Benlysta (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.
Benlysta is used in to treat active systemic lupus erythematosus (SLE) in adults.
Benlysta 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).
Important information
Before you receive Benlysta, tell your doctor if you have an active or chronic infection, a history of cancer, or a history of depression or mental illness.
Benlysta may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.
Serious and sometimes fatal infections may occur during treatment with Benlysta. Stop using this medicine 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.
Benlysta can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections.
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection. Do not receive a "live" vaccine within 30 days before or after you are treated with Benlysta.
You may have thoughts about suicide while receiving belimumab, especially if you have a history of suicidal thoughts or actions. Report any new or worsening symptoms to your doctor, such as: depression, anxiety, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others.
Before taking this medicine
You should not use Benlysta if you are allergic to belimumab.
To make sure Benlysta is safe for you, tell your doctor if you have:
You may have thoughts about suicide while receiving Benlysta, especially if you have a history of suicidal thoughts or actions.
Benlysta may increase your risk of certain cancers by changing the way your immune system works. Ask your doctor about your individual risk.
FDA pregnancy category C. It is not known whether Benlysta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
See also: Pregnancy and breastfeeding warnings (in more detail)
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Benlysta on the baby.
It is not known whether belimumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medicine.
How is Benlysta given?
Benlysta is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. The injection must be given slowly, and the IV infusion can take about an hour to complete.
The first 3 doses of Benlysta are given 2 weeks apart. Then the injections are given every 4 weeks. Your dosing schedule may be different. Follow your doctor"s instructions.
You may be given other medicines to prevent certain side effects of Benlysta.
Benlysta dosing information
Usual Adult Dose for Systemic Lupus Erythematosus:
10 mg/kg IV at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.
Comments:
-Infuse over a 1-hour period.
-Consider premedication including an antihistamine, with or without an antipyretic, before the infusion.
Use: Treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
What happens if I miss a dose?
Contact your doctor if you miss an appointment for your Benlysta injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving Benlysta?
Avoid being near people who have colds, the flu, or other contagious illnesses.
Do not receive a "live" vaccine while using Benlysta. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Benlysta side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Benlysta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people receiving a Benlysta injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel anxious, nauseated, light-headed, itchy, or have trouble breathing, severe headache, or skin redness and swelling.
Serious and sometimes fatal infections may occur during treatment with this medicine. Stop using this medicine and call your doctor right away if you have signs of infection such as:
Benlysta may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. 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, or thoughts about hurting yourself or others;
-
wheezing, chest tightness, trouble breathing; or
-
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, dizziness, sweating, general ill feeling.
Common Benlysta side effects may include:
-
nausea, vomiting, diarrhea, stomach pain;
-
urination problems;
-
fever, sore throat, runny or stuffy nose, cough;
-
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. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Benlysta?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Benlysta, especially:
-
cyclophosphamide (Cytoxan); or
-
drugs that weaken your immune system such as cancer medicine, steroids, and medicines to prevent rejection of a transplanted organ.
This list is not complete. Other drugs may interact with belimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
