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RESTASIS®
(cyciosporine ophthalmic emuision) 0.05%
Sterile, Preservative-Free
INDICATIONS AND USAGE
RESTASIS® ophthalmic emulsion is indicated t increase tear production in patients whose
fear production is presumed to be suppressed due to ocular inflammation associated with
keratoconjunctivitis sicca. Increased tear producion was not seen in patients currently taking
topicalant-inflammatory drugs o using punctal pugs.
CONTRAINDICATIONS
RESTASIS® is contraindicated in patients with active ocular infections and in patients with
Known or suspected hypersensiivity to any of the ingredients in the formuation.
WARNING
RESTASIS® ophthaimic emulsion has not been studied in patients with a hiskry of herpes keralitis.
PRECAUTIONS
General: For ophthalmic use only.
information for Patients
The emuision from one individual single-use vial s to be used immediately after opening
for administration to one or both eyes, and the remaining contents should be discarded
immediately after administration.
Do not allow the pof the vial o touch the eye or any surface, as tis may contaminate the emulsion.
RESTASIS® shoukd not be administered while wearing contact lenses. Patients with decreased
tear production typically should not wear contact lenses. If contact lenses are wom, they
should be removed prior o the administration of the emuision. Lenses may be reinserted 15
minutes folowing administration of RESTASIS® ophthalmic emulsion.
Carcinogenesis, Mutagenesis, and impairment of Fertility
Systemic carcinogenicity studies were camied outin male and female mice and rats. In the
78-week oral (diet) mouse study, at doses of 1,4, and 16 mkg/day, evidence of a statisticaly
significant trend was found for lymphocytic lymphomas in females, and the incidence of
hepatoceliuiar carcinomeas in mid-dose males significantly exceeded the control value.
n the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mig/kg/day, pancreatic islet
cell adenomas significantly exceeded the control rate in the low dose level. The hepatoceitar
carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice
and rats are approximately 1000 and 500 times reater, respectively, than the daily human dose
of one drop (28 )of 0.05% RESTASIS® BID into each eye of a6O kg person (0.001 mg/kg/
day), assuming that the entire dose is absorbed.
Cyclosporing has not been found mutagenic/genotoric in the Ames Test, the V79-HGPRT Test,
the micronucieus test in mice and Chinese hamsters, the chromosome-aberation tests in
Chinese hamster bone-marow, the mouse dominant lethal assay, and the DNA-fepair test
in spem from treated mice. A study analyzing sister chromatid exchange (SCE) induction
by cyckosporine using human ymphocytes in vito gave indication of a positive effect (..,
induction of SCE).
No impairment in fertiity was demonstrated in studies in male and female ras receiving oral
doses of cyciosporine up to 15 mykg/day (approvimately 15,000 times the human daily dose of
0.001 mykg/day) for § weeks (male) and 2 weeks (femae) prior 10 mating.
Pregnancy-Teratogenic Effects
Pregnancy category C.
Teratogenic Effects: No evidence of teratogenicity was observed inrats or rabbits receiving
oral doses of cyclosporine up o 300 mo/ky/day during organogenesis. These doses in rats and
rabbits are approximately 300,000 times reater than the daily human dose of one drop (28 1)
0.05% RESTASIS® 81D into each eye of 260 kg person (0.001 mg/kg/day), assuming that the
entire dose s absorbed.
Non-Teratogenic Effects: Adverse effects were seen in reproduction studies in rats and
rabbits only at dose levels toxic to dams. At toxic doses (rats at 30 mg/kg/day and rabbits at
100 mg/kg/day), cyclosporine oral solution, USP, was embryo- and fetotoric as indicated by
increased pre- and postnatal mortaiity and reduced fetal weight together with related skeletal
retardations. These doses are 30,000 and 100,000 times greates, respectively than the daily
human dose of one-drop (28 )of 0.05% RESTASIS® BID into each eye of a6O kg person
{O.OOI mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryoietal
foxicity was observed in rats or rabbits receiving cyclosporine at oral doses up to 17 mg/kg/
day or 30 mg/kg/day, respectively, during organogenesis. These doses in rats and rabbits are
‘approximately 17,000 and 30,000 times greater, respectively, han the dally human dose.
Offspring of rats receiving a 45 mi/kg/day oral dose of cyclosporine from Day 15 of pregnancy
until Day 21 post partum, a matemally toxic level, exhibited an increase in postatal mortaity;
this dose is 45,000 times greater than the daily human topical dose, 0.001 mg/kg/day,
‘assuming that the entire dose is asorbed. No adverse events were observed at oral doses up
015 mg/gy/day (15,000 times greater than the daily human dose).
There are no adequate and well-controlied studies of RESTASIS® in pregnant women.
RESTASIS® shouid be administered o a pregnant woman only f clearly needed.
Nursing Mothers
Cyclosporine is known to be excreted in human mik following systemic administration but
excretion in human milk after topical reatment has not been investigated. Although blood
‘concentrations are undetectable after topical administration of RESTASIS® ophthalmic
emulsion, caution should be exercised when RESTASIS® is administered to a nursing woman.
Pediatric Use
The safety and efficacy of RESTASIS® ophthalmic emulsion have not been established in
pediatric patients below the age of 16.
Geriatric Use
No overall difference in safety or effectiveness has been observed between elderly and
younger patients.
ADVERSE REACTIONS
The most common adverse event following the use of RESTASIS® was ocular burning (17%).
Other events reported in 1% 05% of patients inciuded conjunciival hyperemia, discharge,
epiphora, eye pain, oreign body sensation, prurtus, stinging, and visual disturbance (most
often bluring).
Rox Only
£ ALLERGAN
Based on package insert 71876U5148 Revised February 2010
©2012 Allergan, Inc.
Irvine, CA 92612, USA
© marks owned by Alergan, Inc. ~ APCI3ZXIO
US. Patent 5,474.979
Made in the USA
As his TV series (R S!
returns, he talks e
family, football *}_"
Y
D
S s,
BY GAYLE JO CARTER
NOWN FOR ROLES in
K movie franchises — Iron
Man 2 and 3 and
Ocean’s Eleven and Twelve —
and quieter Oscar-noticed films
such as Hotel Rwanda and
Crash, Don Cheadle, 48, now
stars in his own TV series.
House of Lies returns Sunday
at 10 ET/PT on Showtime.
You play a liar. In real life,
are you a good liar? “I'm a
terrible liar. ... I want the
straight skinny all the time. So
I try to give it.”
You usually travel for
work. How’s life on a TV set?
“It's nice to be at home and
sleep in my own bed at night.
I'm 20 minutes away from the
studio [in Los Angeles]...lt'sa
consistency I cherish.”
Does your family like it
when you're home? “It de
pends upon the day. I have two
teenagers, so you know..."”
10
USA WEEKEND - Jan, 11-13, 2013