Optiray 350

OPTIRAY 350- ioversol injection
OPTIRAY 320- ioversol injection
OPTIRAY 300- ioversol injection
Liebel-Flarsheim Company LLC

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 [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

OPTIRAY is indicated for:

1.1 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.

1.2 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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

  • OPTIRAY is for intravascular use only [see Boxed Warning, Contraindications (4), Warnings and Precautions (5.1)].
  • 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 [see Warnings and Precautions (5.6)].
  • Hydrate patients before and after OPTIRAY administration [see Warnings and Precautions (5.3)].

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).

2.2 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):

Diagnostic area Dose Maximum Cumulative Dose
carotid or vertebral arteries 2 to 12 mL 200 mL

aortic arch injection

(four vessel study)

20 to 50 mL 200 mL
  • 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):

Diagnostic area Dose Maximum Cumulative Dose
aorta-iliac runoff 60 mL (range 20 to 90 mL) 250 mL
common iliac, femoral 40 mL (range 10 to 50 mL) 250 mL
subclavian, brachial 20 mL (range 15 to 30 mL) 250 mL
  • 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):

Diagnostic area Dose Maximum Cumulative Dose
aorta 45 mL (range 10 to 80 mL) 250 mL
celiac 45 mL (range 12 to 60 mL) 250 mL
superior mesenteric 45 mL (range 15 to 60 mL) 250 mL
renal or inferior mesenteric 9 mL (range 6 to 15 mL) 250 mL
  • 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):

Diagnostic area Dose Maximum Cumulative Dose
left coronary 8 mL (range 2 to 10 mL) 250 mL
right coronary 6 mL (range 1 to 10 mL) 250 mL
left ventricle 40 mL (range 30 to 50 mL) 250 mL

2.3 Intravenous Procedures in Adults

  • Computed Tomography

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

Head ImagingThe recommended dosing is shown below:

  • Scan immediately after completion of the intravenous administration.

Infusion

OPTIRAY 300 50 to 150 mL
OPTIRAY 320 50 to 150 mL
OPTIRAY 350 50 to 150 mL

Body ImagingOPTIRAY 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

Bolus Injection

Infusion

OPTIRAY 300 25 to 75mL 50 to 150 mL
OPTIRAY 320 25 to 75mL 50 to 150 mL
OPTIRAY 350 25 to 75mL 50 to 150 mL
  • 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:

Usual Dose

High Dose Urography

Maximum Dose

OPTIRAY 300 50 to 75mL 1.6 mL/kg 150 mL
OPTIRAY 320 50 to 75mL 1.5 to 2 mL/kg 150 mL
OPTIRAY 350 50 to 75mL 1.4 mL/kg 150 mL
  • 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.

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