Lebanese Society of Medical Oncology (LSMO) National Forum ... · Moderators: Georges El Hachem - Clemence Matta - Riwa Sakr - Sami El Khatib 16:30 - 16:50 Genomic Expression Profiling

MULTIDISCIPLINARY APPROACH

Lebanese Society of Medical Oncology (LSMO)National Forum

April 11-13, 2019 | Phoenicia Hotel - Beirut, Lebanon


in collaboration with:

MULTIDISCIPLINARYAPPROACH

Lebanese Societyof MedicalOncology (LSMO)National Forum

16th

LOP: 11 CME Order of Nurses: 12 CNE

ZYTIGA® as first-line therapy in mCRPC and mHSPC delivers remarkable overall survival benefits without compromising quality of life, so your patients can stay active for longer.

FIRST NOVEL HORMONAL AGENT IN mCRPC*1

4.4 months median life extension vs prednisone alone in post-ADT (HR 0.81; 95% CI 0.70–0.93; P=0.0033)**2

4.6 months median life extension in post-chemotherapy patients (HR 0.74; 95% CI 0.64–0.86; P<0.0001)3

FIRST IN NEWLY DIAGNOSED HIGH-RISK mHSPC*1 Superior median overall survival vs ADT alone (HR 0.62; 95% CI 0.51–0.76; P<0.001)†4

SINCE 2011

FOR MAXIMUM IMPACT, USE ZYTIGA® PLUS PREDNISONE FIRST-LINE IN mCRPC AND mHSPC

Time for life

mCRPC=metastatic castration-resistant prostate cancer; mHSPC=metastatic hormone-sensitive prostate cancer; ADT=androgen deprivation therapy * ZYTIGA® approved for mCRPC post-chemotherapy in September 2011, mCRPC post-ADT in December 2012 and for newly diagnosed high-risk mHSPC in November 2017 ** Asymptomatic or mildly symptomatic patients with mCRPC post-ADT † Median time not reached for ZYTIGA® group




Welcome Letter

On behalf of the LSMO Organizing Committee, It gives me great pleasure to invite you all to participate in the “16th Lebanese Society of Medical Oncology National Forum LSMO” which will be held from 11-13 April 2019 at Phoenicia Hotel in Beirut Lebanon.

The objective of this unique conference is to promote the highest standards of healthcare in the management and support of patients with cancer. The program aims at equipping healthcare professionals with knowledge about recent developments, advance the effectiveness of healthcare practice and delivery and increase the quality of patient care.

The congress will provide both a forum for exchange on cutting-edge scientific and clinical information and will facilitate interactions among physicians, researchers, scientists, clinicians and other healthcare professionals from around the world to navigate the various challenges faced in further refining the health outcomes of patients suffering from cancer.

The scientific program contains a series of high-profile plenary presentations, symposia and concurrent sessions. Our aim is to bridge gaps and pave the future by hosting several international speakers from North America, Europe and the region who will be giving lectures on the recent updates in primary care, share valuable scientific knowledge in oncology, ranging from diagnostic and therapeutic tools and techniques to cutting-edge research.

I sincerely hope that this conference will deliberate and discuss all the different facets of oncology and come up with recommendations that will lead to a better, healthier world. The LSMO congresses have been very successful & well attended congresses with outstanding scientific programs where we can ensure that the 16th Annual Congress will not be an exception. We will put together another milestone on the way to success, focusing on the most important instrument to further improve our society: multiplying knowledge by sharing it with each other.I am convinced, the program will provide you with new information, better knowledge in oncology, provide ideas on how to improve your research and results and it will be a stimulus to further harmonize our medical standards and to successfully compete with our neighboring disciplines. Looking forward to a successful and fruitful congress and hoping to see you all there!

Nizar Bitar, MDLSMO President




Scientific Committee PresidentRoger Khater, MD

Past PresidentJoseph Makdessi, MD

TreasurerTherese Abou Nasr, MD

PresidentNizar Bitar, MD

President ElectRoger Khater, MD

General SecretaryOussama Jradi, MD

LSMO PresidentNizar Bitar, MD

Ahmad Awada, MDJeffrey Gregg, MDPeter Niehoff, MDPeter Schmid, MDRuben Cabanillas, MD

Scientific Committee

Executive Board

International Faculty

Members

Ali Shamseddine, MDArafat Tfayli, MDFadi Nasr , MD

MembersHanane Yassine, MD Mohamad Haidar, MDNaji Amro, MD

Rita Murr , MDWalid Moukadem, MD

Hazem Assi, MD Jad Wakim, MD Joseph Kattan, MD

Joseph Makdessi, MDRita Murr , MD Therese Abou Nasr , MD

Sana Al-Sukhun, MDShouki Bazarbachi, MDStephan Chia, MDSuayib Yalcin, MDYohann Loriot, MD







Thursday, April 11, 201908:00 Registration

Moderator: Fadi EL Karak

09:00 - 09:45 Optimizing Management of Pre/Post Menopausal Women with HR+ve ABC Patients

Novartis Symposium

Stephen Chia

09:45 - 10:30 Current Practice and Opportunities in the Management of HR+/HER2- mBC: Optimizing the Role of CDK4/6 Inhibitors in Clinical Practice

Pfizer Symposium

Hady Ghanem

10:30 - 10:50 Coffee Break

10:50 - 11:35 Are all CDK4/6i the same? How Abemaciclib was Designed to be Different

Lilly Symposium

Hazem Assi

11:35 - 12:05 Opening CeremonyMaster of CeremonyAddress of the President of LSMO Prof. Nizar Bitar

Address of AMACC General SecretaryProf. Sami Khatib

Address of the President of The Lebanese Order of Physicians in BeirutProf. Raymond Sayegh

Address of the President of the Lebanese RepublicGeneral Michel Aoun




Thursday, April 11, 2019

Moderator: Nizar Bitar

12:05 - 12:50 Current Questions on Why, When and How to Treat Non-Metastatic Castration-Resistant Prostate Cancer

Janssen Symposium

Marwan GhosnMichel Jabbour

12:50 - 13:50 Lunch Break

13:50 - 14:50 General SessionModerators: Ali Youssef - Zahera Fahed

13:50 - 14:15 Sequence of Treatment in Advanced Neuroendocrine Tumors

Ali Shamseddine

14:15 - 14:40 Role of Checkpoints Inhibitors in the Adjuvant and Neoadjuvant Settings of Solid Tumors

Ahmad Awada

14:40 - 15:25 Reshaping the Management Paradigm of ALK/ROS1 Positive Non-Small Cell Lung Cancer (NSCLC)

Pfizer Symposium

Arafat Tfayli


Moderators: Nizar Bitar - Arafat Tfayli

15:45 - 16:30 The Role of Denosumab for Prevention of Skeletal Related Complications in Multiple Myeloma

Georges Chahine

Denosumab for the Prevention of Skeletal-Related Events in Patients with Bone Metastasis fromSolid Tumors

Amgen Symposium

Sana Al-Sukhun




Thursday, April 11, 2019

16:30 - 18:30 Breast SessionModerators: Georges El Hachem - Clemence Matta - Riwa Sakr - Sami El Khatib

16:30 - 16:50 Genomic Expression Profiling and Selection ofAdjuvant Systemic Therapy in Early Breast Cancer

Stephen Chia

16:50 - 17:10 Optimizing Adjuvant Therapy Decisions for HER2-Positive Early Breast Cancer

Nagi Saghir

17:10 - 17:30 Neoadjuvant Treatment in Primary Operable Breast Cancer: A More Individualized Approach to Systemic Therapies

Stephen Chia

17:30 - 17:50 Beyond HER2 and CDK4/6 Agents in Advanced Breast Cancers: Molecular Aberrations, New Targets and New Molecular Agents

Ahmad Awada

17:50 - 18:10 Targeting Immune Checkpoints in TNBC Hazem Assi

18:10 - 18:30 Adjuvant Endocrine Therapy in Early HR-Positive Breast Cancer, the Controversy of Duration

Sana Al-Sukhun

18:30 - 19:15 Role of Immunotherapy in mTNBC Roche Symposium

Peter Schmid




Friday, April 12, 2019

08:30 - 10:10 Lung CancerModerators: Rita El Murr - Ali Youssef - Ali Monzer

08:30 - 08:55 Local Ablation Techniques in Early Stage NSCLC Nadim Muallem

08:55 - 09:20 Immunotherapy in Non-Mutation Driven Advanced NSCLC Fadi Karak

09:20 - 09:45 Advances in the Management of SCLC Ghazi Nsouli

09:45 - 10:10 Approach to Patients with EGFR or ALK Mutated NSCLC Arafat Tfayli

10:10 - 10:35 Mesothelioma: New Treatment Options Therese Abi Nasr


10:55 - 11:40 The Promise of Immunotherapy in Melanoma

BMS Symposium

Hady Ghanem

11:40 - 12:40 Head & NeckModerators: Mouin Moubarak - Marcel Massoud - Abdel Fattah Kheir

11:40 - 12:00 Immunotherapy in Head and Neck Cancers Hady Ghanem

12:00 - 12:20 Approach to Patients with Iodine-Refractory Thyroid Cancer Marwan Ghosn

12:20 - 12:40 Chemotherapy/Radiation vs. Cetuximab/Radiation Bassem Youssef

12:40 - 13:25 Pembrolizumab, Redefining the Standard of Care inMetastatic Non-Small Cell Lung Cancer

MSD Symposium

Ziad Salem


14:25 - 15:25 Cancers in Young AdultsModerators: Hanane Yassine - Abir El Ahmadie

14:25 - 14:45 Bone Sarcoma Treatment in 2020: Current Advances Raya Saab

14:45 - 15:05 Surgery for Bone Sarcomas:Tumor Control and Functional Outcome

Johnny Abdel Nour

15:05 - 15:25 Role of Radiation Therapy in Bone Sarcomas Caroline Jabbour




Friday, April 12, 2019

15:25 - 16:10 Implementing a Treatment Strategy in ManagingGastric and GEJ Cancer Eli Lilly Symposium

Ali Shamseddine


16:30 - 17:15 Looking Beyond Second-Line Treatment in Metastatic Colorectal Cancer

Servier Symposium

Joseph KattanFadi Nasr

17:15 - 18:15 GI SessionModerators: Oussama Jradi - Sally Tamraz - Haifa Dbouk

17:15 - 17:35 Recent Management of Advanced Cholangiocarcinoma Shouki Bazarbashi

17:35 - 17:55 Adjuvant and Neoadjuvant Treatment in Gastric Cancer Suayib Yalcin

17:55 - 18:15 Is Total Neoadjuvant Therapy is Becoming the Standard of Care for Locally Advanced Rectal Cancer

Ali Shamseddine

18:15 - 19:00 Pancreatic Session; Management of Resectable Pancreatic CancerModerators: Mahmoud Wehbe - Evelyne Helou

18:15 - 18:30 The role Of Hepatobiliary Surgery on Outcome Claude Tayyar

18:30 - 18:45 Adjuvant and Neoadjuvant Therapy in PancreaticCancer

Fadi Farhat

18:45 - 19:00 Impact of Radiation Therapy on Survival in PancreaticCancer

Yousef Zaidan

Moderator: Nizar Bitar

19:00 - 20:15 Unlocking the Potential in Precision Medicine Roche Launching Symposium

Ruben CabanillasJeffrey Gregg

In advanced gastric/GEJ adenocarcinomaAdding CYRAMZA to paclitaxel significantly increased OS vs paclitaxel alone1

you’ve gotI need everything

I don’t want a

fairy tale

CYRAMZA Summary of Product Characteristics:CYRAMZA® is a human vascular endothelial growth factor receptor 2 Antagonist indicated • as a single agent or in combination with paclitaxel, for treatment of advanced gastric or gastro-esophageal junction adenocarcinoma, with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. • in combination with docetaxel, for treatment of metastatic nonsmall cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.• in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. DOSE AND ADMINISTRATION: For intravenous infusion only. Do not administer as an intravenous push or bolus. Gastric Cancer• The recommended dose of CYRAMZA either as a single agent or in combination with weekly paclitaxel is 8 mg/kg every 2 weeks. Non-Small Cell Lung Cancer• Administer CYRAMZA at 10 mg/kg intravenously on day 1 of a 21-day cycle prior to docetaxel infusion. Colorectal Cancer • Administer CYRAMZA at 8 mg/kg intravenously every 2 weeks, prior to FOLFIRI administration. DOSAGE FORMS AND STRENGTHS: Injection: 100 mg/10 mL (10 mg per mL) solution, single-dose vial and 500 mg/50 mL (10 mg per mL) solution, single-dose vial. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS • Arterial Thromboembolic Events (ATEs): Serious, sometimes fatal ATEs have been reported in clinical trials. Discontinue CYRAMZA for severe ATEs.• Hypertension: Monitor blood pressure and treat hypertension. Temporarily suspend CYRAMZA for severe hypertension. Discontinue CYRAMZA for hypertension that cannot be medically controlled. • Infusion-Related Reactions: Monitor for signs and symptoms during infusion.• Impaired Wound Healing: Withhold CYRAMZA prior to surgery.• Clinical Deterioration in Patients with Cirrhosis: New onset orworsening encephalopathy, ascites, or hepatorenal syndrome canoccur in patients with Child-Pugh B or C cirrhosis.• Reversible Posterior Leukoencephalopathy Syndrome: Discontinue CYRAMZA.• Proteinuria Including Nephrotic Syndrome: Monitor proteinuria. Interrupt CYRAMZA for urine protein levels ≥2 g/24 hours. Permanently discontinue CYRAMZA for urine protein levels>3 g/24 hours or for nephrotic syndrome. • Thyroid Dysfunction: Monitor thyroid function during treatment with CYRAMZA. • Embryofetal Risk: Can cause fetal harm. ADVERSE REACTIONS • The most common adverse reactions observed in single-agent CYRAMZA-treated patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea. • The most common adverse reactions observed in patients treated with CYRAMZA plus paclitaxel at a rate of ≥30% and ≥2% higher than placebo plus paclitaxel were fatigue, neutropenia, diarrhea, and epistaxis.• The most common adverse reactions observed in patients treatedwith CYRAMZA plus docetaxel at a rate of ≥30% and ≥2% higher than placebo plus docetaxel were neutropenia, fatigue/asthenia, and stomatitis/mucosal inflammation. • The most common adverse reactions observed in patients treated with CYRAMZA plus FOLFIRI at a rate of ≥30% and ≥2% higher than placebo plus FOLFIRI were diarrhea, neutropenia, decreased appetite, epistaxis, and stomatitis.

For further information about Lilly and Lilly products please contact us on the below address:Lebanon: Jisr el Wati, Sin El Fil, Fouad Ammoun Street, Plot #2252, 4th & 5th Floors, POB: 55-158Tel: (961) 1 504 700, Fax: (961) 1 504 701

For adverse events and safety reporting, please send an email to the following email address : [email protected].

PP-R

B-LB

-001

1

40 %40.1% (34.7, 45.5)

(n=330)In the placebo + paclitaxel arm

n=335), OS rate was 30.2%(25.1, 35.3) at 1 year.

1-yearOS rate

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28

OS

PR

OB

AB

ILIT

Y

TIME FROM RANDOMIZATION (MONTHS)

CYRAMZA+ paclitaxel

(n=330)

Placebo+ paclitaxel(n=335)

9.6MONTHS(8.5, 10.8)

7.4MONTHS

(6.3, 8.4)

1.0

0.8

0.6

0.4

0.2

0.0

CYRAMZA+ paclitaxel

Placebo+ paclitaxel

330 308 267 228 185 148 116 78 60 41 24 13 6 1 0

335 294 241 180 143 109 81 64 47 30 22 13 5 2 0

NUMBER AT RISK

CYRAMZA + paclitaxel

Placebo+ paclitaxel

CI=confidence interval; GEJ=gastroesophageal junction; HR=hazard ratio; OS=overall survival. References: 1. Wilke H, Muro K, Van Cutsem E, et al; for the RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224-1235.




In advanced gastric/GEJ adenocarcinomaAdding CYRAMZA to paclitaxel significantly increased OS vs paclitaxel alone1

you’ve gotI need everything

I don’t want a

fairy tale

CYRAMZA Summary of Product Characteristics:CYRAMZA® is a human vascular endothelial growth factor receptor 2 Antagonist indicated • as a single agent or in combination with paclitaxel, for treatment of advanced gastric or gastro-esophageal junction adenocarcinoma, with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. • in combination with docetaxel, for treatment of metastatic nonsmall cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.• in combination with FOLFIRI, for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. DOSE AND ADMINISTRATION: For intravenous infusion only. Do not administer as an intravenous push or bolus. Gastric Cancer• The recommended dose of CYRAMZA either as a single agent or in combination with weekly paclitaxel is 8 mg/kg every 2 weeks. Non-Small Cell Lung Cancer• Administer CYRAMZA at 10 mg/kg intravenously on day 1 of a 21-day cycle prior to docetaxel infusion. Colorectal Cancer • Administer CYRAMZA at 8 mg/kg intravenously every 2 weeks, prior to FOLFIRI administration. DOSAGE FORMS AND STRENGTHS: Injection: 100 mg/10 mL (10 mg per mL) solution, single-dose vial and 500 mg/50 mL (10 mg per mL) solution, single-dose vial. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS • Arterial Thromboembolic Events (ATEs): Serious, sometimes fatal ATEs have been reported in clinical trials. Discontinue CYRAMZA for severe ATEs.• Hypertension: Monitor blood pressure and treat hypertension. Temporarily suspend CYRAMZA for severe hypertension. Discontinue CYRAMZA for hypertension that cannot be medically controlled. • Infusion-Related Reactions: Monitor for signs and symptoms during infusion.• Impaired Wound Healing: Withhold CYRAMZA prior to surgery.• Clinical Deterioration in Patients with Cirrhosis: New onset orworsening encephalopathy, ascites, or hepatorenal syndrome canoccur in patients with Child-Pugh B or C cirrhosis.• Reversible Posterior Leukoencephalopathy Syndrome: Discontinue CYRAMZA.• Proteinuria Including Nephrotic Syndrome: Monitor proteinuria. Interrupt CYRAMZA for urine protein levels ≥2 g/24 hours. Permanently discontinue CYRAMZA for urine protein levels>3 g/24 hours or for nephrotic syndrome. • Thyroid Dysfunction: Monitor thyroid function during treatment with CYRAMZA. • Embryofetal Risk: Can cause fetal harm. ADVERSE REACTIONS • The most common adverse reactions observed in single-agent CYRAMZA-treated patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea. • The most common adverse reactions observed in patients treated with CYRAMZA plus paclitaxel at a rate of ≥30% and ≥2% higher than placebo plus paclitaxel were fatigue, neutropenia, diarrhea, and epistaxis.• The most common adverse reactions observed in patients treatedwith CYRAMZA plus docetaxel at a rate of ≥30% and ≥2% higher than placebo plus docetaxel were neutropenia, fatigue/asthenia, and stomatitis/mucosal inflammation. • The most common adverse reactions observed in patients treated with CYRAMZA plus FOLFIRI at a rate of ≥30% and ≥2% higher than placebo plus FOLFIRI were diarrhea, neutropenia, decreased appetite, epistaxis, and stomatitis.

For further information about Lilly and Lilly products please contact us on the below address:Lebanon: Jisr el Wati, Sin El Fil, Fouad Ammoun Street, Plot #2252, 4th & 5th Floors, POB: 55-158Tel: (961) 1 504 700, Fax: (961) 1 504 701

For adverse events and safety reporting, please send an email to the following email address : [email protected].

PP-R

B-LB

-001

1

40 %40.1% (34.7, 45.5)

(n=330)In the placebo + paclitaxel arm

n=335), OS rate was 30.2%(25.1, 35.3) at 1 year.

1-yearOS rate

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28

OS

PR

OB

AB

ILIT

Y

TIME FROM RANDOMIZATION (MONTHS)

CYRAMZA+ paclitaxel

(n=330)

Placebo+ paclitaxel(n=335)

9.6MONTHS(8.5, 10.8)

7.4MONTHS

(6.3, 8.4)

1.0

0.8

0.6

0.4

0.2

0.0

CYRAMZA+ paclitaxel

Placebo+ paclitaxel

330 308 267 228 185 148 116 78 60 41 24 13 6 1 0

335 294 241 180 143 109 81 64 47 30 22 13 5 2 0

NUMBER AT RISK

CYRAMZA + paclitaxel

Placebo+ paclitaxel

CI=confidence interval; GEJ=gastroesophageal junction; HR=hazard ratio; OS=overall survival. References: 1. Wilke H, Muro K, Van Cutsem E, et al; for the RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224-1235.




Saturday, April 13, 2019

08:15 - 09:00 Extend the Possibilities for Multiple Myeloma with NinlaroTakeda Symposium

Colette Hanna

09:00 - 09:45 From Theory to Clinical Practice:Hallmarks of Immunotherapy CombinationsBMS Symposium

Sally Tamraz

09:45 - 10:45 Prostate SessionModerators: Moussa Dhainy - Maha Manachi - Fouad Khoury

09:45 - 10:05 The Paradigm Shift in Metastatic Hormone-Sensitive Prostate Cancer

Yohann Loriot

10:05 - 10:25 Nonsurgical Treatment of Localised Prostate Cancer Peter Niehoff

10:25 - 10:45 PSA Rising in Non-Metastatic Castration ResistantProstate Cancer

Elie Nemr

10:45 - 11:30 mCRPC Management: Clinical Cases Discussion from a Multidisciplinary Perspective

Astellas Symposium

Elie Nemr Deborah Mukherji


12:00 - 12:15 An Evolving CLL Treatment Paradigm:VenclextaTM in Relapsed/Refractory CLLLecture Sponsored by Abbvie

Colette Hanna





12:15 - 13:15 Bladder SessionModerators: Anthony Saroufim - Layale Halabi - Rami Nasr

12:15 - 12:35 Immunotherapy in Early Stages Bladder Cancer Joseph Kattan

12:35 - 12:55 Nonsurgical Treatment in Localised Bladder Cancer Peter Niehoff

12:55 - 13:15 The State of the Art in the Treatment of AdvancedBladder Cancer

Yohann Loriot


14:15 - 15:00 Maximizing Treatment Benefits in advanced Renal Cell CarcinomaBiologix Symposium

Ali Shamseddine

15:00 - 15:45 Role of Pembrolizumab in Metastatic UrothelialCarcinoma

MSD Symposium

Ghazi Nsouli

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epat

ic im

pairm

ent (

Child

-Pug

h cl

ass

A).

The

reco

mm

ende

d st

artin

g do

se is

400

mg

KISQ

ALI o

nce

daily

for p

atie

nts

with

mod

erat

e (C

hild

-Pug

h cl

ass

B) a

nd s

ever

e he

patic

impa

irmen

t (Ch

ild-P

ugh

clas

s C)

. R

evie

w th

e Fu

ll Pr

escr

ibin

g In

form

atio

n fo

r th

e ar

omat

ase

inhi

bito

r fo

r do

se

mod

ifica

tions

rel

ated

to

hepa

tic im

pairm

ent.

Cont

rain

dica

tions

: •

None

W

arni

ngs

and

prec

autio

ns:

•Neu

trope

nia

was

m

ost f

requ

ently

rep

orte

d. A

com

plet

e bl

ood

coun

t (CB

C) s

houl

d be

per

form

ed b

efor

e in

itiat

ing

ther

apy.

CBC

sho

uld

be

mon

itore

d ev

ery

2 w

eeks

for

the

firs

t 2

cycl

es,

at t

he b

egin

ning

of

each

of

the

subs

eque

nt 4

cyc

les

then

as

clin

ical

ly in

dica

ted.

Feb

rile

neut

rope

nia

was

repo

rted

in %

1.5

of p

atie

nts

expo

sed

to K

isqal

i and

letro

zole

. Ba

sed

on th

e se

verit

y of

the

neut

rope

nia,

Kisq

ali m

ay re

quire

dos

e in

terru

ptio

n, re

duct

ion,

or d

iscon

tinua

tion.

•In

crea

ses

in A

LT a

nd A

ST h

ave

been

repo

rted,

with

the

maj

ority

of t

hem

with

out c

oncu

rrent

ele

vatio

ns o

f bilir

ubin

. Con

curre

nt e

leva

tions

of A

LT o

r AST

>

3 x

ULN

and

of to

tal b

ilirub

in >

2 x

ULN,

with

nor

mal

alk

alin

e ph

osph

atas

e le

vels

and

no c

hole

stas

is oc

curre

d in

%1.

2 of

pat

ient

s; a

ll pa

tient

s re

turn

ed to

nor

mal

with

in 1

54 d

ays

afte

r di

scon

tinua

tion

of K

isqal

i. Li

ver

func

tion

test

s (L

FTs)

sh

ould

be

perfo

rmed

bef

ore

initi

atin

g th

erap

y w

ith K

isqal

i. LF

Ts s

houl

d be

mon

itore

d ev

ery

2 w

eeks

for t

he fi

rst 2

cyc

les,

at

the

begi

nnin

g of

eac

h of

the

subs

eque

nt 4

cyc

les,

then

as

clin

ical

ly in

dica

ted.

Bas

ed o

n th

e se

verit

y of

tran

sam

inas

e el

evat

ions

, Kisq

ali m

ay re

quire

dos

e in

terru

ptio

n, re

duct

ion,

or d

iscon

tinua

tion.

•Q

T in

terv

al p

rolo

ngat

ion

has

been

repo

rted

with

Kisq

ali.

The

use

of K

isqal

i sho

uld

be a

void

ed in

pat

ient

s w

ho h

ave

alre

ady

or w

ho a

re a

t sig

nific

ant r

isk o

f dev

elop

ing

QTc

pr

olon

gatio

n. T

he E

CG s

houl

d be

ass

esse

d pr

ior

to in

itiat

ion

of tr

eatm

ent.

Trea

tmen

t with

Kisq

ali s

houl

d be

initi

ated

onl

y in

pat

ient

s w

ith

QTc

F va

lues

<45

0 m

sec.

The

ECG

sho

uld

be re

peat

ed a

t app

roxim

atel

y Da

y 14

of t

he fi

rst c

ycle

and

at t

he b

egin

ning

of t

he s

econ

d cy

cle,

then

as

clin

ical

ly in

dica

ted.

App

ropr

iate

mon

itorin

g of

ser

um e

lect

rolyt

es (

incl

udin

g po

tass

ium

, ca

lciu

m,

phos

phor

ous,

and

mag

nesiu

m)

shou

ld b

e pe

rform

ed p

rior t

o in

itiat

ion

of tr

eatm

ent,

at th

e be

ginn

ing

of th

e fir

st 6

cyc

les,

and

then

as

clin

ical

ly in

dica

ted.

Any

abn

orm

ality

sho

uld

be c

orre

cted

be

fore

the

sta

rt of

Kisq

ali t

hera

py.

Base

d on

the

obs

erve

d Q

T pr

olon

gatio

n du

ring

treat

men

t, Ki

sqal

i may

req

uire

dos

e in

terru

ptio

n, r

educ

tion,

or

disc

ontin

uatio

n. P

regn

ancy

, la

ctat

ion,

fem

ales

and

mal

es o

f rep

rodu

ctive

pot

entia

l: Pr

egna

ncy:

It is

pos

sible

that

Kisq

ali c

an c

ause

feta

l har

m w

hen

adm

inist

ered

to a

pre

gnan

t wom

an. T

he p

atie

nt s

houl

d be

adv

ised

of th

e ris

k to

a fe

tus

if Ki

sqal

i is

used

dur

ing

preg

nanc

y or

if th

e pa

tient

bec

omes

pr

egna

nt w

hile

taki

ng K

isqal

i. La

ctat

ion:

A d

ecisi

on s

houl

d be

mad

e w

heth

er to

disc

ontin

ue n

ursin

g or

to d

iscon

tinue

Kisq

ali,

taki

ng in

to a

ccou

nt th

e im

porta

nce

of K

isqal

i to

the

mot

her.

It is

reco

mm

ende

d th

at w

omen

taki

ng K

isqal

i sho

uld

not b

reas

tfeed

for a

t lea

st 2

1 da

ys a

fter t

he la

st d

ose.

Fem

ales

an

d m

ales

of r

epro

duct

ive p

oten

tial:

•Pre

gnan

cy te

stin

g: F

or fe

mal

es o

f rep

rodu

ctive

pot

entia

l the

pre

gnan

cy s

tatu

s sh

ould

be

verifi

ed p

rior t

o in

itiat

ing

treat

men

t with

Kisq

ali.

•Con

trace

ptio

n: S

exua

lly a

ctive

fem

ales

of r

epro

duct

ive p

oten

tial s

houl

d us

e ef

fect

ive c

ontra

cept

ion

(met

hods

that

resu

lt in

< 1

%

preg

nanc

y ra

tes)

whe

n us

ing

Kisq

ali d

urin

g tre

atm

ent a

nd fo

r 21

days

afte

r sto

ppin

g tre

atm

ent w

ith K

isqal

i. •

Infe

rtilit

y: B

ased

on

anim

al s

tudi

es, K

isqal

i m

ay im

pair

ferti

lity

in m

ales

of

repr

oduc

tive

pote

ntia

l. Ad

vers

e dr

ug r

eact

ions

: Ve

ry c

omm

on (

≥%10

): Ur

inar

y tra

ct in

fect

ion,

neu

trope

nia,

leuk

open

ia,

anae

mia

, lym

phop

enia

, de

crea

sed

appe

tite,

hea

dach

e, in

som

nia,

dys

pnoe

a, b

ack

pain

, na

usea

, di

arrh

oea,

vom

iting

, co

nstip

atio

n, s

tom

atiti

s, a

bdom

inal

pa

in,

alop

ecia

, ra

sh,

prur

itus,

fat

igue

, pe

riphe

ral o

edem

a, a

sthe

nia,

pyr

exia

, ab

norm

al li

ver

func

tion

test

s, le

ukoc

yte

coun

t de

crea

sed,

neu

troph

il co

unt

decr

ease

d,

haem

oglo

bin

decr

ease

d,

lymph

ocyt

e co

unt

decr

ease

d,

plat

elet

co

unt

decr

ease

d,

alan

ine

amin

otra

nsfe

rase

in

crea

sed,

as

parta

te

amin

otra

nsfe

rase

inc

reas

ed,

crea

tinin

e in

crea

sed,

pho

spho

rous

dec

reas

ed,

pota

ssiu

m d

ecre

ased

. .

Inte

ract

ions

: •C

onco

mita

nt u

se o

f st

rong

CYP

3A

inhi

bito

rs s

houl

d be

avo

ided

, in

clud

ing

but n

ot li

mite

d to

cla

rithr

omyc

in,

indi

navir

, itr

acon

azol

e, k

etoc

onaz

ole,

lopi

navir

, rit

onav

ir, n

efaz

odon

e, n

elfin

avir,

po

saco

nazo

le, r

itona

vir, s

aqui

navir

, and

vor

icon

azol

e. A

ltern

ative

med

icat

ions

with

less

pot

entia

l to

inhi

bit C

YP3A

sho

uld

be c

onsid

ered

. Pat

ient

s sh

ould

be

mon

itore

d fo

r ADR

s. If

con

com

itant

use

of a

stro

ng C

YP3A

inhi

bito

r can

not b

e av

oide

d, th

e Ki

sqal

i dos

e sh

ould

be

redu

ced

to 4

00 m

g. P

omeg

rana

tes

or p

omeg

rana

te ju

ice

and

gra

pefru

it or

gra

pefru

it ju

ice

shou

ld b

e av

oide

d. •

Conc

omita

nt u

se o

f stro

ng C

YP3A

indu

cers

sho

uld

be a

void

ed, i

nclu

ding

but

no

t lim

ited

to p

heny

toin

, rif

ampi

n, c

arba

maz

epin

e an

d St

Joh

n’s

Wor

t (Hy

peric

um p

erfo

ratu

m).

•Cau

tion

is ad

vised

whe

n Ki

sqal

i is

adm

inist

ered

with

CY

P3A

subs

trate

s w

ith n

arro

w t

hera

peut

ic i

ndex

(in

clud

ing

but

not

limite

d to

alfe

ntan

il, c

yclo

spor

ine,

dih

ydro

ergo

tam

ine,

erg

otam

ine,

eve

rolim

us,

fent

anyl,

pim

ozid

e, q

uini

dine

, siro

limus

, and

tacr

olim

us),

and

thei

r dos

e m

ay n

eed

to b

e re

duce

d. •

Co-a

dmin

istra

tion

of K

isqal

i with

med

icat

ions

with

kn

own

pote

ntia

l to

prol

ong

the

QT

inte

rval

sho

uld

be a

void

ed s

uch

as a

nti-a

rrhyt

hmic

med

icin

es (i

nclu

ding

but

not

lim

ited

to a

mio

daro

ne, d

isopy

ram

ide,

pr

ocai

nam

ide,

qui

nidi

ne, a

nd s

otal

ol),

othe

r med

icin

al p

rodu

cts

know

n to

pro

long

the

QT

inte

rval

incl

udin

g bu

t not

lim

ited

to c

hlor

oqui

ne, h

alof

antri

ne,

clar

ithro

myc

in,

halo

perid

ol,

met

hado

ne,

mox

iflox

acin

, be

prid

il, p

imoz

ide,

and

ond

anse

tron

(i.v)

. Pa

cks

and

pric

es:

Coun

try-s

peci

fic.

Lega

l cl

assifi

catio

n: C

ount

ry-s

peci

fic. L

eafle

t rev

ision

dat

e: M

arch

201

7

March/2019/Kis-Leb/1/Adpage

RA

PID

PO

WER

THA

T R

ED

EFI

NES

FI

RST

LIN

E I

N...

Nova

rtis

Phar

ma

Sevic

es In

c.Fa

ttal,

Daul

phin

Bld

gP.

O B

ox 1

1-34

48Si

n el

Fil,

Leb

anon

Tel +

961

1 4

8248

1Fa

x +

961

1 4

8558

5




HR+/

HER2

– met

asta

ticbr

east

canc

er is

a

DIAG

NOSI

SNo

w’s

the

mom

ent

to d

ecid

e…

W

hat c

omes

nex

t?

STRE

NGTH

COME

S FIR

ST

Afte

r diag

nosis

of H

R+/H

ER2–

m

etas

tatic

brea

st ca

ncer

PO

STME

NOPA

USAL

wom

en w

ith

an A

Ias

initi

al th

erap

y

KISQ

ALI®

Im

porta

nt n

ote:

Bef

ore

pres

crib

ing,

con

sult

full

pres

crib

ing

info

rmat

ion.

Pre

sent

atio

n:

Each

fil

m-c

oate

d ta

blet

con

tain

s 20

0 m

g of

rib

ocic

lib f

ree

base

. In

dica

tions

: K

ISQ

ALI®

is

indi

cate

d in

co

mbi

natio

n w

ith

an

arom

atas

e in

hibi

tor

as

initi

al

endo

crin

e-ba

sed

ther

apy

for

the

treat

men

t of

po

stm

enop

ausa

l wom

en w

ith h

orm

one

rece

ptor

(HR)

-pos

itive

, hum

an e

pide

rmal

gro

wth

fact

or re

cept

or 2

(H

ER2)

-neg

ative

adv

ance

d or

met

asta

tic b

reas

t ca

ncer

. Do

sage

and

adm

inist

ratio

n: 2

.1 D

osin

g an

d Ad

min

istra

tion

The

reco

mm

ende

d do

se o

f KIS

QAL

I is

600

mg

(thre

e 20

0 m

g fil

m-c

oate

d ta

blet

s) ta

ken

oral

ly, o

nce

daily

for 2

1 co

nsec

utive

day

s fo

llow

ed b

y 7

days

off

treat

men

t res

ultin

g in

a c

ompl

ete

cycl

e of

28

days

. KIS

QAL

I can

be

take

n w

ith o

r with

out f

ood

. Coa

dmin

ister

KIS

QAL

I with

letro

zole

2.5

mg

take

n on

ce d

aily

thro

ugho

ut th

e -2

8day

cyc

le. R

efer

to th

e fu

ll pr

escr

ibin

g in

form

atio

n of

letro

zole

. For

do

sing

and

adm

inist

ratio

n w

ith o

ther

aro

mat

ase

inhi

bito

rs r

efer

to

the

appl

icab

le f

ull

pres

crib

ing

info

rmat

ion.

Pat

ient

s sh

ould

take

thei

r dos

e of

KIS

QAL

I and

letro

zole

at a

ppro

ximat

ely

the

sam

e tim

e ea

ch d

ay, p

refe

rabl

y in

the

mor

ning

. If

the

patie

nt v

omits

afte

r tak

ing

the

dose

, or m

isses

a d

ose,

no

addi

tiona

l dos

e sh

ould

be

take

n th

at d

ay. T

he n

ext p

resc

ribed

dos

e sh

ould

be

take

n at

the

usua

l tim

e.

KISQ

ALI t

able

ts s

houl

d be

sw

allo

wed

who

le (

tabl

ets

shou

ld n

ot b

e ch

ewed

, cr

ushe

d or

spl

it pr

ior

to

swal

low

ing)

. No

tab

let

shou

ld b

e in

gest

ed i

f it

is br

oken

, cr

acke

d, o

r ot

herw

ise n

ot i

ntac

t. D

ose

Mod

ifica

tion

for U

se w

ith S

trong

CYP

3A In

hibi

tors

Avo

id c

onco

mita

nt u

se o

f KIS

QAL

I with

stro

ng C

YP3A

in

hibi

tors

and

con

sider

an

alte

rnat

ive c

onco

mita

nt m

edic

atio

n w

ith le

ss p

oten

tial f

or C

YP3A

inhi

bitio

n. If

a

stro

ng C

YP3A

inhi

bito

r m

ust

be c

oadm

inist

ered

, re

duce

the

KIS

QAL

I dos

e to

400

mg

once

dai

ly. If

the

st

rong

inhi

bito

r is

disc

ontin

ued,

cha

nge

the

KISQ

ALI d

ose

(afte

r at

leas

t 5

half-

lives

of

the

stro

ng C

YP3A

in

hibi

tor)

to th

e do

se u

sed

prio

r to

the

initi

atio

n of

the

stro

ng C

YP3A

inhi

bito

r. Do

se M

odifi

catio

n fo

r He

patic

Im

pairm

ent N

o do

se a

djus

tmen

t is

nece

ssar

y in

pat

ient

s w

ith m

ild h

epat

ic im

pairm

ent (

Child

-Pug

h cl

ass

A).

The

reco

mm

ende

d st

artin

g do

se is

400

mg

KISQ

ALI o

nce

daily

for p

atie

nts

with

mod

erat

e (C

hild

-Pug

h cl

ass

B) a

nd s

ever

e he

patic

impa

irmen

t (Ch

ild-P

ugh

clas

s C)

. R

evie

w th

e Fu

ll Pr

escr

ibin

g In

form

atio

n fo

r th

e ar

omat

ase

inhi

bito

r fo

r do

se

mod

ifica

tions

rel

ated

to

hepa

tic im

pairm

ent.

Cont

rain

dica

tions

: •

None

W

arni

ngs

and

prec

autio

ns:

•Neu

trope

nia

was

m

ost f

requ

ently

rep

orte

d. A

com

plet

e bl

ood

coun

t (CB

C) s

houl

d be

per

form

ed b

efor

e in

itiat

ing

ther

apy.

CBC

sho

uld

be

mon

itore

d ev

ery

2 w

eeks

for

the

firs

t 2

cycl

es,

at t

he b

egin

ning

of

each

of

the

subs

eque

nt 4

cyc

les

then

as

clin

ical

ly in

dica

ted.

Feb

rile

neut

rope

nia

was

repo

rted

in %

1.5

of p

atie

nts

expo

sed

to K

isqal

i and

letro

zole

. Ba

sed

on th

e se

verit

y of

the

neut

rope

nia,

Kisq

ali m

ay re

quire

dos

e in

terru

ptio

n, re

duct

ion,

or d

iscon

tinua

tion.

•In

crea

ses

in A

LT a

nd A

ST h

ave

been

repo

rted,

with

the

maj

ority

of t

hem

with

out c

oncu

rrent

ele

vatio

ns o

f bilir

ubin

. Con

curre

nt e

leva

tions

of A

LT o

r AST

>

3 x

ULN

and

of to

tal b

ilirub

in >

2 x

ULN,

with

nor

mal

alk

alin

e ph

osph

atas

e le

vels

and

no c

hole

stas

is oc

curre

d in

%1.

2 of

pat

ient

s; a

ll pa

tient

s re

turn

ed to

nor

mal

with

in 1

54 d

ays

afte

r di

scon

tinua

tion

of K

isqal

i. Li

ver

func

tion

test

s (L

FTs)

sh

ould

be

perfo

rmed

bef

ore

initi

atin

g th

erap

y w

ith K

isqal

i. LF

Ts s

houl

d be

mon

itore

d ev

ery

2 w

eeks

for t

he fi

rst 2

cyc

les,

at

the

begi

nnin

g of

eac

h of

the

subs

eque

nt 4

cyc

les,

then

as

clin

ical

ly in

dica

ted.

Bas

ed o

n th

e se

verit

y of

tran

sam

inas

e el

evat

ions

, Kisq

ali m

ay re

quire

dos

e in

terru

ptio

n, re

duct

ion,

or d

iscon

tinua

tion.

•Q

T in

terv

al p

rolo

ngat

ion

has

been

repo

rted

with

Kisq

ali.

The

use

of K

isqal

i sho

uld

be a

void

ed in

pat

ient

s w

ho h

ave

alre

ady

or w

ho a

re a

t sig

nific

ant r

isk o

f dev

elop

ing

QTc

pr

olon

gatio

n. T

he E

CG s

houl

d be

ass

esse

d pr

ior

to in

itiat

ion

of tr

eatm

ent.

Trea

tmen

t with

Kisq

ali s

houl

d be

initi

ated

onl

y in

pat

ient

s w

ith

QTc

F va

lues

<45

0 m

sec.

The

ECG

sho

uld

be re

peat

ed a

t app

roxim

atel

y Da

y 14

of t

he fi

rst c

ycle

and

at t

he b

egin

ning

of t

he s

econ

d cy

cle,

then

as

clin

ical

ly in

dica

ted.

App

ropr

iate

mon

itorin

g of

ser

um e

lect

rolyt

es (

incl

udin

g po

tass

ium

, ca

lciu

m,

phos

phor

ous,

and

mag

nesiu

m)

shou

ld b

e pe

rform

ed p

rior t

o in

itiat

ion

of tr

eatm

ent,

at th

e be

ginn

ing

of th

e fir

st 6

cyc

les,

and

then

as

clin

ical

ly in

dica

ted.

Any

abn

orm

ality

sho

uld

be c

orre

cted

be

fore

the

sta

rt of

Kisq

ali t

hera

py.

Base

d on

the

obs

erve

d Q

T pr

olon

gatio

n du

ring

treat

men

t, Ki

sqal

i may

req

uire

dos

e in

terru

ptio

n, r

educ

tion,

or

disc

ontin

uatio

n. P

regn

ancy

, la

ctat

ion,

fem

ales

and

mal

es o

f rep

rodu

ctive

pot

entia

l: Pr

egna

ncy:

It is

pos

sible

that

Kisq

ali c

an c

ause

feta

l har

m w

hen

adm

inist

ered

to a

pre

gnan

t wom

an. T

he p

atie

nt s

houl

d be

adv

ised

of th

e ris

k to

a fe

tus

if Ki

sqal

i is

used

dur

ing

preg

nanc

y or

if th

e pa

tient

bec

omes

pr

egna

nt w

hile

taki

ng K

isqal

i. La

ctat

ion:

A d

ecisi

on s

houl

d be

mad

e w

heth

er to

disc

ontin

ue n

ursin

g or

to d

iscon

tinue

Kisq

ali,

taki

ng in

to a

ccou

nt th

e im

porta

nce

of K

isqal

i to

the

mot

her.

It is

reco

mm

ende

d th

at w

omen

taki

ng K

isqal

i sho

uld

not b

reas

tfeed

for a

t lea

st 2

1 da

ys a

fter t

he la

st d

ose.

Fem

ales

an

d m

ales

of r

epro

duct

ive p

oten

tial:

•Pre

gnan

cy te

stin

g: F

or fe

mal

es o

f rep

rodu

ctive

pot

entia

l the

pre

gnan

cy s

tatu

s sh

ould

be

verifi

ed p

rior t

o in

itiat

ing

treat

men

t with

Kisq

ali.

•Con

trace

ptio

n: S

exua

lly a

ctive

fem

ales

of r

epro

duct

ive p

oten

tial s

houl

d us

e ef

fect

ive c

ontra

cept

ion

(met

hods

that

resu

lt in

< 1

%

preg

nanc

y ra

tes)

whe

n us

ing

Kisq

ali d

urin

g tre

atm

ent a

nd fo

r 21

days

afte

r sto

ppin

g tre

atm

ent w

ith K

isqal

i. •

Infe

rtilit

y: B

ased

on

anim

al s

tudi

es, K

isqal

i m

ay im

pair

ferti

lity

in m

ales

of

repr

oduc

tive

pote

ntia

l. Ad

vers

e dr

ug r

eact

ions

: Ve

ry c

omm

on (

≥%10

): Ur

inar

y tra

ct in

fect

ion,

neu

trope

nia,

leuk

open

ia,

anae

mia

, lym

phop

enia

, de

crea

sed

appe

tite,

hea

dach

e, in

som

nia,

dys

pnoe

a, b

ack

pain

, na

usea

, di

arrh

oea,

vom

iting

, co

nstip

atio

n, s

tom

atiti

s, a

bdom

inal

pa

in,

alop

ecia

, ra

sh,

prur

itus,

fat

igue

, pe

riphe

ral o

edem

a, a

sthe

nia,

pyr

exia

, ab

norm

al li

ver

func

tion

test

s, le

ukoc

yte

coun

t de

crea

sed,

neu

troph

il co

unt

decr

ease

d,

haem

oglo

bin

decr

ease

d,

lymph

ocyt

e co

unt

decr

ease

d,

plat

elet

co

unt

decr

ease

d,

alan

ine

amin

otra

nsfe

rase

in

crea

sed,

as

parta

te

amin

otra

nsfe

rase

inc

reas

ed,

crea

tinin

e in

crea

sed,

pho

spho

rous

dec

reas

ed,

pota

ssiu

m d

ecre

ased

. .

Inte

ract

ions

: •C

onco

mita

nt u

se o

f st

rong

CYP

3A

inhi

bito

rs s

houl

d be

avo

ided

, in

clud

ing

but n

ot li

mite

d to

cla

rithr

omyc

in,

indi

navir

, itr

acon

azol

e, k

etoc

onaz

ole,

lopi

navir

, rit

onav

ir, n

efaz

odon

e, n

elfin

avir,

po

saco

nazo

le, r

itona

vir, s

aqui

navir

, and

vor

icon

azol

e. A

ltern

ative

med

icat

ions

with

less

pot

entia

l to

inhi

bit C

YP3A

sho

uld

be c

onsid

ered

. Pat

ient

s sh

ould

be

mon

itore

d fo

r ADR

s. If

con

com

itant

use

of a

stro

ng C

YP3A

inhi

bito

r can

not b

e av

oide

d, th

e Ki

sqal

i dos

e sh

ould

be

redu

ced

to 4

00 m

g. P

omeg

rana

tes

or p

omeg

rana

te ju

ice

and

gra

pefru

it or

gra

pefru

it ju

ice

shou

ld b

e av

oide

d. •

Conc

omita

nt u

se o

f stro

ng C

YP3A

indu

cers

sho

uld

be a

void

ed, i

nclu

ding

but

no

t lim

ited

to p

heny

toin

, rif

ampi

n, c

arba

maz

epin

e an

d St

Joh

n’s

Wor

t (Hy

peric

um p

erfo

ratu

m).

•Cau

tion

is ad

vised

whe

n Ki

sqal

i is

adm

inist

ered

with

CY

P3A

subs

trate

s w

ith n

arro

w t

hera

peut

ic i

ndex

(in

clud

ing

but

not

limite

d to

alfe

ntan

il, c

yclo

spor

ine,

dih

ydro

ergo

tam

ine,

erg

otam

ine,

eve

rolim

us,

fent

anyl,

pim

ozid

e, q

uini

dine

, siro

limus

, and

tacr

olim

us),

and

thei

r dos

e m

ay n

eed

to b

e re

duce

d. •

Co-a

dmin

istra

tion

of K

isqal

i with

med

icat

ions

with

kn

own

pote

ntia

l to

prol

ong

the

QT

inte

rval

sho

uld

be a

void

ed s

uch

as a

nti-a

rrhyt

hmic

med

icin

es (i

nclu

ding

but

not

lim

ited

to a

mio

daro

ne, d

isopy

ram

ide,

pr

ocai

nam

ide,

qui

nidi

ne, a

nd s

otal

ol),

othe

r med

icin

al p

rodu

cts

know

n to

pro

long

the

QT

inte

rval

incl

udin

g bu

t not

lim

ited

to c

hlor

oqui

ne, h

alof

antri

ne,

clar

ithro

myc

in,

halo

perid

ol,

met

hado

ne,

mox

iflox

acin

, be

prid

il, p

imoz

ide,

and

ond

anse

tron

(i.v)

. Pa

cks

and

pric

es:

Coun

try-s

peci

fic.

Lega

l cl

assifi

catio

n: C

ount

ry-s

peci

fic. L

eafle

t rev

ision

dat

e: M

arch

201

7

March/2019/Kis-Leb/1/Adpage

RA

PID

PO

WER

THA

T R

ED

EFI

NES

FI

RST

LIN

E I

N...

Nova

rtis

Phar

ma

Sevic

es In

c.Fa

ttal,

Daul

phin

Bld

gP.

O B

ox 1

1-34

48Si

n el

Fil,

Leb

anon

Tel +

961

1 4

8248

1Fa

x +

961

1 4

8558

5


PARALLEL SESSION | NURSE SESSION CARTHAGE HALL

08:30 - 10:35 Improving Quality CareModerator: Gladys Honein

08:30 - 08:35 Introduction to the Session

08:35 - 08:50 Establishment of A Nurse Navigator Programin Oncology Setting

Wafaa Skaf

08:50 - 09:05 Quality Care Monitoring for Oncology Patients Mariam El Sabae

09:05 - 09:25 Optimizing Drug Safety In Oncology Settings:Clinical Pharmacy Perspective

Aya Kabbani

09:25 - 09:40 Integrated Palliative Care Sarah Lattouf

09:40 - 10:00 Palliation beyond the Traditional:Reaching Out to Patients and Caregivers

Antoine Finianos

10:00 - 10:15 Psychological Support to Cancer Patients Dina Mouzayen

10:15 - 10:30 Benefits of Art Therapy in Managing Oncology Patients Linda Harris

10:30 - 10:35 Wrap-Up Session


11:00 - 12:00 Pain ControlModerator: Mona El Ayoubi

11:20 - 11:40 The Cancer Pain Management in Daily Practice Ghassan Mohanna

11:00 - 11:20 Clinical Nurse Specialist Janane Hanna

11:40 - 12:00 Finding Peace Beyond the Pain:The Total Pain Concept

Rana Yamout




Notes

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Notes

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Organized by: 4th Floor, Qubic CenterDaoud Ammoun StreetHorsh Tabet - Sin El FilP.O. Box: 90-361 BeirutTel: +961 1 510880/1/2/3 Mobile: +961 71 103123

[email protected] | www.infomedweb.com

LEBANON UAE

|DMCC Business CentreAlmas TowerJumeirah Lakes Dubai, United Arab EmiratesUnit No: 3820Mobile: +971 50 9110475

The Lebanese Society of Medical Oncology (LSMO)would like to thank the following companies

for their contribution to the success of its annual congress

Improving lives since 1896.

A tradition of advancing science and medicine. Then, now and in the future.

NOW APPROVED FOR THE FIRST LINE TREATMENT OF PATIENTS WITH aRCC *1,2

®

* intermediate- or poor-risk aRCC patients

HIGHLIGHTS OF PRESCRIBING INFORMATION1

These highlights do not include all the information needed to use OPDIVO® safely and e�ectively. See full prescribing information for OPDIVO®.OPDIVO® (Nivolumab) injection, for intravenous use. Initial U.S. Approval: 2014INDICATIONS AND USAGE OPDIVO® is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of: Patients with BRAF V600 wild-type unresectable or metastatic melanoma as a single agent; with BRAF V600 mutation-positive unresectable or metastatic melanoma as a single agent;a with unresectable or metastatic melanoma, in combination with ipilimumab;a with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting. Patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy, with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO®. Patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy; with intermediate or poor risk, previously untreated advanced renal cell carcinoma, in combination with ipilimumab. Adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: b autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin; or 3 or more lines of systemic therapy that includes autologous HSCT. Patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. Patients with locally advanced or metastatic urothelial carcinoma who: b have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.b Patients with hepatocellular carcinoma who have been previously treated with sorafenib.a DOSAGE AND ADMINISTRATION Administer as an intravenous infusion over 30 minutes. Unresectable or metastatic melanoma: OPDIVO® 240 mg every 2 weeks or 480 mg every 4 weeks. OPDIVO® with ipilimumab: OPDIVO® 1 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then OPDIVO® 240 mg every 2 weeks or 480 mg every 4 weeks. Adjuvant treatment of melanoma: OPDIVO® 240 mg every 2 weeks or 480 mg every 4 weeks. Metastatic non-small cell lung cancer: OPDIVO® 240 mg every 2 weeks or 480 mg every 4 weeks. Advanced renal cell carcinoma: OPDIVO® 240 mg every 2 weeks or 480 mg every 4 weeks. OPDIVO® with ipilimumab: OPDIVO® 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then OPDIVO® 240 mg every 2 weeks or 480 mg every 4 weeks. Classical Hodgkin lymphoma: OPDIVO® 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Recurrent or metastatic squamous cell carcinoma of the head and neck: OPDIVO® 240mg every 2 weeks or 480 mg every 4 weeks. Locally advanced or metastatic urothelial carcinoma: OPDIVO® 240 mg every 2 weeks or 480 mg every 4 weeks. Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer: OPDIVO® 240 mg every 2 weeks. Hepatocellular carcinoma: OPDIVO® 240 mg every 2 weeks or 480 mg every 4 weeks. WARNINGS AND PRECAUTIONS Immune-mediated pneumonitis: Withhold for moderate and permanently discontinue for severe or life-threatening pneumonitis. Immune-mediated colitis: Withhold OPDIVO® when given as a single agent for moderate or severe and permanently discontinue for life-threatening colitis. Withhold OPDIVO® when given with ipilimumab for moderate and permanently discontinue for severe or life-threatening colitis. Immune-mediated hepatitis: Monitor for changes in liver function. Withhold for moderate and permanently discontinue for severe or life-threatening transaminase or total bilirubin elevation. Immune-mediated endocrinopathies: Withhold for moderate or severe and permanently discontinue for life-threatening hypophysitis. Withhold for moderate and permanently discontinue for severe or life-threatening adrenal insu�ciency. Monitor for changes in thyroid function. Initiate thyroid hormone replacement as needed. Monitor for hyperglycemia. Withhold for severe and permanently discontinue for life-threatening hyperglycemia. Immune-mediated nephritis and renal dysfunction: Monitor for changes in renal function. Withhold for moderate or severe and permanently discontinue for life-threatening serum creatinine elevation. Immune-mediated skin adverse reactions: Withhold for severe and permanently discontinue for life-threatening rash. Immune-mediated encephalitis: Monitor for changes in neurologic function. Withhold for new-onset moderate to severe neurological signs or symptoms and permanently discontinue for immune-mediated encephalitis. Infusion reactions: Discontinue OPDIVO® for severe and life-threatening infusion reactions. Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. Complications of allogeneic HSCT after OPDIVO®: Monitor for hyperacute graft-versus-host-disease (GVHD), grade 3-4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions. Transplant-related mortality has occurred. Embryo-fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of e�ective contraception. ADVERSE REACTIONS Most common adverse reactions (≥20%) in patients were: OPDIVO® as a single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, and abdominal pain. OPDIVO® with ipilimumab for melanoma: fatigue, rash, diarrhea, nausea, pyrexia, vomiting, and dyspnea. OPDIVO® with ipilimumab for renal cell carcinoma: fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite. USE IN SPECIFIC POPULATIONS Lactation: Discontinue breastfeeding.For any additional information or adverse events reporting, please contact Bristol-Myers Squibb Medical Information on http://www.globalbmsmedinfo.coma This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. b This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.aRCC=advanced renal cell carcinoma

OPDIVO® is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma, in combination with Ipilimumab1

Bristol-Myers SquibbLaboratory Complex

Dubai Science ParkP.O. Box: 454409, Dubai, UAE

Tel: +971-4-45021001506AE18PR04170-01

References:1. OPDIVO® (Nivolumab) US PI, April 2018 . 2. Motzer RJ, Tannir NM, McDermott DF, et al; Checkmate 214 Investigators. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med. 2018;37B(14): 1277-1290.

Documents

Lebanese Society of Medical Oncology (LSMO) National Forum ... · Moderators: Georges El Hachem - Clemence Matta - Riwa Sakr - Sami El Khatib 16:30 - 16:50 Genomic Expression Profiling