This medicine is authorised for use in the European Union. Benlysta is given to patients whose disease is still highly active despite standard treatment. Benlysta contains the active substance belimumab. Expand section Collapse section How is Benlysta used? Benlysta can only be obtained with a prescription and treatment should only be started and supervised by a doctor who has experience in the diagnosis and treatment of SLE.
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More What is Benlysta? 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 together with other lupus medicines to treat active systemic lupus erythematosus SLE. Benlysta helps decrease disease activity more than when the other medicines are used alone. Benlysta is for use in adults and children at least 5 years old. 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 When Benlysta 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.
Benlysta 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 Benlysta if you are allergic to belimumab. To make sure Benlysta is safe for you, tell your doctor if you have ever had: an active or chronic infection; depression or mental illness; cancer; or if you are using cyclophosphamide , biologic medicines, or other monoclonal antibody medicines.
Belimumab may increase your risk of certain cancers by changing the way your immune system works. Ask your doctor about your individual risk. Some people have thoughts about suicide while using Benlysta.
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 affect the immune system of your baby if you use this medicine while you are pregnant. Use effective birth control to prevent pregnancy while you are using Benlysta and for at least 4 months after your last dose.
Tell your doctor if you become pregnant. SLE in the mother may also cause lupus or heart problems to develop in the newborn. The benefit of treating SLE may outweigh any risks to the baby. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Benlysta on the baby. Make sure any doctor caring for your newborn baby knows if you used Benlysta while you were pregnant.
It may not be safe to breastfeed while using Benlysta. Ask your doctor about any risk. How is Benlysta given? Benlysta is given as an infusion into a vein, usually every 2 to 4 weeks. A healthcare provider will give you this injection. The medicine must be given slowly, and the infusion can take about 1 hour to complete. Benlysta is also injected under the skin, usually once per week. A healthcare provider may teach you how to properly use the medication by yourself.
Do not inject this medicine into skin that is bruised, tender, red, or hard. Benlysta can be given as an intravenous infusion to adults or children.
This medicine is injected under the skin only in adults. If you give injections at home, use the medicine on the same day each week.
Read and carefully follow any Instructions for Use provided with your medicine. Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine. You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.
Store the prefilled syringe or injection pen in its original packaging in the refrigerator. Do not freeze or expose to light or high heat. Do not shake the medicine. Take the syringe or injection pen out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose.
Do not use if the medicine has been left at room temperature longer than 12 hours. Do not put it back into the refrigerator. Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.
Throw away used needles, syringes, or injection pens in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container.
Keep it out of the reach of children and pets.
BENLYSTA PRESCRIBING INFORMATION PDF
Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: Biologics in oral medicine: However, there are still unmet needs. Circulating antibody-secreting cells were enumerated using enzyme-linked immunospot assay. No serious adverse events AEs were seen. Belimumab Benlysta The authors concluded that recent studies suggested several new agents including tocilizumab, belimumab, daratumumab, plerixafor, and C1 esterase inhibitor as potentially novel and effective therapies to employ in AMR treatment. The decrease in biomarkers of B-cell activation observed at week 28 persisted unchanged until week 52, with RF decreasing further.