Risks and Side Effects
What is the most important information I should know about BENLYSTA?
BENLYSTA can cause serious side effects. Some of these side effects may cause death. It is not known if BENLYSTA causes these serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while receiving BENLYSTA.
Symptoms of an infection can include:
- pain or burning with urination
- urinating often
- coughing up mucus
- skin or sores that are warm, red or painful
Symptoms of heart problems can include:
- chest discomfort or pain
- shortness of breath
- cold sweats
- discomfort in other areas of the upper body
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
What is BENLYSTA?
BENLYSTA is a prescription medicine used to treat adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.
BENLYSTA contains belimumab which is in a group of medicines called monoclonal antibodies. Lupus is a disease of the immune system (the body system that fights infection). People with active lupus often have high levels of a certain protein in their blood. BENLYSTA binds to and limits the activity of the protein. When given together with other medicines for lupus, BENLYSTA decreases lupus disease activity more than other lupus medicines alone.
- It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus.
- It is not known if BENLYSTA is safe and effective in children.
Who should not receive BENLYSTA?
Do not receive BENLYSTA if you:
- are allergic to belimumab or any of the ingredients in BENLYSTA. See the end of the Medication Guide for a complete list of ingredients in BENLYSTA.
What should I tell my healthcare provider before receiving BENLYSTA?
- think you have an infection or have infections that keep coming back. You should not receive BENLYSTA if you have an infection unless your healthcare provider tells you to. See "What is the most important information I should know about BENLYSTA?".
- 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 BENLYSTA, you should not receive live vaccines.
- are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- are allergic to other medicines.
- are receiving other biologic medicines, monoclonal antibodies or intravenous 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 BENLYSTA will harm your unborn baby. If you are able to become pregnant, you should talk to your healthcare provider about whether or not to use birth control (contraception) and receive BENLYSTA. If BENLYSTA is recommended, you should use an effective method of birth control while receiving BENLYSTA and for at least 4 months after the final dose of BENLYSTA.
- Tell your healthcare provider right away if you become pregnant or you think you may be pregnant while receiving treatment with BENLYSTA. If you become pregnant, talk to your healthcare provider about enrolling in the BENLYSTA Pregnancy Registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of the registry is to monitor the health of you and your baby.
- are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your healthcare provider should discuss whether or not you should receive BENLYSTA and breastfeed.
How will I receive BENLYSTA?
- You will be given BENLYSTA 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 BENLYSTA.
- Your healthcare provider will tell you how often you should receive BENLYSTA.
- Your healthcare provider may give you medicines before you receive BENLYSTA to help reduce your chance of having a reaction. A healthcare provider will watch you closely while you are receiving BENLYSTA and after your infusion for signs of a reaction.
What are the possible side effects of BENLYSTA?
BENLYSTA can cause serious side effects.
- See "What is the most important information I should know about BENLYSTA?"
- Cancer. BENLYSTA may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.
Allergic (hypersensitivity) and infusion reactions. Serious allergic or infusion reactions can happen on the day of or days after receiving BENLYSTA and may cause death. Your healthcare provider will watch you closely while you are receiving BENLYSTA and after your infusion for signs of a reaction. Allergic reactions can sometimes be delayed; tell your healthcare provider right away if you have any of the following symptoms of an allergic or infusion reaction:
- swelling of the face, lips, mouth, tongue, or throat
- trouble breathing
- low blood pressure
- dizziness or fainting
- skin rash, redness, or swelling
Tell your healthcare provider or get emergency medical help right away if you have any of these symptoms.
Progressive multifocal leukoencephalopathy (PML). PML is a serious and life-threatening brain infection. Your chance of getting PML may be higher if you are treated with medicines that weaken your immune system, including BENLYSTA. PML can result in death or severe disability. If you notice any new or worsening medical problems such as those below, tell your healthcare provider right away:
- memory loss
- trouble thinking
- dizziness or loss of balance
- difficulty talking or walking
- loss of vision
The most common side effects of BENLYSTA include:
- stuffy or runny nose and sore throat (nasopharyngitis)
- cough (bronchitis)
- trouble sleeping
- leg or arm pain
- headache (migraine)
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 BENLYSTA. For more information, ask your healthcare provider.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.