gadoteridol: clinical use

Prescribing considerations

• Use only where essential diagnostic information is unavailable from unenhanced MRI.
• Screen for renal dysfunction, particularly in older people, severe renal impairment and the perioperative liver-transplantation period.
• Assess previous gadolinium or contrast reactions, allergy history, epilepsy or brain lesions, pregnancy and immature renal function in infants.
• Ensure trained staff and facilities for immediate management of hypersensitivity, anaphylaxis and convulsions are available.
• Avoid extravasation and document the product, batch and administered amount.

Contraindications and cautions

• Hypersensitivity to gadoteridol, any listed excipient or another gadolinium-based contrast agent.
• Severe renal impairment or use around liver transplantation requires careful individual benefit–risk assessment rather than routine administration.
• Whole-body MRI is not recommended below 18 years for the selected prefilled-syringe product.

Monitoring

• Assess renal function before administration.
• Observe for immediate hypersensitivity, cardiovascular, respiratory or mucocutaneous reactions during and after administration as clinically appropriate.
• Monitor higher-risk patients for convulsions and assess the injection site for extravasation.
• In severe renal impairment, remain alert to acute kidney injury and the rare possibility of nephrogenic systemic fibrosis.

Clinical pharmacology

Gadoteridol is a non-ionic paramagnetic macrocyclic extracellular contrast agent. It shortens T1 relaxation time, has no detectable biotransformation and is eliminated essentially unchanged through glomerular filtration.

Formulation and product differences

• The selected product is a sterile intravenous solution in Type I glass prefilled syringes with rubber stoppers and polypropylene plunger rods.
• Excipients include calteridol calcium, tromethamine, hydrochloric acid, sodium hydroxide and water for injections.
• It must not be mixed with another medicine. Frozen syringes should be discarded and the product protected from light.