Anifrolumab

Anifrolumab-fnia (brand name: Saphnelo) is a prescription biologic medicine used to treat moderate to severe systemic lupus erythematosus (SLE or lupus) in adults. It is used in combination with other lupus medicines. It helps reduce the body's overactive immune and inflammatory response, which helps reduce overall disease activity and flares, and improves skin rashes, joint pain, and swelling.

Anifrolumab-fnia is an IFN-1 receptor antagonist that works by blocking type I interferon, a protein that drives inflammation in SLE. By blocking the IFN-1 receptor.

Anifrolumab-fnia can be self-administered as a subcutaneous injection once weekly using the autoinjector pen or pre-filled syringe. It may also be administered as an intravenous (IV) infusion over 30 minutes once every four weeks by your healthcare professional.

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.

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.

IV Infusion

• Anifrolumab can be given as an IV infusion through a vein, usually over about 30 minutes.
• It is typically administered once every 4 weeks, although your doctor may adjust the schedule depending on your response.

Subcutaneous Injection

• Anifrolumab pen and prefilled syringe are given as a subcutaneous injection (injection under the skin)
• The recommended subcutaneous dosage is 120 mg once every week
• Before administration, the autoinjector pen and prefilled syringe should be removed from the refrigerator and allowed to reach room temperature for 60 minutes.

If you miss an appointment for an IV infusion, call your healthcare provider as soon as possible to reschedule. If you miss a subcutaneous dose, inject a dose as soon as you remember. Then, continue to inject once each week based on the new day it was injected or at your regularly scheduled time, as long as there are at least 3 days between doses. Call your healthcare provider if you are not sure when to inject.

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 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 or visiting https://anifrolumabpregnancyandbreastfeedingstudy.us/.

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.

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 anaphylaxis 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 (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 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.

Usual Anifrolumab Adult Intravenous 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.

Usual Anifrolumab Adult Subcutaneous Dose for Systemic Lupus Erythematosus:

• 120 mg once every week, as a subcutaneous injection
• Available as 120 mg/0.8 mL in a single-dose prefilled syringe or single-dose autoinjector (Saphnelo Pen)

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.

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

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.

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).

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.

• Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. If needed, the prefilled syringe or autoinjector can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days in the original carton to protect from light. Do not return to the refrigerator once it has reached room temperature. Throw away if not used within 7 days at room temperature.
• Do not freeze. Do not shake.

Active ingredient: anifrolumab-fnia

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