(belimumab) Injection for intravenous use
Read this Medication Guide before
you start receiving BENLYSTA and before each treatment. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
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.
- Infections. Symptoms of an infection can include:
- Heart Problems. Symptoms of heart problems can include:
- 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
What is BENLYSTA?
BENLYSTA is a prescription medicine used to treat adults
with active systemic lupus erythematosus (SLE or lupus) who are receiving other
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 this Medication Guide for a complete list of
ingredients in BENLYSTA.
What should I tell my healthcare provider before receiving BENLYSTA?
Before you receive BENLYSTA, tell your healthcare provider if you:
- 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
- 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
BENLYSTA will harm your unborn baby. Tell your healthcare provider if you
become pregnant during your treatment with BENLYSTA.
- If you become pregnant while receiving BENLYSTA, 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 this
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
decide if you will receive BENLYSTA 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
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
- 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 the day after
receiving BENLYSTA and may cause death. Tell your healthcare provider right
away if you have any of the following symptoms of an allergic or infusion
Your healthcare provider will watch you closely while you
are receiving BENLYSTA and after your infusion for signs of a reaction.
The most common side effects of BENLYSTA include:
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.
General information about the safe and effective use of
Medicines are sometimes prescribed for purposes other than
those listed in a Medication Guide. Do not use BENLYSTA for a condition for
which it was not prescribed.
This Medication Guide summarizes the most important
information about BENLYSTA. For more information about BENLYSTA, talk with your
You can ask your healthcare provider or pharmacist for
information about BENLYSTA that is written for healthcare professionals.
For more information about BENLYSTA, go to www.BENLYSTA.com or
What are the ingredients in BENLYSTA?
Active ingredient: belimumab.
Inactive ingredients: citric acid, polysorbate 80, sodium citrate, sucrose.
What are the possible side effects of belimumab (Benlysta)?
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 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: 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...
Read All Potential Side Effects and See Pictures of Benlysta »
What are the precautions when taking belimumab (Benlysta)?
Before using belimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: infections (current infections, infections that return), mental/mood problems (such as depression, thoughts of suicide), cancer.
Belimumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you...
Read All Potential Precautions of Benlysta »
Last reviewed on RxList: 4/26/2012
This monograph has been modified to include the generic and brand name in many instances.