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DATE 2021-12-01

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MESSAGE
DATE 2021-12-10
FROM From: "APhA - American Pharmacists Association"
SUBJECT Subject: [Hangout - NYLXS] Information from Industry: Updated Distribution
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----1129F08A252B7D3006075C2ABC3FCA
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Rybelsus(R)
https://apha.msgfocus.com/c/1EYB0BhVhQCAffwDvVEE8ATxHGcd

Important Safety Information
https://apha.msgfocus.com/c/1EYB0Qu0rwu4Ffkz9Ni8XPfNuvQA
Rybelsus(R)
https://apha.msgfocus.com/c/1EYB1kSaKSd3veWqrwz8ChYj4b9k
Prescribing Information
https://apha.msgfocus.com/c/1EYB1A4fUy4xVeKm5ocDrwkyR0NH
Rybelsus(R)
https://apha.msgfocus.com/c/1EYB1Pgl4dW2leyhJfQ8gKGODQs4
Rybelsus(R) Indicated as an adjunct to diet and exercise to improve glycemi=
c control in adults with

Indications and Usage

RYBELSUS=C2=AE (semaglutide) tablets 7 mg or 14 mg is indicated as an adjun=
ct to diet and exercise to improve glycemic control in adults with type 2 d=
iabetes.

Limitations of Use

=E2=80=A2
RYBELSUS=C2=AE is not recommended as a first-line therapy for patients who =
have inadequate glycemic control on diet and exercise because of the uncert=
ain relevance of rodent C-cell tumor findings to humans
=E2=80=A2
RYBELSUS=C2=AE has not been studied in patients with a history of pancreati=
tis. Consider other antidiabetic therapies in patients with a history of pa=
ncreatitis
=E2=80=A2
RYBELSUS=C2=AE is not indicated for use in patients with type 1 diabetes or=
for the treatment of patients with diabetic ketoacidosis

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS
=E2=80=A2
In rodents, semaglutide causes dose-dependent and treatment-duration-depend=
ent thyroid C-cell tumors at clinically relevant exposures. It is unknown w=
hether RYBELSUS=C2=AE causes thyroid C-cell tumors, including medullary thy=
roid carcinoma (MTC), in humans as human relevance of semaglutide-induced r=
odent thyroid C-cell tumors has not been determined
=E2=80=A2
RYBELSUS=C2=AE is contraindicated in patients with a personal or family his=
tory of MTC and in patients with Multiple Endocrine Neoplasia syndrome type=
2 (MEN 2). Counsel patients regarding the potential risk for MTC with the =
use of RYBELSUS=C2=AE and inform them of symptoms of thyroid tumors (e.g. a=
mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine moni=
toring of serum calcitonin or using thyroid ultrasound is of uncertain valu=
e for early detection of MTC in patients treated with RYBELSUS=C2=AE

Please click here
https://apha.msgfocus.com/c/1EYB24sqdTNwLemdn7tD5Z34qG6r or scroll below fo=
r additional Important Safety Information.

Want to know more?

Get answers to your frequently asked questions.

Read FAQ
https://apha.msgfocus.com/c/1EYB2jEvnzF1bea90Z77VdpkdvKO

Rybelsus(R)

Important Safety Information (cont'd)

Contraindications

=E2=80=A2
RYBELSUS=C2=AE is contraindicated in patients with a personal or family his=
tory of medullary thyroid carcinoma (MTC) or in patients with Multiple Endo=
crine Neoplasia syndrome type 2 (MEN 2), and in patients with known hyperse=
nsitivity to semaglutide or to any of the components in RYBELSUS=C2=AE

Warnings and Precautions

=E2=80=A2
Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if seru=
m calcitonin is measured and found to be elevated or thyroid nodules are no=
ted on physical examination or neck imaging
=E2=80=A2
Pancreatitis: Has been reported in clinical trials. Observe patients carefu=
lly for signs and symptoms of pancreatitis (including persistent severe abd=
ominal pain, sometimes radiating to the back and which may or may not be ac=
companied by vomiting). If pancreatitis is suspected, discontinue RYBELSUS=
=C2=AE and initiate appropriate management; if confirmed, do not restart RY=
BELSUS=C2=AE
=E2=80=A2
Diabetic Retinopathy Complications: In a pooled analysis of glycemic contro=
l trials with RYBELSUS=C2=AE, patients reported diabetic retinopathy relate=
d adverse reactions during the trial (4.2% with RYBELSUS=C2=AE and 3.8% wit=
h comparator). In a 2-year trial with semaglutide injection involving patie=
nts with type 2 diabetes and high cardiovascular risk, more events of diabe=
tic retinopathy complications occurred in patients treated with semaglutide=
injection (3.0%) compared to placebo (1.8%). The absolute risk increase fo=
r diabetic retinopathy complications was larger among patients with a histo=
ry of diabetic retinopathy at baseline than among patients without a known =
history of diabetic retinopathy.
Rapid improvement in glucose control has been associated with a temporary w=
orsening of diabetic retinopathy. Patients with a history of diabetic retin=
opathy should be monitored for progression of diabetic retinopathy
=E2=80=A2
Hypoglycemia: The risk of hypoglycemia is increased when RYBELSUS=C2=AE is =
used in combination with insulin secretagogues (e.g., sulfonylureas) or ins=
ulin. Patients may require a lower dose of the secretagogue or insulin to r=
educe the risk of hypoglycemia in this setting
=E2=80=A2
Acute kidney injury: There have been postmarketing reports of acute kidney =
injury and worsening of chronic renal failure, which may sometimes require =
hemodialysis, in patients treated with GLP-1 receptor agonists, including s=
emaglutide. Some of these events have been reported in patients without kno=
wn underlying renal disease. A majority of the reported events occurred in =
patients who had experienced nausea, vomiting, diarrhea, or dehydration. Mo=
nitor renal function when initiating or escalating doses of RYBELSUS=C2=AE =
in patients reporting severe adverse gastrointestinal reactions
=E2=80=A2
Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, an=
gioedema) have been reported with GLP-1 receptor agonists, including semagl=
utide. If hypersensitivity reactions occur, discontinue use of RYBELSUS=C2=
=AE, treat promptly per standard of care, and monitor until signs and sympt=
oms resolve. Use caution in a patient with a history of angioedema or anaph=
ylaxis with another GLP-1 receptor agonist

Adverse Reactions

=E2=80=A2
The most common adverse reactions, reported in =E2=89=A55% of patients trea=
ted with RYBELSUS=C2=AE are nausea, abdominal pain, diarrhea, decreased app=
etite, vomiting and constipation

Drug Interactions

=E2=80=A2
The risk of hypoglycemia may be lowered by a reduction in the dose of conco=
mitantly administered secretagogues or insulin
=E2=80=A2
RYBELSUS=C2=AE delays gastric emptying and has the potential to impact the =
absorption of other oral medications. Closely follow RYBELSUS=C2=AE adminis=
tration instructions when coadministering with other oral medications and c=
onsider increased monitoring for medications with a narrow therapeutic inde=
x, such as levothyroxine

Use in Specific Populations

=E2=80=A2
Pregnancy: Available data with RYBELSUS=C2=AE are not sufficient to determi=
ne a drug-associated risk for major birth defects, miscarriage, or other ad=
verse maternal or fetal outcomes. Based on animal reproduction studies, the=
re may be risks to the fetus from exposure to RYBELSUS=C2=AE. Use only if t=
he potential benefit justifies the potential risk to the fetus
=E2=80=A2
Lactation: There are no data on the presence of semaglutide in human milk, =
the effects on the breastfed infant, or the effects on milk production. Bec=
ause of the unknown potential for serious adverse reactions in the breastfe=
d infant due to the possible accumulation of salcaprozate sodium (SNAC), an=
absorption enhancer in RYBELSUS=C2=AE, from breastfeeding and because ther=
e are alternative formulations of semaglutide that can be used during lacta=
tion, advise patients that breastfeeding is not recommended during treatmen=
t with RYBELSUS=C2=AE
=E2=80=A2
Discontinue RYBELSUS=C2=AE in women at least 2 months before a planned preg=
nancy due to the long washout period for semaglutide
=E2=80=A2
Pediatric Use: Safety and efficacy of RYBELSUS=C2=AE have not been establis=
hed in pediatric patients (younger than 18 years)

Please click here for Prescribing Information, including Boxed Warning.
https://apha.msgfocus.com/c/1EYB2yQAxfwvBdY4EQKCKrLA0lpb

References:

RYBELSUS=C2=AE [package insert]. Plainsboro, NJ: Novo Nordisk Inc; January =
2020.
Rosenstock J, Allison D, Birkenfeld AL, et al. Effect of additional oral se=
maglutide vs sitagliptin on glycated hemoglobin in adults with type 2 diabe=
tes uncontrolled with metformin alone or with sulfonylurea: the PIONEER 3 r=
andomized clinical trial. JAMA. 2019;321(15):1466-1480.
Rodbard HW, Rosenstock J, Canani LH, et al. Oral semaglutide versus empagli=
flozin in patients with type 2 diabetes uncontrolled on metformin: the PION=
EER 2 trial. Diabetes Care. 2019;42(12):2272-2281.
Data on file. Novo Nordisk Inc; Plainsboro, NJ.

Please click on the link to see WAC pricing for the product mentioned above=
: RYBELSUS
https://apha.msgfocus.com/c/1EYB2O2FGVo01dM0iIo7zG7PNb3y=C2=AE.

To ensure receipt of future emails, please add mail-at-communications.novonord=
iskinfo.com
mail-at-communications.novonordiskinfo.com to your address book.

Please do not respond to this email. If you would like to contact us, pleas=
e click here
https://apha.msgfocus.com/c/1EYB33eKQBfurdzVWA1CoUu5A0HV or call 1=E2=80=91=
800=E2=80=91727=E2=80=916500.

UNSUBSCRIBE NOTICE
If you no longer want to receive communications from Novo Nordisk, click he=
re to unsubscribe
https://apha.msgfocus.com/c/1EYB3iqQ0h6YRdnRArF7e8QlmQmi. You also may call=
us at 1=E2=80=91877=E2=80=91744=E2=80=912579 or send us a letter that incl=
udes your full contact information (e.g. name, email address, phone) to Nov=
o Nordisk, 800 Scudders Mill Road, Plainsboro, New Jersey 08536. To better =
understand how Novo Nordisk values your privacy, see our Privacy Statement
https://apha.msgfocus.com/c/1EYB3xCV9WYthdbNejiC3ncB9G0F.

RYBELSUS=C2=AE is a registered trademark of Novo Nordisk A/S.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

=C2=A9 2021 Novo Nordisk
All rights reserved.
US20RYB00675 January 2021

Novo Nordisk

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<BR> e-Pharm/alert: Pharmacist Update for FDA-Approved Antiviral for COVID=<BR>-19<BR>



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kg, please refer to the Emergency Use Authorization Fact Sheet for Healthc=
are Providers
available at /c/1EYB4hdaCYyWxcBA9Ud6x4hmwaXM" style=3D"color: #0077cf;" target=3D"_blank=
">gilead.com/remdesivir

align=3D"center" width=3D"100%" style=3D"border-bottom: 2px solid #dadada;=
">



ans-serif; color: #000000; margin: 0; padding-bottom: 10px;" valign=3D"top">
ECMO =3D extracorporeal membrane oxygenation; IV =
=3D intravenous.

ng-bottom: 10px;">

erif; color: #0077cf; margin: 0;">

In the ACTT-1 overall study population,

patients experienced



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ng-right: 20px; padding-bottom: 10px;">

erif; color: #4f6cae; margin: 0;">
(Median 10 days vs 15 days with placebo; recovery rat=
e ratio: 1.29 [95% CI, 1.12-1.49], p<0.001)



llspacing=3D"0" align=3D"center">




#0075cf; padding-right: 5px;">


sans-serif; color: #000000; margin: 0;">
Recovery included hospital discharge for some p=
atients with or without limitations on activities10px; line-height: 10px; vertical-align: 5px;">1





j0C9" target=3D"_blank">
CP-AV-Email/Images/104555_001_gilmmkt_veklury_epharm_alert_email_lo-Recover=
ed-Recovered_13.jpg" alt=3D"need tag here" width=3D"600" />

: 15px;" bgcolor=3D"#f5fafd">

rgin: 0;">
ACTT-1 trial design: The eff=
icacy and safety of VEKLURY were studied in a randomized, double-blind, pla=
cebo-controlled clinical trial in hospitalized subjects with mild, moderate=
, and severe
COVID-19. Patients received VEKLURY (n=3D541) or placebo (n=
=3D521) for up to 10 days. The primary endpoint was time to recovery within=
29 days after randomization.
lign: 5px;">1,2


10px; padding-right: 20px; padding-bottom: 5px;">

lor: #000000; margin: 0;">
Adverse reaction (AR) frequency was comparable between VEK=
LURY (n=3D532) and placebo (n=3D516)ight: 10px; vertical-align: 5px;">1



g=3D"0" bgcolor=3D"#f5fafd">
=20=20=20=20=20=20=20=20=20=20=20=20=20=20












=20=20=20=20=20=20=20=20=20=20=20=20=20=20
: 15px; color: #0075cf; padding-right: 5px;">


erif; color: #000000; margin: 0;">
Grades ≥3: 41 (8%) vs 46 (9%)


: 15px; color: #0075cf; padding-right: 5px;">


erif; color: #000000; margin: 0;">
Serious ARs: 2 (0.4%)* vs 3 (0.6%)


: 15px; color: #0075cf; padding-right: 5px;">


erif; color: #000000; margin: 0;">
ARs leading to treatment discontinuation: 11 (2%)n style=3D"font-size: 10px; line-height: 10px; vertical-align: 5px;">&dagge=
r;
vs 15 (3%)



=3D"center" width=3D"100%">








f; color: #000000; padding-bottom: 0px; padding-top: 10px; line-height: 10p=
x;" valign=3D"top">
*
f; color: #000000; padding-bottom: 0px; padding-top: 8px;" valign=3D"top">
Seizure (n=3D1), infusion-related reaction (n=3D1).
f; color: #000000; padding-bottom: 10px; padding-top: 1px;" valign=3D"top">
l-align: 5px;">
f; color: #000000; padding-bottom: 10px; padding-top: 0px;" valign=3D"top">
Seizure (n=3D1), infusion-related reaction (n=3D1), trans=
aminases increased (n=3D3), ALT increased and AST increased (n=3D1), GFR de=
creased (n=3D2), acute kidney injury (n=3D3).


lor: #0077cf; margin: 0; margin-bottom: 8px;">
IMPORTANT SAFETY INFORMATION (cont’d)


lor: #000000; margin: 0; margin-bottom: 0px;">
Warnings and precautions


g=3D"0" style=3D"border-bottom: 2px solid #ededed;">
=20=20=20=20=20=20=20=20=20=20=20=20=20=20







=20=20=20=20=20=20=20=20=20=20=20=20=20=20
5px; color: #0075cf; padding-right: 5px;">


erif; color: #000000; margin: 0;">
Hypersensitivity, including infusion-related and a=
naphylactic reactions:

Hypersensitivity, including infusion-related and anap=
hylactic reactions, has been observed during and following administration o=
f VEKLURY. Monitor patients under close medical supervision for hypersensit=
ivity reactions
during and following administration of VEKLURY. Sympt=
oms may include hypotension, hypertension, tachycardia, bradycardia, hypoxi=
a, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shi=
vering. Slower
infusion rates (maximum infusion time ≤120 minutes=
) can potentially prevent these reactions. If a severe infusion-related hyp=
ersensitivity reaction occurs, immediately discontinue VEKLURY and initiate=
appropriate
treatment (see Contraindications).


arial, sans-serif; color: #000000;">


See additional Important Safety Information below and=
click to see the full
drrDu6bwZS5Qgw" style=3D"color: #0077cf;" target=3D"_blank">Prescribing =
Information

for VEKLURY.



: 20px;">
=3D"center" width=3D"100%" bgcolor=3D"#f5fafd">











font-size: 20px; font-weight: bold; text-align: center; color: #0075cf; pad=
ding: 10px 0;">
Our distribution network has expanded
rial, sans-serif;" width=3D"33%">
ry/HCP-AV-Email/Images/104555_001_gilmmk_19.jpg" alt=3D"need tag here" styl=
e=3D"display: block; border: 0;" />
tyle=3D"border-right: 2px solid #73b4e5;" width=3D"100%">



e: 15px; font-weight: bold; text-align: center; padding-top: 10px;">

yle: italic; font-size: 12px;">
CALL TO ORDER


AmerisourceBergen

Corporation

1-8=
00-74fafd;">‌6-6273



rial, sans-serif;" width=3D"33%">
ry/HCP-AV-Email/Images/104555_001_gilmmk_19.jpg" alt=3D"need tag here" styl=
e=3D"display: block; border: 0;" />
tyle=3D"border-right: 2px solid #73b4e5;" width=3D"100%">



e: 15px; font-weight: bold; text-align: center; padding-top: 10px;">

yle: italic; font-size: 12px;">
CALL TO ORDER


Cardinal

Specialty

1-8=
55-85fafd;">‌5-0708



rial, sans-serif;" width=3D"33%">
ry/HCP-AV-Email/Images/104555_001_gilmmk_19.jpg" alt=3D"need tag here" styl=
e=3D"display: block; border: 0;" />
idth=3D"100%">



e: 15px; font-weight: bold; text-align: center; padding-top: 10px;">

yle: italic; font-size: 12px;">
CALL TO ORDER


McKesson Plasma

and Biologics

1-8=
77-62fafd;">‌5-2566



font-size: 18px; padding: 20px 0; text-align: center; font-weight: bold;">
Supplier will confirm order quantity

and ship directly to hospitals.


=3D"center" width=3D"100%" style=3D"border-bottom: 2px solid #dadada;">



f; padding: 10px 0 20px 0;">

Get additional product information for VEKLURY, includi=
ng price and ICD-10 codes.
5v7B0Lm7SFUT" style=3D"color: #0077cf;" target=3D"_blank">Click here



lor: #0077cf; margin: 0; margin-left: 20px; margin-top: 20px; margin-right:=
20px;">
Dose preparation and administration designed for inpatient=
care;">1


lor: #000000; margin: 0; margin-bottom: 0px; margin-left: 20px; margin-top:=
10px; margin-right: 20px;">
VEKLURYvertical-align: 5px;">® (remdesivir) 100 mg for injection, lyoph=
ilized powder


=3D"0">
=20=20=20=20=20=20=20=20=20=20=20=20=20=20








=20=20=20=20=20=20=20=20=20=20=20=20=20=20
px; color: #0075cf; padding-right: 0px; padding-left: 20px; padding-right: =
5px; padding-bottom: 10px; padding-top: 5px;">


erif; color: #000000; margin: 0; padding-bottom: 3px; padding-top: 5px;">
Single-dose vial with red cap*


px; color: #0075cf; padding-left: 20px; padding-right: 5px;">


erif; color: #000000; margin: 0;">
Must be prepared and administered under the supervisi=
on of a healthcare provider by intravenous infusion only



lor: #000000; margin: 0; margin-bottom: 0px; margin-left: 20px; margin-top:=
10px; margin-right: 20px;">
Dose preparation


=3D"0">
=20=20=20=20=20=20=20=20=20=20=20=20=20=20




=20=20=20=20=20=20=20=20=20=20=20=20=20=20
px; color: #0075cf; padding-left: 20px; padding-right: 5px; padding-top: 5p=
x;">


erif; color: #000000; margin: 0; padding-top: 5px;">
Lyophilized powder must be reconstituted with 19 mL S=
terile Water for Injection and diluted in a 100 mL or 250 mL 0.9% sodium ch=
loride infusion bag prior to administration



lor: #000000; margin: 0; margin-bottom: 0px; margin-left: 20px; margin-top:=
10px; margin-right: 20px;">
Administration


=3D"0">
=20=20=20=20=20=20=20=20=20=20=20=20=20=20




=20=20=20=20=20=20=20=20=20=20=20=20=20=20
px; color: #0075cf; padding-left: 15px; padding-right: 5px; padding-top: 5p=
x;">


erif; color: #000000; margin: 0; padding-top: 5px;">
Diluted solution is administered intravenously by inf=
usion for 30-120 minutes




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CP-AV-Email/Images/104555_001_gilmmkt_veklury_epharm_alert_email_lo-Recover=
ed-Recovered_19.jpg" alt=3D"need tag here" width=3D"600" />


=3D"center" width=3D"100%" style=3D"border-bottom: 2px solid #ededed;">




f; padding-bottom: 30px;" valign=3D"top">
*
f; padding-bottom: 20px;" valign=3D"top">


The lyophilized solution is supplied with a red cap, an=
d the concentrated solution is supplied with a blue cap. Concentrated solut=
ion in blue cap vials may still be present in some institutions but are no =
longer
available to order.




gin-right: 20px; margin-bottom: 10px; font-size: 22px; font-family: arial, =
sans-serif; color: #0077cf;">
Storage and handling guidelines0px; line-height: 10px; vertical-align: 7px;">1


=3D"0">
=20=20=20=20=20=20=20=20=20=20=20=20=20=20












=20=20=20=20=20=20=20=20=20=20=20=20=20=20
m: 15px; font-size: 15px; color: #0075cf; padding-left: 20px; padding-right=
: 5px;">

: 8px;">

erif; color: #000000; margin: 0;">
Unopened vials of lyophilized powder can be stored be=
low 30 °C (86 °F). It requires reconstitution and further dilution =
prior to administration by intravenous infusion


m: 15px; font-size: 15px; color: #0075cf; padding-left: 20px; padding-right=
: 5px;">

: 8px;">

erif; color: #000000; margin: 0;">
After reconstitution, use vials immediately to prepar=
e diluted solution. The diluted VEKLURY solution in the infusion bags can b=
e stored up to 24 hours at room temperature (20 °C to 25 °C [68 &de=
g;F to 77 °F]) prior to
administration or 48 hours at refrigerated temperatur=
e (2 °C to 8 °C [36 °F to 46 °F])


m: 15px; font-size: 15px; color: #0075cf; padding-left: 20px; padding-right=
: 5px;">


erif; color: #000000; margin: 0;">
Once opened, do not reuse or save reconstituted or di=
luted VEKLURY for future use. These products contain no preservative; there=
fore, partially used vials should be discarded



lor: #000000; margin: 10px 20px 0px 20px;">

See the full
Fe4DsldD" style=3D"color: #0077cf;" target=3D"_blank">Prescribing Inform=
ation

for additional information on the storage and handling of V=
EKLURY.



=3D"center" width=3D"100%">



f; padding-top: 15px;">


IMPORTANT SAFETY INFORMATION (cont’d)




argin-right: 20px; font-size: 15px; font-family: arial, sans-serif; color: =
#000000;">
Warnings and precautions (cont’d)


=3D"0">
=20=20=20=20=20=20=20=20=20=20=20=20=20=20








=20=20=20=20=20=20=20=20=20=20=20=20=20=20
px; color: #0075cf; padding-left: 20px; padding-right: 5px; padding-top: 1p=
x;">

px;">

erif; color: #000000; margin: 0;">
Increased risk of transaminase elevations:
Transaminase elevations have been observed in healthy=
volunteers and in patients with COVID-19 who received VEKLURY; these eleva=
tions have also been reported as a clinical feature of COVID-19. Perform he=
patic
laboratory testing in all patients (see Dosage and ad=
ministration). Consider discontinuing VEKLURY if ALT levels increase to >=
;10x ULN. Discontinue VEKLURY if ALT elevation is accompanied by signs or s=
ymptoms of
liver inflammation.


px; color: #0075cf; padding-left: 20px; padding-right: 5px; padding-top: 8p=
x;">

px;">

erif; color: #000000; margin: 0;">
Risk of reduced antiviral activity when coadminist=
ered with chloroquine or hydroxychloroquine:

Coadministration of VEKLURY with chloroquine phosphat=
e or hydroxychloroquine sulfate is not recommended based on data from cell =
culture experiments, demonstrating potential antagonism, which may lead to =
a decrease in the
antiviral activity of VEKLURY.



lor: #000000; margin: 0; margin: 5px; margin-bottom: 0; margin-left: 20px; =
margin-right: 20px;">
Adverse reactions


=3D"0">
=20=20=20=20=20=20=20=20=20=20=20=20=20=20








=20=20=20=20=20=20=20=20=20=20=20=20=20=20
15px; color: #0075cf; padding-right: 5px; padding-left: 20px;">


erif; color: #000000; margin: 0;">
The most common adverse reaction (≥5% all grades) =
was nausea.


px; color: #0075cf; padding-right: 5px; padding-left: 20px; padding-top: 5p=
x;">

px;">

erif; color: #000000; margin: 0;">
The most common lab abnormalities (≥5% all grades)=
were increases in ALT and AST.



lor: #000000; margin: 0; margin-left: 20px; padding-margin: 20px; margin-to=
p: 5px; margin-bottom: 0px;">
Drug interactions


=3D"0">
=20=20=20=20=20=20=20=20=20=20=20=20=20=20




=20=20=20=20=20=20=20=20=20=20=20=20=20=20
px; color: #0075cf; padding-right: 5px; padding-left: 20px;">


erif; color: #000000; margin: 0;">
Drug interaction trials of VEKLURY and other concomit=
ant medications have not been conducted in humans.



lor: #000000; margin: 0; margin-left: 20px; padding-margin: 20px; margin-to=
p: 10px; margin-bottom: 0px;">
Dosage and administration


=3D"0">
=20=20=20=20=20=20=20=20=20=20=20=20=20=20




















=20=20=20=20=20=20=20=20=20=20=20=20=20=20
px; color: #0075cf; padding-left: 20px; padding-right: 5px; padding-bottom:=
5px;">

: 8px;">

erif; color: #000000; margin: 0;">
Dosage: For adults and pediatric patients ≥=
12 years old and weighing ≥40 kg: 200 mg on Day 1, followed by once-dail=
y maintenance doses of 100 mg from Day 2 administered only via intravenous =
infusion over 30 to
120 minutes.


px; color: #0075cf; padding-right: 5px; padding-bottom: 5px;">

: 8px;">

erif; color: #000000; margin: 0;">
Treatment duration: For patients not requiring=
invasive mechanical ventilation and/or extracorporeal membrane oxygenation=
(ECMO): 5 days; may be extended up to 5 additional days (10 days total) if=
clinical
improvement is not observed. For patients requiring i=
nvasive mechanical ventilation and/or ECMO: 10 days.


px; color: #0075cf; padding-right: 5px; padding-bottom: 5px;">

: 8px;">

erif; color: #000000; margin: 0;">
Testing prior to and during treatment: Perform=
eGFR, hepatic laboratory, and prothrombin time testing prior to initiating=
VEKLURY and during use as clinically appropriate.


px; color: #0075cf; padding-right: 5px; padding-bottom: 5px;">

: 8px;">

erif; color: #000000; margin: 0;">Renal impairment: VEKLURY is not r=
ecommended in individuals with eGFR <30 mL/min.


px; color: #0075cf; padding-right: 5px;">


erif; color: #000000; margin: 0;">Dose preparation and administration:b> See full Prescribing Information.



lor: #000000; margin: 0; margin-left: 20px; margin-right: 20px; margin-top:=
11px; margin-bottom: 0px;">
Pregnancy and lactation


=3D"0">
=20=20=20=20=20=20=20=20=20=20=20=20=20=20








=20=20=20=20=20=20=20=20=20=20=20=20=20=20
px; color: #0075cf; padding-right: 5px; padding-left: 20px; padding-bottom:=
5px;">

: 8px;">

erif; color: #000000; margin: 0;">
Pregnancy: There are insufficient human data o=
n the use of VEKLURY during pregnancy. Pregnant women hospitalized with COV=
ID-19 are at risk for serious morbidity and mortality. VEKLURY should be us=
ed during
pregnancy only if the potential benefit justifies the=
potential risk for the mother and the fetus.


px; color: #0075cf; padding-right: 5px; padding-left: 20px;">


erif; color: #000000; margin: 0;">
Lactation: It is not known whether VEKLURY can=
pass into breast milk. Breastfeeding individuals with COVID-19 should foll=
ow practices according to clinical guidelines to avoid exposing the infant =
to COVID-19.



lor: #000000; margin: 0; margin-left: 20px; margin-bottom: 20px; margin-rig=
ht: 20px; margin-top: 15px;">
Please see full
qTfaS0" style=3D"color: #0077cf;" target=3D"_blank">Prescribing Informat=
ion

for VEKLURY. For more information, visit
N920wn" style=3D"color: #0077cf;" target=3D"_blank">VEKLURYhcp.coma>


lor: #000000; margin: 0; margin-left: 20px; margin-right: 20px;">
References: 1. VEKLURY. Prescribing Information. Gilea=
d Sciences, Inc.; 2021. 2. Beigel JH, Tomashek KM, Dodd LE; ACTT-1 S=
tudy Group Members. Remdesivir for the treatment of Covid-19—final re=
port.
N Engl J Med. 2020;383(19):1‌813-1‌826.



OQaK" target=3D"_blank">
CP-AV-Email/Images/VEKLURY-Hospital-ePharm-Alert_02.jpg" width=3D"600" alt=
=3D"need tag here" />


ovtu" target=3D"_blank">
CP-AV-Email/Images/104555_001_gilmmkt_veklury_epharm_alert_email_lo-Recover=
ed-Recovered_21.jpg" width=3D"600" alt=3D"need tag here" />

lor: #ffffff; margin: 0; margin-left: 20px; margin-bottom: 25px; margin-top=
: 15px; margin-right: 20px;" align=3D"center">
VEKLURY, the VEKLURY Logo, GILEAD, and the GILEAD Logo are />
trademarks of Gilead Sciences, Inc., or its related companies=
.

© 2021 Gilead Sciences, Inc. All rights reserved. US-VKY=
M-0001 11/21



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  28. 2021-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Chinese Learn Atrosurfing from Bill Gates - trust
  29. 2021-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Chinese Learn Atrosurfing from Bill Gates - trust
  30. 2021-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Adding Additional domains and outgoing email
  31. 2021-12-21 raf <postfix-at-raf.org> Re: [Hangout - NYLXS] Adding Additional domains and outgoing email
  32. 2021-12-22 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout - NYLXS] Adding Additional domains and outgoing email
  33. 2021-12-21 From: =?utf-8?Q?Zo=C3=AB_Kooyman=2C_FSF?= <info-at-fsf.org> Subject: [Hangout - NYLXS] Support the Freedom Ladder campaign: Lessons we
  34. 2021-12-22 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Whis is that that comes up on my broadcast ping?
  35. 2021-12-23 Amin Bandali <bandali-at-gnu.org> Subject: [Hangout - NYLXS] Jami Taranis released [stable]
  36. 2021-12-23 Ruben Safir <mrbrklyn-at-panix.com> Subject: [Hangout - NYLXS] =?utf-8?q?Fwd=3A_Don=E2=80=99t_donate_to_Hebro?=
  37. 2021-12-24 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Privacy problems is just scraping the surface
  38. 2021-12-24 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Privacy problems is just scraping the surface
  39. 2021-12-24 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Privacy problems is just scraping the surface
  40. 2021-12-24 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout - NYLXS] Privacy problems is just scraping the surface
  41. 2021-12-24 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Tagging the population like we are cattle
  42. 2021-12-24 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Linux Foundation and Vaccine tracking
  43. 2021-12-24 Riccardo Mottola via info-gnu <info-gnu-at-gnu.org> Subject: [Hangout - NYLXS] ANN: GWorkspace 1.0
  44. 2021-12-23 Piper H <potthua-at-gmail.com> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2
  45. 2021-12-23 Chris Bennett <cpb_mod_perl-at-bennettconstruction.us> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2
  46. 2021-12-22 Wes Peng <pentwes-at-gmail.com> Re: [Hangout - NYLXS] Raku
  47. 2021-12-22 From: =?UTF-8?Q?Andr=c3=a9_Warnier_=28tomcat/perl=29?= <aw-at-ice-sa.com> Re: [Hangout - NYLXS] Raku
  48. 2021-12-22 John D Groenveld <groenveld-at-acm.org> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2
  49. 2021-12-22 John Dunlap <John-at-lariat.co> Re: [Hangout - NYLXS] Raku
  50. 2021-12-22 From: =?UTF-8?Q?Andr=c3=a9_Warnier_=28tomcat/perl=29?= <aw-at-ice-sa.com> Re: [Hangout - NYLXS] Raku
  51. 2021-12-22 Tom Browder <tom.browder-at-gmail.com> Subject: [Hangout - NYLXS] Raku
  52. 2021-12-22 black jack <iblackjack-at-e1.ru> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2
  53. 2021-12-22 Wes Peng <pentwes-at-gmail.com> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2
  54. 2021-12-22 Jacques Deguest <jack-at-deguest.jp> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2
  55. 2021-12-22 From: =?UTF-8?Q?Andr=c3=a9_Warnier_=28tomcat/perl=29?= <aw-at-ice-sa.com> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2
  56. 2021-12-25 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] The privacy privileged and the Press
  57. 2021-12-26 Richard Stallman <rms-at-gnu.org> Re: [Hangout - NYLXS] The privacy privileged and the Press
  58. 2021-12-27 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout - NYLXS] The privacy privileged and the Press
  59. 2021-12-27 G?bor Szab? <gabor-at-szabgab.com> Subject: [Hangout - NYLXS] [Perlweekly] #544 - Merry Christmas
  60. 2021-12-27 Petr Kovar <pknbe-at-volny.cz> Re: [Hangout - NYLXS] [Pan-users] [ANNOUNCE] Pan release 0.149
  61. 2021-12-27 baruchd <baruchd-at-optonline.net> Re: [Hangout - NYLXS] The privacy privileged and the Press
  62. 2021-12-27 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] A Networked world
  63. 2021-12-27 Richard Stallman <rms-at-gnu.org> Re: [Hangout - NYLXS] The privacy privileged and the Press
  64. 2021-12-28 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout - NYLXS] The privacy privileged and the Press
  65. 2021-12-28 From: "Greg Farough, DbD" <info-at-defectivebydesign.org> Subject: [Hangout - NYLXS] IDAD 2021: Counteracting Disney+'s attack on
  66. 2021-12-28 Richard Stallman <rms-at-gnu.org> Re: [Hangout - NYLXS] The privacy privileged and the Press
  67. 2021-12-27 From: "Randolf Richardson" <randolf-at-modperl.pl> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2 (with
  68. 2021-12-23 Piper H <potthua-at-gmail.com> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2
  69. 2021-12-27 From: "Randolf Richardson" <randolf-at-modperl.pl> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2
  70. 2021-12-23 Chris Bennett <cpb_mod_perl-at-bennettconstruction.us> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2
  71. 2021-12-22 Wes Peng <pentwes-at-gmail.com> Re: [Hangout - NYLXS] Raku
  72. 2021-12-22 From: =?UTF-8?Q?Andr=c3=a9_Warnier_=28tomcat/perl=29?= <aw-at-ice-sa.com> Re: [Hangout - NYLXS] Raku
  73. 2021-12-22 John D Groenveld <groenveld-at-acm.org> Re: [Hangout - NYLXS] [RELEASE CANDIDATE] mod_perl-2.0.12 RC2
  74. 2021-12-22 John Dunlap <John-at-lariat.co> Re: [Hangout - NYLXS] Raku
  75. 2021-12-22 From: =?UTF-8?Q?Andr=c3=a9_Warnier_=28tomcat/perl=29?= <aw-at-ice-sa.com> Re: [Hangout - NYLXS] Raku
  76. 2021-12-22 Tom Browder <tom.browder-at-gmail.com> Subject: [Hangout - NYLXS] Raku
  77. 2021-12-30 From: "Geoffrey Knauth, FSF" <info-at-fsf.org> Subject: [Hangout - NYLXS] Will you support user freedom by helping to reach
  78. 2021-12-22 raf <postfix-at-raf.org> Re: [Hangout - NYLXS] Adding Additional domains and outgoing email
  79. 2021-12-21 raf <postfix-at-raf.org> Re: [Hangout - NYLXS] Adding Additional domains and outgoing email
  80. 2021-12-22 Ruben Safir <ruben-at-mrbrklyn.com> Re: [Hangout - NYLXS] Adding Additional domains and outgoing email
  81. 2021-12-21 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [Hangout - NYLXS] Adding Additional domains and outgoing email

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