"March 9, 2011 -- The FDA has approved Benlysta, the first new lupus treatment in 50 years.
An FDA advisory panel last November voted 13-2 in favor of approval. But the panel noted that Benlysta is no wonder drug. Overall, it offered a"...
Benlysta Patient Information Including Side Effects
Brand Names: Benlysta
Generic Name: belimumab (Pronunciation: be LIM ue mab)
- What is belimumab (Benlysta)?
- What are the possible side effects of belimumab (Benlysta)?
- What is the most important information I should know about belimumab (Benlysta)?
- What should I discuss with my healthcare provider before receiving belimumab (Benlysta)?
- How is belimumab given (Benlysta)?
- What happens if I miss a dose (Benlysta)?
- What happens if I overdose (Benlysta)?
- What should I avoid while receiving belimumab (Benlysta)?
- What other drugs will affect belimumab (Benlysta)?
- Where can I get more information?
What is belimumab (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.
Belimumab is used in 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.
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 sleeping, or thoughts about hurting yourself or others;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.
- wheezing, chest tightness, trouble breathing; or
Serious and sometimes fatal infections may occur during treatment with belimumab. Call your doctor right away if you have signs of infection such as:
- fever, chills, flu symptoms, night sweats, weight loss;
- increased urination, pain or burning when you urinate;
- cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
- swelling, pain, tenderness, or redness anywhere on your body; or
- bloody diarrhea.
Less serious side effects may include:
- nausea, diarrhea, stomach pain;
- mild pain in your arms or legs; or
- mild cold symptoms such as stuffy nose, sneezing, sore throat.
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.
Read the Benlysta (belimumab) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about belimumab (Benlysta)?
You should not use belimumab if you are allergic to it.
Before you receive belimumab, tell your doctor if you have an active or chronic infection, a history of cancer, or a history of depression or mental illness.
Serious and sometimes fatal infections may occur during treatment with belimumab. Call your doctor right away if you have signs of infection such as fever, chills, flu symptoms, night sweats, pain or burning when you urinate, cough with mucus, stabbing chest pain, feeling short of breath, bloody diarrhea, or swelling, pain, tenderness, or redness anywhere on your body.
Belimumab 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 belimumab.
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.
Additional Benlysta Information
- Benlysta Drug Interactions Center: belimumab iv
- Benlysta Side Effects Center
- Benlysta Overview including Precautions
- Benlysta FDA Approved Prescribing Information including Dosage
Benlysta - User Reviews
Benlysta User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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