Benlysta

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

What is Benlysta?

Benlysta (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.

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

Benlysta 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).

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

Important information

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

Before you receive Benlysta, tell your doctor if you have an active or chronic infection, a history of cancer, or a history of depression or mental illness.

Serious and sometimes fatal infections may occur during treatment with Benlysta. Call your doctor right away if you have signs of infection such as fever, chills, flu symptoms, night sweats, pain or burning when you urinate, cough with mucus, stabbing chest pain, feeling short of breath, bloody diarrhea, or swelling, pain, tenderness, or redness anywhere on your body.

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Benlysta can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection. Do not receive a "live" vaccine within 30 days before or after you are treated with Benlysta.

You may have thoughts about suicide while receiving Benlysta, especially if you have a history of suicidal thoughts or actions. Report any new or worsening symptoms to your doctor, such as: depression, anxiety, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others.

Before receiving Benlysta

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

To make sure you can safely receive Benlysta, tell your doctor if you have any of these other conditions:

  • 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 Benlysta, especially if you have a history of suicidal thoughts or actions.

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

See also: Pregnancy and breastfeeding warnings (in more detail)

How is Benlysta given?

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

The first 3 doses of Benlysta 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 medications to prevent certain side effects of Benlysta.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your Benlysta 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?

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

Do not receive a "live" vaccine while you are being treated with Benlysta. 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), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Benlysta side effects

Some people receiving a Benlysta injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel nauseated, light-headed, itchy, or have muscle pain, severe headache, or slow heartbeats. Get emergency medical help if you have any of these signs of an allergic reaction to Benlysta: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • new or worsening depression, anxiety, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others;

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

  • wheezing, chest tightness, trouble breathing; or

Serious and sometimes fatal infections may occur during treatment with Benlysta. Call your doctor right away if you have signs of infection such as:
  • fever, chills, flu symptoms, night sweats, weight loss;

  • increased urination, pain or burning when you urinate;

  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

  • swelling, pain, tenderness, or redness anywhere on your body; or

  • bloody diarrhea.

Less serious Benlysta side effects may include:

  • nausea, diarrhea, stomach pain;

  • mild pain in your arms or legs; or

  • mild cold symptoms such as stuffy nose, sneezing, sore throat.

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)

Benlysta dosing information

Usual Adult Benlysta Dose for Systemic Lupus Erythematosus:

10 mg/kg as an intravenous infusion only, over a period of 1 hour, at 2 week intervals for the first 3 doses and at 4 week intervals thereafter.

Consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions.

What other drugs will affect Benlysta?

Tell your doctor about all other medicines you use, 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 and other drugs may interact with Benlysta. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about Benlysta.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Benlysta 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 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 4/6/2011 11:21:42 PM.

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