eptinezumab: clinical use

Prescribing considerations

• Initiation and infusion supervision should be by healthcare professionals experienced in migraine diagnosis and treatment.
• Take a detailed history for hereditary fructose intolerance because the formulation contains sorbitol.
• Safety data are limited in clinically significant cardiovascular disease and some uncontrolled or untreated neurological or psychiatric conditions because these groups were excluded from trials.

Contraindications and cautions

• Hypersensitivity to eptinezumab or any formulation excipient.
• Do not administer to a person with hereditary fructose intolerance unless strictly necessary after individual assessment.

Monitoring

• Observe during and after infusion for hypersensitivity and infusion-related reactions.
• Stop administration immediately and treat appropriately if a serious hypersensitivity reaction occurs.
• Record the product name and batch number for biological-medicine traceability.
• Use migraine records or a headache diary to assess benefit and tolerability.

Clinical pharmacology

Eptinezumab is a humanised IgG1 monoclonal antibody that binds alpha- and beta-CGRP ligands and prevents CGRP-receptor activation. Intravenous bioavailability is complete. It is expected to undergo proteolytic degradation to peptides and amino acids, with an average terminal elimination half-life of about 27 days.

Formulation and product differences

• Sterile concentrate for intravenous infusion that requires dilution before administration.
• The preparation is single-use, contains no preservative and requires a suitable in-line filter.
• No oral or patient-administered formulation is represented.

Solution for infusion

Route: Intravenous

Strengths: 100 mg