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nipocalimab

Imaavy · ATC code L04AL03

Also known as: Nipokalimab

Key facts
Active substance
nipocalimab
Drug class
Immunosuppressive drug
ATC code
L04AL03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Imaavy 185 mg/mL concentrate for solution for infusion
Marketing authorisation holder
Janssen Cilag International NV
Information as of
2026-10-29

Key facts

Nipocalimab is an antibody against the neonatal Fc receptor (FcRn) that lowers IgG levels. It is used as add-on to standard therapy for generalised myasthenia gravis from 12 years of age.

What it is used for

  • Add-on to standard therapy for generalised myasthenia gravis (gMG) in adults and adolescents aged 12 years and older who are anti-acetylcholine receptor (AChR) or anti-MuSK antibody positive (Imaavy).

Dosing

  • Intravenous infusion by a healthcare professional, with filtration, after dilution in sodium chloride solution; not as a push or bolus.
  • Adults and adolescents 12 years and older: single initial dose 30 mg/kg (over about 30 minutes), then maintenance 15 mg/kg every 2 weeks (over about 15 minutes).
  • A missed infusion should be given as soon as possible, then every 2 weeks again.
  • No dose adjustment in the elderly or in renal or hepatic impairment. Monitor for 30 minutes after each infusion.

Contraindications

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

Important warnings

  • Not studied in myasthenic crisis (MGFA Class V).
  • Infusion-related and hypersensitivity reactions (including headache, rash, urticaria); one case of anaphylaxis has been reported.
  • Increased plasma lipids are very common.
  • Increased risk of infection (e.g. herpes zoster): delay starting or withhold treatment during active infection.
  • Live or live-attenuated vaccines not recommended; if needed, give at least 4 weeks before starting or at least 2 weeks after the last dose.

Side effects

  • Most common: muscle spasms (12%) and peripheral oedema (12%).
  • Very common: lipids increased, decreased serum albumin.
  • Common: herpes zoster, urinary tract infection, lower respiratory tract infection, insomnia, dizziness, diarrhoea, abdominal pain, nausea.

Interactions

  • Likely to reduce exposure to medicines that bind FcRn (IgG products, IgG-based monoclonal antibodies, Fc fusion proteins); e.g. fremanezumab AUC was reduced by 66%.

Pregnancy and breastfeeding

  • Limited data in pregnancy; see the full text for pregnancy and breast-feeding information.

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)

  • ImaavyJanssen Cilag International NV · EMEA/H/C/006379

Source: European Medicines Agency (EMA), product information

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

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.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Imaavy – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/imaavy-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC L04AL.

Editorial: Medelix editorial team · last updated 2026-10-29 · 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.