Anifrolumab is used with other medications to treat moderate to severe systemic lupus erythematosus (SLE or lupus; an autoimmune disease in which the immune system attacks healthy parts of the body such as joints, skin, blood vessels, and organs) in adults. Anifrolumab injection is in a class of medications called monoclonal antibodies. It works by blocking the activity of a certain protein in people with SLE.

Anifrolumab comes as a solution (liquid) to be injected intravenously (into a vein). It is usually given over a 30-minute period every 4 weeks. Your doctor will decide how often you are to receive anifrolumab based on your body’s response to this medication.

Anifrolumab helps to control lupus but does not cure it. Your doctor will watch you carefully to see how well anifrolumab works for you. It is important to tell your doctor how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving anifrolumab,

• Tell your doctor and pharmacist if you are allergic to anifrolumab, any other medications, or any of the ingredients in anifrolumab injection. Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have an infection or an infection that keeps coming back, or if you have or have had any type of cancer.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving anifrolumab, call your doctor.
• Do not have any vaccinations during your treatment without talking to your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive anifrolumab, call your doctor as soon as possible.

Anifrolumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Headache
• Nausea
• Vomiting
• Tiredness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• Fever, sore throat, chills, cough, or other signs of infection
• Stomach pain or diarrhea
• Frequent, painful, or difficult urination
• Red or painful skin or sores on your body
• Swelling of the face, tongue, or mouth
• Fainting or lightheadedness
• Difficulty breathing

Anifrolumab may increase your risk of certain cancers. Talk to your doctor about the risks of receiving this medication.

Anifrolumab may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about anifrolumab.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.