Bayan Asem Ibrahim
second year pharm.D
Instructor : Dr.Adham Abu Taha
Benlysta(belimumab)
Date of Approval: March 10, 2011
Treatment for: Systemic Lupus
Erythematosus
Company: Human Genome Sciences,
Inc. and GlaxoSmithKline
what is Systemic Lupus
Erythematosus
• is a systemic autoimmune disease (or
autoimmune connective tissue disease) that can
affect any part of the body. As occurs in other
autoimmune diseases, the immune system
attacks the body's cells and tissue, resulting in
inflammation and tissue damage. It is a Type III
hypersensitivity reaction caused by antibodyimmune complex formation. SLE most often
harms the heart, joints, skin, lungs, blood vessels,
liver, kidneys, and nervous system..
MOA:
Belimumab is a human IgG1gamma
monoclonal antibody specific for soluble
human B lymphocyte stimulator protein
(BLyS), a B cell survivor factor. It blocks the
binding of soluble BLyS to its receptors on B
cells, thus inhibiting the survival of B cells,
including autoreactive B cells, and reduces
the differentiation of B cells into
immunoglobulin-producing plasma
DOSING: The recommended
dose of belimumab is 10
mg/kg at two-week intervals
for the first three doses and
at four-week intervals
thereafter. Belimumab is
administered intravenously
over a one-hour period
What's new about this drug?
• Benlysta: is the first inhibitor designed to
target B-lymphocyte stimulator (BLyS) protein,
which may reduce the number of abnormal B
cells that the problem in lupus.
Adverse Reaction(s):
Infections (eg, URI, UTI, nasopharyngitis, sinusitis,
bronchitis, influenza; may be serious/fatal),
psychological effects (eg, depression, insomnia,
anxiety, suicide), GI upset, fever, migraine,
extremity pain, infusion and/or hypersensitivity
reactions.
NURSING MOTHERS and pregnants should not
take benlysta
DRUG INTERACTIONS: Drug interactions have not
been studied. Since belimumab reduces the activity
of the immune system it may interfere with the
response to immunizations. Live vaccines should
not be administered concurrently with belimumab
or at least 30 days before administration of
belimumab.
• See “What is the most important information I
should know about BENLYSTA?”
• 1. Cancer. BENLYSTA may reduce the activity of
your immune system. Medicines that affect the
immune system may increase your risk of
certain cancers.
• 2. Allergic (hypersensitivity) and infusion
reactions. Serious allergic or infusion reactions
can happen on the day of or the day after
receiving BENLYSTA.
• In my view, Benlysta’s benefits appear to be marginal and
even questionable for patients.
• the approval of Benlysta may encourage other companies to
move forward with drugs for lupus, because it is the first new
lupus drug to come to market in more than 50 years,. In that
way, perhaps, the medication may have more significant
benefits for patients.
References
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www.fda.gov
www.emp.com
www.drugs.com
www.medicinenet.com
www.makpive.us