OPTIRAY 300 (ioversol)
Optiray 300 (ioversol) is a nonionic, radiographic contrast agent indicated for use in adult diagnostic imaging. For intra-arterial procedures, it is used in cerebral and peripheral arteriography. For intravenous procedures, it is indicated for CT imaging of the head and body, venography, and excretory urography. It enhances the visualization of vascular structures and internal organs by increasing the attenuation of X-rays.
How OPTIRAY 300 Works
Ioversol provides radiographic opacification of blood vessels along its flow path, permitting clear visualization of internal structures until significant hemodilution occurs. In general body imaging, the agent diffuses from the vascular space into the extravascular (interstitial) space. In the brain, the agent is normally excluded from the extravascular space by an intact blood-brain barrier; however, in areas where the barrier is disrupted, the contrast accumulates in the interstitial space, highlighting the site of pathology.
Details
- Status
- Prescription
- First Approved
- 1988-12-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OPTIRAY 300 Approval History
What OPTIRAY 300 Treats
8 indicationsOPTIRAY 300 is approved for 8 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cerebral Arteriography
- Peripheral Arteriography
- Visceral Arteriography
- Renal Arteriography
- Aortography
- Coronary Arteriography
- Left Ventriculography
- Angiocardiography
OPTIRAY 300 Boxed 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. [see Warnings and Precautions ( 5.1 )] WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRA-ARTERIAL AND INTRAVENOUS USE ONLY Inadvertent intrathecal administration may cause...
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. [see Warnings and Precautions ( 5.1 )] 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 )
OPTIRAY 300 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03631771 | GE-012-103/19476/OPY-44-002 | Ph 4 | withdrawn | Pediatric Risk of Hypothyroidism With Iodinated Contrast Media |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OPTIRAY 300 FDA Label Details
Indications & Usage
FDA Label (PDF)OPTIRAY 300 is indicated for the treatment of Cerebral Arteriography; Peripheral Arteriography; Visceral Arteriography; Renal Arteriography; Aortography; Coronary Arteriography; Left Ventriculography; Angiocardiography.
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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.