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BELIMUMAB (Benlysta) is a targeted, human monoclonal antibody that binds to soluble B lymphocyte stimulator (BLyS). Benlysta does not bind to B cells directly. By binding BLyS, Benlysta allows more B cells to undergo the normally occurring process of apoptosis, which inhibits the survival of B cells, including autoreactive B cells and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Benlysta is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy. Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations.
FDA-Approved Indication - Benlysta is indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
Benlysta is administered as a 1-hour IV infusion only and given every 4 weeks after the loading phase.
(If the answer is yes to any of these questions, review with ordering provider.)
Benlysta is provided as a lyophilized powder in a single-use vial for intravenous infusion only and should be reconstituted and diluted by a healthcare professional using aseptic technique as follows:
There were no specific guidelines in the medication guide from the manufacturer for vital signs monitoring. It is reasonable and prudent however, to obtain vital signs (patient temperature, blood pressure and pulse) upon arrival, after the start of Benlysta, upon discontinuing infusion, and before the patient departs the facility. If the patient has a prior history of an acute infusion reaction, monitor vitals every 10 minutes for 30 minutes and for 30 minutes after infusion.
Prior to dosing with Benlysta, the provider should consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions. The infusion nurse should check for pre-medication orders.
Acute infusion reaction can occur during the administration of this agent. Patients may also have an infusion reaction the following day after the infusion. Anaphylactoid and anaphylaxis reactions can result. If patient reports mild reactions (such as dizziness, hives, flushing, chills, etc.), slow down the infusion rate and assess patient. For more severe reactions (such as difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, fever, chills or anaphylaxis) or where mild reactions persist, stop the infusion and treat the acute reaction. Notify the supervising provider immediately to coordinate next plan of action. Patients should be informed that infusion reactions can be delayed, and should contact their provider at the first sign of an allergic reaction which may include:
Updated January 2017 - ARHP Practice Committee
DISCLAIMER:The information contained in this biologic reference guide is offered solely for purposes of providing health care professionals with a quick and initial reference. Before prescribing or administering any drug contained in this biologic reference guide, health professionals should read the manufacturer's complete prescribing information in order to be informed of the various clinical considerations to be taken into account.
The American College of Rheumatology is providing this information as a benefit and service in furtherance of its educational mission. By providing this information, ACR is not endorsing or recommending any of the listed companies or any of their drugs or other products. The information contained in the biologic reference guides reflect the conclusions of the individual companies and not those of the ACR which specifically disclaims any responsibility or liability for the use of such information and/or for the performance of any of the drugs listed in this biologic reference guide.
© 2017 American College of Rheumatology