Optiray<sup>®</sup> (ioversol) Injection

Optiray® (ioversol) Injection

Important Safety Information

WARNING: NOT FOR INTRATHECAL USE

Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

 

Important Safety Information (Continued)

Adult Indications 

  Optiray 240 Optiray 300 Optiray 320* Optiray 350
Intra-arterial Procedure        
Cerebral Arteriography X X X  
Peripheral Arteriography   X X X
Visceral Arteriography     X  
Renal Arteriography     X  
Aortography     X  
Coronary Arteriography     X X
Left Ventriculography     X X
Intravenous Procedures        
CT Imaging of the Head and Body X X X X
Venography X X X X
Excretory Urography X X X X
Digital Subtraction Angiography (IV-DSA)       X

*Optiray 320 is indicated in adults for angiography throughout the cardiovascular system. The uses included those marked above.

Pediatric Indications 

  Optiray 240 Optiray 300 Optiray 320* Optiray 350
Intra-arterial Procedure        
Angiocardiography     X X
Intravenous Procedures        
CT Imaging of the Head and Body     X  
Excretory Urography     X  

 

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 other hypersensitivities.
  • 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 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.
  • Hypertensive crisis has occurred after the use of iodinated radiopaque contrast agents in patient 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 StevensJohnson 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. Avoid administering Optiray to patients with a history of a severe cutaneous adverse reaction to Optiray.

Adverse Reactions 

  • The most common reaction is nausea, occurring at a rate of 1 percent.
  • Serious adverse reactions have been reported during post-approval use of Optiray. These serious adverse reactions include but are not limited to: anaphylactic reactions, arrhythmias, temporary blindness, 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 computed tomographic imaging of the head and body, and intravenous excretory urography. Safety and effectiveness of Optiray 240/300 have not been established in pediatric patients.

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.

 

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

Packaging 

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 300 636 300 651 8.2 5.5 1.352
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)

OptiRay 300

Glass Plastic RFID-Tagged Syringes*
  • 25x50 mL bottles (NDC 0019-1332-06)
  • 12x100 mL bottles (NDC 0019-1332-11)
  • 12x150 mL bottles (NDC 0019-1332-16)
  • 12x200 mL fill/250 mL bottles (NDC 0019-1332-21)
  • 6x500 mL fill/500 mL bottles (NDC 0019-1332-61)
  • 20x100 mL fill/125 mL power injector syringes (NDC 0019-1332-90)
  • 20x100 mL fill/125 mL power injector syringes (NDC 0019-1332-00)

*Radio Frequency Identification (RFID) Technology

Important Safety Information 

WARNING: NOT FOR INTRATHECAL USE

Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

 

Adult Indications 

  Optiray 240 Optiray 300 Optiray 320* Optiray 350
Intra-arterial Procedure        
Cerebral Arteriography X X X  
Peripheral Arteriography   X X X
Visceral Arteriography     X  
Renal Arteriography     X  
Aortography     X  
Coronary Arteriography     X X
Left Ventriculography     X X
Intravenous Procedures        
CT Imaging of the Head and Body X X X X
Venography X X X X
Excretory Urography X X X X
Digital Subtraction Angiography (IV-DSA)       X

*Optiray 320 is indicated in adults for angiography throughout the cardiovascular system. The uses included those marked above.

Pediatric Indications 

  Optiray 240 Optiray 300 Optiray 320* Optiray 350
Intra-arterial Procedure        
Angiocardiography     X X
Intravenous Procedures        
CT Imaging of the Head and Body     X  
Excretory Urography     X  

 

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 other hypersensitivities.
  • 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 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.
  • Hypertensive crisis has occurred after the use of iodinated radiopaque contrast agents in patient 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 StevensJohnson 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. Avoid administering Optiray to patients with a history of a severe cutaneous adverse reaction to Optiray.

Adverse Reactions 

  • The most common reaction is nausea, occurring at a rate of 1 percent.
  • Serious adverse reactions have been reported during post-approval use of Optiray. These serious adverse reactions include but are not limited to: anaphylactic reactions, arrhythmias, temporary blindness, 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 computed tomographic imaging of the head and body, and intravenous excretory urography. Safety and effectiveness of Optiray 240/300 have not been established in pediatric patients.

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.

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; 2017.

 

GU05201138