gadobutrol: clinical use

Prescribing considerations

• Use only when essential diagnostic information is unavailable from unenhanced MRI.
• Administration should be undertaken by healthcare professionals experienced in clinical MRI, with resuscitation facilities available.
• Carefully assess patients with severe renal impairment, perioperative liver transplantation, previous contrast reactions, asthma, allergic disorders, cardiovascular disease or a low seizure threshold.
• Use in neonates and infants requires particular consideration because renal function is immature.

Contraindications and cautions

• Hypersensitivity to gadobutrol or any excipient.
• Intrathecal administration is prohibited and has caused severe or fatal neurological reactions.

Monitoring

• Screen for renal dysfunction with laboratory testing before administration; this is particularly important in older people.
• Observe after administration because most hypersensitivity reactions occur early, while recognising that delayed reactions are possible.
• Monitor the injection site for extravasation, pain, redness or swelling.
• Record the exact product, batch and administered amount in the patient record.

Clinical pharmacology

Gadobutrol is a non-ionic macrocyclic extracellular contrast agent with negligible protein binding and no detected metabolism. It is eliminated unchanged, predominantly by glomerular filtration; clearance is delayed when renal function is impaired.

Formulation and product differences

• The selected product is a clear, colourless to pale-yellow 1.0 mmol/mL solution for intravenous injection.
• It is supplied in glass or plastic prefilled syringes and injector cartridges.
• Containers are intended for single use; unused solution from an examination must be discarded.
• The formulation is essentially sodium-free and must not be mixed with other medicines.

Injection

Route: Parenteral

Strengths: 1.0 mmol/mL