Your healthcare professional will discuss the most suitable place for you to receive your infusion of BENLYSTA. You may receive your infusion at various locations, such as your doctor’s office, a hospital, or an infusion center.
How long it takes
The infusion of BENLYSTA is given over approximately one hour. Preparation time before and observation time after the infusion may vary.
How often it happens
The recommended dosing schedule for BENLYSTA is the following: For the first three infusions, BENLYSTA is given every two weeks. After that, BENLYSTA is given once every four weeks. See the diagram below as an example. It’s important to continue to receive BENLYSTA as prescribed, even if you’re feeling better.
GlaxoSmithKline sponsors ambassadors for BENLYSTA and pays them for their time and expense in sharing their experiences. Individual results may vary.
Before your infusion
When you arrive for your treatment, a healthcare professional will help you prepare for your infusion. He or she may ask questions about how you are feeling, take your temperature, measure your pulse rate, check your blood pressure, and discuss your medical history. You may receive medication prior to the infusion, such as an antihistamine, which may help reduce your chance of having an allergic reaction. It is not known if these medications will help reduce the chance of an allergic reaction to BENLYSTA.
After your infusion
After the infusion, you may feel some discomfort where the IV line was inserted. This discomfort should go away within a few hours. You may also feel a little drowsy if you took an antihistamine and may want to go home and rest. It’s important that you have someone drive you home, especially if you are drowsy. Depending on how you feel, you may be able to return to your usual activities. Contact your healthcare professional if you don’t feel well or have soreness or tenderness at the infusion site that does not go away.
If you have any questions or concerns about the infusion process, be sure to ask your healthcare professional.
If you miss your infusion appointment, ask your healthcare professional when to schedule your next infusion.
Your doctor will tell you how often you should receive BENLYSTA. It is important to continue to receive BENLYSTA as prescribed, even if you're feeling better.
Allergic (hypersensitivity) and infusion reactions
Serious reactions can happen on the day of or the day after receiving BENLYSTA and may cause death. Tell your healthcare professional right away if you have any of the following symptoms of a reaction: itching; swelling of the face, lips, mouth, tongue, or throat; trouble breathing; anxiousness; low blood pressure; dizziness or fainting; headache; nausea; or skin rash, redness, or swelling. Tell your healthcare professional or get emergency medical help right away if you have any of these symptoms.
What is BENLYSTA?
BENLYSTA is a prescription medication used to treat adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.
It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus, and it has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.
Important Safety Information
The most important information to 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 professional right away if you have any of the symptoms listed below while receiving BENLYSTA
Infections: Symptoms can include fever, chills, pain or burning with urination, urinating often, bloody diarrhea, or coughing up mucus.
Heart Problems: Symptoms can include chest discomfort or pain, shortness of breath, cold sweats, nausea, dizziness, or discomfort in other areas of the upper body.
Mental health problems and suicide: Symptoms 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, or thoughts of hurting yourself or others.
Do not receive BENLYSTA if you are allergic to belimumab or to any of the ingredients in BENLYSTA.
Before receiving BENLYSTA also discuss with your healthcare professional 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 professional tells you to.
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 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.
are pregnant or plan to become pregnant. It is not known if BENLYSTA will harm your unborn baby. Tell your healthcare professional if you become pregnant during your treatment with BENLYSTA.
are breastfeeding or plan to breastfeed. It is not known if BENLYSTA passes into your breast milk. You and your healthcare professional should decide if you will receive BENLYSTA or breastfeed. You should not do both.
Women of childbearing age should use adequate birth control measures while taking BENLYSTA and for at least four months after their final treatment with BENLYSTA.
Remember to tell your healthcare professional about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Possible side effects of 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 reactions can happen on the day of or the day after receiving BENLYSTA and may cause death. Tell your healthcare professional right away if you have any of the following symptoms of a reaction: itching; swelling of the face, lips, mouth, tongue, or throat; trouble breathing; anxiousness; low blood pressure; dizziness or fainting; headache; nausea; or skin rash, redness, or swelling. Tell your healthcare professional or get emergency medical help right away if you have any of these symptoms.
The most common side effects of BENLYSTA include:
Stuffy or runny nose
Leg or arm pain
Urinary tract infection
Decreased white blood cell count (leukopenia)
Tell your healthcare professional 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 professional.
Other Important Information
In 2 of 3 studies, fewer blacks/African Americans who received BENLYSTA responded to treatment compared to blacks/African Americans who did not receive BENLYSTA. Therefore, caution should be used when considering BENLYSTA treatment in blacks/African Americans. It is important to discuss with your healthcare professional whether BENLYSTA is right for you. A clinical trial is planned to study BENLYSTA specifically in blacks/African Americans with lupus.
For more information, call the BENLYSTA® Gateway at 1-877-4-BENLYSTA (1-877-423-6597) Monday through Friday, 8 AM to 8 PM Eastern Time.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.