Belimumab (be-LIM-ue-mab)

Treats lupus.

Brand Name(s):

Benlysta

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• A nurse or other health provider will give you this medicine.
• This medicine is given through an IV catheter that is placed into one of your veins or as a shot under your skin, usually in the stomach or thighs. If the medicine is given through a needle placed into one of your veins, it must be given slowly, so the IV will have to remain in place for at least 1 hour.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine is available in 3 forms: a vial (glass container), a prefilled syringe, or an autoinjector. The prefilled syringe and autoinjector are the dosage forms you can use at home.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, red, bruised, or hard.
• Use a new needle and syringe each time you inject your medicine.
• Allow the medicine to warm to room temperature for 30 minutes before you use it. Do not warm it in any other way.
• Do not remove the needle cap from the prefilled syringe or the ring cap from the autoinjector until you are ready to use it.
• Check the liquid in the prefilled syringe or autoinjector. It should be colorless or slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it. Do not shake.
• 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.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Store this medicine in its original container until you are ready to use it. Keep it refrigerated until 30 minutes before use. You may also store this medicine at room temperature for up to 12 hours if protected from sunlight. Do not use and do not place this medicine back in the refrigerator if it has been left out for more than 12 hours.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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 or other biologic treatments (including rituximab).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live vaccines 30 days before or during treatment with this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment with this medicine and for at least 4 months after your last dose.
• Tell your doctor if you are 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.
• This medicine may cause the following problems:
  • Increased risk for infection, including pneumonia, urinary tract infections, cellulitis, bronchitis, progressive multifocal leukoencephalopathy
  • Infusion reactions
  • Changes in mood or behavior
  • Increased risk for certain types of cancer
• 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 do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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 feeling when you urinate
• Chest pain, trouble breathing
• Confusion, memory loss, problems with vision, speech, or walking
• Fever, chills, cough, runny or stuffy nose, sore throat, 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:

• Arm or leg pain
• 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