What is Saphnelo? Uses, warnings & side effects

Medically reviewed by Keith Gardner, R.Ph.
Registered Pharmacist
Updated Dec 18, 2025  •  Published Aug 31, 2022
Datos Verificados

Saphnelo overview

BRAND NAMES:

  • Saphnelo

Generic Names:

  • Anifrolumab-fnia

Uses:

  • To help reduce disease activity in adults with moderate to severe lupus when given together with other lupus medicines.

Therapeutic Classes:

  • Monoclonal antibody

Forms:

  • Injectable solution

How it’s taken:

  • Intravenous (IV) infusion

What is Saphnelo used for?

  • The treatment of moderate to severe systemic lupus erythematosus (SLE or lupus) in adults.

Key takeaways

  • When given together with other medicines for lupus, Saphnelo may help to reduce lupus disease activity more than other lupus medicines alone. 

  • It is not known if Saphnelo is effective in patients with severe active lupus nephritis or severe active central nervous system lupus.

  • Saphnelo is usually given one time every four weeks. If you miss an appointment, call your healthcare provider as soon as possible to reschedule your appointment.

  • Saphnelo may cause serious side effects, including serious infections, allergic (hypersensitivity) reactions, and increased risk of certain cancers.

What form(s) does Saphnelo come in?

  • Single-dose 2 ml vial for intravenous (IV) infusion

    • 300 mg/2 ml

What are common Saphnelo dosages?

  • 300 mg, administered as an intravenous (IV) infusion over a 30-minute period, once every four weeks

Saphnelo images - What does Saphnelo look like?

  • Saphnelo
    2ml of 300mg/2ml vial

How to take Saphnelo

  • Your healthcare provider will give you Saphnelo through a needle placed in a vein (IV or intravenous infusion). 

  • It takes about 30 minutes to give the full dose.

  • Saphnelois is usually given once every four weeks.

What to do if you miss a dose of Saphnelo

  • If a planned infusion is missed, Saphnelo should be administered as soon as possible. 

  • There should be a minimum interval of 14 days between infusions.

Saphnelo contraindications - Who shouldn't take Saphnelo?

  • Do not take Saphnelo if you are allergic to the active ingredient anifrolumab-fnia or to any of its inactive ingredients.

Saphnelo warnings

  • Before you receive Saphnelo, tell your healthcare provider about all your medical conditions, including if you:

    • Have an infection or have infections that keep coming back. 

    • Are scheduled to receive a vaccination. You should not receive live vaccines during treatment with Saphnelo.

    • Have or have had any type of cancer.

    • Are receiving other biologic medicines or monoclonal antibodies.

    • Are pregnant or plan to become pregnant. It is not known if Saphnelo will harm your unborn baby.

    • Are breastfeeding or plan to breastfeed. It is not known if Saphnelo passes into breast milk.

Saphnelo interactions & what to avoid when taking Saphnelo

  • Although no formal drug interaction studies have been conducted for Saphnelo, it is still important to tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Saphnelo side effects - How does Saphnelo make you feel?

  • The most common side effects of Saphnelo include:

    • Upper respiratory infections

    • Bronchitis

    • Infusion reactions 

    • Shingles (herpes zoster) 

    • Cough

Potential serious side effects include:

  • Serious Infections. Saphnelo can lower the ability of your immune system to fight infections. You may be at a higher risk of developing respiratory infections and shingles (herpes zoster) during treatment with Saphnelo. Infections (including COVID-19) could be serious, leading to hospitalization or death. Tell your healthcare provider right away if you have any of the following symptoms of an infection:

    • Fever, sweating, or chills

    • Muscle aches 

    • Cough

    • Shortness of breath

    • Burning when urinating

    • Urinating more often

    • Diarrhea or stomach pain

    • Warm, red, or painful skin or sores on your body

  • Allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen during or after you get your Saphnelo infusion. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of a serious allergic reaction:

    • Swelling of your face, mouth, and tongue 

    • Fainting or dizziness

    • Breathing problems 

    • Feeling lightheaded (low blood pressure)

  • Cancer. Saphnelo may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers

Saphnelo News & Research

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Medically reviewed by Keith Gardner, R.Ph.
Registered Pharmacist

Keith Gardner, R.Ph., is a graduate of Southwestern Oklahoma State University School of Pharmacy. He has 10 years of community pharmacy experience followed by a 22-year career with a major pharmaceutical company in which he served as a medical information consultant. In that role, Gardner provided medical information to consumers and healthcare providers in numerous disease states. He currently resides in Monument, Colorado, with his wife and three dogs.

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