Belimumab

Belimumab treats an immune system disease, lupus. Can increase your chance of getting an infection. Tell your doctor if you notice any signs of infection such as a fever.

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Belimumab Overview

Reviewed: September 7, 2012
Updated: 

Belimumab is a prescription medicine that is used with other medicines to treat lupus. Belimumab is in a class of medications called monoclonal antibodies and works by affecting the immune system by blocking the activity of a certain protein in people with lupus. 

Belimumab comes in an injectable form that is given through a needle in a vein (IV) by a healthcare provider. 
 
Common side effects include nausea, diarrhea, and fever.

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Belimumab Cautionary Labels

precautionsprecautionsprecautions

Uses of Belimumab

Belimumab is a prescription medicine used to treat adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Belimumab Brand Names

Belimumab may be found in some form under the following brand names:

Belimumab Drug Class

Belimumab is part of the drug class:

Side Effects of Belimumab

Belimumab can cause serious side effects. See “Drug Precautions” 

The most common side effects of belimumab include: 

  • nausea 
  • diarrhea 
  • fever 
  • stuffy or runny nose 
  • sore throat 
  • cough (bronchitis) 
  • trouble sleeping 
  • leg or arm pain 
  • headache (migraine) 
  • urinary tract infection 
  • decreased white blood cell count (leukopenia) 
  • vomiting 
  • stomach pain 

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of belimumab. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

Belimumab Precautions

Do not receive belimumab if you are allergic to belimumab or any of the ingredients in belimumab.

Belimumab can cause serious side effects. Some of these side effects may cause death. It is not known if belimumab causes these serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while receiving belimumab. 
 
1.  Infections. Symptoms of an infection can include: 
  • fever  
  • chills 
  • pain or burning with urination 
  • urinating often  
  • bloody diarrhea 
  • coughing up mucus 
 
2.  Heart Problems. Symptoms of heart problems can include: 
  • chest discomfort or pain 
  • shortness of breath 
  • cold sweats 
  • nausea 
  • dizziness 
  • discomfort in other areas of the upper body 
 
3.  Mental health problems and suicide. Symptoms of mental health problems can include: 
  • thoughts of suicide or dying 
  • attempt to commit suicide 
  • trouble sleeping (insomnia) 
  • new or worse anxiety  
  • new or worse depression 
  • acting on dangerous impulses 
  • other unusual changes in your behavior or mood 
  • thoughts of hurting yourself or others

4.  Cancer. Belimumab may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.  

5.  Allergic (hypersensitivity) and infusion reactions. Serious allergic or infusion reactions can happen on the day of or the day after receiving belimumab and may cause death. Tell your healthcare provider right away if you have any of the following symptoms of an allergic or infusion reaction:

  • itching
  • swelling of the face, lips, mouth, tongue, or throat
  • trouble breathing
  • anxiousness 
  • low blood pressure 
  • dizziness or fainting 
  • headache 
  • nausea 
  • skin rash, redness, or swelling 
Your healthcare provider will watch you closely while you are receiving belimumab and after your infusion for signs of a reaction. 

Belimumab Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of belimumab there are no specific foods that you must exclude from your diet when receiving belimumab.

 

Inform MD

Before you receive belimumab, tell your healthcare provider if you: 

  • think you have an infection or have infections that keep coming back. You should not receive belimumab if you have an infection unless your healthcare provider tells you to. See “Drug Precautions”.
  • have or have had mental health problems such as depression or thoughts of suicide 
  • have recently received a vaccination or if you think you may need a vaccination. If you are receiving belimumab, you should not receive live vaccines. 
  • are allergic to other medicines 
  • are receiving other biologic medicines, monoclonal antibodies or IV infusions of cyclophosphamide (Cytoxan
  • have or have had any type of cancer 
  • have any other medical conditions 
  • are pregnant or plan to become pregnant. It is not known if belimumab will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with belimumab. 
  • If you become pregnant while receiving belimumab, talk to your healthcare provider about enrolling in the pregnancy registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of this registry is to monitor the health of you and your baby. 
  • are breastfeeding or plan to breastfeed. It is not known if belimumab passes into your breast milk. You and your healthcare provider should decide if you will receive belimumab or breastfeed. You should not do both. 
 
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.  Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine. 

Belimumab and Pregnancy

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if belimumab will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with belimumab. 

  • If you become pregnant while receiving belimumab, talk to your healthcare provider about enrolling in the belimumab pregnancy registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of this registry is to monitor the health of you and your baby.

Belimumab and Lactation

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if belimumab passes into your breast milk. You and your healthcare provider should decide if you will receive belimumab or breastfeed. You should not do both. 

Belimumab Usage

  • You will be given belimumab by a healthcare provider through a needle placed in a vein (IV infusion). It takes about 1 hour to give you the full dose of belimumab. 
  • Your healthcare provider will tell you how often you should receive belimumab. 
  • Your healthcare provider may give you medicines before you receive belimumab to help reduce your chance of having a reaction. A healthcare provider will watch you closely while you are receiving belimumab and after your infusion for signs of a reaction.  

Belimumab Dosage

Take this medication exactly as prescribed by your doctor.

The dose your doctor recommends may be based on your weight.

The recommended dose of belimumab is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.

Belimumab Overdose

If belimumab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.