anifrolumab

What is the most important information I should know about anifrolumab?

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is anifrolumab?

Anifrolumab is used to treat moderate to severe systemic lupus erythematosus (SLE) in adults who already receive standard treatment for SLE.

Anifrolumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving anifrolumab?

Tell your doctor if you have ever had:

• an active or chronic infection;
• cancer;
• treatment with a biologic medicine or monoclonal antibody; or
• if you are scheduled to receive a vaccine.

Make sure you are current on all vaccines before you start using anifrolumab.

Tell your doctor if you are pregnant or you become pregnant, or if you are breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of anifrolumab on the baby.

Anifrolumab may affect your baby's immune system, but having SLE during pregnancy may cause complications such as worsened lupus, eclampsia (dangerously high blood pressure), premature birth, miscarriage, or growth problems in the unborn baby. SLE in the mother may also cause lupus or heart problems to develop in the newborn. The benefit of treating SLE may outweigh any risks to the baby.

How is anifrolumab given?

Anifrolumab is injected into a vein by a healthcare provider, usually once ever 4 weeks.

This medicine must be given slowly over 30 minutes.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving anifrolumab?

Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using anifrolumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What are the possible side effects of anifrolumab?

• fever, chills, sweats, muscle aches;
• painful skin sores with warmth or redness;
• urinating more, pain or burning when you urinate;
• diarrhea, stomach pain; or
• cough, shortness of breath.

• fever, chills, cough with mucus, chest pain, feeling short of breath; or
• symptoms of herpes zoster (shingles) --skin sores or blisters, itching, tingling, burning pain, rash on your face or torso.

Common side effects may include:

• shingles;
• cough, trouble breathing;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• headache, tiredness, dizziness, or nausea when the medicine is injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect anifrolumab?

Other drugs may affect anifrolumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your pharmacist can provide more information about anifrolumab.