Section 02 · Monograph

Eptinezumab

Reviewed Nov 2026FDA label

VyeptiCGRP mAb · IV infusion

Indications

Humanized IgG1 monoclonal antibody that binds calcitonin gene-related peptide (CGRP) ligand
Blocks binding of CGRP to its receptor, a pathway implicated in migraine pathophysiology
Administered directly by IV infusion, producing immediate maximal plasma concentrations rather than the gradual absorption seen with subcutaneous anti-CGRP antibodies
Elimination half-life of approximately 27 days, supporting quarterly dosing

100 mg administered by intravenous infusion once every 3 months; some patients may benefit from 300 mg every 3 months
Administered by a healthcare provider as an IV infusion over approximately 30 minutes
Dilute in 100 mL of 0.9% Sodium Chloride Injection only, using a polyvinyl chloride, polyethylene, or polyolefin infusion bag
Infuse through a line containing a 0.2 or 0.22 micron in-line or add-on filter
Do not administer as an intravenous push or bolus
Infuse the diluted solution within 8 hours of preparation if kept at room temperature; do not freeze or shake
No other medications should be injected into the infusion set side port or mixed with VYEPTI

Serious hypersensitivity to eptinezumab-jjmr or to any excipient, including reactions involving anaphylaxis and angioedema

Not metabolized via cytochrome P450 pathways; low potential for drug-drug interactions
Coadministration with sumatriptan did not significantly alter the pharmacokinetics of either drug
No other medication should be administered through the same infusion line or mixed with VYEPTI

Nasopharyngitis (~6-8% vs 6% placebo)
Hypersensitivity reactions including angioedema, urticaria, facial flushing, dyspnea, and rash — most occur during the infusion
Postmarketing reports: anaphylaxis, fatigue, hypertension, Raynaud's phenomenon
Approximately 1.9% of trial patients discontinued therapy due to adverse reactions

Observe patients during infusion for signs of hypersensitivity; have treatment for anaphylaxis available
Monitor blood pressure, particularly within the first week after dosing, for new-onset or worsening hypertension
Screen for Raynaud's phenomenon, especially in patients with a prior history
Monitor for reduced efficacy suggestive of anti-drug antibody development (detected in 18-20.6% of patients in trials)

A pregnancy exposure registry is available (1-855-810-8549; www.vyeptipregnancyregistry.lundbeck.com)
No adequate data on developmental risk associated with use in human pregnancy
Animal studies in rats and rabbits at doses ~30 times the maximum recommended human dose showed no adverse developmental effects
No data on presence in human milk, effects on the breastfed infant, or effects on milk production