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PIK3CA TESTING
NAVIGATOR
Your guide to navigating
PIK3CA mutation testing
Indication
PIQRAY® (alpelisib) tablets is indicated in combination with fulvestrant for the treatment of
postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an
FDA-approved test following progression on or after an endocrine-based regimen.
Important Safety Information
PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.
Severe Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and anaphylactic
shock, can occur in patients treated with PIQRAY. Severe hypersensitivity reactions were manifested by
symptoms including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia. The incidence of
grade 3 and 4 hypersensitivity reactions was 0.7%. Advise patients of the signs and symptoms of severe
hypersensitivity reactions. Permanently discontinue PIQRAY in the event of severe hypersensitivity.
Please see additional Important Safety Information throughout
and on pages 11-12. Please click here for full Prescribing Information.
Single-gene Multi-gene Important
Why to When to How to Key Safety
testing testing
test? test? test? contacts Information
(PCR) (NGS)
Why to test?
PIK3CA is the most commonly mutated gene in HR+/HER2- aBC1
• • • • ~40 %
of patients with HR+/HER2- aBC
have a PIK3CA mutation1
''''
~40 %%
~40
of patients with HR+/HER2-
aBC have a PIK3CA mutation1-4
of patients with HR+/HER2-
Patients with a PIK3CA mutation face
aBC have a PIK3CA a worse prognosis2
mutation 1-4
► PIK3CA mutations have been identified in patients with endocrine resistance
3,4
Knowledge of PIK3CA mutation status can inform up-front
treatment planning for appropriate patients
Important Safety Information (cont)
Severe Cutaneous Adverse Reactions (SCARs): SCARs, including Stevens-Johnson syndrome (SJS),
erythema multiforme (EM), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and
systemic symptoms (DRESS) can occur in patients treated with PIQRAY. In the SOLAR-1 study, SJS and
EM were reported in 0.4% and 1.1% of patients, respectively. DRESS was reported in patients in the
postmarketing setting. If signs or symptoms of SCARs occur, interrupt PIQRAY until the etiology of the
reaction has been determined. Consultation with a dermatologist is recommended.
Please see additional Important Safety Information throughout and
~ PIQRAY"
(alpelisib)
tablets
on pages 11-12. Please click here for full Prescribing Information. 50mg·150mg·200mg
2
Single-gene Multi-gene Important
Why to When to How to Key Safety
testing testing
test? test? test? contacts Information
(PCR) (NGS)
When to test?
Test for PIK3CA mutations at initial MBC diagnosis if tumor is
HR+/HER2-*
*Following progression on or after an endocrine-based regimen.
NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) include
recommendations on when PIK3CA mutation testing should be considered5
Per NCCN Guidelines®, assess for PIK3CA mutation as part of the initial MBC workup if all
of the following are true5:
Patient has recurrent/ Tumor is HR+/HER2- Considering therapy with
Stage IV (M1) disease alpelisib + fulvestrant*
Tumor tissue biopsy Liquid biopsy†
Positive for Negative for Positive for Negative for
PIK3CA mutation PIK3CA mutation PIK3CA mutation PIK3CA mutation
Alpelisib + Alpelisib + Test tumor
fulvestrant‡ fulvestrant‡ tissue
If PIK3CA mutation is not detected in plasma,
retest the patient using tumor tissue
Category Alpelisib (PIQRAY®) + fulvestrant is a Category 1 preferred
1 option in NCCN Guidelines5*
MBC, metastatic breast cancer.
†
If liquid biopsy is negative, tumor tissue testing is recommended.
‡
The safety of alpelisib in patients with type 1 or uncontrolled type 2 diabetes has not been established.
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2021. © 2021 National Comprehensive
Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written
permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may
be refined as often as new significant data becomes available.
Important Safety Information (cont)
Severe Cutaneous Adverse Reactions (SCARs) (cont): If a SCAR is confirmed, permanently discontinue
PIQRAY. Do not reintroduce PIQRAY in patients who have experienced previous SCARs during PIQRAY
treatment. If it is not confirmed, PIQRAY may require dose modifications, topical corticosteroids, or oral
antihistamine treatment.
Advise patients of the signs and symptoms of SCARs (eg, a prodrome of fever, flu-like symptoms, mucosal
lesions, progressive skin rash, or lymphadenopathy).
Please see additional Important Safety Information throughout and ~ PIQRAY"
3 (alpelisib)
tablets
on pages 11-12. Please click here for full Prescribing Information. 50mg•150mg•200mg
Single-gene Multi-gene Important
Why to When to How to Key Safety
testing testing
test? test? test? contacts Information
(PCR) (NGS)
How to test?
How to test? (cont)
PIK3CA mutations can be detected in tissue or plasma specimens6
PIK3CA mutations are generally stable; therefore, archival specimens and recent or new biopsies can
be tested4
If no mutation is detected in a plasma specimen, retest the patient using tumor tissue.6 Click here to
learn more
Tumor tissue Plasma
PIK3CA mutations can be detected in PIK3CA mutations can be detected
primary tumors or metastatic sites.4 in peripheral whole blood.7,8
The PIK3CA mutation companion diagnostic tests for PIQRAY® (alpelisib) tablets include
11 different mutations in the PIK3CA gene as part of the FDA-approved indication6-9
PIK3CA gene-functional domains7
Exon 9
PIK3CA gene Exon 7 E542K Exon 20
subunits C420R E545K/A/D/G H1047R/L/Y
Q546R/E
Adaptor Ras C2 Helical
domain domain Kinase domain
BD BD
hese are among the most common PIK3CA mutations in breast cancer and were assessed at
T
screening to enroll in the PIK3CA mutant cohort in the SOLAR-1 trial4
Important Safety Information (cont)
Hyperglycemia: Severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar non-
ketotic syndrome (HHNKS) or ketoacidosis has occurred in patients treated with PIQRAY. Some fatal cases
of ketoacidosis have occurred in the postmarketing setting.
Hyperglycemia was reported in 65% of patients treated with PIQRAY. Grade 3 (FPG >250-500 mg/dL)
and grade 4 (FPG >500 mg/dL) hyperglycemia were reported in 33% and 3.9% of patients, respectively.
Ketoacidosis was reported in 0.7% of patients (n=2) treated with PIQRAY.
4
Please see additional Important Safety Information throughout and
on pages 11-12. Please click here for full Prescribing Information.
Single-gene Multi-gene Important
Why to When to How to Key Safety
testing testing
test? test? test? contacts Information
(PCR) (NGS)How to test (cont)
Negative results for PIK3CA mutation using plasma require
further investigation
Multiple factors may contribute to false negatives in plasma testing 6,10,11
QIAGEN companion
Biological differences
Specimen handling diagnostic (CDx) differences in
in plasma testing
plasma and tissue in SOLAR-1
► Tumors in cancer types that have low-level DNA shedding may result in false negatives in plasma testing
10
► Specimen handling can lead to additional false negatives when using plasma-based tests
11
44 % with PIK3CA mutations confirmed in tumor tissue and
who had plasma specimen available for testing with the
of patients FDA-approved therascreen® PIK3CA RGQ PCR Kit did not
(140/317) have PIK3CA mutations identified in plasma6
If PIK3CA mutation is not detected in plasma,
retest the patient using tumor tissue6
Important Safety Information (cont)
Hyperglycemia (cont): Before initiating treatment with PIQRAY, test fasting plasma glucose (FPG),
HbA1c, and optimize blood glucose. After initiating treatment, monitor fasting glucose (FPG or fasting
blood glucose) at least once every week for the first 2 weeks, then at least once every 4 weeks, and
as clinically indicated. Monitor HbA1c every 3 months and as clinically indicated. Monitor fasting
glucose more frequently for the first few weeks during treatment in patients with risk factors for
hyperglycemia such as obesity (BMI ≥30), elevated FPG, HbA1c at the upper limit of normal or above, use
of concomitant systemic corticosteroids, or age ≥75.
If a patient experiences hyperglycemia after initiating treatment, monitor fasting glucose as
clinically indicated, and at least twice weekly until fasting glucose decreases to normal levels. During
treatment with anti-hyperglycemic medication, continue monitoring fasting glucose at least once a
week for 8 weeks, followed by once every 2 weeks and as clinically indicated. Consider consultation
with a health care practitioner with expertise in the treatment of hyperglycemia and counsel
patients on lifestyle changes.
Please see additional Important Safety Information throughout and ~ PIQRAY"
5 (alpelisib)
tablets
on pages 11-12. Please click here for full Prescribing Information. 50mg•150mg•200mg
Single-gene Multi-gene Important
Why to When to How to Key Safety
testing testing
test? test? test? contacts Information
(PCR) (NGS)Single-gene testing (PCR)
Single-gene testing (PCR) (cont)
Access the PIK3CA Mutation CDx Testing Program
NeoGenomics Laboratories will conduct tumor tissue and plasma testing using the QIAGEN
therascreen® PIK3CA RGQ PCR Kit.7 Appropriate patients may receive one tumor tissue or
plasma PIK3CA mutation test at no cost for the purpose of determining whether or not the
patient has a PIK3CA mutation and is eligible for alpelisib for an FDA-approved indication,
without regard to purchase of any prescribed drug or any other product.
If the patient tests negative for PIK3CA mutation using plasma, eligible patients may
also receive one PIK3CA reflex tissue test at no cost. No patient, health care program, or
beneficiary shall be billed for this mutation test. The test shall not be included in a bundled
payment to any health care facility including, but not limited to, a hospital. The ordering
physician shall not be compensated any fees in connection with this mutation testing,
such as for specimen collection, handling, or data reporting. Program is not valid where
prohibited by law. Novartis reserves the right to rescind, revoke, or amend the program
without notice.
If no mutation is detected in a plasma specimen, confirm with a tumor tissue reflex test.
FDA-approved single-gene tissue and plasma testing
PIK3CA TESTING
NAVIGATOR
PIK3CA CDx Testing
Program Ordering Guide
Indication
PIQRAY® (alpelisib) tablets is indicated in combination with fulvestrant for the treatment of postmenopausal women,
and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-
mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or
after an endocrine-based regimen.
Important Safety Information
PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.
Severe Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, can occur
in patients treated with PIQRAY. Severe hypersensitivity reactions were manifested by symptoms including, but not
limited to, dyspnea, flushing, rash, fever, or tachycardia. The incidence of grade 3 and 4 hypersensitivity reactions
was 0.7%. Advise patients of the signs and symptoms of severe hypersensitivity reactions. Permanently discontinue
PIQRAY in the event of severe hypersensitivity.
Please see additional Important Safety Information on pages 8-9.
Please click here for full Prescribing Information.
Get the Ordering Guide
Have you received your PIK3CA CDx
Testing Program Ordering Guide? Reach out
to your Novartis Specialist using the contact
information on page 10 of this brochure.
QIAGEN therascreen® PIK3CA RGQ PCR Kit
PIK3CA mutation testing is available to appropriate patients at no cost
Information on FDA-approved tests for the detection of PIK3CA mutations in breast cancer is available
at www.fda.gov/companiondiagnostics
therascreen is a registered trademark of QIAGEN group.
Important Safety Information (cont)
Hyperglycemia (cont): The safety of PIQRAY in patients with type 1 and uncontrolled type 2 diabetes
has not been established as these patients were excluded from the SOLAR-1 trial. Patients with a medical
history of controlled type 2 diabetes were included. Patients with a history of diabetes mellitus may require
intensified diabetic treatment. Closely monitor patients with diabetes.
Based on the severity of the hyperglycemia, PIQRAY may require dose interruption, reduction, or
discontinuation. Advise patients of the signs and symptoms of hyperglycemia (eg,
excessive thirst, urinating more often than usual or higher amount of urine than usual,
or increased appetite with weight loss).
6
Please see additional Important Safety Information throughout and
on pages 11-12. Please click here for full Prescribing Information.
Single-gene Multi-gene Important
Why to When to How to Key Safety
testing testing
test? test? test? contacts Information
(PCR) (NGS)Single-gene testing (PCR) (cont)
Reports for
patients
P L E
S A M P L E
S A M
Reports for health
care professionals
FFPE tissue
Breast tumor tissue (either primary or metastatic) is required; non-breast tumors are not
accepted for this test. Paraffin block is preferred. Alternatively, send 1 H&E slide plus 6-12
unstained slides for core needle biopsy (or 5-10 slides for resection) cut at 5 microns. Please
use positively charged slides and 10% NBF fixative. Do not use zinc fixatives. Decalcified
specimens are not accepted.12
Peripheral blood
Please contact Client Services at 1-866-776-5907, option 3, to review special collection and
handling requirements and to receive the test request form and shipping supplies.
Turnaround time
NeoGenomics generally expects to provide results within 1 week of specimen receipt.
PIK3CA Mutation CDx findings using NeoGenomics PCR
are found on the first page of the report
To find alternate labs that have verified the QIAGEN therascreen® PIK3CA
RGQ PCR Kit, visit QIAGEN.com/PIK3CA-lab-finder or call 1-800-362-7737
Important Safety Information (cont)
Pneumonitis: Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung
disease, can occur in patients treated with PIQRAY. Pneumonitis was reported in 1.8% of patients
treated with PIQRAY.
7
Please see additional Important Safety Information throughout and
on pages 11-12. Please click here for full Prescribing Information.
Single-gene Multi-gene Important
Why to When to How to Key Safety
testing testing
test? test? test? contacts Information
(PCR) (NGS)Multi-gene testing (NGS)
FDA-approved multi-gene tissue and plasma testing
FoundationOne®CDx
for tissue or
FoundationOne®Liquid CDx
for blood
FoundationOne®CDx and FoundationOne®Liquid CDx are covered
by Original Medicare and Medicare Advantage for qualifying beneficiaries13
Foundation Medicine offers in-home blood draw with mobile phlebotomy through
its partner, ExamOne®, to support broader access to FoundationOne®Liquid CDx,
at no additional cost
Information on FDA-approved tests for the detection of PIK3CA mutations in breast cancer is available at
www.fda.gov/companiondiagnostics
Novartis is not responsible for any such third party content that may be accessed via the above provided resources. Novartis does not endorse
the content contained in these sites, nor the organizations publishing those sites, and hereby disclaims any responsibility for such content.
Foundation Medicine, FoundationOne CDx, and FoundationOne Liquid CDx are registered trademarks of Foundation Medicine, Inc.
ExamOne is a registered trademark of Quest Diagnostics.
Important Safety Information (cont)
Pneumonitis (cont): In patients who have new or worsening respiratory symptoms or are suspected to
have developed pneumonitis, interrupt PIQRAY immediately and evaluate the patient for pneumonitis.
Consider a diagnosis of noninfectious pneumonitis in patients presenting with nonspecific respiratory signs
and symptoms such as hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams and in whom
infectious, neoplastic, and other causes have been excluded by means of appropriate investigations.
Permanently discontinue PIQRAY in all patients with confirmed pneumonitis. Advise patients to immediately
report new or worsening respiratory symptoms.
8
Please see additional Important Safety Information throughout and
on pages 11-12. Please click here for full Prescribing Information.
Single-gene Multi-gene Important
Why to When to How to Key Safety
testing testing
test? test? test? contacts Information
(PCR) (NGS)Multi-gene testing (NGS) (cont)
TUMOR
TYPE
Q FOUNDAT10NONE COX Breastcarclnoma(NOS)
CDx for tissue
testing results
PATIENT PHYSICIAN
ORDERINGPHYSKIAN PWMEN IT
OISEAS£Breastcarcinoma(NOS) >"l'.IM(N
MEDICALFAClLITY
Sf«.MENTYP,
ADOITIONALRECIP1ENT
DATEOfBIRlH D,t,TE.Jl'ClECTION
MEDICAL
FACILITY
ID
SEX Q>fllMf.NRl((IVEI
PAHIOlOGIST
MEOICAtRECOROII
PATIENT lUl40f!TYPE IIEPORTDA,T(
FOUNDATIONONE LIQUIDCDx Samp1e,Jane Breastcarcinoma(NOS) 01June2020
Companion Diagnostic (CDx) Associated Findings
OROERt:OTEST•
ORO-XXXXXXX-XX
EUlll":'iiilii
IHi¼i-iiUSd· Piqray•(Alpelisib)
PATIENT
PIK3CAE542K OP:OERINGPHYSICIAN NotGiven \PEC EW NotGiven
DISEASEBreastcarcinoma(NOS)
MEOICAlfACIUTY NotGiven SI' IMlN NotGiven
NAME Not Given 11'1. IM(NTYPINotGiven
AOOITK>NAlRWP1(NT NotGiven
OATEOfBIRTH NotGiven If OIINo!Givtn
MEOICAlfACITYIO Not Given
SEX NotGiven
p,t,fHOl()(StNotGiven
MEOICA.t
RECORD.Not Given
Companion Diagnostic (CDx) Associated Findings
1'1"!-iJJ·l·fli,■lil!·i·iJi 1 1119·1Jll·ilf
12Ul'it?lll31Wilil% PIQRAY*
(alpelisib)
PIK3CA E542K
Microsotellite
status MS-Stable§ §
TumorMutational Burden 5 Muts/Mb
CDK4 amplification§
CDx for blood
testing results
FoundationOne®CDx uses DNA isolated from FFPE tumor tissue specimens. When feasible,
please send FFPE tissue block + 1 H&E slide OR 10 unstained slides (positively charged and
unbaked at 4-5 microns thick) + 1 H&E slide.14
FoundationOne®Liquid CDx uses two tubes of peripheral whole blood (8.5 mL per tube).8
Foundation Medicine generally expects to provide results in 10 days or less from
specimen receipt.
PIK3CA Mutation CDx findings using next-generation
sequencing are found on the first page of the report
Important Safety Information (cont)
Diarrhea: Severe diarrhea, including dehydration and acute kidney injury, can occur in patients treated
with PIQRAY. Most patients (58%) experienced diarrhea during treatment with PIQRAY. Grade 3 diarrhea
occurred in 7% (n=19) of patients. Based on the severity of the diarrhea, PIQRAY may require dose
interruption, reduction, or discontinuation. Advise patients to start antidiarrheal treatment, increase oral
fluids, and notify their health care provider if diarrhea occurs while taking PIQRAY.
Please see additional Important Safety Information throughout and ~ PIQRAY"
9 (alpelisib)
tablets
on pages 11-12. Please click here for full Prescribing Information. 50mg•150mg•200mg
Single-gene Multi-gene Important
Why to When to How to Key Safety
testing testing
test? test? test? contacts Information
(PCR) (NGS)Key contacts
NeoGenomics Laboratories
Client Services Foundation Medicine
neogenomics.com/pik3ca Order online through
Order online through NeoLINK® at foundationmedicine.com/order
neolink.neogenomics.com Call Client Services at 1-888-988-3639
1-866-776-5907
QIAGEN Lab Finder Novartis Specialist
QIAGEN.com/PIK3CA-lab-finder hcp.novartis.com/contact
1-800-362-7737
PIK3CA TESTING
NAVIGATOR
PIK3CA Testing Navigator
For a general introduction to PIK3CA
For detailed testing information, visit our
mutation testing, please visit PIQRAY at
comprehensive PIK3CA Testing Navigator at
HCP-PIQRAY.com/Testing
PIK3CA-Testing.com
Learn more about PIK3CA mutation testing
NeoLINK is a registered trademark of NeoGenomics Laboratories, Inc.
10
Please see additional Important Safety Information throughout and
on pages 11-12. Please click here for full Prescribing Information.
Single-gene Multi-gene Important
Why to When to How to Key Safety
testing testing
test? test? test? contacts Information
(PCR) (NGS)Important Safety Information
Important Safety Information (cont)
Indication
PIQRAY® (alpelisib) tablets is indicated in combination with fulvestrant for the treatment of postmenopausal
women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-
negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test
following progression on or after an endocrine-based regimen.
Important Safety Information
PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.
Severe Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock,
can occur in patients treated with PIQRAY. Severe hypersensitivity reactions were manifested by symptoms
including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia. The incidence of grade 3 and 4
hypersensitivity reactions was 0.7%. Advise patients of the signs and symptoms of severe hypersensitivity
reactions. Permanently discontinue PIQRAY in the event of severe hypersensitivity.
Severe Cutaneous Adverse Reactions (SCARs): SCARs, including Stevens-Johnson syndrome (SJS), erythema
multiforme (EM), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic
symptoms (DRESS) can occur in patients treated with PIQRAY. In the SOLAR-1 study, SJS and EM were reported
in 0.4% and 1.1% of patients, respectively. DRESS was reported in patients in the postmarketing setting. If
signs or symptoms of SCARs occur, interrupt PIQRAY until the etiology of the reaction has been determined.
Consultation with a dermatologist is recommended.
If a SCAR is confirmed, permanently discontinue PIQRAY. Do not reintroduce PIQRAY in patients who have
experienced previous SCARs during PIQRAY treatment. If it is not confirmed, PIQRAY may require dose
modifications, topical corticosteroids, or oral antihistamine treatment.
Advise patients of the signs and symptoms of SCARs (eg, a prodrome of fever, flu-like symptoms, mucosal
lesions, progressive skin rash, or lymphadenopathy).
Hyperglycemia: Severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar non-
ketotic syndrome (HHNKS) or ketoacidosis has occurred in patients treated with PIQRAY. Some fatal cases of
ketoacidosis have occurred in the postmarketing setting.
Hyperglycemia was reported in 65% of patients treated with PIQRAY. Grade 3 (FPG >250-500 mg/dL)
and grade 4 (FPG >500 mg/dL) hyperglycemia were reported in 33% and 3.9% of patients, respectively.
Ketoacidosis was reported in 0.7% of patients (n=2) treated with PIQRAY.
Before initiating treatment with PIQRAY, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose.
After initiating treatment, monitor fasting glucose (FPG or fasting blood glucose) at least once every week for
the first 2 weeks, then at least once every 4 weeks, and as clinically indicated. Monitor HbA1c every 3 months
and as clinically indicated. Monitor fasting glucose more frequently for the first few weeks during treatment in
patients with risk factors for hyperglycemia such as obesity (BMI ≥30), elevated FPG, HbA1c at the upper limit
of normal or above, use of concomitant systemic corticosteroids, or age ≥75.
If a patient experiences hyperglycemia after initiating treatment, monitor fasting glucose as clinically
indicated, and at least twice weekly until fasting glucose decreases to normal levels. During treatment
with anti-hyperglycemic medication, continue monitoring fasting glucose at least once a week for 8
weeks, followed by once every 2 weeks and as clinically indicated. Consider consultation with a health
care practitioner with expertise in the treatment of hyperglycemia and counsel patients on lifestyle
changes.
The safety of PIQRAY in patients with type 1 and uncontrolled type 2 diabetes has not been established
as these patients were excluded from the SOLAR-1 trial. Patients with a medical history of controlled type
2 diabetes were included. Patients with a history of diabetes mellitus may require intensified diabetic
treatment. Closely monitor patients with diabetes.
Based on the severity of the hyperglycemia, PIQRAY may require dose interruption, reduction, or
discontinuation. Advise patients of the signs and symptoms of hyperglycemia (eg, excessive thirst, urinating
more often than usual or higher amount of urine than usual, or increased appetite with weight loss).
11
Please see additional Important Safety Information throughout and
on pages 11-12. Please click here for full Prescribing Information.
Single-gene Multi-gene Important
Important
Why to When to How to Key Safety
testing testing Safety
test? test? test? contacts Information
(PCR) (NGS) InformationImportant Safety Information (cont)
Pneumonitis: Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease,
can occur in patients treated with PIQRAY. Pneumonitis was reported in 1.8% of patients treated with
PIQRAY® (alpelisib) tablets.
In patients who have new or worsening respiratory symptoms or are suspected to have developed
pneumonitis, interrupt PIQRAY immediately and evaluate the patient for pneumonitis. Consider a diagnosis of
noninfectious pneumonitis in patients presenting with nonspecific respiratory signs and symptoms such as
hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams and in whom infectious, neoplastic, and
other causes have been excluded by means of appropriate investigations.
Permanently discontinue PIQRAY in all patients with confirmed pneumonitis. Advise patients to immediately
report new or worsening respiratory symptoms.
Diarrhea: Severe diarrhea, including dehydration and acute kidney injury, can occur in patients treated with
PIQRAY. Most patients (58%) experienced diarrhea during treatment with PIQRAY. Grade 3 diarrhea occurred
in 7% (n=19) of patients. Based on the severity of the diarrhea, PIQRAY may require dose interruption,
reduction, or discontinuation. Advise patients to start antidiarrheal treatment, increase oral fluids, and notify
their health care provider if diarrhea occurs while taking PIQRAY.
Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, PIQRAY can cause fetal
harm when administered to a pregnant woman. Advise pregnant women and females of reproductive
potential of the potential risk to a fetus. Advise females of reproductive potential to use effective
contraception during treatment with PIQRAY and for 1 week after the last dose. Advise male patients with
female partners of reproductive potential to use condoms and effective contraception during treatment
with PIQRAY and for 1 week after the last dose. Refer to the full Prescribing Information of fulvestrant for
pregnancy and contraception information.
The most common adverse reactions (all grades, incidence ≥20%) were diarrhea (58%), rash (52%), nausea
(45%), fatigue (42%), decreased appetite (36%), stomatitis (30%), vomiting (27%), weight decreased (27%), and
alopecia (20%). The most common grade 3/4 adverse reactions (incidence ≥2%) were rash (20%), diarrhea
(7%), fatigue (5%), weight decreased (3.9%), nausea (2.5%), stomatitis (2.5%), and mucosal inflammation (2.1%).
The most common laboratory abnormalities (all grades, incidence ≥20%) were glucose increased (79%),
creatinine increased (67%), lymphocyte count decreased (52%), gamma-glutamyl transferase (GGT) increased
(52%), alanine aminotransferase (ALT) increased (44%), hemoglobin decreased (42%), lipase increased
(42%), calcium decreased (27%), glucose decreased (26%), and activated partial thromboplastin time (aPTT)
prolonged (21%). The most common grade 3/4 laboratory abnormalities (incidence ≥5%) were glucose
increased (39%), GGT increased (11%), lymphocyte count decreased (8%), lipase increased (7%), and potassium
decreased (6%).
Please click here for full Prescribing Information.
FoundationOne®CDx and FoundationOne®Liquid CDx are qualitative next-generation sequencing based
in vitro diagnostic tests for advanced cancer patients with solid tumors and are for prescription use
only. FoundationOne CDx utilizes FFPE tissue and analyzes 324 genes as well as genomic signatures.
FoundationOne Liquid CDx analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved
to report short variants in 311 genes. The tests are companion diagnostics to identify patients who may
benefit from treatment with specific therapies in accordance with the therapeutic product labeling.
Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any
specific therapeutic product. Use of the tests does not guarantee a patient will be matched to a treatment.
A negative result does not rule out the presence of an alteration. Some patients may require a biopsy for
testing with FoundationOne CDx when archival tissue is not available which may pose a risk. Patients who
are tested with FoundationOne Liquid CDx and are negative for companion diagnostic mutations should
be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue
test, if available. For the complete label, including companion diagnostic indications and important risk
information, please visit www.F1CDxLabel.com and www.F1LCDxLabel.com.
12
Please see additional Important Safety Information throughout and
on pages 11-12. Please click here for full Prescribing Information.
Single-gene Multi-gene Important
Important
Why to When to How to Key Safety
testing testing Safety
test? test? test? contacts Information
(PCR) (NGS) InformationReferences
References: 1. The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast
tumours. Nature. 2012;490(7418):61-70. 2. Mosele F, Stefanovska B, Lusque A, et al. Outcome and molecular
landscape of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol. 2020;31(3):377-386.
3. André F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced
breast cancer. N Engl J Med. 2019;380(20):1929-1940. 4. Data on file. Novartis Pharmaceuticals Corp; 2018.
5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for
Breast Cancer V.5.2021. © 2021 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed
July 9, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. 6. Piqray
[prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 7. QIAGEN therascreen®
PIK3CA RGQ PCR Kit Instructions for Use. Germantown, MD: QIAGEN; May 2019. 8. FoundationOne®Liquid CDx
technical information. Foundation Medicine, Inc. 9. FoundationOne®CDx technical information. Foundation
Medicine, Inc. 10. Bettegowda C, Sausen M, Leary RJ, et al. Detection of circulating tumor DNA in early- and late-
stage human malignancies. Sci Transl Med. 2014;6(224):224ra24. doi:10.1126/scitranslmed.3007094.
11. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem.
2007;53(7):1338-1342. 12. PIK3CA Mutation CDx tissue & plasma. NeoGenomics Laboratories website.
https://www.neogenomics.com/pik3ca#tissue-requirements. Accessed November 11, 2020. 13. Billing and
Financial Assistance. Foundation Medicine website. https://www.foundationmedicine.com/resource/billing-and-
financial-assistance. Accessed November 19, 2020. 14. Foundation Medicine, Inc. Specimen instructions.
https://assets.ctfassets.net/vhribv12lmne/6ms7OiT5PaQgGiMWue2MAM/52d91048be64b72e73ffa0c1cab043c0/
F1CDx_Specimen_Instructions.pdf. Accessed October 29, 2020.
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Please see additional Important Safety Information
East Hanover, New Jersey 07936-1080
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© 2021 Novartis 9/21 140041
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