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Saphnelo

Generic name:  anifrolumab-fnia
Dosage form: injection, for intravenous use
Drug class: Selective immunosuppressants

Medically reviewed by Judith Stewart, BPharm. Last updated on Oct 20, 2021.

What is Saphnelo?

  • Saphnelo is a prescription medicine used to treat adults with moderate to severe systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.
  • Saphnelo contains anifrolumab-fnia which is in a group of medicines called monoclonal antibodies. Lupus is a disease of the immune system (the body system that fights infection). When given together with other medicines for lupus, Saphnelo may help to reduce your lupus disease activity more than other lupus medicines alone.
  • It is not known if this medicine is effective in people with severe active lupus nephritis or central nervous system lupus.
  • It is not known if this medicine is safe and effective in children under 18 years of age.

Who should not use Saphnelo?

Do not use Saphnelo if you are allergic to anifrolumab-fnia or any of the ingredients in the injection. See the end of this page for a complete list of ingredients.

Before receiving Saphnelo

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

  • think you have an infection or have infections that keep coming back. You should not receive Saphnelo if you have an infection unless your healthcare provider tells you to.
  • are scheduled to receive a vaccination or if you think you may need 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. Tell your healthcare provider if you are pregnant, think you might be pregnant, or plan to become pregnant during your treatment.
    • Pregnancy Exposure Registry. If you become pregnant while receiving Saphnelo, talk to your healthcare provider. A pregnancy exposure registry monitors pregnancy outcomes in women exposed to anifrolumab-fnia. You can find out more information about the registry by calling AstraZeneca at 1-877-693-9268.
  • are breastfeeding or plan to breastfeed. It is not known if Saphnelo passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while receiving this medicine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Saphnelo may affect the way other medicines work, and other medicines may affect how this medicine works.

How will I receive 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 you the full dose.
  • Saphnelo is usually given 1 time every 4 weeks.
  • If you miss an appointment, call your healthcare provider as soon as possible to reschedule your appointment.

Saphnelo dosing information

Usual Adult Dose for Systemic Lupus Erythematosus:

300 mg IV over 30 minutes every 4 weeks

Comment:
-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.
-If a planned infusion is missed, administer as soon as possible but maintain a minimum interval of 14 days between infusions.

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

Saphnelo side effects

Saphnelo may cause serious side effects, including:

  • Serious Infections. Anifrolumab-fnia 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:
    • 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. Anifrolumab-fnia may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.

The most common side effects include:

  • upper respiratory infections
  • infusion reactions
  • cough
  • bronchitis
  • shingles (herpes zoster)

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.

What other drugs will affect Saphnelo?

Many drugs can interact with anifrolumab, 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.

General information about the safe and effective use of Saphnelo

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for health professionals.

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.

Popular FAQ

Is Saphnelo a chemo drug or immunosuppressant?

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.

How long does it take for Saphnelo to work?

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.

How long does a Saphnelo infusion take?

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

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