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Generic name: anifrolumab [ AN-i-FROL-ue-mab ]
Brand name: Saphnelo
Dosage form: intravenous solution (fnia 300 mg/2 mL)
Drug class: Selective immunosuppressants

Medically reviewed by on Sep 5, 2023. Written by Cerner Multum.

What is anifrolumab?

Anifrolumab is used to treat moderate to severe systemic lupus erythematosus (SLE) in adults who already receive standard treatment for SLE.

Anifrolumab may also be used for purposes not listed in this medication guide.

Anifrolumab side effects

Get emergency medical help if you have signs of an allergic reaction: hives; feeling lightheaded; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

Anifrolumab may cause serious side effects. Call your doctor at once if you have:

Common side effects of anifrolumab may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not be treated with anifrolumab if you are allergic to it.

Tell your doctor if you have ever had:

Make sure you are current on all vaccines before you start using anifrolumab.

Tell your doctor if you are pregnant or you become pregnant, or if you are breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of anifrolumab on the baby.

Anifrolumab may affect your baby's immune system, but having SLE during pregnancy may cause complications such as worsened lupus, eclampsia (dangerously high blood pressure), premature birth, miscarriage, or growth problems in the unborn baby. SLE in the mother may also cause lupus or heart problems to develop in the newborn. The benefit of treating SLE may outweigh any risks to the baby.

Not approved for use by anyone younger than 18 years old.

How is anifrolumab given?

Anifrolumab is injected into a vein by a healthcare provider, usually once ever 4 weeks.

anifrolumab must be given slowly over 30 minutes.

Anifrolumab dosing information

Usual Adult Dose for Systemic Lupus Erythematosus:

300 mg IV over 30 minutes every 4 weeks

-The efficacy of this drug has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, therefore, the use in these situations is not recommended.

-For the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your anifrolumab injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving anifrolumab?

Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using anifrolumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What other drugs will affect anifrolumab?

Other drugs may affect anifrolumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Popular FAQ

Saphnelo starts to block interferon receptors as soon as it is administered, but it may take about 3 to 6 months of regular monthly injections before you notice the full effects of the medication and noticeable symptom relief. The endpoint of most trials was an improvement in disease activity after 52 weeks which was significantly improved in 62% to 100% of trial participants, depending on the trial.

A Saphnelo infusion takes about 30 minutes to administer. The medicine is diluted into an infusion bag by your healthcare provider, and while you are seated, the infusion mixture will run into your vein through a needle (this is called an intravenous infusion). A Saphnelo infusion is usually given at doctor’s office, a hospital, or an infusion center.

Benlysta and Saphnelo are both targeted treatments, but they target different parts of the immune system that are particularly overactive in lupus. Benlysta targets and blocks the activity of a type of white blood cell called a B cell, which produces antibodies that attack tissue, causing symptoms of SLE. It is classified as a B-lymphocyte stimulator (BLyS)-specific inhibitor. Saphnelo targets the type I interferon receptor and inhibits the activity of type 1 interferons. Activation of the interferon system is a common underlying characteristic of SLE that leads to the immune system being constantly “switched on”, contributing to SLE symptoms. Saphnelo is classified as a type 1 interferon receptor antagonist. Benlysta was first approved in 2011 and Saphnelo was approved in 2021. Continue reading

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.