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rituximab

MabThera · ATC code L01XC02

Brand names: MabThera, Novex, Redditux, Rixathon, Ruxience, Truxima

Key facts
Active substance
rituximab
ATC code
L01XC02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
MabThera 100 mg concentrate for solution for infusion / MabThera 500 mg concentrate for solution for infusion · MabThera 1400 mg solution for subcutaneous injection · MabThera 1600 mg solution for subcutaneous injection
Marketing authorisation holder
Roche Registration GmbH
Information as of
2026-10-27

Key facts

Rituximab (MabThera) is an anti-CD20 monoclonal antibody. It is used for non-Hodgkin's lymphoma and chronic lymphocytic leukaemia, and intravenously for rheumatoid arthritis, GPA/MPA and pemphigus vulgaris.

What it is used for

  • Stage III-IV follicular lymphoma: first line with chemotherapy, maintenance after response, monotherapy if chemoresistant or relapsed
  • CD20 positive diffuse large B-cell lymphoma with CHOP
  • Children from 6 months (IV): previously untreated advanced DLBCL, Burkitt lymphoma/leukaemia or Burkitt-like lymphoma, with chemotherapy
  • CLL (previously untreated or relapsed/refractory) with chemotherapy
  • Severe active rheumatoid arthritis with methotrexate after inadequate response to other DMARDs including TNF inhibitors
  • Severe active GPA and MPA (with glucocorticoids); moderate to severe pemphigus vulgaris
  • Subcutaneous form: oncology indications in adults only

Dosing

  • Given under close supervision with full resuscitation facilities; premedication with an anti-pyretic and an antihistamine before each administration
  • Follicular lymphoma, IV monotherapy: 375 mg/m² once weekly for four weeks; with chemotherapy 375 mg/m² per cycle
  • CLL IV: 375 mg/m² on Day 0 of the first cycle, then 500 mg/m² on Day 1 of each subsequent cycle
  • Rheumatoid arthritis: 1000 mg IV followed by a second 1000 mg infusion two weeks later
  • Subcutaneous (1400 mg for NHL, 1600 mg for CLL): only after a full intravenous dose
  • Other regimens (maintenance, GPA/MPA, pemphigus, children): see the full product information

Contraindications

  • Hypersensitivity to the active substance, murine proteins or any excipient (subcutaneous form also hyaluronidase)
  • Active, severe infections
  • Severely immunocompromised patients

Important warnings

  • Progressive multifocal leukoencephalopathy (PML), very rarely fatal; suspend dosing if suspected
  • Infusion-related reactions including cytokine release and tumour lysis syndrome, some fatal
  • Increased risk of infections, including serious infections
  • Hepatitis B reactivation, including fatal cases: HBV screening before treatment
  • Cardiac events (angina, arrhythmias, heart failure, myocardial infarction): monitor patients with cardiac history closely
  • Severe skin reactions (TEN, Stevens-Johnson syndrome); live virus vaccines not recommended

Side effects

  • Most frequent: infusion-related reactions, mainly at the first infusion
  • Infections (predominantly bacterial and viral) in approximately 30-55% of NHL trial patients
  • Serious: infections, cardiovascular events, hepatitis B reactivation, PML
  • Subcutaneous: very common local cutaneous reactions (injection erythema, pain, oedema)

Interactions

  • Limited data on drug interactions
  • No effect on the pharmacokinetics of fludarabine or cyclophosphamide; methotrexate does not affect rituximab
  • Patients with HAMA or anti-drug antibodies may react allergically to other monoclonal antibodies

Pregnancy and breastfeeding

  • Women of childbearing potential: effective contraception during and for 12 months after treatment; IgG crosses the placenta, transient B-cell depletion reported in some infants
  • Breast-feeding not recommended during treatment and optimally for 6 months afterwards

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)

  • Blitzima · biosimilarCelltrion Healthcare Hungary Kft. · EMEA/H/C/004723
  • Ituxredi · biosimilarReddy Holding GmbH · EMEA/H/C/006224
  • MabTheraRoche Registration GmbH · EMEA/H/C/000165
  • Rixathon · biosimilarSandoz GmbH · EMEA/H/C/003903
  • Riximyo · biosimilarSandoz GmbH · EMEA/H/C/004729
  • Ruxience · biosimilarPfizer Europe MA EEIG · EMEA/H/C/004696
  • Truxima · biosimilarCelltrion Healthcare Hungary Kft. · EMEA/H/C/004112

Source: European Medicines Agency (EMA), product information

Turkey

  • MabtheraROCHE MÜSTAHZARLARI SAN.A.Ş. · 3 register entries
  • NovexABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • ReddituxTRPHARM İLAÇ SAN. TİC. A.Ş. · 2 register entries
  • RixathonSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • RuxiencePFİZER PFE İLAÇLARI A.Ş. · 2 register entries
  • TruximaCELLTRİON HEALTHCARE İLAÇ SAN. VE TİC. LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Blitzima, Mabthera, Rixathon, Riximyo, Ruxience, Truxima
Liechtenstein
Blitzima, Mabthera, Rixathon, Riximyo, Ruxience, Truxima
Norway
Blitzima, Mabthera, Rixathon, Riximyo, Ruxience, Truxima

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. MabThera – 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/mabthera-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

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.