Belimumab (be-LIM-ue-mab)

Treats systemic lupus erythematosus (SLE or lupus).

Brand Name(s):

Benlysta

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine.
• This medicine must be given slowly, so the needle will remain in place for at least one hour. You may also receive medicines to help prevent possible allergic reactions to the injection.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, 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.

• Make sure your doctor knows if you are also using medicines that may weaken your immune system, such as cancer medicines or steroids.
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have any kind of infection, a weak immune system, or a history of depression or mental illness.
• Tell your doctor if you plan to become pregnant. Women who could potentially get pregnant while receiving this medicine must use an effective form of birth control during therapy and for at least 4 months after the last dose. If you become pregnant while receiving this medicine, your doctor may want you to join a registry for pregnant patients.
• This medicine may increase your risk of developing infections. Avoid being near people who are sick while you are receiving this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you receive the medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
• Call your doctor right away if you have blurred vision; a cough that won't go away; fever, chills, or flu-like symptoms, such as a runny or stuffy nose; a headache; night sweats; or weight loss. These may be signs that you have an infection.
• This medicine may cause an infusion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have a headache; itching; dizziness, fainting, or lightheadedness; nausea; muscle or joint pain; or a rash.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have chest pain; hives; itching; a rash; swelling of the face, tongue, and throat; or trouble breathing after you receive the medicine.
• This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

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
• Anxiety, confusion, or depression.
• Bloody or cloudy urine.
• Burning pain on urination, or change in how much or how often you urinate.
• Fever, chills, runny or stuffy nose, cough, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.
• Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle is placed.
• Shortness of breath or troubled breathing.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Arm or leg pain.
• Diarrhea, nausea, loss of appetite, or stomach pain.
• Severe headache.
• Trouble sleeping.

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