MedeliX
Start asking

inebilizumab

Uplizna · ATC code L04AA

Also known as: İnebilizumab

Key facts
Active substance
inebilizumab
Drug class
Immunosuppressive drug
ATC code
L04AA
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Uplizna 100 mg concentrate for solution for infusion
Marketing authorisation holder
Amgen Europe B.V.
Information as of
2026-10-28

Key facts

Inebilizumab (Uplizna) is a CD19-directed, B-cell-depleting monoclonal antibody used in adults with NMOSD, IgG4-related disease and generalised myasthenia gravis.

What it is used for

  • Monotherapy for adults with neuromyelitis optica spectrum disorders (NMOSD) who are AQP4-IgG seropositive.
  • Adults with active IgG4-related disease (IgG4-RD).
  • Add-on to standard therapy in adults with generalised myasthenia gravis who are anti-AChR or anti-MuSK antibody positive.

Dosing

  • Loading: 300 mg (3 vials of 100 mg) by intravenous infusion, followed 2 weeks later by a second 300 mg infusion.
  • Maintenance: 300 mg intravenously every 6 months (chronic treatment); in IgG4-RD, treatment beyond 52 weeks is guided by disease activity.
  • Premedication before each infusion: corticosteroid (e.g. methylprednisolone 80-125 mg IV) about 30 minutes before, plus antihistamine and antipyretic 30-60 minutes before; monitor for at least one hour after the infusion.
  • Before starting: immunoglobulins, B-cell and blood counts, hepatitis B and C screening and tuberculosis testing; live or live-attenuated vaccines at least 4 weeks before.
  • Elderly: no dose adjustment.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Severe active infection, including active chronic infection such as hepatitis B; active or untreated latent tuberculosis.
  • History of progressive multifocal leukoencephalopathy (PML); severely immunocompromised state; active malignancies.

Important warnings

  • Infusion-related and hypersensitivity reactions, most common with the first infusion; rarely serious.
  • Increased risk of infections, including serious and opportunistic infections, viral reactivation and PML; delay the infusion during a clinically significant infection.
  • Decreases in immunoglobulins and lymphopenia may occur.
  • Complete vaccinations before starting; vaccine response may be impaired when B cells are depleted.

Side effects

  • Most frequent: urinary tract infection (26.2%), nasopharyngitis (20.9%), arthralgia (17.3%), upper respiratory tract infection (15.6%), back pain (13.8%), lymphopenia (10.7%) and headache (10.3%).
  • Most frequent serious reactions: infections (11.1%), including urinary tract infections (4.0%) and pneumonia (1.8%).

Interactions

  • Low risk of pharmacokinetic interactions.
  • Live vaccines after starting therapy have not been studied; for combination with other immunosuppressants see the full text.

Pregnancy and breastfeeding

  • Effective contraception during treatment and for 6 months after the last dose.
  • Transient B-cell depletion and lymphocytopenia have been reported in infants of mothers exposed to other B-cell-depleting antibodies.

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 →

Common questions – ask Medelix

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)

  • UpliznaAmgen Europe B.V. · EMEA/H/C/005818

Source: European Medicines Agency (EMA), product information

Brand names in 2 more European countries
Iceland
Uplizna
Norway
Uplizna

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?

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

Sources

  1. European Medicines Agency. Uplizna – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/uplizna-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC L04AA.

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.