OPTIRAY

What it is

OPTIRAY is a sterile, non-pyrogenic, aqueous solution intended for intravascular administration as a diagnostic radiopaque medium. The medicine contains ioversol as the active ingredient. OPTIRAY 320 provides 32% organically bound iodine (678 mg ioversol per millilitre), while OPTIRAY 350 provides 35% organically bound iodine (741 mg ioversol per millilitre).

Approved indications

— Adults: angiography throughout the cardiovascular system by conventional or digital subtraction techniques, including cerebral, coronary, peripheral, visceral and renal arteriography, aortography, left ventriculography and venography. — Adults: intravenous excretory urography. — Children (excluding neonates): angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography (OPTIRAY 320 only).

Dosing overview

Only the lowest dose necessary to obtain adequate visualisation should be used. Dosing varies significantly by procedure type and patient population.

Key safety warnings

Serious or fatal reactions have been associated with the administration of iodine-containing radiopaque media, and it is of utmost importance to be completely prepared to treat any contrast medium reactions. A fully equipped emergency cart and competent personnel should always be available, and emergency facilities should remain available for at least 30–60 minutes after administration since severe delayed reactions have been known to occur. Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetics and susceptible non-diabetics; patients should be well hydrated prior to and following OPTIRAY administration. Serious thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures; meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimise thromboembolic events. Contrast-induced encephalopathy may manifest with headache, visual disturbance, cortical blindness, confusion, seizures, loss of coordination, hemiparesis, aphasia, unconsciousness or coma, usually occurring within minutes to hours after administration and generally resolving within days; if encephalopathy is suspected, OPTIRAY must not be repeated. Severe cutaneous adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis and drug reaction with eosinophilia and systemic symptoms may develop from 1 hour to several weeks after administration.

Contraindications

Known hypersensitivity to ioversol or any excipients; manifest hyperthyroidism; thyrotoxicosis; anuria; decompensated cardiac insufficiency; and certain specific procedures and situations such as carotid artery angiography during the progressive period of stroke, coronary arteriography in the first four weeks after myocardial infarction and the presence of infection or open injury in or near the region to be examined.

Regulatory history

OPTIRAY 320 was first registered on the Australian Register of Therapeutic Goods on 10 September 1991. Additional presentations of OPTIRAY 320 and OPTIRAY 350 were registered from 1993 onwards, with the most recent registration (OPTIRAY 350 in 500 mL vials) occurring on 15 September 2020.