Anifrolumab

Pronunciation: AN-i-FROL-ue-mab
Generic name: anifrolumab-fnia
Brand name: Saphnelo
Dosage form: Injection: 300 mg/2 mL (150 mg/mL)
Drug class: Selective immunosuppressants

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 10, 2024.

What is anifrolumab?

 Anifrolumab infusion is used for moderate to severe systemic lupus erythematosus (SLE) in adults who are also receiving other lupus medicines.  Anifrolumab works to reduce the body's immune and inflammatory response, which helps improve symptoms of SLE.  Anifrolumab brand name is Saphnelo. Anifrolumab is a monoclonal antibody that works by blocking type I interferon (INF-1) receptors, it is from the drug class interferon antagonists.

SLE is the most common form of lupus. It is an autoimmune disease that causes pain and inflammation in the 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. 

Anifrolumab mechanism of action (MOA) is it blocks INF-1 receptors in the immune system, which decreases inflammatory signals, so improves the symptoms of SLE, and reduces lupus flares.

Anifrolumab-fnia 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

Anifrolumab FDA approval was granted on July 30, 2021, for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Anifrolumab approval was based on positive results from the TULIP-2 Phase III clinical trials.

Anifrolumab side effects

Common anifrolumab side effects

Common anifrolumab side effects may include cough, trouble breathing, shingles, cold symptoms such as stuffy nose, sneezing, sore throat (upper respiratory tract infection), or headache, tiredness, dizziness, or nausea when the medicine is injected.

Serious anifrolumab side effects

Anifrolumab can cause serious side effects including serious infections allergic reactions including anaphlyaxis and increase your risk of cancer.

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:

• 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 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 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 the FDA at 1-800-FDA-1088.

Before receiving anifrolumab

You should not use this medicine 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 anifroluma-fnia it is important to tell your healthcare provider about all of your medical conditions, especially if you:

• may have an infection or have infections that keep coming back. If you have an infection you should not receive anifrolumab unless your doctor or other healthcare provider tells you to. See the Side Effects section below for a list of infection symptoms.
• have or have had any type of cancer as there is an increased risk of cancer with the use of immunosuppressants.
• are receiving other biologic medicines or monoclonal antibodies.

Before you start using this medicine, make sure you are up to date on all vaccines. 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 Anifrolumab will harm your unborn baby.

Anifrolumab 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 Anifrolumab, you should talk to your healthcare professional. 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.

How will I receive anifrolumab?

• anifrolumab is a solution your healthcare provider will give you through a needle placed in a vein (IV or intravenous infusion). It takes about 30 minutes to give you the full dose.
• Anifrolumab is usually given once every 4 weeks, but your doctor will decide how often you have this medicine depending on how your body responds to it.
• This medicine helps to control SLE but does not cure it.
• If you miss an appointment, call your healthcare provider as soon as possible to reschedule your appointment.

Anifrolumab Dosing information

Usual Adult Anifrolumab Dose for Systemic Lupus Erythematosus:

• 300 mg intravenous infusion given over 30 minutes every 4 weeks.
• Available as 300 mg/2 mL (150 mg/mL) single-dose vial.

Comment:

• This medicine is not recommended for patients with severe active lupus nephritis or severe active central nervous system lupus as the efficacy in these patients has not been evaluated.

Related/similar drugs

Benlysta, aspirin, prednisone, triamcinolone, dexamethasone, hydroxychloroquine, Plaquenil

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.

Anifrolumab Package Insert 

Review the anifrolumab package insert (Saphnelo Prescribing Information) for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

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?

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.

Storage

• Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
• Do not freeze. Do not shake.

Saphnelo ingredients

Active ingredient: anifrolumab-fnia

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

Anifrolumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for anifrolumab.

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Further information

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

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