ULTRAVIST

What it is

Ultravist is iopromide, a triiodinated, non-ionic, water-soluble X-ray contrast medium. It is available in four strengths: Ultravist 150 (150 mg iodine per mL), Ultravist 240 (240 mg iodine per mL), Ultravist 300 (300 mg iodine per mL), and Ultravist 370 (370 mg iodine per mL). Ultravist is supplied as a clear, colourless to pale yellow solution for injection or infusion, free of particles.

Approved indications

— Angiographic examinations — Urographic examinations — Contrast enhancement in computerised tomography — Contrast-enhanced mammography in adults (Ultravist 300 or 370) to visualise known or suspected lesions of the breast as an adjunct to mammography — Lumbar myelography in adults (Ultravist 240)

Dosing overview

Dosage should be adapted to age, weight, clinical question and examination technique, with recommended doses representing common doses for an average normal adult weighing 70 kg. Generally, doses of up to 1.5 g iodine per kg body weight are well tolerated. For intravenous urography in adults, the dose should be 300 mg iodine per kg body weight. For children undergoing intravenous urography, newborns require 1.2 g iodine per kg body weight, infants aged 1 month to 2 years require 1.0 g iodine per kg body weight, and children aged 2 to 11 years require 0.5 g iodine per kg body weight. For whole-body computerised tomography, Ultravist 300 is administered at 0.5–1.5 mL per kg body weight. For contrast-enhanced mammography in adults, Ultravist 300 or 370 is given at 1.5 mL per kg body weight. For myelography, the recommended dose is up to 12.5 mL of Ultravist 240, which corresponds to a total iodine dose of 3 g and should not be exceeded.

Key safety warnings

Ultravist can be associated with anaphylactoid or hypersensitivity reactions characterised by cardiovascular, respiratory and cutaneous manifestations, with allergy-like reactions ranging from mild to severe reactions including shock being possible. Most reactions occur within one hour of administration, although delayed reactions after hours to days may occur. The risk of hypersensitivity reactions is higher in patients with a previous reaction to contrast media or a history of bronchial asthma or other allergic disorders. Particularly careful risk–benefit judgement is required in patients with known or suspected hyperthyroidism or goitre, as iodinated contrast media may induce hyperthyroidism or thyreotoxic crisis in these patients, and should not be given to patients with manifest hyperthyroidism. In neonates, especially preterm infants, exposed to Ultravist through the mother during pregnancy or in the neonatal period, it is recommended to monitor thyroid function, as exposure to excess iodine may cause hypothyroidism. Post-contrast acute kidney injury may occur after intravascular administration of Ultravist, presenting as a transient impairment of renal function, and acute renal failure may occur in some cases. Risk factors for post-contrast acute kidney injury include pre-existing renal insufficiency, dehydration, diabetes mellitus, multiple myeloma, gout, age over 70 years, concurrent administration of nephrotoxic drugs, and repetitive or large doses. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures, and meticulous intravascular administration technique is necessary to minimise such events. Patients with significant cardiac disease or severe coronary artery disease are at increased risk of developing clinically relevant haemodynamic changes and arrhythmia, and in patients with valvular disease and pulmonary hypertension, contrast medium administration may lead to pronounced haemodynamic changes.

Contraindications

Ultravist should not be administered to patients with known hypersensitivity or previous reaction to iodinated contrast media or any excipients. Immediate repeat myelography in the event of technical failure is contraindicated because of overdosage considerations. Ultravist 300 and Ultravist 370 are contraindicated for intrathecal use.

Regulatory history

Ultravist 240, Ultravist 370 and Ultravist 300 (50 mL bottles) were first listed on the Australian Register of Therapeutic Goods on 12 September 1991. Additional presentations of Ultravist 300 (20 mL vials) and Ultravist 300 (100 mL bottles) were registered on 4 January 1994 and 8 June 1994 respectively, alongside further presentations of Ultravist 150, Ultravist 240, and Ultravist 370. Ultravist 370 (500 mL bottles) was registered on 22 September 2020.