"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"...
(belimumab) Injection for Intravenous Use
BENLYSTA (belimumab) is a human IgG1λ monoclonal antibody specific for soluble human B lymphocyte stimulator protein (BLyS, also referred to as BAFF and TNFSF13B). Belimumab has a molecular weight of approximately 147 kDa. Belimumab is produced by recombinant DNA technology in a mammalian cell expression system.
BENLYSTA is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous infusion. Upon reconstitution with Sterile Water for Injection, USP [see DOSAGE AND ADMINISTRATION], each single-use vial delivers 80 mg/mL belimumab in 0.16 mg/mL citric acid, 0.4 mg/mL polysorbate 80, 2.7 mg/mL sodium citrate, and 80 mg/mL sucrose, with a pH of 6.5.
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...
What are the precautions when taking belimumab (Benlysta)?
Before using belimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: infections (current infections, infections that return), mental/mood problems (such as depression, thoughts of suicide), cancer.
Belimumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you...
Last reviewed on RxList: 3/22/2016
This monograph has been modified to include the generic and brand name in many instances.
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