belimumab

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

Report any new or worsening mental health symptoms to your doctor, such as: depression, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others.

What is belimumab?

Belimumab is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Belimumab is used together with other lupus medicines to treat active systemic lupus erythematosus (SLE). Belimumab helps decrease disease activity more than when the other medicines are used alone.

Belimumab is for use in adults and children at least 5 years old.

Belimumab is not for use in people who have severe kidney problems caused by SLE, or have active SLE that affects the central nervous system (brain, nerves, and spinal cord).

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

What should I discuss with my healthcare provider before using belimumab?

Tell your doctor if you have ever had:

• an active or chronic infection;
• depression or mental illness;
• suicidal thoughts or actions;
• cancer; or
• if you are using cyclophosphamide, biologic medicines, or other monoclonal antibody medicines.

Belimumab may increase your risk of certain cancers by changing the way your immune system works. Ask your doctor about your individual risk.

Some people have thoughts about suicide while using belimumab. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Belimumab 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.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of belimumab on the baby. Make sure any doctor caring for your newborn baby knows if you used belimumab while you were pregnant.

How is belimumab given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Belimumab is given as an infusion into a vein, usually every 2 to 4 weeks. A healthcare provider will give you this injection. The medicine must be given slowly, and the infusion can take about 1 hour to complete.

Belimumab is also injected under the skin, usually once per week. A healthcare provider may teach you how to properly use the medication by yourself. Do not inject this medicine into skin that is bruised, tender, red, or hard.

Belimumab can be given as an intravenous infusion to adults or children. This medicine is injected under the skin only in adults.

If you give injections at home, use the medicine on the same day each week. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Take the syringe or injection pen out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not use if the medicine has been left at room temperature longer than 12 hours. Do not put it back into the refrigerator. Call your pharmacist for new medicine.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

Throw away used needles, syringes, or injection pens in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Use the medicine as soon as you remember. You can either restart a weekly schedule based on the new injection day, or you can go back to your regular injection schedule. Do not use 2 injections on the same day.

What happens if I overdose?

What should I avoid while using belimumab?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using belimumab. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of belimumab?

• fever, chills;
• skin sores, warmth, or redness;
• cough with mucus, chest pain, shortness of breath;
• pain or burning when you urinate;
• urinating more than usual; or
• bloody diarrhea.

• wheezing, chest tightness, trouble breathing; or
• new or worsening depression, anxiety, mood or behavior changes, trouble sleeping, risk-taking behavior, or thoughts about hurting yourself or others.

Common side effects may include:

• nausea, diarrhea;
• fever, sore throat, runny or stuffy nose, cough, chest tightness;
• pain, itching, redness, or swelling where the injection was given;
• pain in your arms or legs;
• headache, depressed mood; or
• sleep problems (insomnia).

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 belimumab?

Other drugs may affect belimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about belimumab.