Teprotumumab: clinical use

Prescribing considerations

• Specialist initiation and supervision are required, with facilities to manage serious infusion reactions.
• Assess glycaemic status and ensure pre-existing diabetes or hyperglycaemia is appropriately controlled.
• Carefully consider benefit and risk in pre-existing hearing impairment or inflammatory bowel disease.
• Record the product name and batch number for traceability.
• Safety and efficacy have not been established in patients younger than 18 years.

Contraindications and cautions

• Pregnancy
• Hypersensitivity to teprotumumab or any excipient

Monitoring

• Blood glucose and symptoms of hyperglycaemia before, during and after treatment.
• Hearing before, during and after treatment; reassess continuation if severe impairment develops.
• Infusion-related reactions during and after administration.
• Diarrhoea, abdominal pain, rectal bleeding and other evidence of inflammatory bowel disease exacerbation.

Clinical pharmacology

A fully human IgG1 monoclonal antibody that binds IGF-1R and blocks receptor activation and signalling. It is expected to be cleared through proteolytic catabolism rather than conventional hepatic drug-metabolising pathways.

Formulation and product differences

• White to off-white lyophilised powder for intravenous infusion.
• Requires reconstitution with water for injections and further dilution in sodium chloride infusion solution by a healthcare professional.
• Contains polysorbate 20, which may cause allergic reactions, and contains no preservative.

Solution for infusion

Route: Intravenous

Strengths: 500 mg