Download Unituxin

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March 18th 2015 FDA approved the release of Unituxin
Used for the treatment of: Children with neuroblastoma
who have seen at least some response to prior combination
therapies.
Dosage Form: Solution for injection.
Marketing Information from Manufacturer: “Unituxin
marks the first approval for a therapy aimed specifically for the
treatment of patients with high-risk neuroblastoma,” said
Richard Pazdur, M.D., director of the Office of Hematology and
Oncology Products in the FDA’s Center for Drug Evaluation
and Research. “Unituxin fulfills a critical need by providing a
treatment option that prolongs survival in children with highrisk neuroblastoma.”
Benefits and Concerns of the Drug: This is a treatment
for young patients with a unique disease, effects 1 in 100,000
children, mostly males, and has shown remission in 63% of
the patients with a survival rate greater than 3 years.
Coverage Recommendations: These recommendations
are available to IPC/EvergreenRx clients from their Account
Manager or Clinical Pharmacist.
Special points of interest
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Un itu xin (u n i tu x in )
(d in u t u x im ab ) is a
ch im er ic m on oc lon a l
an t ib od y com p o sed of
m u r in e v ar i ab le h ea v y
an d li gh t ch a in r e gio n s
an d th e h u m an con s tan t
r eg ion for t h e h e a vy
ch a in I g G1 an d l i gh t
ch a in k ap p a . Un itu x in
b in d s to t h e g ly co lip id
d is i a lo gan g li os id e
(G D2) . D in u tu x im ab i s
p r od u ced i n th e m u r in e
m ye lom a ce l l l in e ,
SP 2/ 0.
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