Anifrolumab Injection

What is this medication?

ANIFROLUMAB (an i frol ue mab) is a monoclonal antibody. It is used to treat lupus. This medicine is used with other medicines. It is not a cure for lupus.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): SAPHNELO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• cancer
• infection, especially a viral infection such as chickenpox, cold sores, or herpes
• recent or upcoming vaccine
• an unusual or allergic reaction to anifrolumab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is injected into a vein. It is given by a health care provider in a hospital or clinic setting.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your health care provider if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medicine with any of the following medicines:

• live virus vaccines

This medicine may also interact with the following medicines:

• biologic medicines, such as adalimumab, certolizumab, etanercept, golimumab, infliximab
• cyclophosphamide
• monoclonal antibodies such as belimumab, ocrelizumab, ofatumumab, rituximab

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider from regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Talk to your health care provider about your risk of cancer. You may be more at risk for certain types of cancer if you take this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• low blood pressure, especially during the infusion (dizziness; feeling faint or lightheaded, falls; unusually weak or tired)
• trouble breathing

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• headache
• nausea
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medicine is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.