray 320: cerebral arteriography, peripheral arteriography, visceral and renal arteriography, aortography, coronary arteriography and left ventriculography

Optiray 350: peripheral arteriography, coronary arteriography and left ventriculography

 

Intra-arterial use in in pediatric patients:

Optiray 320 and Optiray 350: angiocardiography

 

Intravenous use in adults:

Optiray 300: computed tomography (CT) imaging of head and body, venography, intravenous excretory urography

Optiray 320: CT imaging of head and body, venography, intravenous excretory urography

Optiray 350: CT imaging of head and body, venography, intravenous excretory urography, intravenous digital subtraction angiography

 

Intravenous 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

  • Inadvertent intrathecal administration can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
  • Optiray can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis andanaphylactic shock.
  • Most severe reactions develop shortly after the start of the injection (e.g. within 1 to 3 minutes), but delayed reactions may occur.
  • 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 other hypersensitivities.
  • Acute kidney injury, including renal failure, may occur after Optiray
  • 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.
  • 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 can occur 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 radiopaque agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule.
  • Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media (ICM) in pediatric patients 0 to 3 years of age.
  • Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure.
  • Hypertensive crisis has occurred after the use of iodinated radiopaque contrast agents in patient with
  • Iodinated contrast agents may promote sickling in individuals who are homozygous for sickle cell
  • Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent 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). Avoid administering Optiray to patients with a history of a severe cutaneous adverse reaction to Optiray.

 

Adverse Reactions

Clinical Trials Experience

  • In adults, the most common reaction is nausea, occurring at a rate of 1
  • In pediatric patients, the most common adverse reactions are nausea and

Postmarketing Experience

  • Adverse reactions include but are not limited to anaphylactic reactions, coronary artery spasm, cyanosis, arrhythmias, temporary blindness, conjunctivitis, tongue edema, seizures, respiratory arrest, bronchospasm, laryngeal spasm and thrombosis.

 

Use in Specific Populations

  • Pregnancy: Postmarketing data with Optiray use in pregnant women are insufficient to determine 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 in very low amounts with poor absorption from the gastrointestinal tract of the breastfed infant.
  • Pediatric Use: Safety and effectiveness in pediatric patients have been established for the use of Optiray 350 and Optiray 320 in angiocardiography; and for Optiray 320 in CT imaging of the head and body, and intravenous excretory urography. Safety and effectiveness of Optiray 300 have not been established in pediatric patients.
  • Geriatric The risk of adverse reactions to Optiray may be greater in patients with impaired renal

 

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.