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anifrolumab

Saphnelo · ATC code L04AG11

Key facts
Active substance
anifrolumab
Drug class
Immunosuppressive drug
ATC code
L04AG11
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Saphnelo 300 mg concentrate for solution for infusion · Saphnelo 120 mg solution for injection in pre-filled syringe / Saphnelo 120 mg solution for injection in pre-filled pen
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-28

Key facts

Anifrolumab (Saphnelo) is a monoclonal antibody and immunosuppressant used as add-on therapy in adults with active systemic lupus erythematosus (SLE).

What it is used for

  • Add-on therapy for adults with moderate to severe, active, autoantibody-positive SLE despite standard therapy.

Dosing

  • Saphnelo 300 mg concentrate (intravenous): 300 mg as an intravenous infusion over 30 minutes every 4 weeks; a minimum interval of 14 days between doses.
  • Saphnelo 120 mg pre-filled syringe/pen (subcutaneous): 120 mg subcutaneously every week; after a missed dose keep at least 3 days between injections.
  • Switching from intravenous to subcutaneous: first injection about 2 weeks after the last infusion; switching back: first infusion about 3 to 4 weeks after the last subcutaneous dose.
  • No dose adjustment for the elderly or for renal or hepatic impairment; no experience in severe renal impairment. Not established in children and adolescents under 18 years.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Serious hypersensitivity reactions including anaphylaxis and angioedema (0.5% of patients in trials); stop administration immediately if they occur.
  • Increased risk of respiratory infections and herpes zoster, including disseminated herpes zoster.
  • Do not give to patients with active tuberculosis; consider anti-TB therapy before starting in untreated latent TB.
  • Avoid live or live attenuated vaccines.
  • Not recommended in combination with other biologic therapies (including B-cell-targeted therapies); not studied in severe active CNS lupus or severe active lupus nephritis.
  • The impact on the development of malignancies is not known.

Side effects

  • Most common: upper respiratory tract infection (32%), bronchitis (9.8%), infusion-related reaction (9.4%) and herpes zoster (5.4%).
  • Most common serious reactions: herpes zoster (0.3%) and bronchitis (0.3%).
  • Common: hypersensitivity, respiratory tract infection; uncommon: anaphylactic reaction; not known: arthralgia.

Interactions

  • No interaction studies. For CYP substrates with a narrow therapeutic index and individually adjusted dose (e.g. warfarin), therapeutic monitoring is recommended.

Pregnancy and breastfeeding

  • Limited data (less than 300 pregnancy outcomes); not recommended in pregnancy or in women of childbearing potential not using contraception, unless the benefit justifies the risk.
  • Breast-feeding: a risk to the child cannot be excluded; weigh breast-feeding against therapy.

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)

  • SaphneloAstraZeneca AB · EMEA/H/C/004975

Source: European Medicines Agency (EMA), product information

Turkey

  • SaphneloASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry

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

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

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. Saphnelo – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/saphnelo-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 L04AG.

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.