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sarilumab

Kevzara · ATC code L04AC14

Key facts
Active substance
sarilumab
Drug class
Immunosuppressive drug
ATC code
L04AC14
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Kevzara 150 mg solution for injection in pre-filled syringe / Kevzara 150 mg solution for injection in pre-filled pen / Kevzara 200 mg solution for injection in pre-filled syringe · Kevzara 175 mg/ml solution for injection
Marketing authorisation holder
Sanofi Winthrop Industrie
Information as of
2026-10-29

Key facts

Sarilumab (Kevzara) is a monoclonal antibody against the interleukin-6 receptor used for rheumatoid arthritis, polymyalgia rheumatica and polyarticular juvenile idiopathic arthritis.

What it is used for

  • Kevzara 150 mg/200 mg: moderately to severely active rheumatoid arthritis in adults with inadequate response to DMARDs, with methotrexate or as monotherapy.
  • Kevzara 150 mg/200 mg: polymyalgia rheumatica in adults with inadequate response to corticosteroids or relapse during corticosteroid taper.
  • Kevzara 175 mg/ml: active polyarticular juvenile idiopathic arthritis from 2 years of age after inadequate response to csDMARDs, alone or with methotrexate.

Dosing

  • Rheumatoid arthritis: 200 mg subcutaneously every 2 weeks; reduce to 150 mg every 2 weeks for neutropenia, thrombocytopenia or liver enzyme elevations.
  • Polymyalgia rheumatica: 200 mg every 2 weeks with a tapering course of corticosteroids, then as monotherapy.
  • pJIA (Kevzara 175 mg/ml): 4 mg/kg every 2 weeks for 10 to less than 30 kg, 3 mg/kg every 2 weeks from 30 kg; capped at 200 mg from 63 kg.
  • Do not start with ANC below 2 x 109/L or platelets below 150 x 103/µL; withhold during serious infection. Further laboratory-based adjustments see the full text.
  • Not studied and not recommended in hepatic impairment.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Active, severe infections.

Important warnings

  • Serious infections, including opportunistic infections and tuberculosis; screen for tuberculosis before starting; do not give during active infection.
  • Neutropenia, thrombocytopenia and raised liver enzymes; laboratory monitoring.
  • Lipid increases; monitor lipid parameters.
  • Gastrointestinal perforation and diverticulitis have been reported.
  • Avoid live and live attenuated vaccines.

Side effects

  • Most frequent (RA and PMR): neutropenia (14.3%), upper respiratory infections (6.8%), increased ALT (6.3%), urinary tract infections (5.3%) and injection site erythema (5.0%).
  • Most common serious reactions: infections (3.1%).
  • Common: oral herpes, cellulitis, pneumonia, leukopenia, thrombocytopenia, hypertriglyceridaemia, hypercholesterolaemia; uncommon diverticulitis.

Interactions

  • IL-6 inhibition may normalise CYP activity (CYP1A2, CYP2C9, CYP2C19, CYP3A4) and lower levels of their substrates.
  • Not studied with JAK inhibitors or biological DMARDs (e.g. TNF antagonists).

Pregnancy and breastfeeding

  • Effective contraception during and up to 3 months after treatment.
  • Use in pregnancy only if the woman's clinical condition requires treatment.

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)

  • KevzaraSanofi Winthrop Industrie · EMEA/H/C/004254

Source: European Medicines Agency (EMA), product information

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

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. Kevzara – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/kevzara-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC L04AC.

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.