belimumab

Generic Name: belimumab (be LIM ue mab)
Brand Name: Benlysta

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 in 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 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.

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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 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.

Belimumab side effects

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.

See also: Side effects (in more detail)

Belimumab dosing information

Usual Adult Dose for Systemic Lupus Erythematosus:

10 mg/kg IV at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.

Comments:
-Infuse over a 1-hour period.
-Consider premedication including an antihistamine, with or without an antipyretic, before the infusion.

Use: Treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.

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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2014-11-14, 1:12:00 PM.

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