Anifrolumab-fnia (Saphnelo)

Reviewed by: HU Medical Review Board | Last reviewed: August 2024 | Last updated: August 2024

Anifrolumab-fnia (Saphnelo™) is approved for the treatment of adults with moderate to severe lupus. It is given in combination with other treatments. Anifrolumab is a type of medicine called a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that act like antibodies in the human immune system.1,2

Anifrolumab is given by infusion, which is a needle inserted into a vein. It takes about 30 minutes to get a full dose. It is usually given once every 4 weeks.1,2

What are the ingredients in anifrolumab?

The active ingredient is anifrolumab.

How does anifrolumab work?

Anifrolumab-fnia is a type I interferon (IFN) receptor antagonist, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody. Antibodies are proteins that stick to other substances called antigens. Each antibody attaches to a specific antigen. Once attached, the antibody destroys the antigen.1-3

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It binds to the type 1 IFN interferon receptor, blocking its activity. This reduces the inflammation and immune system overreaction of lupus. Type 1 IFN levels are high in 6 to 8 out of 10 people with lupus.1

What are the possible side effects of anifrolumab?

The most common side effects of anifrolumab include:1-3

  • Respiratory tract infections
  • Infusion reactions
  • Cough
  • Shingles

Anifrolumab may cause serious side effects, including:1-3

  • Infections causing hospitalization
  • Allergic reactions, including anaphylaxis
  • Increased risk of certain cancers

These are not all the possible side effects of anifrolumab. Talk to your doctor about what to expect or if you experience any changes that concern you while taking this drug.

Other things to know

Doctors did not study the use of anifrolumab in people with severe lupus nephritis or severe active lupus of the central nervous system. It is not recommended for people who have these conditions.1-3

Doctors do not yet know if anifrolumab is safe for use before or during pregnancy or while breastfeeding.1-3

People receiving anifrolumab should not receive live or live-attenuated vaccines while being treated.1-3

Anifrolumab is not approved for use in children and teens younger than 18. Doctors do not know if anifrolumab is safe for people 65 and older.1-3

People taking other biologic drugs should not use anifrolumab.1-3

Before beginning this treatment, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of anifrolumab.

Treatment results and side effects can vary from person to person. This treatment information is not meant to replace professional medical advice. Talk to your doctor about what to expect before starting and while taking any treatment.