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Treatment of patients with metastatic non-small cell lung cancer (NSCLC) who
have disease progression during or following platinum-containing chemotherapy:
Clinical evidence for formulary and pathway considerations
INDICATION
TECENTRIQ is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease
progression during or following platinum-containing therapy. Patients with EGFR or ALK genomic tumor aberrations should have
disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ.
SELECT IMPORTANT SAFETY INFORMATION
Serious and sometimes fatal adverse reactions occurred with TECENTRIQ treatment. Warnings and precautions include
immune-related serious adverse reactions, including pneumonitis, hepatitis, colitis, endocrinopathies, and other immune-related
adverse events. Other warnings and precautions include infection, infusion-related reactions, and embryo-fetal toxicity.
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
TABLE OF CONTENTS
Contact your Genentech representative
for additional information.
Clinical summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Indication, dosage and administration, and warnings and precautions. . . . . . . . 4
Efficacy and safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Clinical pharmacology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Pharmacokinetics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Clinical efficacy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
OAK study design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Overall survival (OS) in OAK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
POPLAR study design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Overall survival (OS), objective response rate (ORR), and
duration of response (DoR) in POPLAR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Clinical safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Adverse reactions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Selected laboratory abnormalities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Dosage and administration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Dose modifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Preparation and storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Material safety data sheet (MSDS). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Important Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
©2016 Genentech USA, Inc. All rights reserved.
3
CLINICAL SUMMARY:
INDICATION, DOSAGE AND ADMINISTRATION, AND WARNINGS AND PRECAUTIONS
CLINICAL SUMMARY: EFFICACY AND SAFETY
TECENTRIQ is the first and only FDA-approved anti-PDL1 cancer immunotherapy
for previously treated metastatic non-small cell lung cancer
Manufactured by
Genentech, Inc
Product name
TECENTRIQ
Established name
atezolizumab
Indication1
• TECENTRIQ® (atezolizumab) is indicated for the treatment of patients with metastatic non-small
cell lung cancer (NSCLC) who have disease progression during or following platinum-containing
therapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression
on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ
Dosage and
administration1
• The recommended dose of TECENTRIQ is 1200 mg administered as an intravenous infusion over
60 minutes every 3 weeks until disease progression or unacceptable toxicity
• If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes
• Do not administer TECENTRIQ as an intravenous push or bolus
Contraindications1
None
Warnings and
precautions1
• Immune-related pneumonitis. Immune-mediated pneumonitis or interstitial lung disease, including
fatal cases, occurred. Permanently discontinue TECENTRIQ for Grade 3 or 4 pneumonitis
• Immune-related hepatitis. Immune-mediated hepatitis, including a fatal case in urothelial
carcinoma (UC), and liver test abnormalities occurred. Permanently discontinue TECENTRIQ for
Grade 3 or 4 immune-mediated hepatitis
• Immune-related colitis. Immune-mediated colitis or diarrhea, including a fatal case of diarrhea-associated
renal failure in UC, occurred. Permanently discontinue TECENTRIQ for Grade 4 diarrhea or colitis
• Immune-related endocrinopathies. Immune-related thyroid disorders, adrenal insufficiency,
hypophysitis, and type 1 diabetes mellitus, including diabetic ketoacidosis, have occurred.
Permanently discontinue TECENTRIQ for Grade 4 hypophysitis.
• Other immune-related adverse reactions. Meningoencephalitis, myasthenic syndrome/myasthenia
gravis, Guillain-Barré syndrome, ocular inflammatory toxicity, and pancreatitis, including increases
in serum amylase and lipase levels, have occurred. Permanently discontinue TECENTRIQ for any
grade of meningitis or encephalitis, or any grade of myasthenic syndrome/myasthenia gravis or GuillainBarré syndrome. Permanently discontinue TECENTRIQ for Grade 4 or any grade of recurrent pancreatitis
• Infection. Severe infections, including fatal cases, occurred. Sepsis, herpes encephalitis, and
mycobacterial infection leading to retroperitoneal hemorrhage have been observed
• Infusion-related reactions. Severe infusion reactions have occurred. Permanently discontinue
TECENTRIQ in patients with Grade 3 or 4 infusion reactions
• Embryo-fetal toxicity. TECENTRIQ can cause fetal harm in pregnant women. Advise patients of
the potential risk to a fetus. Advise females of reproductive potential to use effective contraception
during treatment with TECENTRIQ and for at least 5 months after the last dose. Advise female
patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose
Please refer to the full Prescribing Information for important dose management information specific to
adverse reactions.
TECENTRIQ was studied in 2 randomized trials
Study designs and
selected baseline
characteristics1-3
• OAK: Pivotal Phase III trial in patients with metastatic NSCLC who progressed during or following a
platinum-containing regimen (N=1225)
• POPLAR: Pivotal Phase II trial in patients with metastatic NSCLC who progressed during or following
a platinum-containing regimen (N=287)
• OAK and POPLAR enrolled patients with a range of baseline characteristics, including
nonsquamous and squamous histologies, a range of PD-L1 expression levels, and current/previous
and never smokers
Study results
(primary endpoint)1
• OAK (median OS [95% CI]): 13.8 months (11.8, 15.7) with TECENTRIQ vs 9.6 months (8.6, 11.2)
with docetaxel (HR=0.74 [95% CI: 0.63, 0.87]; P=0.0004) in the primary analysis population after
a median follow-up of 21 months
• POPLAR (median OS [95% CI]): 12.6 months (9.7, 16.0) with TECENTRIQ vs 9.7 months (8.6, 12.0)
with docetaxel (HR=0.69; 95% CI: 0.52, 0.92) after a median follow-up of 22 months
Adverse reactions1
• The safety of TECENTRIQ was evaluated in the POPLAR trial
• TECENTRIQ was discontinued due to adverse reactions in 4% (6/142) of patients and was
interrupted in 24% of patients
• The most common adverse reactions (≥20%) in patients receiving TECENTRIQ were fatigue (46%),
decreased appetite (35%), dyspnea (32%), cough (30%), nausea (22%), musculoskeletal pain
(22%), and constipation (20%)
• The most common Grade 3 or 4 adverse reactions (≥2%) were dyspnea, pneumonia, hypoxia,
hyponatremia, fatigue, anemia, musculoskeletal pain, AST increase, ALT increase, dysphagia, and
arthralgia
• 6.3% (9/142) of patients experienced either pulmonary embolism (2/9), pneumonia (2/9),
pneumothorax, ulcer hemorrhage, cachexia secondary to dysphagia, myocardial infarction, or large
intestinal perforation which led to death
• Serious or life-threatening adverse reactions occurred in 37% of patients
– The most frequent serious adverse reactions (>2%) were pneumonia, dyspnea, pleural effusion,
pyrexia, and venous thromboembolism
How supplied1
• TECENTRIQ injection is a sterile, preservative-free, and colorless to slightly yellow solution for
intravenous infusion supplied as a carton containing one 1200 mg/20 mL single-dose vial
(NDC 50242-917-01)
Storage and handling1
• Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original carton to protect from light
• Do not freeze
• Do not shake
Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; CI, confidence interval; HR, hazard ratio; OS, overall survival.
Abbreviations: ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor.
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
©2016 Genentech USA, Inc. All rights reserved.
5
CLINICAL PHARMACOLOGY
PHARMACOKINETICS1
TECENTRIQ is a humanized anti-PDL1 antibody indicated for the treatment of patients with metastatic non-small cell lung cancer
(NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic
tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ.
Patient exposures to atezolizumab increased dose proportionally over the dose range of 1 mg/kg to 20 mg/kg, including the fixed
dose of 1200 mg administered every 3 weeks. Based on a population analysis that included 472 patients in the dose range, the
typical population clearance was 0.20 L/day, volume of distribution at steady state was 6.9 L, and the terminal half-life was 27 days.
The population PK analysis suggests steady state is obtained after 6 to 9 weeks (2 to 3 cycles) of repeated dosing. The systemic
accumulation in the area under the curve (AUC), maximum concentration (Cmax), and trough concentration (Cmin) was 1.91,
1.46 and 2.75-fold, respectively.
Description1
TECENTRIQ is an Fc-engineered, humanized, monoclonal antibody that binds to PD-L1 and blocks interactions with the PD-1 and
B7.1 receptors. TECENTRIQ is a non-glycosylated IgG1 kappa immunoglobulin that has a calculated molecular mass of 145 kDa.
• TECENTRIQ is a sterile, preservative-free, colorless to slightly yellow solution
Specific populations
• TECENTRIQ injection for intravenous infusion is supplied in single-use vials. Each mL of TECENTRIQ contains 60 mg of
atezolizumab and is formulated in glacial acetic acid (16.5 mg), L-histidine (62 mg), sucrose (821.6 mg), polysorbate 20
(8 mg), pH 5.8
No clinically significant effect on the systemic exposure of TECENTRIQ was observed based on age (21-89 years), body weight,
gender, positive antitherapeutic antibody (ATA) status, albumin levels, tumor burden, region or race, mild or moderate renal
impairment (estimated glomerular filtration rate [eGFR] 30 to 89 mL/min/1.73 m2), mild hepatic impairment (bilirubin ≤ULN
and AST >ULN or bilirubin <1.0 to 1.5 × ULN and any AST), level of PD-L1 expression, or ECOG status.
Proposed Mechanism of action1
The effect of severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2) or moderate or severe hepatic impairment (bilirubin >ULN
and AST >ULN or bilirubin ≥1.0 to 1.5 × ULN and any AST) on the pharmacokinetics of atezolizumab is unknown.
PD-L1 may be expressed on tumor cells and/or tumor-infiltrating immune cells and can contribute to the inhibition of the antitumor
immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigenpresenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production.
Special populations
TECENTRIQ is a monoclonal antibody that binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. This
releases the PD-L1/PD-1–mediated inhibition of the immune response, including activation of the anti-tumor immune response
without inducing antibody-dependent cellular cytotoxicity. In syngeneic mouse tumor models, blocking PD-L1 activity resulted
in decreased tumor growth.
Based on a population pharmacokinetic analysis, no dose adjustment of TECENTRIQ is recommended for patients with
renal impairment.
Renal impairment
Hepatic impairment
Based on a population pharmacokinetic analysis, no dose adjustment of TECENTRIQ is recommended for patients with mild hepatic
impairment. TECENTRIQ has not been studied in patients with moderate or severe hepatic impairment.
Distinct features of TECENTRIQ:
DIRECT: TECENTRIQ binds to the ligand PD-L1 on tumor cells and immune cells
COMPLETE: Dual blockade of PD-L1 binding to its inhibitory receptors PD-1 and B7.1
Abbreviations: ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; IgG1, immunoglobulin G1.
Geriatric use
Of the 142 patients with NSCLC treated with TECENTRIQ in POPLAR, 39% were 65 years or older. No overall differences in safety
or efficacy were observed between patients ≥65 years of age and younger patients.
Females and males of reproductive potential
Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman. Advise females of
reproductive potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months following the last
dose. Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving treatment.
SELECT IMPORTANT SAFETY INFORMATION
Immune-Related Hepatitis
SELECT IMPORTANT SAFETY INFORMATION
Serious Adverse Reactions
Please refer to the full Prescribing Information for important dose management information specific to adverse reactions.
Immune-Related Pneumonitis
• Immune-mediated pneumonitis or interstitial lung disease, including 2 fatal cases, occurred with TECENTRIQ treatment
• In non-small cell lung cancer (NSCLC), pneumonitis occurred in 3.7% of patients
• Monitor patients for signs with radiographic imaging and symptoms of pneumonitis. Administer steroids for ≥Grade 2
pneumonitis. Withhold TECENTRIQ until resolution of Grade 2 pneumonitis. Permanently discontinue for Grade 3 or 4
pneumonitis
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
©2016 Genentech USA, Inc. All rights reserved.
• Immune-mediated hepatitis, including a fatal case in urothelial carcinoma (UC), and liver test abnormalities have occurred with
TECENTRIQ treatment
• Across clinical trials, Grade 3 or 4 elevation occurred in ALT (2.5%), AST (2.3%), and total bilirubin (1.6%). In NSCLC, immunemediated hepatitis occurred in 0.9% of patients
• Monitor patients for signs and symptoms of hepatitis. Monitor AST, ALT, and bilirubin prior to and periodically during treatment
• Administer corticosteroids for ≥Grade 2 transaminase elevations, with or without concomitant elevation in total bilirubin. Withhold
TECENTRIQ for Grade 2, and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
7
CLINICAL EFFICACY: OAK STUDY DESIGN
CLINICAL EFFICACY: OVERALL SURVIVAL (OS) IN OAK
For previously treated metastatic NSCLC, regardless of PD-L1 expression
TECENTRIQ was evaluated in OAK, a pivotal Phase III, multicenter, international, randomized,
open-label trial in patients with previously treated NSCLC1,2
Study design1
• Randomized trial involving 1225 patients with previously treated NSCLC who progressed during
or following a platinum-containing regimen
OS at medianSURVIVAL
21-month follow-up
TECENTRIQ®: PROVENOAK:
SUPERIOR
VS DOCETAXEL
1,3
• The primary analysis population consisted of the first 850 randomized patients
• TECENTRIQ was administered intravenously at 1200 mg every 3 weeks until unacceptable toxicity
or either radiographic or clinical progression
• Docetaxel was administered intravenously at 75 mg/m2 every 3 weeks until unacceptable toxicity or
disease progression
• Tumor assessments were conducted every 6 weeks for the first 36 weeks, and every 9 weeks thereafter
Baseline patient characteristics (N=850)
Study population1
Median age (years)
Gender
Male
Female
61%
39%
Race
White
70%
Histology
Nonsquamous
Squamous
74%
26%
ECOG performance status
0
1
37%
63%
Current or previous smoker
Yes
No
82%
18%
Prior treatment
1 prior platinum-based regimen
Study endpoints1
64
• A large pivotal Phase III
cancer immunotherapy study
in previously treated NSCLC,
regardless of PD-L1 expression
• OAK enrolled patients with
nonsquamous and squamous
histologies
• Patients were excluded if they
had a history of autoimmune
disease, active or corticosteroiddependent brain metastasis,
administration of a live, attenuated
vaccine within 28 days prior to
enrollment, administration of
systemic immunostimulatory
agents within 4 weeks or systemic
immunosuppressive medications
75%
Median OS, months
100
TECENTRIQ
90
13.8
80
Probability of Survival (%)
Therapeutic regimen1
POPLAR
OAK: more than half of patients were alive at 1 year with TECENTRIQ1
(95% CI: 11.8, 15.7)
55%
70
40%
50
(95% CI, 35%, 45%)
40
Median
TECENTRIQ
(n=22
41%
30
(95% CI, 36%, 46%)
27%
20
10
(95% CI, 22%, 37%)
TECENTRIQ
Docetaxel
0
0
3
6
9
12
15
Docetaxe
(n=21
18
21
24
27
157
98
74
51
28
16
1
Time (months)
Number at risk
TECENTRIQ
Docetaxel
9.6
• 1-year
• Media
(95%
(95% CI: 8.6, 11.2)
HR=0.74 (95% CI: 0.63, 0.87); P=0.0004
(95% CI, 50%, 60%)
60
Docetaxel
425
425
363
336
305
263
248
195
218
151
188
123
Abbreviation: NE
CI=confidence interval; HR=hazard ratio.
• Median
Abbreviations: CI, confidence interval; HR, hazard ratio.
• The Kaplan-Meier curves demonstrated clear separation at 3 months
• Minimum follow-up was 19 months
• The Kaplan-Meier curves showed separation starting at approximately 3 months
• Median follow-up was 21 months
Superior median OS vs docetaxel
across histologies
Superior median OS vs docetaxel
regardless of PD-L1 expression
• Non-squamous: 15.6 vs 11.2 months
(HR=0.73; 95% CI, 0.60, 0.89)
PD-L1
• Squamous: 8.9 vs 7.7 months
(HR=0.73; 95% CI, 0.54, 0.98)
• TC or IC ≥1%; 15.7 vs 10.3 months (HR=0.74)
• TC or IC <1%; 12.6 vs 8.9 months (HR=0.75)
testing is not required to prescribe TECENTRIQ.
Respons
• ORR wa
with do
PD-L
• Primary efficacy endpoint: Overall survival (OS)
Importa
Abbreviation: ECOG, Eastern Cooperative Oncology Group.
Immune-
Important Safety Information (cont’d)
• In 1027 p
Immune-Related Pneumonitis
patients.
• Immune-mediated
pneumonitis
or interstitial
lung disease, defined as requiring use of corticosteroids and with no clear
SELECT
IMPORTANT
SAFETY
INFORMATION
eleven w
alternate etiology, occurred
in patients receiving TECENTRIQ. Monitor patients for signs with radiographic imaging and
Immune-Related
Endocrinopathies
TECENTR
symptoms of pneumonitis.
steroids
at a insufficiency,
dose of 1 to 2 mg/kg/day
prednisone
equivalents
for Grade 2mellitus,
or greaterincluding diabetic
• Immune-related
thyroidAdminister
disorders,
adrenal
hypophysitis,
and
type 1 diabetes
corticost
pneumonitis, followed
by corticosteroid
taper. Withhold
TECENTRIQ
until resolution
for Grade
2 pneumonitis.
Permanently
ketoacidosis,
have occurred
in patients
receiving
TECENTRIQ.
Monitor
patients
for clinical
signs and symptoms of
discontinue TECENTRIQ for Grade 3 or 4 pneumonitis
endocrinopathies
Please see
• In
patients
with
NSCLC,
hyperthyroidism
occurred
in 4.2%
and in
1.1%,
respectively. Monitor thyroid function prior to additional
• Across
clinical
trials,
2.6% ofhypopatientsand
developed
pneumonitis. Fatal
pneumonitis
occurred
2 patients
and periodically during treatment with TECENTRIQ. For symptomatic hypothyroidism, withhold TECENTRIQ and initiate hormone
4
replacement as needed. Manage isolated hypothyroidism with replacement therapy and without corticosteroids. For symptomatic
hyperthyroidism, withhold TECENTRIQ and initiate an anti-thyroid drug as needed
O
FP
SELECT IMPORTANT SAFETY INFORMATION
Immune-Related Colitis
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
• Immune-mediated colitis or diarrhea have occurred with TECENTRIQ treatment
• Across clinical trials, colitis or diarrhea occurred in 19.7% of patients, including a fatal case of diarrhea-associated renal failure in
UC. In patients with NSCLC, immune-mediated colitis or diarrhea occurred in 0.5% of patients
• Monitor patients for signs and symptoms of diarrhea or colitis. Withhold TECENTRIQ for Grade 2 or Grade 3 diarrhea or colitis.
Permanently discontinue for Grade 4 diarrhea or colitis
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
©2016 Genentech USA, Inc. All rights reserved.
9
CLINICAL EFFICACY: POPLAR STUDY DESIGN
TECENTRIQ was also evaluated in POPLAR, a pivotal Phase II, multicenter, international,
randomized, open-label trial in patients with previously treated NSCLC1,4
Study design1
• Randomized trial of 287 patients with previously treated NSCLC who progressed during or following
a platinum-containing regimen
Therapeutic regimen1
• TECENTRIQ was administered intravenously at 1200 mg every 3 weeks until unacceptable toxicity
or either radiographic or clinical progression
CLINICAL EFFICACY: OS, OBJECTIVE RESPONSE RATE (ORR), AND DURATION OF RESPONSE
(DoR) IN POPLAR
In POPLAR, median OS was greater than 1 year1
• Primary endpoint: median OS was 12.6 months (95% CI: 9.7, 16.0) with TECENTRIQ vs
9.7 months (95% CI: 8.6, 12.0) with docetaxel (HR=0.69; 95% CI: 0.52, 0.92)
• Docetaxel was administered intravenously at 75 mg/m2 every 3 weeks until unacceptable toxicity or
disease progression
• Tumor assessments were conducted every 6 weeks for the first 36 weeks, and every 9 weeks thereafter
Median age (years)
Gender
Male
Female
Race
White
Median DoR, a secondary endpoint in POPLAR, exceeded 18 months1
62
59%
41%
79%
Histology
Nonsquamous
Squamous
66%
34%
ECOG performance status
0
1
33%
67%
Current or previous smoker
Yes
No
80%
20%
Prior treatment
1 prior platinum-based regimen
Study endpoints1
• ORR was 15% (95% CI: 10%, 22%) (22/144) with TECENTRIQ vs 15% (95% CI: 9%, 22%) (21/143) with docetaxel
Baseline patient characteristics (N=287)
Study population1
Response rates were similar between TECENTRIQ and docetaxel
• Patients were enrolled regardless of
PD-L1 expression level
• POPLAR enrolled patients with
nonsquamous and squamous
histologies
• Patients were excluded if they
had a history of autoimmune
disease, active or corticosteroiddependent brain metastasis,
administration of a live, attenuated
vaccine within 28 days prior to
enrollment, administration of
systemic immunostimulatory
agents within 4 weeks or systemic
immunosuppressive medications
66%
• Primary efficacy endpoint: Overall survival (OS)
18.6 months
TECENTRIQ
(n=22)
(95% CI: 11.6, NE)
7.2 months
Docetaxel
(n=21)
(95% CI: 5.6, 12.5)
0
2
4
6
8
10
12
14
16
18
20
Median duration of response (months)
Abbreviations: CI, confidence interval; NE, not estimable.
• Median DoR among patients with an objective response was 18.6 months with TECENTRIQ (n=22) vs 7.2 months with
docetaxel (n=21)
• Median follow-up was 22 months
• Other efficacy outcome measures:
– Investigator-assessed objective response rate (ORR)
– Duration of response (DoR) per RECIST v1.1
Abbreviations: ECOG, Eastern Cooperative Onocology Group; RECIST, Response Criteria in Solid Tumors.
SELECT IMPORTANT SAFETY INFORMATION
Other Immune-Related Adverse Reactions
SELECT IMPORTANT SAFETY INFORMATION
Immune-Related Endocrinopathies (cont)
• Across clinical trials, adrenal insufficiency occurred in 0.4% of patients. For symptomatic adrenal insufficiency, withhold
TECENTRIQ and administer steroids
• In UC, hypophysitis occurred in 0.2% of patients. Administer corticosteroids and hormone replacement as clinically indicated.
Withhold for Grade 2 or Grade 3, and permanently discontinue for Grade 4 hypophysitis
• New onset diabetes with ketoacidosis occurred in patients. Diabetes mellitus without an alternative etiology occurred in 0.3%
of patients with NSCLC. Initiate treatment with insulin for type 1 diabetes mellitus. For ≥Grade 3 hyperglycemia (fasting glucose
>250-500 mg/dL), withhold TECENTRIQ
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
©2016 Genentech USA, Inc. All rights reserved.
• Other immune-related adverse reactions, including meningoencephalitis, myasthenic syndrome/myasthenia gravis, Guillain-Barré
syndrome, ocular inflammatory toxicity, and pancreatitis, including increases in serum amylase and lipase levels, have occurred
in ≤1.0% of patients treated with TECENTRIQ
• Symptomatic pancreatitis without an alternative etiology occurred in 0.1% of patients across clinical trials
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
11
CLINICAL SAFETY: ADVERSE REACTIONS
CLINICAL SAFETY: SELECTED LABORATORY ABNORMALITIES
In POPLAR, 4% (6/142) of patients in the TECENTRIQ arm discontinued due to an adverse reaction1
Selected laboratory abnormalities worsening from baseline occurring in ≥10% of patients treated with TECENTRIQ and at a higher
incidence than in the docetaxel arm1,a
Adverse reactions occurring in ≥10% of patients treated with TECENTRIQ and at a higher incidence than in the docetaxel arm1,a
TECENTRIQ (n=142)
Adverse Reaction
TECENTRIQ
Docetaxel (n=135)
All Grades (%)
Grades 3-4 (%)
All Grades (%)
Grades 3-4 (%)
Pyrexia
18
0
13
0
Pneumonia
18
6
4
2
Decreased appetite
35
1
22
0
Arthralgia
16
2
9
2
Back pain
14
1
9
1
Insomnia
14
0
8
2
Dyspnea
32
7
24
2
Cough
30
1
25
0
Test
Docetaxel
All Grades (%)
Grades 3-4 (%)
All Grades (%)
Grades 3-4 (%)
Hyponatremia
48
13
28
8
Hypoalbuminemia
48
5
49
1
Alkaline phosphatase increased
42
2
24
1
Aspartate aminotransferase increased
33
2
15
0
Alanine aminotransferase increased
31
2
9
1
Creatinine inreased
19
1
14
2
Hypokalemia
18
2
11
4
Hypercalcemia
13
0
5
0
Total bilirubin increased
11
0
5
1
Higher incidence was defined as a between-arm difference of ≥5% for all grades or ≥2% for Grades 3 to 4.
a
Higher incidence was defined as a between-arm difference of ≥5% for all grades or ≥2% for Grades 3 to 4.
a
• The most common adverse reactions (≥20%) in patients receiving TECENTRIQ were fatigue (46%), decreased appetite (35%),
dyspnea (32%), cough (30%), nausea (22%), musculoskeletal pain (22%), and constipation (20%)1
• Adverse reactions led to discontinuation of TECENTRIQ in 4% (6/142) of patients1
• Adverse reactions led to interruption of TECENTRIQ in 24% of patients1
• 6.3% (9/142) of patients experienced either pulmonary embolism (2/9), pneumonia (2/9), pneumothorax, ulcer hemorrhage,
cachexia secondary to dysphagia, myocardial infarction, or large intestinal perforation which led to death
• Serious or life-threatening adverse reactions occurred in 37% of patients
– The most frequent frequent serious adverse reactions (>2%) were pneumonia, dyspnea, pleural effusion, pyrexia,
and venous thromboembolism
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
©2016 Genentech USA, Inc. All rights reserved.
13
DOSAGE AND ADMINISTRATION: DOSE MODIFICATIONS
DOSAGE AND ADMINISTRATION: PREPARATION AND STORAGE
Recommended dosage1
Preparation and administration1
Preparation
Visually inspect drug product for particulate matter and discoloration prior to administration whenever solution and container permit.
TECENTRIQ is a colorless to slightly yellow solution. Discard the vial if the solution is cloudy, discolored, or visible particles are
observed. Do not shake the vial.
IF TOLERATED
3
weeks
FIXED DOSE
1200 MG IV
60-MINUTE
INITIAL INFUSION
30-MINUTE
SUBSEQUENT INFUSIONS
EVERY
3 WEEKS
UNTIL DISEASE PROGRESSION OR UNACCEPTABLE TOXICITY
Prepare the solution for infusion as follows:
• Withdraw 20 mL of TECENTRIQ from the vial
• Dilute into a 250 mL polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO) infusion bag containing 0.9% Sodium Chloride
Injection, USP
• Dilute with 0.9% Sodium Chloride Injection only
• Mix diluted solution by gentle inversion. Do not shake
• Discard used or empty vials of TECENTRIQ
Dose modifications1
Administration
Administer the initial infusion over 60 minutes through an intravenous line with or without a sterile, nonpyrogenic, low-protein
binding in-line filter (pore size of 0.2–0.22 micron). If the first infusion is tolerated, all subsequent infusions may be delivered over
30 minutes.
Withhold
Discontinue
Withhold TECENTRIQ for any of the following:
• Grade 2 pneumonitis
Permanently discontinue TECENTRIQ for any of the following:
• Grade 3 or 4 pneumonitis
• AST or ALT >3 and ≤5 times ULN, or total bilirubin >1.5
and ≤3 times ULN
• AST or ALT >5 times ULN or total bilirubin >3 times ULN
• Grade 4 diarrhea or colitis
How supplied/storage and handling1
• Grade 2 or 3 diarrhea or colitis
• Grade 4 hypophysitis
• Symptomatic hypophysitis, adrenal insufficiency,
hypothyroidism, hyperthyroidism, or Grade 3 or
4 hyperglycemia
• Myasthenic syndrome/myasthenia gravis, Guillain-Barré or
meningoencephalitis (all grades)
TECENTRIQ injection is a sterile, preservative-free, and colorless to slightly yellow solution for intravenous infusion supplied as a
carton containing one 1200 mg/20 mL single-dose vial (NDC 50242-917-01).
• Grade 2 ocular inflammatory toxicity
• Grade 2 or 3 pancreatitis, or Grade 3 or 4 increases
in amylase or lipase levels (>2 times ULN)
• Grade 3 or 4 infection
• Grade 3 or 4 ocular inflammatory toxicity
• Grade 4 or any grade of recurrent pancreatitis
Storage of vials
Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.
• Grade 3 or 4 infusion-related reactions
Storage of Infusion Solution
This product does not contain a preservative.
• Grade 4 rash
Administer immediately once prepared. If diluted TECENTRIQ infusion solution is not used immediately, it can be stored either:
• At room temperature for no more than 6 hours from the time of preparation. This includes room temperature storage of the
infusion in the infusion bag and time for administration for infusion.
• Grade 2 infusion-related reactions
• Grade 3 rash
• Under refrigeration at 2°C–8°C (36°F–46°F) for no more than 24 hours.
Resume
TECENTRIQ may be resumed in patients whose adverse events
recover to Grade 0 to 1.
Do not co-administer other drugs through the same intravenous line.
No dose reductions of TECENTRIQ are recommended
in the Prescribing Information.
Do not freeze.
Do not shake.
Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; IV, intravenous; ULN , upper limit of normal.
Overdosage1
There is no information on overdose with TECENTRIQ.
SELECT IMPORTANT SAFETY INFORMATION
Other Immune-Related Adverse Reactions (cont)
SELECT IMPORTANT SAFETY INFORMATION
Infection
• Severe infections, including sepsis, herpes encephalitis, and mycobacterial infection leading to retroperitoneal hemorrhage,
occurred in patients receiving TECENTRIQ
• In patients with NSCLC, infection occurred in 43% of patients treated with TECENTRIQ compared with 34% of patients treated
with docetaxel. Grade 3 or 4 infection occurred in 9.2% of patients treated with TECENTRIQ compared with 2.2% with docetaxel.
Two patients (1.4%) treated with TECENTRIQ died. Pneumonia was the most common cause of Grade 3 or higher infection,
occurring in 7.7% of patients
• Monitor patients for signs and symptoms of infection and treat with antibiotics for suspected or confirmed bacterial infections.
Withhold TECENTRIQ for ≥Grade 3 infection
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
• Monitor patients for clinical signs and symptoms of meningitis or encephalitis, as well as symptoms of motor and sensory neuropathy.
Permanently discontinue TECENTRIQ for any grade of meningitis or encephalitis, or any grade of myasthenic syndrome/myasthenia
gravis or Guillain-Barré syndrome
• Monitor patients for signs and symptoms of acute pancreatitis. Withhold TECENTRIQ for ≥Grade 3 serum amylase or lipase levels
(>2.0 ULN), or Grade 2 or 3 pancreatitis. Permanently discontinue for Grade 4 or any grade of recurrent pancreatitis
Please see additional Important Safety Information on pages 24-25 and in full Prescribing Information.
©2016 Genentech USA, Inc. All rights reserved.
15
TECENTRIQ® (atezolizumab) MATERIAL SAFETY DATA SHEET
MATERIAL SAFETY DATA SHEET (cont)
Safety Data Sheet
TECENTRIQ® Vials (1,200 mg/20 ml)
SECTION 3: Composition/information on ingredients
Date: 14.6.16/LS (SEISMO)
Replacing edition of:
Ingredients
Concentration
Atezolizumab
1380723-44-3
5.43 %
L-Histidine
71-00-1
0.28 %
Sucrose
57-50-1
3.72 %
Polysorbate 20
9005-64-5
0.04 %
*1
Atezolizumab
13.6.16
SECTION 1: Identification of the substance/mixture and of the
company/undertaking
1.1. Product identifier
Product name
TECENTRIQ® Vials (1,200 mg/20 ml)
Product code
SAP-10154949
Synonyms
- Atezolizumab Drug Product
- TECENTRIQ(R) (1,200 mg/20 ml)
- MPDL3280A
*1
1.2. Relevant identified uses of the substance or mixture and uses advised against
Use
- pharmaceutical active substance (antineoplastic)
1.3. Details of the supplier of the safety data sheet
Company information
Enquiries:
Genentech, Inc.
1 DNA Way
South San Francisco
USA-CA 94080
United States of America
Local representation:
Phone
001-(650) 225-1000
E-Mail
[email protected]
US Chemtrec phone:
(800)-424-9300
Emergency telephone number
US Chemtrec phone: (800)-424-9300
*1
Atezolizumab
SECTION 2: Hazards identification
Classification of the substance or mixture / Label elements
GHS Classification
no classification and labelling according to GHS
Other hazards
Note
©2016 Genentech USA, Inc. All rights reserved.
SECTION 4: First aid measures
4.1. Description of first aid measures
Eye contact
- rinse immediately with tap water for at least 20 minutes - open
eyelids forcibly
Skin contact
- remove immediately contaminated clothes, wash affected skin
with water and soap - do not use any solvents
Inhalation
- remove the casualty to fresh air
- in the event of symptoms get medical treatment
4.2. Most important symptoms and effects, both acute and delayed
Note
1.4. Emergency telephone number
referring to:
*1
referring to:
- no information available
GHS-Classification
(pure ingredient)
- no information available
4.3. Indication of any immediate medical attention and special treatment needed
Note to physician
- treat symptomatically
SECTION 5: Firefighting measures
5.1. Extinguishing media
Suitable extinguishing media
Flash point (liquid)
- water spray jet, dry powder, foam, carbon dioxide
- adapt extinguishing media to surrounding fire conditions
> 110 °C
*2
17
MATERIAL SAFETY DATA SHEET (cont)
MATERIAL SAFETY DATA SHEET (cont)
SECTION 8: Exposure controls/personal protection
5.2. Special hazards arising from the substance or mixture
Specific hazards
- no particular hazards known
Threshold value (Roche) air
5.3. Advice for firefighters
Protection of fire-fighters
*2
8.1. Control parameters
- precipitate gases/vapours/mists with water spray
referring to:
Polysorbate 20
Personal precautions
- no special precautions required
Respiratory protection
- Respiratory protection is recommended as a precaution to
minimize exposure. Effective engineering controls are considered
to be the primary means to control worker exposure. Respiratory
protection should not substitute for feasible engineering controls.
- respiratory protection not necessary during normal operations
Hand protection
- protective gloves (eg made of neoprene, nitrile or butyl rubber)
Eye protection
- safety glasses
*1
6.2. Environmental precautions
Environmental protection
- no special environmental precautions required
*1
8.2. Exposure controls
SECTION 6: Accidental release measures
6.1. Personal precautions, protective equipment and emergency procedures
- IOEL (Internal Occupational Exposure Limit): 0.12 mg/m3
referring to:
Atezolizumab
SECTION 9: Physical and chemical properties
6.3. Methods and material for containment and cleaning up
9.1. Information on basic physical and chemical properties
Methods for cleaning up
Color
colorless to slightly yellow
Form
sterile liquid
Solubility
38.2 g/l, water (20 °C)
100 g/l, water
*3
7.1. Precautions for safe handling
Partition coefficient
log Pow -3.32 (octanol/water)
*3
Technical measures
- no special measures necessary if stored and handled as
prescribed
pH value
5.8
Suitable materials
- glass, enamel, stainless steel
- collect liquids by means of sand, earth or another suitable material
- rinse with plenty of water
SECTION 7: Handling and storage
7.2. Conditions for safe storage, including any incompatibilities
Storage conditions
- 2 - 8 °C
- protected from heat and light
- do not shake solution
Validity
- in the unopened original container, after opening the content
should be used within a short period, see expiry date on the label
Packaging materials
- vials
9.2. Other information
Note
*2
*3
- no information available
referring to:
referring to:
Polysorbate 20
L-Histidine
SECTION 10: Stability and reactivity
10.1. Reactivity
Note
©2016 Genentech USA, Inc. All rights reserved.
*2
- no information available
19
MATERIAL SAFETY DATA SHEET (cont)
MATERIAL SAFETY DATA SHEET (cont)
Note
10.2. Chemical stability
Stability
*1
*2
*3
*4
- does not contain any antimicrobial preservative; therefore, care
must be taken to ensure the sterility of the prepared solution
10.3. Possibility of hazardous reactions
Note
referring to:
referring to:
referring to:
referring to:
- no information available
Ecotoxicity
- no information available
- monoclonal antibodies are proteins with highly specific affinity to a
certain antigen; therefore, no appreciable ecotoxic potential is to
be expected
*1
12.2. Persistence and degradability
10.6. Hazardous decomposition products
Note
Atezolizumab
Polysorbate 20
L-Histidine
Sucrose
12.1. Toxicity
10.5. Incompatible materials
Note
*1
SECTION 12: Ecological information
- no information available
10.4. Conditions to avoid
Note
- therapeutic dose (i.v.): 15 mg/kg/3w
Ready biodegradability
- no information available
SECTION 11: Toxicological information
- globular proteins are generally well biodegradable
- readily biodegradable
60.3 %, 28 d
(Manometric Respirometry Test, OECD No. 301 F)
*1
*2
12.3. Bioaccumulative potential
11.1. Information on toxicological effects
Acute toxicity
Note
- not bioavailable by oral administration
- LD50
> 15ʼ000
mg/kg (oral, rat)
- LD50
> 32ʼ850
mg/kg (oral, rat)
(OECD No. 401)
- LD50
29ʼ700
mg/kg (oral, rat)
*1
Local effects
- skin: non-irritant (rabbit; OECD No. 404)
*2
Sensitization
anaphylactic reactions may occur following the intravenous
application of proteins; after inhalative exposure no cases of
hypersensitivity have been described
*1
Mutagenicity
- negative, both with and without metabolic activation (OECD No.
476 (Mammalian Cell Gene Mutation Test))
*2
Carcinogenicity
- no information available
Reproductive toxicity
- critical exposure in human after parenteral administration only
- parenteral administration to pregnant women can cause fetal harm *1
STOT-single exposure
- no information available
STOT-repeated exposure
- no information available
Aspiration hazard
- no information available
©2016 Genentech USA, Inc. All rights reserved.
*3
*2
*4
- no information available
12.4. Mobility in soil
Note
- no information available
12.5. Results of PBT and vPvB assessment
Note
- no information available
12.6. Other adverse effects
Note
*1
*2
- no information available
referring to:
referring to:
Atezolizumab
Polysorbate 20
SECTION 13: Disposal considerations
13.1. Waste treatment methods
Waste from residues
- observe local/national regulations regarding waste disposal
- drain very small quantities into wastewater treatment plant
21
MATERIAL SAFETY DATA SHEET (cont)
SECTION 14: Transport information
Note
- not classified as Dangerous Good according to the Dangerous
Goods Regulations, proper shipping name non-regulated
SECTION 15: Regulatory information
15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
TSCA Status
- FDA Exemption - not on inventory
Reporting Requirements
- The United States Environmental Protection Agency (USEPA) has
not established a Reportable Quantity (RQ) for releases of this
material.
- In New Jersey, report all releases which are likely to endanger the
public health, harm the environment or cause a complaint to the
NJDEPE Hotline (1-609-292-5560) and to local officials.
- State and local regulations vary and may impose additional
reporting requirements.
SECTION 16: Other information
Note
- none
Edition documentation
- changes from previous version in sections 11
The information in this safety data sheet is based on current scientific knowledge. It should not be
taken as expressing or implying any warranty concerning product characteristics.
©2016 Genentech USA, Inc. All rights reserved.
23
IMPORTANT SAFETY INFORMATION
Serious Adverse Reactions
Please refer to the full Prescribing Information for important
dose management information specific to adverse reactions.
Immune-Related Pneumonitis
•Immune-mediated pneumonitis or interstitial lung disease,
including 2 fatal cases, occurred with TECENTRIQ treatment
•In non-small cell lung cancer (NSCLC), pneumonitis occurred
in 3.7% of patients
•Monitor patients for signs with radiographic imaging and
symptoms of pneumonitis. Administer steroids for ≥Grade 2
pneumonitis. Withhold TECENTRIQ until resolution of Grade 2
pneumonitis. Permanently discontinue for Grade 3 or
4 pneumonitis
Immune-Related Hepatitis
•Immune-mediated hepatitis, including a fatal case in
urothelial carcinoma (UC), and liver test abnormalities have
occurred with TECENTRIQ treatment
•Across clinical trials, Grade 3 or 4 elevation occurred in ALT
(2.5%), AST (2.3%), and total bilirubin (1.6%). In NSCLC,
immune-mediated hepatitis occurred in 0.9% of patients
•Monitor patients for signs and symptoms of hepatitis. Monitor
AST, ALT, and bilirubin prior to and periodically during treatment
•Administer corticosteroids for ≥Grade 2 transaminase
elevations, with or without concomitant elevation in total
bilirubin. Withhold TECENTRIQ for Grade 2, and permanently
discontinue for Grade 3 or 4 immune-mediated hepatitis
Immune-Related Colitis
•Immune-mediated colitis or diarrhea have occurred with
TECENTRIQ treatment
•Across clinical trials, colitis or diarrhea occurred in 19.7%
of patients, including a fatal case of diarrhea-associated
renal failure in UC. In patients with NSCLC, immune-mediated
colitis or diarrhea occurred in 0.5% of patients
•Monitor patients for signs and symptoms of diarrhea or colitis.
Withhold TECENTRIQ for Grade 2 or Grade 3 diarrhea or colitis.
Permanently discontinue for Grade 4 diarrhea or colitis
IMPORTANT SAFETY INFORMATION (cont)
Immune-Related Endocrinopathies
•Immune-related thyroid disorders, adrenal insufficiency,
hypophysitis, and type 1 diabetes mellitus, including
diabetic ketoacidosis, have occurred in patients receiving
TECENTRIQ. Monitor patients for clinical signs and symptoms
of endocrinopathies
•In patients with NSCLC, hypo- and hyperthyroidism occurred
in 4.2% and 1.1%, respectively. Monitor thyroid function
prior to and periodically during treatment with TECENTRIQ.
For symptomatic hypothyroidism, withhold TECENTRIQ and
initiate hormone replacement as needed. Manage isolated
hypothyroidism with replacement therapy and without
corticosteroids. For symptomatic hyperthyroidism, withhold
TECENTRIQ and initiate an anti-thyroid drug as needed
•Across clinical trials, adrenal insufficiency occurred in 0.4%
of patients. For symptomatic adrenal insufficiency, withhold
TECENTRIQ and administer steroids
•In UC, hypophysitis occurred in 0.2% of patients. Administer
corticosteroids and hormone replacement as clinically
indicated. Withhold for Grade 2 or Grade 3, and permanently
discontinue for Grade 4 hypophysitis
•New onset diabetes with ketoacidosis occurred in patients.
Diabetes mellitus without an alternative etiology occurred in
0.3% of patients with NSCLC. Initiate treatment with insulin
for type 1 diabetes mellitus. For ≥Grade 3 hyperglycemia
(fasting glucose >250-500 mg/dL), withhold TECENTRIQ
Other Immune-Related Adverse Reactions
•Other immune-related adverse reactions, including
meningoencephalitis, myasthenic syndrome/myasthenia
gravis, Guillain-Barré syndrome, ocular inflammatory toxicity,
and pancreatitis, including increases in serum amylase
and lipase levels, have occurred in ≤1.0% of patients treated
with TECENTRIQ
•Symptomatic pancreatitis without an alternative etiology
occurred in 0.1% of patients across clinical trials
Other Immune-Related Adverse Reactions (cont)
•Monitor patients for clinical signs and symptoms of meningitis
or encephalitis, as well as symptoms of motor and sensory
neuropathy. Permanently discontinue TECENTRIQ for any grade
of meningitis or encephalitis, or any grade of myasthenic
syndrome/myasthenia gravis or Guillain-Barré syndrome
•Monitor patients for signs and symptoms of acute pancreatitis.
Withhold TECENTRIQ for ≥Grade 3 serum amylase or lipase
levels (>2.0 ULN), or Grade 2 or 3 pancreatitis. Permanently
discontinue for Grade 4 or any grade of recurrent pancreatitis
Infection
•Severe infections, including sepsis, herpes encephalitis, and
mycobacterial infection leading to retroperitoneal hemorrhage,
occurred in patients receiving TECENTRIQ
•In patients with NSCLC, infection occurred in 43% of patients
treated with TECENTRIQ compared with 34% of patients
treated with docetaxel. Grade 3 or 4 infection occurred in
9.2% of patients treated with TECENTRIQ compared with
2.2% with docetaxel. Two patients (1.4%) treated with
TECENTRIQ died. Pneumonia was the most common cause of
Grade 3 or higher infection, occurring in 7.7% of patients
•Monitor patients for signs and symptoms of infection and
treat with antibiotics for suspected or confirmed bacterial
infections. Withhold TECENTRIQ for ≥Grade 3 infection
Infusion-Related Reactions
•Severe infusion reactions have occurred in patients in clinical
trials of TECENTRIQ
•In patients with NSCLC, infusion-related reactions occurred in
1.6% of patients
•Interrupt or slow the rate of infusion in patients with Grade
2 infusion-related reactions. Permanently discontinue
TECENTRIQ in patients with Grade 3 or 4 infusion reactions
Embryo-Fetal Toxicity
•Based on its mechanism of action, TECENTRIQ can cause
fetal harm when administered to a pregnant woman. Advise
pregnant women or women planning to become pregnant
of the potential risk to the fetus. Advise females of
reproductive potential to use effective contraception during
treatment with TECENTRIQ and for at least 5 months after
the last dose of TECENTRIQ
Nursing Mothers
•Because of the potential for serious adverse reactions in
breastfed infants from TECENTRIQ, advise female patients
not to breastfeed while taking TECENTRIQ and for at least 5
months after the last dose
Most Common Adverse Reactions
The most common adverse reactions in NSCLC (rate ≥20%)
included fatigue (46%), decreased appetite (35%), dyspnea (32%),
cough (30%), nausea (22%), musculoskeletal pain (22%), and
constipation (20%).
You may report side effects to the FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch. You may also report side effects to
Genentech at 1-888-835-2555.
Please see accompanying full Prescribing Information for
additional Important Safety Information.
Please see full Prescribing Information for additional Important Safety Information.
Please see full Prescribing Information for additional Important Safety Information.
©2016 Genentech USA, Inc. All rights reserved.
25
References: 1. TECENTRIQ (atezolizumab) [package insert]. South San Francisco, CA: Genentech, Inc; 2016. 2. A randomized phase 3 study of
atezolizumab (an engineered anti-PDL1 antibody) compared to docetaxel in patients with locally advanced or metastatic non-small cell lung
cancer who have failed platinum therapy—”OAK.” ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT02008227?term=OAK&rank=2.
Updated September 1, 2016. Accessed October 2, 2016. 3. Data on file. Genentech, Inc. 4. A randomized phase 2 study of atezolizumab (an
engineered anti-PDL1 antibody) compared with docetaxel in patients with locally advanced or metastatic non-small cell lung cancer who have
failed platinum therapy—”POPLAR.” ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT01903993. Updated June 16, 2016. Accessed
October 2, 2016.
Please see Important Safety Information on pages 24-25 and in full Prescribing Information.
©2016 Genentech USA, Inc. All rights reserved. CA PDL/090116/0231 10/16 Printed in USA.