University of Cagayan Valley College of Health | Pharmacology | Summer Class 2011-2012

Drug Name: Benlysta (belimumab)

Approval Status: Approved March 2011 Benlysta (belimumab) is a human IgG 1a monoclonal antibody specific for soluble human B lymphocyte stimulator protein (BLyS). Elevated levels of BLyS are seen in the blood or joint fluid of patients with autoimmune and inflammatory disorders. It is the first new drug for lupus in 50 years. Dose and route of administration Benlysta is supplied as a solution for intravenous infusion. It must be reconstituted and diluted prior to intravenous administration. The recommended initial dose is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. It should be administered as an intravenous infusion over a period of 1 hour. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. Mechanism of Action Benlysta (belimumab) blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. Benlysta does not bind B cells directly, but by binding BLyS, it inhibits the survival of B cells, including auto reactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Use Benlysta is specifically indicated for the treatment of adult patients with active, autoantibodypositive, systemic lupus erythematosus who are receiving standard therapy. Side Effects Adverse effects associated with the use of Benlysta may include, but are not limited to, the following:

nausea diarrhea pyrexia nasopharyngitis bronchitis

insomnia pain in extremity depression migraine pharyngitis

Jocris A. Cabaguan

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University of Cagayan Valley College of Health | Pharmacology | Summer Class 2011-2012

References

Katzung, B. G., Masters, S. B., & Trevor, A. J. (2011) Basic and Clinical Pharmacology. Twelfth Edition. McGraw-Hill Companies, Inc.
Navarra, S. V., Guzman, R. M., Gallacher, A. E., Hall, S., Levy, R. A., Jimenez, R. E., Li, E. K., Thomas, M., Kim, H. Y., Leon, M. G., Tanasescu, C., Nasonov, E., Lan, J. L., Pineda, L., Zhong, Z. J., Freimuth, W., & Petri, M. A. (2011). Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. BLISS-52 Study Group. 26;377(9767):721-31 Jacobi, A. M., Huang, W., Wang, T., Freimuth, W., Sanz, I., Furie, R., Mackay, M., Aranow, C., Diamond, B., & Davidson, A. (2010). Effect of long-term belimumab treatment on B cells in systemic lupus erythematosus: extension of a phase II, double-blind, placebocontrolled, dose-ranging study. Arthritis and Rheumatism. 62(1):201-10 Wallace, D. J., Stohl, W., Furie, R. A., Lisse, J. R., McKay, J. D., Merrill, J. T., Petri, M. A., Ginzler, E. M., Chatham, W. W., McCune, W. J., Fernandez, V., Chevrier, M. R., Zhong, Z. J., & Freimuth, W. W. (2009). A phase II, randomized, double-blind, placebocontrolled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis and Rheumatism. 61(9):1168-78 Furie, R., Stohl, W., Ginzler, E. M., Becker, M., Mishra, N., Chatham, W., Merrill, J. T., Weinstein, A., McCune, W. J., Zhong, J., Cai, W., & Freimuth, W. (2008). Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus. Belimumab Study Group. Arthritis Research and Therapy. 10(5):R109.

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