eptinezumab

Vyepti · ATC code N02CD

Key facts
Active substance
eptinezumab
Drug class
Antimigraine
ATC code
N02CD
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
VYEPTI 100 mg concentrate for solution for infusion. / VYEPTI 300 mg concentrate for solution for infusion.
Marketing authorisation holder
H. Lundbeck A/S
Information as of
2026-10-28

Key facts

Eptinezumab (Vyepti) is a monoclonal antibody against calcitonin gene-related peptide (CGRP) given by intravenous infusion for migraine prophylaxis in adults.

What it is used for

  • Prophylaxis of migraine in adults who have at least 4 migraine days per month.

Dosing

  • 100 mg by intravenous infusion every 12 weeks; some patients may benefit from 300 mg every 12 weeks.
  • The need for dose escalation should be assessed within 12 weeks of starting; a new dose regimen starts on the next scheduled dosing date.
  • Overall benefit should be assessed 6 months after starting.
  • Given only after dilution, as an infusion over approximately 30 minutes; not as a bolus injection. Infusions are started and supervised by a healthcare professional.
  • No dose adjustment in the elderly or in renal or hepatic impairment.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.

Important warnings

  • Serious hypersensitivity reactions including anaphylaxis may develop within minutes of the infusion; the infusion must be stopped immediately if a serious reaction occurs.
  • Limited safety data in patients with significant cardiovascular disease or cardiovascular risk factors, as such patients were excluded from studies.
  • Limited data in patients with neurological diseases or uncontrolled/untreated psychiatric conditions.

Side effects

  • Common: hypersensitivity reactions, infusion-related reactions, fatigue.
  • Uncommon: anaphylactic reaction.
  • Infusion site events were infrequent (< 1%).

Interactions

  • Not metabolised by cytochrome P450 enzymes; interactions with CYP substrates, inducers or inhibitors are considered unlikely.

Pregnancy and breastfeeding

  • As a precaution, it is preferable to avoid use during pregnancy; human IgG crosses the placenta.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • VyeptiH. Lundbeck A/S · EMEA/H/C/005287

Source: European Medicines Agency (EMA), product information

Brand names in 2 more European countries
Iceland
Vyepti
Norway
Vyepti

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

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Sources

  1. European Medicines Agency. Vyepti – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/vyepti-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC N02CD.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.