Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.
OptiMARK (Mallinckrodt)
0.5 mmol/mL solution in 10 mL, 15 mL, 20 mL or 30 mL
pre-filled syringes and vials containing 5 mL, 10 mL, 15 mL or 20 mL
Approved indication: magnetic resonance imaging
Gadoversetamide is an injectable contrast medium. It can enhance the signal intensity during magnetic resonance imaging (MRI) of intracranial and spinal lesions when the blood-brain barrier is abnormal. The medium can also be used when imaging the liver.
An injection of gadoversetamide is given not more than an hour before the MRI. The medium is distributed into the extra cellular fluid space. Most of the dose is excreted unchanged in the urine within 24 hours.
Clinical trials have compared gadoversetamide with gadopentetate dimeglumine, another gadolinium-containing medium. The image enhancement was considered to be equivalent.
Approximately 30% of patients experience an adverse effect after receiving gadoversetamide. They may complain of headache, altered taste, dizziness and nausea. The use of this contrast medium has not been studied in patients with renal impairment.
