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DATE 2019-06-01

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MESSAGE
DATE 2019-06-14
FROM From: "APhA - American Pharmacists Association"
SUBJECT Subject: [Hangout - NYLXS] Information from Industry: Thinking GLP-1
From hangout-bounces-at-nylxs.com Sun Jun 16 02:51:06 2019
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From: "APhA - American Pharmacists Association"
Date: Fri, 14 Jun 2019 17:33:34 +0100
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Subject: [Hangout - NYLXS] Information from Industry: Thinking GLP-1
Receptor Agonist? Access Patient Resources Now
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Bydureon

Starting Patients on a GLP-1 Receptor Agonist Helpful Information

=E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=
=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=
=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =
=E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=
=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=
=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =
=E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=
=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=
=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =
=E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=
=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=
=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =
=E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=
=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=
=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =
=E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=
=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=
=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =
=E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=
=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=
=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C =E2=80=8C

http://messaging.aphanet.org/q/1faRyEGaQuVWjaoUMGUPlze/wv | Unsubscribe
http://messaging.aphanet.org/c/158j8pjock15OluLXBDDhzIxl2y

Information from Industry
BYDUREON BCise=C2=AE
(exenatide extended-release) injectable suspension 2 mg
View Prescribing Information, including Boxed WARNING
http://messaging.aphanet.org/c/158j8x66R9bALMyk6LbHNYuPFXL | Important Safe=
ty Information
http://messaging.aphanet.org/c/158j8ESPvYm5JdBSfUJMknh80SY |
Indication and Limitations of Use
http://messaging.aphanet.org/c/158j8MFyaNwAGEFqp4hQQM3qlOb

BYDUREON BCise=E2=80=94For adult patients with T2D uncontrolled on one or m=
ore oral antidiabetic agents in addition to diet and exercise to improve gl=
ycemic control

Additional Support and
Resources for Your
BYDUREON BCise Patients

BYDUREON BCise and Patient Resources

Dear Ruben:

A BYDUREON BCise representative may not be available to offer support in yo=
ur region at this time. Despite that, we want to make sure you have the inf=
ormation to support your patients when you prescribe BYDUREON BCise. Click =
here
http://messaging.aphanet.org/c/158j8UsgPCH5E5IYydPVnaPIGJo to support your =
patients.

What follows are links to information on BYDUREON BCise as well as tools an=
d resources related to treatment with this GLP-1 receptor agonist. We hope =
they will be useful as you start or continue patients on BYDUREON BCise.

Show Your
Patients How to Use
BYDUREON BCise

Watch this video
http://messaging.aphanet.org/c/158j92eZurRABwMwHnnZTzC11EB

Mira este video en Espa=C3=B1ol
http://messaging.aphanet.org/c/158j9a1I9h25yXQ4QwW4pYojmzO
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Save with the BYDUREON Savings Card
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A number of tools and resources are available for access and download to se=
rve as a source of information and support for you, your practice, and your=
patients, including:
=E2=80=A2 Starting Brochure
=E2=80=A2 Customizable Doctor Discussion Guide
=E2=80=A2 Blood Sugar Tracker
=E2=80=A2 E-mail Support
=E2=80=A2 SMS Text Messaging

http://messaging.aphanet.org/c/158j9FaAMzI5oI4hr98mvzvuIgE
Download Support Information You Can Share With Your Patients
http://messaging.aphanet.org/c/158j9MXjroSAm97PAiGr1YhN3bR

http://messaging.aphanet.org/c/158j9UK26e35jAbnJsevyn45o74

BYDUREON BCise
http://messaging.aphanet.org/c/158ja2wKL3dAh1eVSBMA4LQnJ2h

Click Here
http://messaging.aphanet.org/c/158jaajtpSo5esiu1LkEBaCG3Xu for Samples

For more information on BYDUREON BCise, encourage your patients to contact =
the AstraZeneca Information Center. Call 1-800-236-9933 for more informatio=
n. We welcome your questions and insights.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF THYROID C-CELL TUMORS

=E2=80=A2
Exenatide extended-release causes an increased incidence in thyroid C-cell =
tumors at clinically relevant exposures in rats compared to controls. It is=
unknown whether BYDUREON BCise causes thyroid C-cell tumors, including med=
ullary thyroid carcinoma (MTC) in humans, as the human relevance of exenati=
de extended-release-induced rodent thyroid C-cell tumors has not been deter=
mined

=E2=80=A2
BYDUREON BCise is contraindicated in patients with a personal or family his=
tory of MTC or in patients with Multiple Endocrine Neoplasia syndrome type =
2 (MEN 2). Counsel patients regarding the potential risk of MTC with the us=
e of BYDUREON BCise and inform them of symptoms of thyroid tumors (eg, mass=
in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitorin=
g of serum calcitonin or using thyroid ultrasound is of uncertain value for=
detection of MTC in patients treated with BYDUREON BCise

CONTRAINDICATIONS

=E2=80=A2
Personal or family history of MTC, patients with MEN 2

=E2=80=A2
Prior serious hypersensitivity reactions to exenatide or product components

WARNINGS AND PRECAUTIONS

=E2=80=A2
Acute Pancreatitis including fatal and non-fatal hemorrhagic or necrotizing=
pancreatitis has been reported. After initiation, observe patients careful=
ly for symptoms of pancreatitis. If suspected, discontinue promptly and do =
not restart if confirmed. Consider other antidiabetic therapies in patients=
with a history of pancreatitis

=E2=80=A2
Hypoglycemia Risk of hypoglycemia is increased when exenatide is coadminist=
ered with insulin or insulin secretagogues. Consider lowering the dose of t=
hese agents when coadministered with BYDUREON BCise

=E2=80=A2
Acute Kidney Injury May induce nausea and vomiting with transient hypovolem=
ia and may worsen renal function. Increased serum creatinine, renal impairm=
ent, worsened chronic renal failure, and acute renal failure, sometimes req=
uiring hemodialysis and kidney transplantation have been reported. Not reco=
mmended in patients with eGFR <45 mL/min/1.73 m2

=E2=80=A2
Gastrointestinal Disease Because exenatide is commonly associated with gast=
rointestinal adverse reactions, not recommended in patients with severe gas=
trointestinal disease (eg, gastroparesis)

=E2=80=A2
Immunogenicity Patients may develop antibodies to exenatide. Patients with =
higher titer antibodies may have an attenuated HbA1c response. In clinical =
trials, attenuated glycemic response was associated with BYDUREON BCise-tre=
ated patients. If worsening of or failure to achieve adequate glycemic cont=
rol occurs, consider alternative antidiabetic therapy

=E2=80=A2
Hypersensitivity Reports of serious hypersensitivity reactions (eg, anaphyl=
axis and angioedema). If this occurs, patients should discontinue BYDUREON =
BCise and promptly seek medical advice

=E2=80=A2
Injection-Site Reactions Serious reactions (eg, abscess, cellulitis, and ne=
crosis), with or without subcutaneous nodules, have been reported

=E2=80=A2
Acute Gallbladder Disease has been reported in GLP-1 receptor agonist trial=
s, including exenatide. If cholelithiasis or cholecystitis are suspected, g=
allbladder studies are indicated

ADVERSE REACTIONS

Most common (=E2=89=A55%) in clinical trials: injection-site nodule (10.5%)=
, nausea (8.2%).

DRUG INTERACTIONS

=E2=80=A2
Oral Medications BYDUREON BCise slows gastric emptying and may reduce the r=
ate of absorption of orally administered drugs

=E2=80=A2
Warfarin Increased international normalized ratio (INR) sometimes associate=
d with bleeding has been reported with concomitant use of exenatide with wa=
rfarin. Monitor INR frequently until stable upon initiation of BYDUREON BCi=
se

PREGNANCY

Use during pregnancy only if the potential benefit justifies the potential =
risk to the fetus.

INDICATION AND LIMITATIONS OF USE

BYDUREON BCise is indicated as an adjunct to diet and exercise to improve g=
lycemic control in adults with type 2 diabetes mellitus

=E2=80=A2
Not recommended as first-line therapy for patients inadequately controlled =
on diet and exercise

=E2=80=A2
Not a substitute for insulin. Should not be used to treat type 1 diabetes o=
r diabetic ketoacidosis

=E2=80=A2
Not recommended for use with insulin

=E2=80=A2
Do not coadminister with other exenatide-containing products

=E2=80=A2
Not studied in patients with a history of pancreatitis. Consider other anti=
diabetic therapies in patients with a history of pancreatitis

Please read Full Prescribing Information, including Boxed WARNING, and Medi=
cation Guide
http://messaging.aphanet.org/c/158jai6c4HyAbTm2aUSJ7zoYoSH for BYDUREON BCi=
se.

You may report side effects related to AstraZeneca products by clicking here
http://messaging.aphanet.org/c/158japSUJwJ59kpAk4qNDYbgJNU.

Abbreviations: GLP-1, glucagon-like peptide-1; T2D, type 2 diabetes.

Contact Us
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This product information is intended for US healthcare professionals only.
The Information Center at AstraZeneca
1800 Concord Pike, PO Box 15437, Wilmington, DE 19850-5437
BYDUREON and BCise are registered trademarks of the AstraZeneca group of co=
mpanies.
=C2=A92019 AstraZeneca. All rights reserved. US-25944 Last Updated 3/19

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Starting Patients on a GLP-1 Receptor Agonist Helpf=
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BYDUREON BCise;">®

(exenatide=
extended-release) injectable suspension 2 mg

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eight:15px;">
View nOrm9hjiLDl6gn" target=3D"_blank" style=3D"color:#4495cf;text-decoration:un=
derline;">Prescribing Information, in=
cluding Boxed WARNING
| g/c/158jbqaG0854OORZviPnPapDrbA" target=3D"_blank" style=3D"color:#4495cf;t=
ext-decoration:underline;">Important =
Safety Information
|

nslzbVM6N" target=3D"_blank" style=3D"color:#4495cf;text-decoration:underli=
ne;">Indication and Limitations of Us=
e
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ial, Helvetica, sans-serif; font-size:12px; color:#ffffff; line-height:15px=
; text-align:center;">BYDUREON BCise—For adult patients with T2D unco=
ntrolled on one or more oral antidiabetic agents in addition to diet and ex=
ercise to improve glycemic control
ial, Helvetica, sans-serif; font-size:26px; color:#ffffff; line-height:30px=
; text-align:center;">Additional Support and

Resources for Your
BYDUREON BCise Patientsong>

mail.astrazeneca.com/res/astrazeneca/e64e5a598bed236ecd8390ca2b007492.png" =
width=3D"480" height=3D"227" style=3D"width:480px; height:279px; display:bl=
ock;" alt=3D"BYDUREON BCise and Patient Resources" title=3D"BYDUREON BCise =
and Patient Resources" />
ght:22px; width:436px;" width=3D"435">
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ns-serif; font-size:12px; color:#000000;">Dear Ruben:

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ns-serif; font-size:12px; line-height:16px; color:#000000;">color:#0000000;">A BYDUREON BCise representative may not be available to of=
fer support in your region at this time.
Despite that, we want to ma=
ke sure you have the information to support your patients when you prescrib=
e BYDUREON BCise. Click Mq4JGZ5NBVwRXYe720" target=3D"_blank" style=3D"text-decoration:underline;co=
lor:#ed8b00;font-weight:600;">here
to support your pat=
ients.

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ns-serif; font-size:12px; line-height:16px; color:#000000;">What follows ar=
e links to information on BYDUREON BCise as well as tools and resources rel=
ated to treatment with this GLP-1 receptor agonist. We hope they will be us=
eful as you start or continue patients on BYDUREON BCise.

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ing-left:23px;padding-right:22px;" bgcolor=3D"#ebebeb" width=3D"435" >
=3D"0" border=3D"0" bgcolor=3D"#e98300" style=3D"backgrouund-color:#e98300;=
width:435px;">




#ffffff;padding-top:20px;padding-bottom:20px;padding-right:20px;padding-lef=
t:25px;font-family:Arial, Helvetica, sans-serif; font-size:14px; font-weigh=
t:600;">
Show Your
Patients How to Use
BYD=
UREON BCise

f=3D"http://messaging.aphanet.org/c/158jbNwPYBAzH82DWLtBomKwrXd" target=3D"=
_blank" style=3D"font-size:12px;color:#ffffff;text-decoration:underline">trong>Watch this video


e:10px;">MSq" target=3D"_blank" style=3D"font-size:12px;color:#ffffff;text-decoratio=
n:underline">Mira este video en Español

al-align:middle;padding-top:20px;padding-bottom:20px;" valign=3D"middle">
158jc36hifVzC09Kf4zKraj77ND" target=3D"_blank">strazeneca.com/res/astrazeneca/c59a302ae20e29be99156f9ace1ddcf5.jpg" alt=3D=
"Innovation in 3 Simple Steps" title=3D"Innovation in 3 Simple Steps" width=
=3D"206" height=3D"125" style=3D"width:177px;height:125px;display:block;out=
line:0;text-decoration:none;border:0px;margin:0px;" border=3D"0"/>


" height=3D"20">
ground-color:#ebebeb;" bgcolor=3D"#ebebeb">net.org/c/158jcaSZX564zrdioe7OXz5psIQ" target=3D"_blank">/t.email.astrazeneca.com/res/astrazeneca/azn_US-20085_savingscard.png" alt=
=3D"Save with the BYDUREON Savings Card" title=3D"Save with the BYDUREON Sa=
vings Card" width=3D"435" height=3D"200" style=3D"width:435px;height:200px;=
display:block;outline:0;text-decoration:none;border:0px;margin:0px;"/>
<=
/td>
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spacing=3D"0" border=3D"0" style=3D"width:435px; border-spacing:0; mso-cell=
spacing:0; mso-padding-alt: 0;">































































































































































































































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ns-serif; font-size:12px; line-height:16px;padding-top:20px;padding-bottom:=
20px;background-color:#ffffff;">
A number of tools and resources are available for access and downl=
oad to serve as a source of information and support for you, your practice,=
and your patients, including:
=20
Starting Brochurer/>
Customizable Doctor=
Discussion Guide

Blood Sugar Tracker=


E-mail Support

SMS Text Messaging<=
br/>

le=3D"width:22px; height:20px;">
le=3D"width:23px; height:20px;"> yle=3D"width:390px; height:20px;"> le=3D"width:22px; height:20px;">
px;"> 90px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">





4" style=3D"width:140px; height:64px;">org/c/158jdO6mvOiz26XsjegLKLdfQIz" target=3D"_blank">mail.astrazeneca.com/res/astrazeneca/03f3782435f15a03fa74c756d42f5be3.jpg" =
width=3D"140" height=3D"64" style=3D"width:140px; height:64px; display:bloc=
k;" />
=3D"64" style=3D"width:155px; height:64px; font-family:Arial, Helvetica, sa=
ns-serif; font-size:12px; color:#ffffff; text-align:left;">//messaging.aphanet.org/c/158jdVT5aDt3Zy10snOQh9ZybDM" target=3D"_blank" st=
yle=3D"color:#ffffff; text-decoration:none;">Download Support
=
Information You Can
Share With Your Patients
style=3D"width:95px; height:64px;">/c/158je3FNPsDyWZ4yBxmUNyLQwyZ" target=3D"_blank">l.astrazeneca.com/res/astrazeneca/US-20082_orange_rightradius.png" width=3D=
"95" height=3D"64" style=3D"width:91px; height:64px; display:block;" />
=

px;">
le=3D"width:23px; height:25px;"> yle=3D"width:390px; height:25px;"> le=3D"width:22px; height:25px;">
le=3D"width:23px; height:20px;"> yle=3D"width:390px; height:20px;"> le=3D"width:22px; height:20px;">
le=3D"width:23px; height:28px;"> yle=3D"width:390px; height:28px;"> le=3D"width:22px; height:28px;">
le=3D"width:23px; height:62px;"> yle=3D"width:390px; height:62px;">ging.aphanet.org/c/158jebswuhO3Uq86KGUZjXy8Ruc">astrazeneca.com/res/astrazeneca/US-20082_bydureoninjectionpen918.png" width=
=3D"390" height=3D"62" style=3D" width:390px; height:62px; display:block;" =
alt=3D"BYDUREON BCise" title=3D"BYDUREON BCise"/>
le=3D"width:22px; height:62px;">
le=3D"width:23px; height:10px;"> yle=3D"width:390px; height:10px;"> le=3D"width:22px; height:10px;">
px;"> 90px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">





th:89px;"> -family:Arial, Helvetica, sans-serif; font-size:12px; color:#ffffff; text-a=
lign:center;">3Qmkrcpp" target=3D"_blank" style=3D"color:#ffffff;">Click Hererong> for Samples
th:95px; ">

px;">
le=3D"width:23px; height:28px;"> yle=3D"width:390px; height:28px;"> le=3D"width:22px; height:28px;">
le=3D"width:23px; height:25px;"> yle=3D"width:390px; height:25px;"> le=3D"width:22px; height:25px;">
le=3D"width:23px; height:25px;"> yle=3D"width:390px; height:25px; padding-bottom:20px; font-family:Arial, He=
lvetica, sans-serif; font-size:12px; line-height:16px;"> For more informati=
on on BYDUREON BCise, encourage your patients to contact the AstraZeneca In=
formation Center. Call 1-80=
0-236-9933 for more information. We welcome your questions and insights.pan>
le=3D"width:22px; height:25px;">
px;"> 390px; font-family:Arial, Helvetica, sans-serif; font-size:16px; color:#ed8=
b00;">IMPORTANT SAFETY INFORMATION
2px;">
le=3D"width:23px; height:10px;"> yle=3D"width:390px; height:10px;"> le=3D"width:22px; height:10px;">
px;"> 390px; font-family:Arial, Helvetica, sans-serif; font-size:12px; color:#046=
a38;">WARNING: RISK OF THYROID C-CELL TUMORS
2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; color:#ed8=
b00;">•
width:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; lin=
e-height:16px; color:#000000;">Exenatide extended-release causes an=
increased incidence in thyroid C-cell tumors at clinically relevant exposu=
res in rats compared to controls. It is unknown whether BYDUREON BCise caus=
es thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in hu=
mans, as the human relevance of exenatide extended-release-induced rodent t=
hyroid C-cell tumors has not been determined

2px;">
px;"> style=3D"width:390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; line-height=
:16px; padding-bottom:5px; color:#ed8b00;">•
padding-bottom:5px; width:381px; font-family:Arial, Helvetica, sans-serif;=
font-size:12px; color:#010101;">BYDUREON BCise is contraindicated =
in patients with a personal or family history of MTC or in patients with Mu=
ltiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regard=
ing the potential risk of MTC with the use of BYDUREON BCise and inform the=
m of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, =
persistent hoarseness). Routine monitoring of serum calcitonin or using thy=
roid ultrasound is of uncertain value for detection of MTC in patients trea=
ted with BYDUREON BCise

2px;">
le=3D"width:23px; height:15px;"> yle=3D"width:390px; height:15px;"> le=3D"width:22px; height:15px;">
px;"> 390px; font-family:Arial, Helvetica, sans-serif; font-size:12px; color:#046=
a38;">CONTRAINDICATIONS
2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; color:#ed8=
b00;">•
width:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; lin=
e-height:16px; color:#010101;">Personal or family history of MTC, patients =
with MEN 2

2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; line-height=
:16px; padding-bottom:5px; color:#ed8b00;">•
padding-bottom:5px; width:381px; font-family:Arial, Helvetica, sans-serif;=
font-size:12px; color:#010101;">Prior serious hypersensitivity reactions t=
o exenatide or product components

2px;">
le=3D"width:23px; height:15px;"> yle=3D"width:390px; height:15px;"> le=3D"width:22px; height:15px;">
px;"> 390px; font-family:Arial, Helvetica, sans-serif; font-size:12px; color:#046=
a38;">WARNINGS AND PRECAUTIONS
2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; color:#ed8=
b00;">•
width:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; lin=
e-height:16px; color:#010101;">Acute Pancr=
eatitis
including fatal and non-fatal hemorrhagic or necrotiz=
ing pancreatitis has been reported. After initiation, observe patients care=
fully for symptoms of pancreatitis. If suspected, discontinue promptly and =
do not restart if confirmed. Consider other antidiabetic therapies in patie=
nts with a history of pancreatitis

2px;">
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ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; color:#ed8=
b00;">•
width:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; lin=
e-height:16px; color:#010101;">Hypoglycemi=
a
Risk of hypoglycemia is increased when exenatide is coadminister=
ed with insulin or insulin secretagogues. Consider lowering the dose of the=
se agents when coadministered with BYDUREON BCise

2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; padding-bot=
tom:5px; color:#ed8b00;">•
width:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; lin=
e-height:16px; color:#010101;">Acute Kidne=
y Injury
May induce nausea and vomiting with transient hypovolemi=
a and may worsen renal function. Increased serum creatinine, renal impairme=
nt, worsened chronic renal failure, and acute renal failure, sometimes requ=
iring hemodialysis and kidney transplantation have been reported. Not recom=
mended in patients with eGFR <45 mL/min/1.73 mpx; line-height:10px;">2

2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; color:#ed8=
b00;">•
width:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; lin=
e-height:16px; color:#010101;">Gastrointes=
tinal Disease
Because exenatide is commonly associated with gastr=
ointestinal adverse reactions, not recommended in patients with severe gast=
rointestinal disease (eg, gastroparesis)

2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; color:#ed8=
b00;">•
width:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; lin=
e-height:16px; color:#010101;">Immunogenic=
ity
Patients may develop antibodies to exenatide. Patients with hi=
gher titer antibodies may have an attenuated HbA1c response. In clinical tr=
ials, attenuated glycemic response was associated with BYDUREON BCise-treat=
ed patients. If worsening of or failure to achieve adequate glycemic contro=
l occurs, consider alternative antidiabetic therapy

2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; color:#ed8=
b00;">•
width:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; lin=
e-height:16px; color:#010101;">Hypersensit=
ivity
Reports of serious hypersensitivity reactions (eg, anaphyla=
xis and angioedema). If this occurs, patients should discontinue BYDUREON B=
Cise and promptly seek medical advice

2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; line-height=
:16px; color:#ed8b00;">•
width:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; co=
lor:#010101;">Injection-Site Reactions trong> Serious reactions (eg, abscess, cellulitis, and necrosis), with or w=
ithout subcutaneous nodules, have been reported

2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; padding-bot=
tom:5px; color:#ed8b00;">•
padding-bottom:5px; width:381px; font-family:Arial, Helvetica, sans-serif;=
font-size:12px; line-height:16px; color:#010101;">046a38;">Acute Gallbladder Disease has been reported in GLP-1 rece=
ptor agonist trials, including exenatide. If cholelithiasis or cholecystiti=
s are suspected, gallbladder studies are indicated

2px;">
le=3D"width:23px; height:15px;"> yle=3D"width:390px; height:15px;"> le=3D"width:22px; height:15px;">
px;"> 390px; font-family:Arial, Helvetica, sans-serif; font-size:12px; color:#046=
a38;">ADVERSE REACTIONS
2px;">
px;"> th:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; line-he=
ight:16px; color:#010101;">Most common (≥5%) in clinical trials: injecti=
on-site nodule (10.5%), nausea (8.2%).
2px;">
le=3D"width:23px; height:15px;"> yle=3D"width:390px; height:15px;"> le=3D"width:22px; height:15px;">
px;"> 390px; font-family:Arial, Helvetica, sans-serif; font-size:12px; line-heigh=
t:16px; color:#046a38;">DRUG INTERACTIONS
2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; line-height=
:16px; color:#ed8b00; ">•
width:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; col=
or:#010101;">Oral Medications BYD=
UREON BCise slows gastric emptying and may reduce the rate of absorption of=
orally administered drugs

2px;">
px;"> 390px;">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">




h:3px;font-family:Arial, Helvetica, sans-serif; font-size:12px; line-height=
:16px; color:#ed8b00;">•
width:381px; font-family:Arial, Helvetica, sans-serif; font-size:12px; col=
or:#010101;">Warfarin Increased i=
nternational normalized ratio (INR) sometimes associated with bleeding has =
been reported with concomitant use of exenatide with warfarin. Monitor INR =
frequently until stable upon initiation of BYDUREON BCise

2px;">
le=3D"width:23px; height:15px;"> yle=3D"width:390px; height:15px;"> le=3D"width:22px; height:15px;">
px;"> 390px; font-family:Arial, Helvetica, sans-serif; font-size:12px; line-heigh=
t:16px; color:#046a38;">PREGNANCY
2px;">
px;"> =3D"390">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">



ns-serif; font-size:12px; line-height:16px; color:#010101;">Use during preg=
nancy only if the potential benefit justifies the potential risk to the fet=
us.

px;">
le=3D"width:23px; height:20px;"> yle=3D"width:390px; height:20px;"> le=3D"width:22px; height:20px;">
px;"> 390px; font-family:Arial, Helvetica, sans-serif; font-size:16px; color:#ed8=
b00;">INDICATION AND LIMITATIONS OF USE
2px;">
le=3D"width:23px; height:10px;"> yle=3D"width:390px; height:10px;"> le=3D"width:22px; height:10px;">
px;"> =3D"390">
ter" cellspacing=3D"0" border=3D"0" style=3D"width:390px; border-spacing:0;=
mso-cellspacing:0; mso-padding-alt: 0;">

ns-serif; font-size:12px; color:#010101; line-height:16px;">BYDUREON BCise =
is indicated as an adjunct to diet and

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  9. 2019-06-05 From: "American Museum of Natural History" <fieldtrips-at-amnh.org> Subject: [Hangout - NYLXS] Earn 45 hours of CTLE credit this summer at the
  10. 2019-06-05 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Pharmacy Finances
  11. 2019-06-11 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Its a jungle out there
  12. 2019-06-10 Gabor Szabo <gabor-at-szabgab.com> Subject: [Hangout - NYLXS] [Perlweekly] #411 - Perl 5.30 was released
  13. 2019-06-11 From: "Virtual Jerusalem" <vjhighlights-at-members.virtualjerusalem.com> Subject: [Hangout - NYLXS] The Situation In Israel is Urgent!
  14. 2019-06-11 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Fwd: Tomorrow: Join us at "Red Hat Enterprise
  15. 2019-06-12 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] 1984 again
  16. 2019-06-12 Ruben Safir <mrbrklyn-at-panix.com> Subject: [Hangout - NYLXS] Fwd: [users-at-httpd] ApacheCon North America 2019
  17. 2019-06-12 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Re: [Hangout - NYLXS] Fwd: Tomorrow: Join us at "Red Hat
  18. 2019-06-12 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout - NYLXS] Fwd: Tomorrow: Join us at "Red Hat Enterprise
  19. 2019-06-11 IEEE Spectrum <deliver-at-ieee.org> Subject: [Hangout - NYLXS] The Institute Alert
  20. 2019-06-12 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] facial recongition
  21. 2019-06-13 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Fwd: [dinosaur] Full scholarships available for
  22. 2019-06-14 From: "Mancini, Sabin (DFS)" <Sabin.Mancini-at-dfs.ny.gov> Re: [Hangout - NYLXS] went to the Red Hat Linux presentation at
  23. 2019-06-16 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Internet destruction to Nationalism and Despots
  24. 2019-06-14 From: "APhA - American Pharmacists Association" <infocenter-at-aphanet.org> Subject: [Hangout - NYLXS] Information from Industry: Thinking GLP-1
  25. 2019-06-15 James E Keenan <jkeenan-at-pobox.com> Subject: [Hangout - NYLXS] ny.pm: July 1 social meeting
  26. 2019-06-16 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Anti-semitism on Artix
  27. 2019-06-13 From: "American Museum of Natural History" <learn-at-amnh.org> Subject: [Hangout - NYLXS] Register for an Online Science Course for
  28. 2019-06-16 Gabor Szabo <gabor-at-szabgab.com> Subject: [Hangout - NYLXS] [Perlweekly] #412 - The Perl Conference in
  29. 2019-06-20 From: =?utf-8?Q?Zo=C3=AB_Kooyman=2C_FSF?= <info-at-fsf.org> Subject: [Hangout - NYLXS] Double the movement: Inspire someone to explore
  30. 2019-06-22 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] On Linksys WAG54G2 1.00.10 devices
  31. 2019-06-24 Gabor Szabo <gabor-at-szabgab.com> Subject: [Hangout - NYLXS] [Perlweekly] #413 - 2 events done, 2 to go
  32. 2019-06-24 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Attacking Jews is now OK in NYC
  33. 2019-06-26 From: "American Museum of Natural History" <publicprograms-at-amnh.org> Subject: [Hangout - NYLXS] 2019 Tony Award-Winning Director Rachel Chavkin
  34. 2019-06-30 Gabor Szabo <gabor-at-szabgab.com> Subject: [Hangout - NYLXS] [Perlweekly] #414 - Do you want to learn Test

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