Optiray (ioversol)

Optiray (ioversol) is a radiopaque contrast agent that contains iodine, a substance that absorbs x-rays, and is used to help diagnose certain disorders of the heart.

Common side effects of Optiray include

• fever,
• warmth and pain at the injection site,
• skin rash or redness,
• headache, or
• nausea.

Some side effects of Optiray can occur up to 24 hours after receiving the medication.

Optiray 350
[Ioversol Injection 74%]

Optiray 320
[Ioversol Injection 68%]

Optiray 300
[Ioversol Injection 64%]

Optiray 240
[Ioversol Injection 51%]

Indications

Optiray is indicated for:

Intra-arterial

In Adults

• Optiray 300: cerebral arteriography, and 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.

In Pediatric Patients

• Optiray 320 and Optiray 350: angiocardiography.

Intra-Venous

In Adults

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

In Pediatric Patients

• Optiray 320: CT imaging of the head and body, and intravenous excretory urography.

Dosage and Administration

Important Dosage And Administration Instructions

• Optiray is for intravascular use only.
• Use sterile technique for all handling and administration of Optiray.
• Inspect glass container prior to use for breakage or other damage and do not use damaged containers.
• Warm Optiray and administer at body or room temperature.
• Inspect Optiray for particulate matter or discoloration before administration. Do not administer if Optiray contains particulate matter or is discolored.
• Do not mix Optiray with other drugs, solutions or total parenteral nutrition mixtures.
• Use the lowest dose necessary to obtain adequate visualization.
• Adjust the volume and concentration of Optiray. Modify the dose accounting for factors such as age, body weight, vessel size, blood flow rate within the vessel,  anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
• Avoid extravasation when injecting Optiray; especially in patients with severe arterial or venous disease.
• Hydrate patients before and after Optiray administration.

Directions For Proper Use Of Optiray Pharmacy Bulk Package

• The Pharmacy Bulk Package is not for direct infusion.
• Penetrate the container closure only one time, utilizing a suitable sterile transfer device or dispensing set which allows measured distribution of the contents.
• Transfer Optiray from the Pharmacy Bulk Package only in a suitable work area, such as a laminar flow hood, utilizing aseptic technique.
• Withdraw container contents immediately. However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations.
• Temperature of container after the closure has been entered should not exceed 25°C (77°F).

Intra-arterial Procedures In Adults

Cerebral Arteriography

Use Optiray 300 or Optiray 320. The recommended dose for visualization of cerebral arteries is shown below (may repeat as necessary):

Peripheral Arteriography

Use Optiray 300, Optiray 320 or Optiray 350. The recommended dose for visualization of peripheral arteries is shown below (may repeat as necessary):

Visceral And Renal Arteriography And Aortography

Use Optiray 320. The recommended dose for visualization for the aorta and visceral arteries is shown below (may repeat as necessary):

Coronary Arteriography And Left Ventriculography

Use Optiray 320 or Optiray 350. The recommended dose for visualization of the coronary arteries and left ventricle is shown below (may repeat as necessary):

Intravenous Procedures In Adults

Computed Tomography

Use Optiray 300, Optiray 320 or Optiray 350 for head and body imaging.

Head Imaging

The recommended dosing is shown below:

• Scan immediately after completion of the intravenous administration.

Body Imaging

Optiray may be administered by bolus injection, by rapid infusion, or by a combination of both. The recommended dosing is shown below:

• Scanning interval will vary with indication and target organ

Venography

Use Optiray 300, Optiray 320 or Optiray 350. The recommended dose is 50 to 100 mL per extremity; with a maximum cumulative dose of 250 mL.

Intravenous Urography

Use Optiray 350, Optiray 320, or Optiray 300. The recommended dose is shown below:

Intravenous Digital Subtraction Angiography (IV-DSA)

Use Optiray 350. The recommended dose range per injection is 30 to 50 mL; may repeat as necessary with a maximum cumulative dose of 250mL.

Injection rates will vary depending on the site of catheter placement and vessel size.

• Central catheter injections are usually made at a rate of between 10 and 30 mL/second.
• Peripheral injections are usually made at a rate of between 12 and 20 mL/second.

Pediatric Dosing

Intra-arterial Procedures

Angiocardiography

Use Optiray 350 or Optiray 320. The recommended single ventricular dose is 1.25 mL/kg (range 1 mL/kg to 1.5 mL/kg). The maximum cumulative dose is 5 mL/kg up to a maximum total volume of 250 mL.

Intravenous Procedures

Computed Tomography

Use Optiray 320.

Head And Body Imaging

The recommended dose in pediatric patients is 1.5 mL/kg to 2 mL/kg (range 1 mL/kg to 3 mL/kg).

Intravenous Urography

Use Optiray 320. The recommended dose for pediatric patients is 1 mL/kg to 1.5 mL/kg (range 0.5 mL/kg to 3 mL/kg); with a maximum cumulative dose not exceeding 3 mL/kg.

How Supplied

Dosage Forms And Strengths

Injection: clear, colorless to pale yellow solutions containing no undissolved solids, available in a pharmacy bulk package multiple-dose container in the following strengths:

• OPTIRAY 300 (Ioversol 64%): 300 mg of organically bound iodine per mL (636 mg of ioversol per mL)
• OPTIRAY 320 (Ioversol 68%): 320 mg of organically bound iodine per mL (678 mg of ioversol per mL)
• OPTIRAY 350 (Ioversol 74%): 350 mg of organically bound iodine per mL (741 mg of ioversol per mL)

Drug-Drug Interactions

Metformin

• In patients with renal impairment, metformin can cause lactic acidosis.
• Iodinated contrast agents appear to increase the risk of metformin induced lactic acidosis, possibly as a result of worsening renal function.
• Stop metformin at the time of, or prior to, Optiray administration in patients with an eGFR between 30 and 60 mL/min/1.73 m²; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast agents.
• Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute only after renal function is stable.

Radioactive Iodine

• Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I-131) and decrease therapeutic efficacy in patients with carcinoma of the thyroid. The decrease in efficacy lasts for 6-8 weeks.

Oral Cholecystographic Contrast Agents

• Renal toxicity has been reported in patients with liver impairment who were given oral cholecystographic agents followed by intravascular contrast agents.
• Administration of Optiray should be postponed in patients who have recently received a cholecystographic contrast agent.

Drug/Laboratory Test Interactions

Protein-Bound Iodine, Radioactive Iodine Determinations

• The results of protein bound iodine and radioactive iodine uptake studies, which depend on iodine estimation, will not accurately reflect thyroid function for up to 16 days following administration of iodinated contrast agent.
• However, thyroid function tests that do not depend on iodine estimations, e.g., T3 resin uptake and total or free thyroxine (T4) assays are not affected.

• Postmarketing data with Optiray use in pregnant women are insufficient to determine if there is a risk of drug-associated adverse developmental outcomes.
• Ioversol crosses the placenta and reaches fetal tissues in small amounts.
• 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.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Optiray and any potential adverse effects on the breastfed infant from Optiray or from the underlying maternal condition.