When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not receive it if you had an allergic reaction to belimumab.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine. This medicine must be given slowly, so the needle will remain in place for at least 1 hour.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: 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.

• Some medicines can affect how belimumab works. Tell your doctor if you are also using cyclophosphamide.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you are allergic to any medicine or have any kind of infection, a weak immune system, or a history of cancer, depression, or mental illness. Also tell your doctor if you have ever had an infection that would not go away or kept coming back.
• Women must use an effective form of birth control during treatment and for at least 4 months after the last dose. Tell your doctor right away if you become pregnant while using this medicine.
• This medicine may cause the following problems:
  
  • A brain infection called progressive multifocal leukoencephalopathy (PML)
  • Increased risk for certain types of cancer
  • Infusion reaction
• This medicine may make it easier for you to get an infection. Take precautions to prevent illness. Avoid people who are ill. Wash your hands often.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

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, depression, thoughts of hurting yourself
• Change in how much or how often you urinate, bloody or cloudy urine, pain or burning when you urinate
• Chest pain or trouble breathing
• Confusion, memory loss, problems with vision, speech, or walking
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Lightheadedness, dizziness, or fainting, severe headache
• Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle is placed

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

• Diarrhea, nausea
• 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