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.
Belimumab is used to treat active systemic
lupus erythematosus (SLE) in adults.
Belimumab 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).
Belimumab may also be used for other purposes not listed in this medication guide.
When belimumab is injected into a vein,
tell your caregiver right away if you feel anxious, nauseated, light-headed,
itchy, or short of breath.
Belimumab affects your immune system. You
may get infections more easily, even serious or fatal infections. Call your
doctor if you have a fever, chills, cough with mucus, skin sores, increased
urination, or burning when you urinate.
Belimumab may also cause heart problems.
Call your doctor at once if you have chest pain, nausea, dizziness, sweating,
and trouble breathing.
Report any new or worsening mental health symptoms to your doctor, such as: depression, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others.
Before taking this medicine
You should not use belimumab if you are
allergic to it.
Tell your doctor if you have ever had:
- an active or chronic infection;
- depression or mental illness;
- suicidal thoughts or actions;
- cancer; or
- if you are using cyclophosphamide, biologic medicines, or other
monoclonal antibody medicines.
Some people have thoughts about suicide
while using belimumab. Your doctor will need to check your progress at regular
visits. Your family or other caregivers should also be alert to changes in your
mood or symptoms.
Belimumab may increase your risk of certain
cancers by changing the way your immune system works. Ask your doctor about
your individual risk.
Belimumab may harm an unborn baby. Use
effective birth control to prevent pregnancy while you are using this medicine
and for at least 4 months after your last dose. Tell your doctor if you become
If you are pregnant, your name may be
listed on a pregnancy registry to track the effects of belimumab on the baby.
It may not be safe to breast-feed while
using this medicine. Ask your doctor about any risk.
Belimumab is not approved for use by anyone younger than 18 years old.
Get emergency medical help if you have
signs of an allergic reaction: hives, itching; feeling anxious or light-headed;
difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the
injection. Tell your caregiver if you feel anxious, nauseated, light-headed,
itchy, or have trouble breathing, severe headache, or skin redness and
You may get infections more easily, even
serious or fatal infections. Stop using belimumab and call your doctor right
away if you have signs of infection such as:
- fever, chills;
- cough with mucus;
- pain or burning when you urinate;
- urinating more than usual; or
- bloody diarrhea.
Belimumab may cause a serious brain
infection that can lead to disability or death. Call your doctor right away if
you have problems with speech, thought, vision, or muscle movement. These
symptoms may start gradually and get worse quickly.
Also call your doctor at once if you have:
- new or worsening depression, anxiety, mood or behavior changes,
trouble sleeping, risk-taking behavior, or thoughts about hurting yourself or
- wheezing, chest tightness, trouble breathing; or
- chest pain or pressure, pain spreading to your jaw or shoulder,
Common side effects may include:
- nausea, diarrhea;
- fever, sore throat, runny or stuffy nose, cough;
- pain, itching, redness, or swelling where the injection was given;
- pain in your arms or legs;
- headache, depressed mood; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
What other drugs will affect belimumab?
Other drugs may affect belimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.