gadoterate meglumine: clinical use

Prescribing considerations

• Use only when essential diagnostic information is unavailable from unenhanced MRI.
• Administration requires trained staff, maintained venous access and immediate access to resuscitation facilities.
• Assess previous gadolinium reactions, uncontrolled asthma, allergy history, seizure susceptibility and severe cardiovascular disease.
• In severe renal impairment or around liver transplantation, use only after careful benefit–risk assessment when contrast information is essential.
• Exercise particular caution in neonates and infants because renal function is immature.

Contraindications and cautions

• Hypersensitivity to gadoterate meglumine or an excipient.
• Intrathecal administration is prohibited because serious and fatal neurological reactions have occurred.

Monitoring

• Screen renal function before administration, particularly in older adults and other at-risk patients.
• Observe for immediate hypersensitivity and assess reported delayed skin reactions.
• Monitor the injection site for extravasation.
• Record the exact product and batch in the patient record.
• Do not start haemodialysis solely to prevent or treat nephrogenic systemic fibrosis; existing haemodialysis may remove gadoterate.

Clinical pharmacology

Gadoterate is an ionic macrocyclic gadolinium chelate with paramagnetic MRI contrast effects. It does not bind appreciably to plasma proteins, is not metabolised and is eliminated unchanged by glomerular filtration; clearance is prolonged when renal function is impaired.

Formulation and product differences

• The selected product is a clear, colourless to slightly yellow intravenous solution supplied in single-use vials or bottles.
• It contains meglumine, tetraxetan and water for injections and should not be mixed with other medicines without compatibility data.

Injection

Route: Parenteral

Strengths: 0.5 mmol/mL