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tocilizumab

RoActemra · ATC code L04AC07

Key facts
Active substance
tocilizumab
Drug class
Immunosuppressive drug
ATC code
L04AC07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
RoActemra 20 mg/mL concentrate for solution for infusion · RoActemra 162 mg solution for injection in pre-filled syringe · RoActemra 162 mg solution for injection in pre-filled pen
Marketing authorisation holder
Roche Registration GmbH
Information as of
2026-10-27

Key facts

Tocilizumab is a monoclonal antibody against the interleukin-6 receptor (RoActemra infusion and subcutaneous syringe/pen). It is used for rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, COVID-19 and CAR T cell-induced cytokine release syndrome.

What it is used for

  • Rheumatoid arthritis in adults, usually with methotrexate (MTX); monotherapy if MTX is not tolerated
  • Systemic and polyarticular juvenile idiopathic arthritis (sJIA, pJIA)
  • Giant cell arteritis in adults (subcutaneous)
  • Infusion: COVID-19 in adults on systemic corticosteroids requiring oxygen or ventilation; severe CAR T cell-induced cytokine release syndrome (CRS)

Dosing

  • RA, infusion: 8 mg/kg once every four weeks; above 100 kg, no more than 800 mg per infusion
  • RA and GCA, subcutaneous: 162 mg once every week
  • COVID-19: single 60-minute infusion of 8 mg/kg; one additional infusion possible after at least 8 hours
  • CRS: 8 mg/kg (30 kg or more) or 12 mg/kg (less than 30 kg) as a 60-minute infusion
  • Dose reduction or interruption for raised liver enzymes, low neutrophils or platelets; weight-based JIA regimens in the full text

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Active, severe infections (for the infusion, except COVID-19)

Important warnings

  • Serious and sometimes fatal infections; interrupt for serious infection
  • Hepatotoxicity up to acute liver failure; monitor transaminases
  • Complications of diverticulitis including perforation
  • Serious hypersensitivity reactions up to anaphylaxis; viral reactivation (e.g. hepatitis B)

Side effects

  • RA, JIA, CRS: most common upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT
  • Most serious: serious infections, complications of diverticulitis, hypersensitivity reactions
  • COVID-19: most common increased transaminases, constipation and urinary tract infection

Interactions

  • Tocilizumab normalises CYP450 expression suppressed by IL-6; levels of CYP substrates (e.g. simvastatin) may fall
  • Narrow-therapeutic-index drugs metabolised by CYP450 may need dose adjustment
  • Hepatotoxic medicines (e.g. MTX) increase the frequency of transaminase elevations

Pregnancy and breastfeeding

  • Pregnancy: only if clearly necessary; effective contraception during and up to 3 months after treatment
  • Breast-feeding: excretion in milk unknown; benefit-risk decision

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

Turkey

  • ActemraROCHE MÜSTAHZARLARI SAN.A.Ş. · 7 register entries

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

Brand names in 3 more European countries
Iceland
Avtozma, Roactemra, Tocilizumab Stada, Tuyory, Tyenne
Liechtenstein
Avtozma, Roactemra, Tocilizumab Stada, Tuyory, Tyenne
Norway
Avtozma, Roactemra, Tocilizumab Stada, Tuyory, Tyenne

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.

Other substances in the same group

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Sources

  1. European Medicines Agency. RoActemra – 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/roactemra-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L04AC.

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.