OMNISCAN

What it is

OMNISCAN is an injectable, non-ionic, linear, paramagnetic, extracellular enhancing agent for magnetic resonance imaging. It is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide. OMNISCAN is administered by intravenous injection. Each mL contains 287 mg gadodiamide.

Approved indications —

Enhancement of magnetic resonance images of intracranial and spinal lesions in adults and children, including infants and neonates less than 6 months of age, where there is an abnormal blood-brain barrier or abnormal vascularity. — Whole body imaging for adults and children over 6 months of age.

Dosing overview

For central nervous system MRI in adults and children (including neonates and infants), the recommended dosage of OMNISCAN is 0.2 mL/kg body weight (0.1 mmol/kg body weight) up to 100 kg. Above 100 kg body weight, 20 mL is usually sufficient to provide diagnostically adequate contrast. When brain metastases are suspected in adults, a dosage of 0.6 mL/kg body weight (0.3 mmol/kg body weight) can be administered up to 100 kg. Above 100 kg body weight, a total dose of up to 60 mL is recommended. For whole body MRI in adults, the recommended dosage is usually 0.2 mL/kg body weight (0.1 mmol/kg body weight) up to 100 kg body weight. Above 100 kg body weight, 20 mL is usually sufficient to provide diagnostically adequate contrast. For children from 6 months of age, the recommended dosage is 0.2 mL/kg body weight (0.1 mmol/kg body weight). The required dose should be administered as a single intravenous injection, followed by a 5 mL sodium chloride 0.9% flush.

Key safety warnings

OMNISCAN increases the risk for nephrogenic systemic fibrosis in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73 m²), or acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period. Nephrogenic systemic fibrosis is a debilitating and sometimes fatal disease affecting the skin, muscle and internal organs. Trace amounts of gadolinium are retained in the brain (particularly in the dentate nucleus and globus pallidus), and in other tissues for months to years after administration. Increased signal intensity on non-contrast T1 weighted images of the brain has been observed after multiple administrations even in patients with normal renal function. The clinical significance of gadolinium retention in the brain is presently unknown. Patients requiring multiple lifetime doses, pregnant and paediatric patients may be at higher risk. To minimise potential risks, it is recommended to use the lowest effective dose and to perform a careful benefit-risk assessment before administering repeated doses. Gadodiamide must not be used intrathecally. Serious, life-threatening and fatal cases, primarily with neurological reactions such as coma, encephalopathy and seizures, have been reported with intrathecal use.

Contraindications

OMNISCAN is contraindicated in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73 m²), and in patients with renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period. OMNISCAN is contraindicated in patients with acute kidney injury and in neonates up to 4 weeks of age. OMNISCAN should not be used in patients with known hypersensitivity to OMNISCAN or its constituents.

Regulatory history

OMNISCAN gadodiamide injection was first registered on the ARTG on 16 December 1993. The date of TGA approval was 31 May 2004. The product information was revised on 29 August 2024, with inclusion of information on intrathecal use.