• Do not use SAPHNELO if you are allergic to anifrolumab-fnia or to any of the ingredients
• Before you receive SAPHNELO, tell your healthcare provider about all of your medical conditions, including if you:
  • think you have an infection or have an infection that keeps coming back
  • 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 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, might be, or plan to become pregnant during treatment with SAPHNELO
    • A pregnancy exposure registry monitors pregnancy outcomes in women exposed to SAPHNELO. 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

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 SAPHNELO works.

SAPHNELO may cause serious side effects, including:

• Serious infections: SAPHNELO 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 with SAPHNELO. Infections could be serious, leading to hospitalization or death
• 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
  • breathing problems
  • fainting, dizziness
  • feeling lightheaded (low blood pressure)
• Cancer: SAPHNELO 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 of SAPHNELO include:

• Upper respiratory infections
• Bronchitis
• Infusion reactions
• Shingles (herpes zoster)
• Cough

Infusion reactions can happen at the time of the infusion or shortly after, symptoms may include headache, nausea, vomiting, feeling tired or weak (fatigue), and dizziness.

These are not all of the possible side effects of SAPHNELO. Call your healthcare provider for medical advice about side effects.

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.

It is not known if SAPHNELO is effective in patients with severe active lupus nephritis or severe active central nervous system lupus. It is not known if SAPHNELO is safe and effective in patients under 18 years of age.