SAPHNELO (anifrolumab-fnia) Injection for NSCLC

• SAPHNELO is an injection available as a prescription used to treat adults with moderate to severe systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.

• SAPHNELO is given together with other medicines for lupus and may help to reduce your lupus disease activity more than other lupus medicines alone.

• It is not known if SAPHNELO is safe to use in people with severe active lupus nephritis or central nervous system lupus.

• It is not known if SAPHNELO is safe to use in children under 18 years of age.

Limitations of Use: SAPHNELO shouldn’t be used in patients with severe active lupus nephritis or severe active central nervous system lupus.

Do not use SAPHNELO if you are allergic to anifrolumab-fnia or any of the inactive ingredients in SAPHNELO.

SAPHNELO shouldn’t be used in patients with a history of anaphylaxis with anifrolumab-fnia.

Before you receive SAPHNELO, tell your doctor about all of your medical conditions, including if you:

• are being treated for an infection, have an infection that keeps coming back, that won’t go away, or think if you have symptoms of an infection.

• received a vaccination or planning to receive a vaccination. You shouldn’t receive live vaccines during treatment with SAPHNELO.

• have cancer or have had any type of cancer.

• are receiving other biologic medicines because SAPHNELO shouldn’t be used with other biologic medicines.

• are pregnant or planning to become pregnant. It is not known if SAPHNELO can harm your unborn baby. Tell your doctor if you think you might be pregnant during your treatment with SAPHNELO.

• are breastfeeding or planning to breastfeed. It is not known if SAPHNELO can pass into your breast milk.

• Tell your doctor about all the medicines you take, including prescriptions, over-the-counter medicines, vitamins, and herbal supplements.

• Your doctor will give you SAPHNELO through (IV or intravenous infusion).

• It will take about 30 minutes to give you the full dose of SAPHNELO.

• SAPHNELO is given 1 time every 4 weeks.

Injection: 300 mg/2 mL (150 mg/mL), colorless to slightly yellow, solution in a single-dose vial.

• upper respiratory infections

• bronchitis

• infusion reactions

• shingles (herpes zoster) cough

SAPHNELO may cause serious side effects, including:

• Serious Infections: SAPHNELO can decrease the ability of your immune system to fight infections. There is an increased chance of you developing respiratory infections and shingles (herpes zoster) during treatment with SAPHNELO. These Infections could be serious and may lead to death. Tell your doctor right away if you have any of the following symptoms of an infection:
  • fever, sweating, or chills
  • burning when urinating
  • muscle aches
  • urinating more often
  • cough
  • diarrhea or stomach pain
  • shortness of breath
  • warm, painful skin, red, 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 doctor 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 increase your risk of certain cancers.

• Store in a refrigerator at 36°F to 46°F

• You can store it in the original carton to protect it from light.

• Do not shake and freeze.

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