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efgartigimod alfa

Vyvgart · ATC code L04AA58

Key facts
Active substance
efgartigimod alfa
Drug class
Immunosuppressive drug
ATC code
L04AA58
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Vyvgart 20 mg/mL concentrate for solution for infusion · Vyvgart 1 000 mg solution for injection / Vyvgart 1 000 mg solution for injection in pre-filled syringe
Marketing authorisation holder
Argenx
Information as of
2026-10-27

Key facts

Efgartigimod alfa (Vyvgart) is an antibody fragment that blocks the neonatal Fc receptor (FcRn), transiently lowering IgG levels. It is used in generalised myasthenia gravis and in CIDP.

What it is used for

  • Generalised myasthenia gravis in adults who are anti-AChR antibody positive, as add-on to standard therapy (infusion and subcutaneous injection)
  • Subcutaneous injection only: monotherapy of progressive or relapsing active CIDP in adults after prior corticosteroids or immunoglobulins

Dosing

  • Infusion concentrate (gMG): 10 mg/kg as a 1-hour infusion once weekly for 4 weeks per cycle; patients 120 kg or more receive 1,200 mg per infusion
  • Subcutaneous injection (gMG): 1,000 mg once weekly for 4 weeks per cycle
  • Subsequent cycles per clinical evaluation; earliest next cycle in trials was 7 weeks after the start of the previous one
  • Subcutaneous injection (CIDP): 1,000 mg once weekly, may be adjusted to every other week based on clinical evaluation
  • No dose adjustment from 65 years, in mild renal impairment or in hepatic impairment
  • Keep at least 3 days between two consecutive doses

Contraindications

  • Hypersensitivity to the active substance or any of the excipients

Important warnings

  • Increased infection risk from transient IgG reduction; consider delaying treatment during serious infections
  • Infusion, injection and hypersensitivity reactions including anaphylaxis
  • Not studied in myasthenic crisis (MGFA Class V)
  • Record name and batch number of the biological product

Side effects

  • Infusion: upper respiratory tract infections (10.7%) and urinary tract infections (9.5%) most frequent
  • Subcutaneous: additionally injection site reactions (33%)
  • Common: bronchitis, nausea, myalgia, procedural headache
  • Anaphylactic reaction (frequency not known)

Interactions

  • May lower levels of immunoglobulins, monoclonal antibodies and Fc-containing products; start these preferably 2 weeks after the last dose
  • Plasma exchange, immunoadsorption and plasmapheresis reduce efgartigimod alfa levels
  • Vaccines according to immunisation guidelines

Pregnancy and breastfeeding

  • No pregnancy data; reduced passive protection of the newborn is anticipated, so live vaccines in exposed infants need benefit-risk consideration

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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

Package leaflet for patients →

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)

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Vyvgart
Liechtenstein
Vyvgart
Norway
Vyvgart

EMA – Article 57 product data (EU/EEA), 2026-10-28

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

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Sources

  1. European Medicines Agency. Vyvgart – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/vyvgart-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC L04AA.

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.