Belimumab

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. 

Common side effects include nausea, diarrhea, and fever.

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

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

• Benlysta

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 
• injection site reactions (if medication is given under the skin)

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. 

Formal drug interaction studies have not been performed. 

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, and herbal supplements. 

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

• fever  
• chills 
• pain or burning with urination 
• urinating often  
• bloody diarrhea 
• coughing up mucus 

• chest discomfort or pain 
• shortness of breath 
• cold sweats 
• nausea 
• dizziness 
• discomfort in other areas of the upper body 

• 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 

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.

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

• are allergic to belimumab or to any of its ingredients 
• 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. 

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.

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. 

Take this medication exactly as prescribed by your doctor.

If injected into the vein:

• 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.

If injected under the skin:

• 200 mg once weekly.

If you use too much belimumab, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

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

• Store autoinjectors and prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
• Keep belimumab and all other medications out of the reach of children. 
• Keep belimumab autoinjectors and prefilled syringes in the original package until time of use to protect from light.
• Do not shake. Keep away from heat.
• Do not use and do not place back in the refrigerator if left out at room temperature for more than 12 hours.
• Safely throw away medicine that is out of date or no longer needed.