belimumab

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Pronunciation: be LIM ue mab

Brand: Benlysta

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

Belimumab may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Serious and sometimes fatal infections may occur during treatment with belimumab. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, cough with mucus, pain or burning when you urinate, urinating more than usual, or bloody diarrhea.

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 to treat active systemic lupus erythematosus (SLE) in adults.

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 receiving belimumab?

You should not use belimumab if you are allergic to it.

To make sure belimumab is safe for you, tell your doctor if you have:

  • an active or chronic infection;
  • a history of cancer; or
  • a history of depression or mental illness.

You may have thoughts about suicide while receiving belimumab, especially if you have a history of suicidal thoughts or actions.

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

FDA pregnancy category C. It is not known whether belimumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of belimumab on the baby.

It is not known whether belimumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using belimumab.

How is belimumab given?

Belimumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Belimumab must be given slowly, and the IV infusion can take about an hour to complete.

The first 3 doses of belimumab are given 2 weeks apart. Then the injections are given every 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.

You may be given other medicines to prevent certain side effects of belimumab.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your belimumab injection.

What happens if I overdose?

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

What should I avoid while receiving belimumab?

Avoid being near people who have colds, the flu, or other contagious illnesses.

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

What are the possible side effects of belimumab?

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

Some people receiving a belimumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel anxious, nauseated, light-headed, itchy, or have trouble breathing, severe headache, or skin redness and swelling.

Serious and sometimes fatal infections may occur during treatment with belimumab. Stop using this medicine and call your doctor right away if you have signs of infection such as:

  • fever, chills;
  • cough with mucus;
  • pain or burning when you urinate;
  • urinating more than usual; or
  • bloody diarrhea.

Belimumab may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Also call your doctor at once if you have:

  • new or worsening depression, anxiety, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others;
  • wheezing, chest tightness, trouble breathing; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, dizziness, sweating, general ill feeling.

Common side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • urination problems;
  • fever, sore throat, runny or stuffy nose, cough;
  • 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?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with belimumab, especially:

  • cyclophosphamide (Cytoxan); or
  • drugs that weaken your immune system such as cancer medicine, steroids, and medicines to prevent rejection of a transplanted organ.

This list is not complete. Other drugs may interact with belimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your doctor or pharmacist can provide more information about belimumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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