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.

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

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

anifrolumab must be given slowly over 30 minutes.

Usual Adult Dose for Systemic Lupus Erythematosus:

300 mg IV over 30 minutes every 4 weeks

Comment:
-The efficacy of this drug has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, therefore, the use in these situations is not recommended.

Uses:
-For the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy

You should not be treated with anifrolumab if you are allergic to it.

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.

Not approved for use by anyone younger than 18 years old.

Call your doctor for instructions if you miss an appointment for your anifrolumab injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

Get emergency medical help if you have signs of an allergic reaction: hives; feeling lightheaded; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• 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.

Anifrolumab may cause serious side effects. Call your doctor at once if you have:

• 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 of anifrolumab 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.

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.