Anifrolumab-fnia (an-i-FROL-ue-mab - fnia)

Treats lupus.

Brand Name(s):

Saphnelo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. It must be given slowly, so the needle will have to remain in place for at least 30 minutes.
• A nurse or other health provider will give you this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how anifrolumab-fnia works. Tell your doctor if you are also receiving other biologic treatments.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live vaccines during treatment with this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding, or if you have any kind of infection, a weak immune system, other types of lupus, or a history of cancer. Also tell your doctor if you have ever had an infection that would not go away or kept coming back.
• This medicine may cause the following problems:
  • Increased risk of serious infections, including lung infections, herpes zoster, COVID-19
  • Infusion reactions
  • Increased risk for certain types of cancer
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Painful blisters on the trunk of the body

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088