ASH News Daily 2017 - Issue 3 - C-18

BRIEF SUMMARY OF PRESCRIBING
INFORMATION
FOR YESCARTA™
BRIEF SUMMARY
OF PRESCRIBING
INFORMATION FOR YESCARTA™
(axicabtagene ciloleucel) suspension
for intravenous
infusion for intravenous infusion
(axicabtagene
ciloleucel) suspension
SEE PACKAGE INSERT FOR FULL
PRESCRIBING
INFORMATION
SEE PACKAGE
INSERT
FOR FULL PRESCRIBING INFORMATION

Table 1. CRSGuidance
Grading and
Management Guidance (continued)
Table 1. CRS Grading and Management
(continued)
CRS Grade (a)
Grade 3

CRS Grade
Tocilizumab
(a)
Grade Per
3 Grade 2

WARNING: CYTOKINE RELEASE
WARNING:
SYNDROME
CYTOKINE
and NEUROLOGIC
RELEASE SYNDROME
TOXICITIES
and NEUROLOGIC TOXICITIES

Symptoms require and respond
Symptoms require and respond
to aggressive
intervention. to aggressive intervention.
* Cytokine Release Syndrome
* Cytokine
(CRS), including
Releasefatal
Syndrome
or life-threatening
(CRS), including
reactions,
fatal or
occurred
life-threatening
in patients
reactions, occurred
in patients
receiving YESCARTA. Do not administer
receiving YESCARTA.
YESCARTADo
to not
patients
administer
with active
YESCARTA
infection
to patients
or inflammatory
with active infection
or inflammatory
Oxygen
requirement greater Oxygen requirement greater
disorders. Treat severe or life-threatening
disorders. Treat
CRS
severe
withor
tocilizumab
life-threatening
or tocilizumab
CRS withand
tocilizumab
corticosteroids
or tocilizumab and
thancorticosteroids
or equal to 40% FiO2 or than or equal to 40% FiO2 or
[see Dosage and Administration
[see (2.2,
Dosage
2.3),and
Warnings
Administration
and Precautions
(2.2, 2.3),(5.1)].
Warnings and Precautions (5.1)]. hypotension requiring high-dose
hypotension requiring high-dose
multiple receiving
vasopressors or or multiple vasopressors or
* Neurologic toxicities, including
* Neurologic
fatal ortoxicities,
life-threatening
including
reactions,
fatal or occurred
life-threatening
in patients
reactions,
receiving
occurred inorpatients
YESCARTA, including concurrently
YESCARTA,
withincluding
CRS or after
concurrently
CRS resolution.
with CRS
Monitor
or after
for CRS
neurologic
resolution. Monitor for
neurologic
Grade
3 organ toxicity or Grade
Grade
4 3 organ toxicity or Grade 4
toxicities after treatment with
toxicities
YESCARTA.
after Provide
treatment
supportive
with YESCARTA.
care and/or
Provide
corticosteroids,
supportive care
as and/or corticosteroids,
transaminitis. as
transaminitis.
needed [see Dosage and Administration
needed [see Dosage
(2.2, 2.3),
and
Warnings
Administration
and Precautions
(2.2, 2.3), (5.2)].
Warnings and Precautions (5.2)].
* YESCARTA is available only* through
YESCARTA
a restricted
is available
program
only through
under a Risk
restricted
Evaluation
program
andunder
Mitigation
a Risk Evaluation
and4Mitigation
Grade
Grade Per
4 Grade 2
Strategy (REMS) called the YESCARTA
Strategy (REMS)
REMS [see
calledWarnings
the YESCARTA
and Precautions
REMS [see(5.3)].
Warnings and Precautions (5.3)].
Life-threatening symptoms. Life-threatening symptoms.

Tocilizumab
Corticosteroids
Corticosteroids
Per Grade
Administer
2
methylprednisolone
Administer methylprednisolone
1 mg/kg intravenously
1 mg/kg intravenously
twice daily or equivalent
twice daily or equivalent
*
dexamethasone (e.g.,
dexamethasone (e.g.,
10 mg intravenously every 10 mg intravenously every
6 hours).
6 hours).
Continue corticosteroids use Continue corticosteroids use *
until the event is Grade 1 or less,
until the event is Grade 1 or less,
then taper over 3 days.
then taper over 3 days.
Per Grade
Administer
2
methylprednisolone
Administer methylprednisolone
1000 mg intravenously per day
1000 mg intravenously per day
for 3 days; if improves, then for 3 days; if improves, then
manage as above.
manage as above.

Requirements for ventilator Requirements for ventilator
support, continuous veno-venous
support, continuous veno-venous
hemodialysis
(CVVHD) or
hemodialysis (CVVHD) or
YESCARTA is a CD19-directedYESCARTA
geneticallyismodified
autologous
T cell immunotherapy
indicated
for immunotherapy
the
a CD19-directed
genetically
modified autologous
T cell
indicated
for the
treatment of adult patients with
relapsedoforadult
refractory
lymphoma
after two
more lymphoma
lines
treatment
patientslarge
withB-cell
relapsed
or refractory
largeorB-cell
after twoGrade
or more
lines toxicity (excluding
4 organ
Grade 4 organ toxicity (excluding
of systemic therapy, includingofdiffuse
large
B-cell including
lymphomadiffuse
(DLBCL)
notB-cell
otherwise
specified,
primary
systemic
therapy,
large
lymphoma
(DLBCL)
not otherwise specified,
primary
transaminitis).
transaminitis).
mediastinal large B-cell lymphoma,
high grade
B-cell lymphoma,
lymphoma, high
and DLBCL
arisinglymphoma,
from follicular
mediastinal
large B-cell
grade B-cell
and DLBCL arising from follicular
(a) Lee et al 2014, (b) Refer to Table (a)
2 for
Leemanagement
et al 2014, (b)
of Refer
neurologic
to Table
toxicity,
2 for (c)
management
Refer to tocilizumab
of neurologic
Prescribing
toxicity, Information
(c) Refer to tocilizumab
for
Prescribing Information for
lymphoma.
lymphoma.
1 INDICATIONS AND USAGE 1 INDICATIONS AND USAGE

details

details

Limitation of Use: YESCARTA is
not indicated
forYESCARTA
the treatment
patients with
primary
central
nervous with primary central nervous
Limitation
of Use:
is notofindicated
for the
treatment
of patients
Neurologic Toxicity: Monitor Neurologic
patients for signs
Toxicity:
and symptoms
Monitor patients
of neurologic
for signstoxicities
and symptoms
(Table 2).ofRule
neurologic
out other
toxicities (Table 2). Rule out other
system lymphoma.
system lymphoma.
causes of neurologic symptoms.
causes
Patients
of neurologic
who experience
symptoms.
GradePatients
2 or higher
whoneurologic
experiencetoxicities
Grade 2should
or higher
be neurologic toxicities should be
2 DOSAGE AND ADMINISTRATION
2 DOSAGE AND ADMINISTRATION
monitored with continuous cardiac
monitored
telemetry
withand
continuous
pulse oximetry.
cardiacProvide
telemetry
intensive
and pulse
careoximetry.
supportive
Provide
therapy
intensive
for care supportive therapy for
lifepatient
threatening neurologic
severetoxicities.
or life threatening
Consider non-sedating,
neurologic toxicities.
anti-seizure
Consider
medicines
non-sedating,
(e.g., levetiracetam)
anti-seizure medicines (e.g., levetiracetam)
2.2 Administration: YESCARTA
for autologous use
only. Theispatient's
identityuse
must
match
the patient
2.2isAdministration:
YESCARTA
for autologous
only.
The patient's
identity mustsevere
matchorthe
seizure prophylaxis
for seizure
2 or higher
prophylaxis
neurologic
for anytoxicities.
Grade 2 or higher neurologic toxicities.
identifiers on the YESCARTA cassette
and
bag. Docassette
not infuse
if theDoinformation
the
identifiers
oninfusion
the YESCARTA
andYESCARTA
infusion bag.
not infuse on
YESCARTA
if theforinformation
on the for any Grade
patient-specific label does notpatient-specific
match the intended
patient
Dosage
and Administration(2.2.3)].
label does
not[see
match
the intended
patient [see Dosage and Administration(2.2.3)].
Table 2. Neurologic ToxicityTable
Grading
2. Neurologic
and Management
ToxicityGuidance
Grading and Management Guidance
Preparing Patient for YESCARTA
Infusion:
Confirm
availabilityInfusion:
of YESCARTA
prioravailability
to starting of
theYESCARTA prior to starting the
Preparing
Patient
for YESCARTA
Confirm
Grading
lymphodepleting regimen. Pre-treatment:
Administer
a lymphodepleting
chemotherapy
regimen of chemotherapyGrading
lymphodepleting
regimen.
Pre-treatment: Administer
a lymphodepleting
regimen of
Concurrent CRS
No Concurrent CRS
Concurrent CRS
No Concurrent CRS
2
2
Assessment
Assessment
cyclophosphamide 500 mg/mcyclophosphamide
mg/m2 intravenously
intravenously and500
fludarabine
30 mg/m2 intravenously
on the
fourth,
and fludarabine
30fifth,
mg/m
intravenously on
the fifth, fourth,
and third day before infusion and
of YESCARTA.
Premedication:
acetaminophen
mg PO and
third day before
infusion ofAdminister
YESCARTA.
Premedication:650
Administer
acetaminophen Grade
650 mg2 PO and AdministerGrade
2 per Table
tocilizumab
Administer
1 for tocilizumab per
Administer
Table 1 for
dexamethasone 10Administer
mg
dexamethasone 10 mg
diphenhydramine 12.5 mg intravenously
or PO approximately
1 hour before
infusion.
Avoid
diphenhydramine
12.5 mg intravenously
or PO YESCARTA
approximately
1 hour
before YESCARTA infusion. Avoid management of Grade 2 CRS. management of Grade 2intravenously
CRS.
every 6 hours. intravenously every 6 hours.
prophylactic use of systemic corticosteroids,
may interfere
with the activity
of YESCARTA.
prophylactic useasofitsystemic
corticosteroids,
as it may
interfere with the activity of YESCARTA.
If no improvement within 24 hours
If no after
improvement
starting withinContinue
24 hoursdexamethasone
after starting
Continue dexamethasone
Preparation of YESCARTA for
Infusion: Coordinate
the timing
of YESCARTA
thaw and
infusion.
Confirm thethaw and infusion. Confirm thetocilizumab, administer dexamethasone
Preparation
of YESCARTA
for Infusion:
Coordinate
the timing
of YESCARTA
tocilizumab,
10administer
mg
dexamethasone
10 mg
use until the event
is Grade 1use
or until the event is Grade 1 or
infusion time in advance, and adjust
startin time
of YESCARTA
thaw
be available
infusion
infusionthetime
advance,
and adjust
thesuch
start that
timeitofwill
YESCARTA
thawforsuch
that it will be available for infusion
intravenously every 6 hours if intravenously
not already taking
every 6 hours
not already
taking
less,ifthen
taper over
3 days. less, then taper over 3 days.
when the patient is ready. Confirm
identity:
Prior to
YESCARTA
preparation,
match
the patient's
identity match the patient's identity
whenpatient
the patient
is ready.
Confirm
patient
identity: Prior
to YESCARTA
preparation,
other corticosteroids. Continueother
dexamethasone
corticosteroids. Continue dexamethasone
with the patient identifiers on the
Doon
notthe
remove
the YESCARTA
product
bag from
withYESCARTA
the patientcassette.
identifiers
YESCARTA
cassette. Do
not remove
thethe
YESCARTA product bag from the use until the event is Grade 1 oruse
less,until
thenthetaper
event is Grade 1 or less, then taper
cassette if the information on the
patient-specific
label does
notpatient-specific
match the intended
patient
cassette
if the information
on the
labelpatient.
does notOnce
match
the intended patient. Once patient over 3 days.
over 3 days.
identification is confirmed, remove
the YESCARTA
productremove
bag from
cassetteproduct
and check
identification
is confirmed,
thethe
YESCARTA
bagthat
fromthe
thepatient
cassette and check that the patient
information on the cassette label
matcheson
thethe
bagcassette
label. Inspect
the product
bag label.
for anyInspect
breaches
of container
information
label matches
the bag
the product
bag for any breaches of container
Consider non-sedating, anti-seizure
Consider
medicines
non-sedating,
(e.g., levetiracetam)
anti-seizure medicines
for seizure(e.g., levetiracetam) for seizure
integrity such as breaks or cracks
before
thawing.
If theorbag
is compromised,
follow
local
guidelines (or follow the local guidelines (or
integrity
such
as breaks
cracks
before thawing.
If thethebag
is compromised,
prophylaxis.
prophylaxis.
call Kite at 1-844-454-KITE). Place
theatinfusion
bag inside aPlace
second
bagbag
perinside
local aguidelines.
Thawbag per local guidelines. Thaw
call Kite
1-844-454-KITE).
thesterile
infusion
second sterile
YESCARTA at approximately 37°C
using either
a water bath37°C
or dry
thaweither
method
until bath
thereorisdry
no thaw
visiblemethod
ice in until there
YESCARTA
at approximately
using
a water
is no3visible ice inAdministerGrade
10Administer
mg
dexamethasone 10 mg
Grade
tocilizumab
3
per Table
Administer
1 for tocilizumab Administer
per Table 1 dexamethasone
for
the infusion bag. Gently mix the
theGently
bag tomix
disperse
clumps of
of the
cellular
material.
If visible
clumps material. If visible cell clumps
thecontents
infusionofbag.
the contents
bag to
disperse
clumpscell
of cellular
every 6 hours. intravenously every 6 hours.
management of Grade 2 CRS.management of Grade 2intravenously
CRS.
remain continue to gently mix remain
the contents
of the
bag. Small
clumps
of cellular
should
disperse
with material should disperse with
continue
to gently
mix the
contents
of the material
bag. Small
clumps
of cellular
Continue dexamethasone
until dexamethasone use until
In addition,10administer
mg
dexamethasone
10 mg useContinue
gentle manual mixing. Do not wash,
down,
and/or
YESCARTA
in new re-suspend
media priorYESCARTA
to infusion.in new media prior to infusion.In addition, administer dexamethasone
gentle spin
manual
mixing.
Dore-suspend
not wash, spin
down, and/or
the event
Grade 1 or less, then
the event is Grade 1 or less, then
intravenously with the first dose
intravenously
of tocilizumab
with the first
dose ofis tocilizumab
Once thawed, YESCARTA may Once
be stored
at room
temperature
to at
25°C)
up to 3 hours.
thawed,
YESCARTA
may be(20°C
stored
roomfortemperature
(20°C to 25°C) for up to 3 hours.
taper over 3 days.
and repeat dose every
and repeat dose every taper over 3 days.
Administration: For autologous
use only. Ensure
tocilizumab
and emergency
available
Administration:
Forthat
autologous
use only.
Ensure thatequipment
tocilizumabareand
emergency equipment are available6 hours. Continue dexamethasone
6 hours.
useContinue
until the dexamethasone use until the
prior to infusion and during the
recovery
period.
NOT use
a leukodepleting
filter.
Central
access isfilter. Central venous accessevent
prior
to infusion
andDoduring
the recovery
period. Do
NOT
use avenous
leukodepleting
is is Grade 1 or less, thenevent
taper isover
Grade
3 days.
1 or less, then taper over 3 days.
recommended for the infusionrecommended
of YESCARTA.for
Confirm
the patient's
identity Confirm
matchesthe
thepatient's
patient identifiers
on
the infusion
of YESCARTA.
identity matches
the patient identifiers on
the YESCARTA product bag. Prime
the tubingproduct
with normal
salinethe
priortubing
to infusion.
Infusesaline
the entire
the YESCARTA
bag. Prime
with normal
prior contents
to infusion. Infuse the entire contents
Consider non-sedating, anti-seizure
Consider
medicines
non-sedating,
(e.g., levetiracetam)
anti-seizure medicines
for seizure(e.g., levetiracetam) for seizure
of the YESCARTA bag within of
30the
minutes
by either
or aminutes
peristaltic
pump.gravity
YESCARTA
stable atpump. YESCARTA is stable at prophylaxis.
YESCARTA
bag gravity
within 30
by either
or a is
peristaltic
prophylaxis.
room temperature for up to 3room
hourstemperature
after thaw. for
Gently
theafter
product
during
YESCARTA
infusion
up toagitate
3 hours
thaw.bag
Gently
agitate
the product
bag during YESCARTA infusion
Administer methylprednisolone
4 with AdministerGrade
tocilizumab
4
per Table
Administer
1 for tocilizumab Administer
per Table 1 methylprednisolone
for
to prevent cell clumping. After
entirecell
content
of theAfter
product
bag iscontent
infused,ofrinse
the tubing
to the
prevent
clumping.
the entire
the product
bagwith
is infused, rinseGrade
the tubing
CRS.mg intravenously per day
1000
for mg intravenously per day for
normal saline at the same infusion
to ensure
all product
is delivered.
YESCARTA
contains
human YESCARTA contains human management of Grade 2 CRS.management of Grade 21000
normalrate
saline
at the same
infusion
rate to ensure
all product
is delivered.
3 days; if improves, then manage
3 days; if improves, then manage
blood cells that are genetically
modified
withare
replication
incompetent
retroviral
vector.incompetent
Follow universal
blood
cells that
genetically
modified with
replication
retroviral vector. Follow universalAdminister methylprednisolone
Administer methylprednisolone
precautions and local biosafety
guidelinesand
forlocal
handling
and disposal
to avoid
potential
of potential transmission of 1000 mg intravenously per day
precautions
biosafety
guidelines
for handling
andtransmission
disposal to avoid
1000
withmg
first
intravenously
dose of as
perabove.
day with first dose of as above.
infectious diseases.
infectious diseases.
tocilizumab and continue methylprednisolone
tocilizumab and continue methylprednisolone
1000 mg intravenously per day
1000
for mg
2 more
intravenously
days;
per day for 2 more days;
Monitoring: Administer YESCARTA
at a certified
healthcare
facility.
patients
at least
dailyMonitor
for 7 days
Monitoring:
Administer
YESCARTA
at aMonitor
certified
healthcare
facility.
patients at least daily for 7 days
if improves, then manage as above.
if improves, then manage as above.
at the certified healthcare facility
for signs
symptoms
of CRS
toxicities.
at thefollowing
certifiedinfusion
healthcare
facilityand
following
infusion
for and
signsneurologic
and symptoms
of CRS and neurologic toxicities.
Instruct patients to remain within
proximity
of to
theremain
certified
healthcare
facility
at least healthcare
4 weeks following
Instruct
patients
within
proximity
of theforcertified
facility for at least 4 weeks following
Consider non-sedating, anti-seizure
Consider
medicines
non-sedating,
(e.g., levetiracetam)
anti-seizure medicines
for seizure(e.g., levetiracetam) for seizure
infusion.
infusion.
prophylaxis.
prophylaxis.
2.3 Management of Severe 2.3
Adverse
Reactions
Management
of Severe Adverse Reactions
Cytokine Release SyndromeCytokine
(CRS): Identify
CRS
based on(CRS):
clinicalIdentify
presentation
[see Warnings
Release
Syndrome
CRS based
on clinicaland
presentation [see Warnings and
Precautions (5.1)]. Evaluate for
and treat other
of fever,
and causes
hypotension.
If CRS
is and hypotension.
Precautions
(5.1)].causes
Evaluate
for andhypoxia,
treat other
of fever,
hypoxia,
If CRS is
4 CONTRAINDICATIONS:
None.
4 CONTRAINDICATIONS: None.
suspected, manage accordingsuspected,
to the recommendations
in Table
1. recommendations
Patients who experience
2 or higher
manage according
to the
in TableGrade
1. Patients
who experience
Grade 2AND
or higher
5 WARNINGS
PRECAUTIONS
5 WARNINGS AND PRECAUTIONS
CRS (e.g., hypotension, not responsive
fluids, or hypoxia
requiring tosupplemental
oxygenation)
be
CRS (e.g.,tohypotension,
not responsive
fluids, or hypoxia
requiringshould
supplemental
oxygenation) should be
5.1 Cytokine
5.1 Cytokine
(CRS): CRS,including
Release Syndrome
fatal or (CRS):
life-threatening reactions, occurred following
monitored with continuous cardiac
telemetry
and pulse oximetry.
For patients
severe
CRS, experiencing
monitored
with continuous
cardiac telemetry
andexperiencing
pulse oximetry.
For patients
severe Release
CRS, Syndrome
treatment withCRS,
YESCARTA. In treatment
Study 1, CRS
withoccurred
YESCARTA.
in 94%
In Study
(101/108)
1, CRSofoccurred
patients in
receiving
94% (101/108)
YESCARTA,
of patients receiving YESCARTA,
consider performing an echocardiogram
to assessan
cardiac
function. Fortosevere
life-threatening
CRS,
consider performing
echocardiogram
assessorcardiac
function. For
severe or life-threatening
including ≥ Grade 3 (Lee grading
including
system)
≥ Grade
CRS in3 13%
(Lee grading
(14/108)system)
of patients.
CRS Among
in 13%patients
(14/108)who
of patients.
died Among patients who died
consider intensive care supportive
therapy.
consider
intensive care supportive therapy.
after receiving YESCARTA, fourafter
hadreceiving
ongoing YESCARTA,
CRS events four
at the
had
time
ongoing
of death.
CRSThe
events
median
at the
time
time
to of
onset
death. The median time to onset
Table 1. CRS Grading and Management
Table 1. CRSGuidance
Grading and Management Guidance
was 2 days (range: 1 to 12 days)
wasand
2 days
the (range:
median1duration
to 12 days)
of CRS
andwas
the 7median
days (range:
duration
2 to
of 58
CRSdays).
was Key
7 days (range: 2 to 58 days). Key
manifestations of CRS includemanifestations
fever (78%), hypotension
of CRS include
(41%),
fever
tachycardia
(78%), hypotension
(28%), hypoxia
(41%),(22%),
tachycardia
and (28%), hypoxia (22%), and
CRS Grade (a)
Tocilizumab
(a)
Tocilizumab
Corticosteroids
Corticosteroids
CRS Grade
chills (20%). Serious events that
chills
may
(20%).
be associated
Serious events
with CRS
that include
may be cardiac
associated
arrhythmias
with CRS(including
include cardiac
atrial arrhythmias (including atrial
N/A N/A
N/A
Grade 1
Grade N/A
1
fibrillation and ventricular tachycardia),
fibrillation cardiac
and ventricular
arrest, cardiac
tachycardia),
failure,cardiac
renal insufficiency,
arrest, cardiac
capillary
failure,leak
renal insufficiency, capillary leak
Symptoms require symptomatic
Symptoms require symptomatic
syndrome, hypotension, hypoxia,
syndrome,
and hemophagocytic
hypotension, hypoxia,
lymphohistiocytosis/macrophage
and hemophagocytic lymphohistiocytosis/macrophage
activation syndrome
activation syndrome
treatment only (e.g., fever, treatment only (e.g., fever,
(HLH/MAS) [see Adverse Reactions
(HLH/MAS)
(6)]. Ensure
[see Adverse
that 2 doses
Reactions
of tocilizumab
(6)]. Ensureare
that
available
2 dosesprior
of tocilizumab
to infusion are available prior to infusion
nausea, fatigue, headache, nausea, fatigue, headache,
of YESCARTA. Monitor patientsofatYESCARTA.
least dailyMonitor
for 7 days
patients
at theatcertified
least daily
healthcare
for 7 days
facility
at thefollowing
certifiedinfusion
healthcare facility following infusion
myalgia, malaise).
myalgia, malaise).
for signs and symptoms of CRS.
for signs
Monitor
andpatients
symptoms
for signs
of CRS.
or symptoms
Monitor patients
of CRSfor
forsigns
4 weeks
or symptoms
after infusion.
of CRS for 4 weeks after infusion.
Counsel patients to seek immediate
Counselmedical
patientsattention
to seek immediate
should signsmedical
or symptoms
attention
of should
CRS occur
signsatorany
symptoms
time of CRS occur at any time
Manage
per Grade
Grade
3 if no
tocilizumab (c) Administer
tocilizumab
(c) 3 if no Manage per[see
Grade 2
Grade Administer
2
Patient
Counseling Information
[see Patient
(17)]. Counseling
At the first sign
Information
of CRS, (17)].
institute
At the
treatment
first sign
with
of CRS,
supportive
institute
care,
treatment with supportive care,
improvement
within
within 24orhours
8 mg/kg
intravenously
over 8 mg/kg
intravenously
over 24 hoursimprovement
tocilizumab
tocilizumab andtocilizumab
corticosteroids
or tocilizumab
as indicated
and[See
corticosteroids
Dosage andasAdministration
indicated [See(2.3)].
Dosage and Administration (2.3)].
Symptoms require and respond
Symptoms
require
and respond
after starting tocilizumab.
1 hourintervention.
(not to exceed 800 mg).
1 hour after
(not tostarting
exceedtocilizumab.
800 mg).
to moderate intervention. to moderate
5.2 Neurologic Toxicities: Neurologic
5.2 Neurologic
toxicities,
Toxicities:
that were
Neurologic
fatal or life-threatening,
toxicities, that were
occurred
fatal following
or life-threatening, occurred following
Repeat
tocilizumab
every
Repeat
tocilizumab
every
treatment with YESCARTA. Neurologic
treatmenttoxicities
with YESCARTA.
occurredNeurologic
in 87% of toxicities
patients. Ninety-eight
occurred in 87%
percent
of patients.
of all Ninety-eight percent of all
Oxygen requirement less thanOxygen requirement less than
8 hours
as needed if not
8 hours as needed if not
neurologic toxicities occurredneurologic
within the toxicities
first 8 weeks
occurred
of YESCARTA
within theinfusion,
first 8 weeks
with a of
median
YESCARTA
time to
infusion,
onset with a median time to onset
40% FiO2 or hypotension
40% FiO
or
hypotension
2
responsive
responsive to intravenous fluids
of 4 days (range: 1 to 43 days).
of The
4 days
median
(range:
duration
1 to 43ofdays).
neurologic
The median
toxicities
duration
was 17ofdays.
neurologic
Gradetoxicities
3 or
was 17 days. Grade 3 or
responsive to fluids or low-dose
responsive
to fluidstoorintravenous
low-dose fluids
or
increasing
supplemental
or
increasing
supplemental
higher neurologic toxicities occurred
higher neurologic
in 31% of toxicities
patients. The
occurred
most in
common
31% ofneurologic
patients. The
toxicities
most common
included neurologic toxicities included
of one vasopressor or
of one vasopressor or
oxygen.
oxygen.
encephalopathy (57%), headache
encephalopathy
(44%), tremor
(57%),
(31%),
headache
dizziness(44%),
(21%),tremor
aphasia
(31%),
(18%),
dizziness
delirium(21%),
(17%),aphasia (18%), delirium (17%),
Grade 2 organ toxicity (b). Grade 2 organ toxicity (b).
insomnia (9%) and anxiety (9%).
insomnia
Prolonged
(9%)encephalopathy
and anxiety (9%).
lasting
Prolonged
up to 173
encephalopathy
days was noted.
lasting
Serious
up to events
173 days was noted. Serious events
Limit to a maximum of 3 doses
Limit to a maximum of 3 doses
including leukoencephalopathyincluding
and seizures
leukoencephalopathy
occurred with YESCARTA.
and seizures
Fataloccurred
and serious
with cases
YESCARTA.
of cerebral
Fatal and serious cases of cerebral
in a 24-hour period; maximumin a 24-hour period; maximum
edema have occurred in patients
edema
treated
havewith
occurred
YESCARTA.
in patients
Monitor
treated
patients
withatYESCARTA.
least dailyMonitor
for 7 days
patients
at theat least daily for 7 days at the
total of 4 doses.
total of 4 doses.
certified healthcare facility following
certifiedinfusion
healthcare
for signs
facilityand
following
symptoms
infusion
of neurologic
for signs toxicities.
and symptoms
Monitor
of neurologic toxicities. Monitor

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Table of Contents for the Digital Edition of ASH News Daily 2017 - Issue 3

ASH News Daily 2017 - Issue 3 - A-1
ASH News Daily 2017 - Issue 3 - A-2
ASH News Daily 2017 - Issue 3 - A-3
ASH News Daily 2017 - Issue 3 - A-4
ASH News Daily 2017 - Issue 3 - A-5
ASH News Daily 2017 - Issue 3 - A-6
ASH News Daily 2017 - Issue 3 - A-7
ASH News Daily 2017 - Issue 3 - A-8
ASH News Daily 2017 - Issue 3 - A-9
ASH News Daily 2017 - Issue 3 - A-10
ASH News Daily 2017 - Issue 3 - A-11
ASH News Daily 2017 - Issue 3 - A-12
ASH News Daily 2017 - Issue 3 - A-13
ASH News Daily 2017 - Issue 3 - A-14
ASH News Daily 2017 - Issue 3 - A-15
ASH News Daily 2017 - Issue 3 - A-16
ASH News Daily 2017 - Issue 3 - A-17
ASH News Daily 2017 - Issue 3 - A-18
ASH News Daily 2017 - Issue 3 - A-19
ASH News Daily 2017 - Issue 3 - A-20
ASH News Daily 2017 - Issue 3 - A-21
ASH News Daily 2017 - Issue 3 - A-22
ASH News Daily 2017 - Issue 3 - A-23
ASH News Daily 2017 - Issue 3 - A-24
ASH News Daily 2017 - Issue 3 - A-25
ASH News Daily 2017 - Issue 3 - A-26
ASH News Daily 2017 - Issue 3 - A-27
ASH News Daily 2017 - Issue 3 - A-28
ASH News Daily 2017 - Issue 3 - B-1
ASH News Daily 2017 - Issue 3 - B-2
ASH News Daily 2017 - Issue 3 - B-3
ASH News Daily 2017 - Issue 3 - B-4
ASH News Daily 2017 - Issue 3 - B-5
ASH News Daily 2017 - Issue 3 - B-6
ASH News Daily 2017 - Issue 3 - B-7
ASH News Daily 2017 - Issue 3 - B-8
ASH News Daily 2017 - Issue 3 - B-9
ASH News Daily 2017 - Issue 3 - B-10
ASH News Daily 2017 - Issue 3 - B-11
ASH News Daily 2017 - Issue 3 - B-12
ASH News Daily 2017 - Issue 3 - B-13
ASH News Daily 2017 - Issue 3 - B-14
ASH News Daily 2017 - Issue 3 - B-15
ASH News Daily 2017 - Issue 3 - B-16
ASH News Daily 2017 - Issue 3 - B-17
ASH News Daily 2017 - Issue 3 - B-18
ASH News Daily 2017 - Issue 3 - B-19
ASH News Daily 2017 - Issue 3 - B-20
ASH News Daily 2017 - Issue 3 - B-21
ASH News Daily 2017 - Issue 3 - B-22
ASH News Daily 2017 - Issue 3 - B-23
ASH News Daily 2017 - Issue 3 - B-24
ASH News Daily 2017 - Issue 3 - B-25
ASH News Daily 2017 - Issue 3 - B-26
ASH News Daily 2017 - Issue 3 - B-27
ASH News Daily 2017 - Issue 3 - B-30
ASH News Daily 2017 - Issue 3 - B-31
ASH News Daily 2017 - Issue 3 - B-32
ASH News Daily 2017 - Issue 3 - B-33
ASH News Daily 2017 - Issue 3 - B-34
ASH News Daily 2017 - Issue 3 - B-35
ASH News Daily 2017 - Issue 3 - B-36
ASH News Daily 2017 - Issue 3 - B-37
ASH News Daily 2017 - Issue 3 - B-38
ASH News Daily 2017 - Issue 3 - B-39
ASH News Daily 2017 - Issue 3 - B-40
ASH News Daily 2017 - Issue 3 - B-41
ASH News Daily 2017 - Issue 3 - B-42
ASH News Daily 2017 - Issue 3 - B-43
ASH News Daily 2017 - Issue 3 - B-44
ASH News Daily 2017 - Issue 3 - B-45
ASH News Daily 2017 - Issue 3 - B-46
ASH News Daily 2017 - Issue 3 - B-47
ASH News Daily 2017 - Issue 3 - B-48
ASH News Daily 2017 - Issue 3 - B-49
ASH News Daily 2017 - Issue 3 - B-50
ASH News Daily 2017 - Issue 3 - B-51
ASH News Daily 2017 - Issue 3 - B-52
ASH News Daily 2017 - Issue 3 - B-53
ASH News Daily 2017 - Issue 3 - B-54
ASH News Daily 2017 - Issue 3 - B-55
ASH News Daily 2017 - Issue 3 - B-56
ASH News Daily 2017 - Issue 3 - C-1
ASH News Daily 2017 - Issue 3 - C-2
ASH News Daily 2017 - Issue 3 - C-3
ASH News Daily 2017 - Issue 3 - C-4
ASH News Daily 2017 - Issue 3 - C-5
ASH News Daily 2017 - Issue 3 - C-6
ASH News Daily 2017 - Issue 3 - C-7
ASH News Daily 2017 - Issue 3 - C-8
ASH News Daily 2017 - Issue 3 - C-9
ASH News Daily 2017 - Issue 3 - C-10
ASH News Daily 2017 - Issue 3 - C-11
ASH News Daily 2017 - Issue 3 - C-12
ASH News Daily 2017 - Issue 3 - C-13
ASH News Daily 2017 - Issue 3 - C-14
ASH News Daily 2017 - Issue 3 - C-15
ASH News Daily 2017 - Issue 3 - C-16
ASH News Daily 2017 - Issue 3 - C-17
ASH News Daily 2017 - Issue 3 - C-18
ASH News Daily 2017 - Issue 3 - C-19
ASH News Daily 2017 - Issue 3 - C-20
ASH News Daily 2017 - Issue 3 - C-21
ASH News Daily 2017 - Issue 3 - C-22
ASH News Daily 2017 - Issue 3 - C-23
ASH News Daily 2017 - Issue 3 - C-24
ASH News Daily 2017 - Issue 3 - C-25
ASH News Daily 2017 - Issue 3 - C-26
ASH News Daily 2017 - Issue 3 - C-27
ASH News Daily 2017 - Issue 3 - C-28
ASH News Daily 2017 - Issue 3 - C-29
ASH News Daily 2017 - Issue 3 - C-30
ASH News Daily 2017 - Issue 3 - C-31
ASH News Daily 2017 - Issue 3 - C-32
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