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Saphnelo

Generic name: anifrolumab-fnia [ AN-i-FROL-ue-mab ]
Dosage form: injection, for intravenous use
Drug class: Selective immunosuppressants

Medically reviewed by Melisa Puckey, BPharm. Last updated on Feb 20, 2023.

What is Saphnelo?

Saphnelo infusion is a prescription medicine used for moderate to severe systemic lupus erythematosus (SLE or lupus) in adults who are also receiving other lupus medicines.  Saphnelo (anifrolumab-fnia) works to reduce the body's immune and inflammatory response, to improve symptoms of SLE. Saphnelo is a monoclonal antibody that works by blocking type I interferon (INF-1) receptors.

SLE is an autoimmune disease that causes pain and inflammation in your body. It is caused by your body’s immune system attacking healthy tissue instead of only fighting infections. Often SLE patients have elevated type I interferon stimulation which means too many unnecessary interferon signals are getting through, leading to inflammation in different parts of the body. Saphnelo blocks INF-1 receptors in the immune system, which decreases inflammatory signals and so improves the symptoms of SLE and reduces lupus flares.

Saphnelo is not recommended for severe active lupus nephritis or severe active central nervous system lupus and is not approved for use by anyone younger than 18 years old

Saphnelo infusion was FDA approved on July 30, 2021.

Before receiving Saphnelo

You should not use Saphnelo if you are allergic to the active ingredient anifrolumab-fnia or any of the inactive ingredients in the injection. There is a complete list of ingredients at the bottom of this page.

Before you receive Saphnelo it is important to tell your healthcare provider about all of your medical conditions, especially if you:

Make sure you are up to date on all vaccines before you start using this medicine. You should not receive live vaccines during treatment with Saphnelo.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant as it is not known if Saphnelo will harm your unborn baby.

Saphnelo may affect your baby's immune system, but having SLE during pregnancy may cause complications such as worsened lupus, dangerously high blood pressure (eclampsia), 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.

Pregnancy Exposure Registry. A pregnancy exposure registry monitors pregnancy outcomes in women who have used this medicine. You can find out more information about the Saphnelo pregnancy registry by calling AstraZeneca at 1-877-693-9268.

Breastfeeding

If you are breastfeeding or planning to breastfeed while on Saphnelo you should talk to your healthcare professional, as it is not known if this medicine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving this medicine.

Saphnelo pregnancy and breastfeeding warnings (more detail)

How will I receive Saphnelo?

Dosing information

Usual Saphnelo Adult Dose for Systemic Lupus Erythematosus:

Comment:

What happens if I miss a dose?

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

If a planned infusion of this medicine is missed, it should be given as soon as possible, but maintain a minimum interval of 14 days between infusions.

What happens if I overdose?

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

Detailed Saphnelo dosage information

Saphnelo side effects

Common side effects of Saphnelo may include:

Saphnelo may cause serious side effects, including:

Serious Infections. This medicine 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. Infections 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:

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

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

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Saphnelo side effects (more detail)

What should I avoid while receiving Saphnelo?

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 Saphnelo?

Many drugs can interact with Saphnelo, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Saphnelo drug interactions (more detail)

Storage

What are the ingredients in Saphnelo?

Active ingredient: anifrolumab-fnia

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-lysine hydrochloride, trehalose dihydrate, polysorbate 80 and Water for Injection.

Manufacturer

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.

Saphnelo is not chemotherapy (chemotherapy works by targeting actively dividing cells), but it is an immunosuppressant because it is a human monoclonal antibody that specifically targets the type I interferon receptor, inhibiting the activity of type 1 interferons. SLE is characterized by an activation of the interferon system which leads to almost continuous immune system activity, and the typical symptoms of SLE such as fatigue; joint pain, stiffness, and swelling; and the butterfly-shaped rash on the face.

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

References

  1. Food and Drug Administration (FDA) Saphnelo Product Label
  2. Trial of Anifrolumab in Active Systemic Lupus Erythematosus

Further information

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

Medical Disclaimer