A Guide to Treatment

While there are data in this guide that are found within the product labeling, this guide also includes data and information regarding potential management strategies from post hoc analyses that are not included in the product labeling, and are indicated as such throughout.

INDICATION VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. SELECTED SAFETY INFORMATION There are no contraindications for VIZIMPRO

Interstitial Lung Disease (ILD): Severe and fatal ILD/pneumonitis occurred in patients treated with VIZIMPRO and occurred in 0.5% of the 394 VIZIMPRO-treated patients; 0.3% of cases were fatal. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold VIZIMPRO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue VIZIMPRO if ILD is confirmed.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com. Table of contents

Start the treatment plan with VIZIMPRO® (dacomitinib)...... Page 3 VIZIMPRO efficacy...... Page 6 VIZIMPRO safety profile...... Page 8 Dosing and administration...... Page 10 VIZIMPRO dose modifications and discontinuations in ARCHER 1050...... Page 11 Proactively monitor...... Page 12 Dose adjust...... Page 14 Management strategies for common adverse reactions Diarrhea...... Page 18 Stomatitis...... Page 20 Rash...... Page 22 Dry skin...... Page 24 Nail disorders...... Page 26 Resources for patients ...... Page 28 Important Safety Information...... Page 30

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

2 Efficacy

START THE TREATMENT PLAN WITH VIZIMPRO® (dacomitinib)

VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.1

START IN FIRST LINE Start with VIZIMPRO 45 mg oral tablets1 PROACTIVELY MONITOR Proactively monitor patients to help manage potential adverse reactions1

DOSE ADJUST If needed, modify the dose. VIZIMPRO is available in 3 doses: 45 mg, 30 mg, 15 mg1

SELECTED SAFETY INFORMATION Diarrhea: Severe and fatal diarrhea occurred in patients treated with VIZIMPRO. Diarrhea occurred in 86% of the 394 VIZIMPRO-treated patients. Grade 3 or 4 diarrhea was reported in 11% of patients and 0.3% of cases were fatal. Withhold VIZIMPRO for Grade 2 or greater diarrhea until recovery to less than or equal to Grade 1 severity, then resume VIZIMPRO at the same or a reduced dose depending on the severity of diarrhea. Promptly initiate anti-diarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

3 START IN FIRST LINE

VIZIMPRO® (dacomitinib) is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.1

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

4 ARCHER 1050 trial design1,2

Patients were randomized (1:1) to receive VIZIMPRO 45 mg (n=227) or gefitinib 250 mg (n=225) orally once daily until disease progression or unacceptable toxicity occurred.1

Patient population (N=452) Major efficacy outcome • Unresectable metastatic NSCLC with measure: Progression-free no prior therapy for metastatic disease, VIZIMPRO survival (PFS) as determined or recurrent disease with a minimum of 45 mg PO QD by blinded Independent 12 months disease-free after completion (n=227) Radiologic Central (IRC) of systemic therapy review per RECIST v1.1 • ECOG performance status of 0 or 1 1:1 • EGFR exon 19 deletion or exon 21 L858R Additional efficacy substitution mutations Gefitinib outcome measures: • Patients were excluded if they 250 mg PO QD PFS (investigator-assessed), had a history of interstitial lung (n=225) overall response rate (ORR) disease (ILD), interstitial pneumonitis, and duration of response or brain metastases (DOR) (per IRC), and overall survival (OS)

Stratification factors1 • EGFR mutation status (exon 19 deletion vs exon 21 L858R substitution mutation) • Region (Japanese vs mainland Chinese vs other East Asian vs non-East Asian)

In ARCHER 1050, subsequent systemic therapies for patients who progressed included chemotherapy, T790M inhibitors, and other agents.3

ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; NSCLC=non-small cell lung cancer; PO=by mouth; QD=once a day; RECIST=Response Evaluation Criteria in Solid Tumors.

SELECTED SAFETY INFORMATION Dermatologic Adverse Reactions: Rash and exfoliative skin reactions occurred in patients treated with VIZIMPRO. Rash occurred in 78% of the 394 VIZIMPRO-treated patients. Grade 3 or 4 rash was reported in 21% of patients. Exfoliative skin reactions of any severity were reported in 7% of patients. Grade 3 or 4 exfoliative skin reactions were reported in 1.8% of patients. Withhold VIZIMPRO for persistent Grade 2 or any Grade 3 or 4 dermatologic adverse reaction until recovery to less than or equal to Grade 1 severity, then resume VIZIMPRO at the same or a reduced dose depending on the severity of the dermatologic adverse reaction. The incidence and severity of rash and exfoliative skin reactions may increase with sun exposure. At the time of initiation of VIZIMPRO, initiate use of moisturizers and appropriate measures to limit sun exposure. Upon development of Grade 1 rash, initiate treatment with topical antibiotics and topical steroids. Initiate oral antibiotics for Grade 2 or more severe dermatologic adverse reactions.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

5 Efficacy

VIZIMPRO® (dacomitinib) demonstrated superior progression-free survival (PFS) vs gefitinib1

VIZIMPRO reduced the risk of progression or death by 41% vs gefitinib (per IRC)1

VIZIMPRO VIZIMPRO demonstrated a median 5.5-MONTH 14.7 months I: IMPROVEMENT 1 in median PFS vs gefitinib

HR=0.59 I: P 3 Geﬁtinib median Proaiit of Proressionree ria Proaiit of Proressionree 9.2 months I: ensored atients 3 3 Proressionree ria Months er of atients at ris VIZIMPRO 3 Geﬁtinib 3

Median PFS by investigator assessment was 16.6 months in the VIZIMPRO arm (95% CI: 12.9-18.4) and 11.0 months in the gefitinib arm (95% CI: 9.4-12.1) (HR=0.62; 95% CI: 0.50-0.78).2

IRC=Independent Radiologic Central.

SELECTED SAFETY INFORMATION Embryo-Fetal Toxicity: VIZIMPRO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with VIZIMPRO and for at least 17 days after the final dose.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

6 Efficacy

VIZIMPRO additional efficacy outcomes in ARCHER 1050 The hierarchical statistical testing order was PFS followed by ORR and then OS. No formal testing of OS was conducted, Safety since the formal comparison of ORR was not statistically significant.1

Overall response rate (per IRC)1 Duration of response (per IRC)1

A similar percentage of patients responded Among responders, duration of response was longer in to treatment in each arm patients who were treated with VIZIMPRO vs gefitinib MEDIAN MEDIAN VIZIMPRO Gefitinib VIZIMPRO Gefitinib I: I: 75% 72% 14.8 I: 8.3 I: MONTHS MONTHS P =0.39 (Not statistically significant)

The median OS for VIZIMPRO was 34.1 months1,3 The median represents a single point in time. It is important to consider the entire Kaplan-Meier curve when evaluating OS. Caution is required for the interpretation of descriptive OS results, as the hierarchical statistical testing procedure prevented formal assessment of the statistical significance of OS. This information should not be used to make comparisons between treatment arms.

1.0

0.9

0.8

0.7

0.6

0.5

0.4

0.3

Overall SurvivalOverall Distribution Function 0.2

0.1 VIZIMPRO Geﬁtinib + Censored patients 0.0 0 6 12 18 24 30 36 42 48 Overall Survival (Months) Number of patients at risk VIZIMPRO 227 206 188 167 138 77 14 3 0 Geﬁtinib 225 213 186 144 113 63 12 3 0

ORR=overall response rate; OS=overall survival. SELECTED SAFETY INFORMATION Adverse Reactions: The most common (>20%) adverse reactions were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%), and pruritus (21%). The most common (≥1%) serious adverse reactions were diarrhea (2.2%) and interstitial lung disease (1.3%).

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

7 Safety profile

Established safety profile The majority of adverse reactions were Grade 1 or 2 in severity1

Adverse reactions in ≥10% of VIZIMPRO-treated patients1*

VIZIMPRO (n=227) Gefitinib (n=224) Adverse Reaction All Grades (%)a Grades 3 & 4 (%) All Grades (%) Grades 3 & 4 (%) Additional adverse reactions (All Grades) with VIZIMPRO1: Gastrointestinal General: fatigue 9% Diarrheab 87 8 56 0.9 Skin and subcutaneous tissue: Stomatitisc 45 4.4 19 0.4 skin fissures 9%, hypertrichosis Nausea 19 1.3 22 0.4 1.3%, skin exfoliation/ Constipation 13 0 14 0 exfoliative skin reactions 3.5% Mouth ulceration 12 0 6 0 Gastrointestinal: vomiting 9% Skin and subcutaneous tissue Nervous system: dysgeusia 7% d Rash 69 23 47 0.4 Respiratory: interstitial lung Paronychiae 64 8 21 1.3 disease 2.6% Dry skinf 30 1.8 19 0.4 Ocular: keratitis 1.8% Alopecia 23 0.4 13 0 Pruritusg 21 0.9 15 1.3 Metabolism and nutrition: dehydration 1.3% Palmar-plantar erythrodysesthesia syndrome 15 0.9 3.1 0 Dermatitis 11 1.8 4 0.4 Metabolism and nutrition Decreased appetite 31 3.1 25 0.4 Decreased weight 26 2.2 17 0.4 *National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03. Respiratory aGrades 1 through 5 are included in Cough 21 0 19 0.4 All Grades. b Nasal mucosal disorderh 19 0 4.9 0 One Grade 5 (fatal) event in the VIZIMPRO arm. 13 2.2 13 1.8 Dyspnea cStomatitis includes mucosal inflammation Upper respiratory and stomatitis. tract infection 12 1.3 13 0 dRash includes dermatitis acneiform, rash, and rash maculo-papular. Chest pain 10 0 14 0 eParonychia includes nail infection, nail Eye toxicity, onychoclasis, onycholysis, onychomadesis, and paronychia. Conjunctivitis 19 0 4 0 fDry skin includes dry skin and xerosis. gPruritus includes pruritus, pruritus Musculoskeletal generalized, and rash pruritic. Pain in extremity 14 0 12 0 hNasal mucosal disorder includes epistaxis, nasal inflammation, nasal mucosal Musculoskeletal pain 12 0.9 13 0 disorder, nasal mucosal ulcer, and rhinitis.

General Asthenia 13 2.2 13 1.3

Psychiatric Insomnia 11 0.4 15 0

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8 Safety profile

Laboratory abnormalities worsening from baseline in >30% of patients1†

Laboratory abnormalities worsening from baseline in >30% of patients (all Grades VIZIMPRO % vs gefitinib %): anemia (44 vs 26), Administration Dosing and lymphopenia (42 vs 35), hypoalbuminemia (44 vs 34), increased alanine aminotransferase (ALT) (40 vs 63), hyperglycemia (36 vs 38), increased aspartate aminotransferase (AST) (35 vs 57), and hypocalcemia (33 vs 28).

Most common adverse reactions with VIZIMPRO1 The most common (>20%) adverse reactions in patients treated with VIZIMPRO were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%), and pruritus (21%). The most common (≥1%) serious adverse reactions were diarrhea (2.2%) and interstitial lung disease (1.3%).

Several of the most common adverse reactions seen with VIZIMPRO, including

Diarrhea Rash Paronychia Stomatitis Dry skin

are considered EGFR-mediated events4

The most common adverse reactions were generally managed with standard medical therapy and dose modifications.4

EGFR=epidermal growth factor receptor. †NCI CTCAE v4.03.

SELECTED SAFETY INFORMATION Drug Interactions: Concomitant use with a proton pump inhibitor (PPI) decreases dacomitinib concentrations, which may reduce VIZIMPRO efficacy. Avoid the concomitant use of PPIs with VIZIMPRO. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer VIZIMPRO at least 6 hours before or 10 hours after taking an H2-receptor antagonist. Concomitant use of VIZIMPRO increases the concentration of drugs that are CYP2D6 substrates which may increase the risk of toxicities of these drugs. Avoid concomitant use of VIZIMPRO with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

9 Dosing

Dosing and administration1 The recommended dose of VIZIMPRO is 45 mg

Available in 3 strengths for dosing flexibility

RECOMMENDED FIRST DOSE SECOND DOSE DOSE REDUCTION REDUCTION

45 mg once daily 30 mg once daily 15 mg once daily Not actual size.

OR VIZIMPRO should be taken at the same time each day. If the patient vomits or misses a dose, instruct VIZIMPRO can be taken with him or her not to take an additional dose or make or without food up a missed dose, but to continue with the next scheduled dose

Avoid the concomitant use of proton pump inhibitors (PPIs) with VIZIMPRO. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer VIZIMPRO at least 6 hours before or 10 hours after taking an H2-receptor antagonist.

Avoid the concomitant use of VIZIMPRO with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

SELECTED SAFETY INFORMATION Lactation: Because of the potential for serious adverse reactions in breastfed infants from VIZIMPRO, advise women not to breastfeed during treatment with VIZIMPRO and for at least 17 days after the last dose.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

10 Dosing

VIZIMPRO dose modifications and discontinuations in ARCHER 1050 (N=227)1

% Dose interruptions due 57 to adverse reactions

The most frequent (>5%) adverse reactions leading to dose interruptions Rash (23%) Paronychia (13%) Diarrhea (10%)

% Dose reductions due 66 to adverse reactions

The most frequent (>5%) adverse reactions leading to dose reductions Rash (29%) Paronychia (17%) Diarrhea (8%)

% Permanent discontinuation 18 due to adverse reactions

The most frequent (>0.5%) adverse reactions leading to permanent discontinuation (all causality) Rash (2.6%) ILD (1.8%) Stomatitis (0.9%) Diarrhea (0.9%)

ILD=interstitial lung disease. SELECTED SAFETY INFORMATION Geriatric: Exploratory analyses suggest a higher incidence of Grade 3/4 adverse reactions and more frequent dose interruptions and discontinuations for adverse reactions in patients 65 years or older.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

11 PROACTIVELY MONITOR

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com. The following data reflect a post hoc pooled safety analysis of 255 patients with EGFR mutation-positive advanced NSCLC who received VIZIMPRO 45 mg/day as first-line therapy. The population comprised 225* patients from ARCHER 1050 and 30 patients from a single-arm trial (Study A7471017). This pooled safety analysis was conducted to analyze incidence and management of key adverse drug reactions associated with VIZIMPRO and is not included in the product labeling.4

Proactive monitoring and management of adverse reactions are important considerations and are recommended for all patients.1

In addition to implementing management guidelines, proactive counseling of patients regarding the types of side effects to expect is integral to patient care.4

Median time to onset of first event (any grade) of most common adverse reactions (N=255)4,5

Diarrhea Nail disorder 7 days Rash 48 days (Range: 1-578) 12 days (Range: 7-812) (Range: 2-521)

Day 1 Day 60

Stomatitis Dry skin 8 days 50 days (Range: 2-666) (Range: 2-673)

Cycle 1 Cycle 2

For more detailed information on the most common adverse reactions, view pages 18-27.

• Based on the onset of the most common adverse events, it is recommended to check in with patients often during the first 2 cycles of therapy4

EGFR=epidermal growth factor receptor; NSCLC=non-small cell lung cancer. *Two patients in the ARCHER 1050 safety population did not receive VIZIMPRO as first-line therapy.5

SELECTED SAFETY INFORMATION Hepatic Impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. The recommended dose of VIZIMPRO has not been established for patients with severe hepatic impairment.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

13 DOSE ADJUST

SELECTED SAFETY INFORMATION Renal Impairment: No dose adjustment is recommended for patients with mild or moderate renal impairment. The recommended dose of VIZIMPRO has not been established for patients with severe renal impairment.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

14 The following data reflect a post hoc analysis that included 227 patients with EGFR mutation-positive advanced NSCLC who received VIZIMPRO 45 mg/day as first-line therapy from the ARCHER 1050 study.1,6 This analysis was conducted to evaluate the reasons for VIZIMPRO dose reductions and examine the incidence of adverse reactions and key efficacy endpoints in dose-reducing patients in the ARCHER 1050 trial and is not included in the product labeling. ARCHER 1050 was not designed to assess frequency or severity of adverse reactions in patients following dose reductions.1,6 This post hoc analysis was not prespecified and was exploratory. Since all patients started at a dose of 45 mg QD, no conclusions can be made as to the potential efficacy of starting doses of either 30 mg QD or 15 mg QD.6

Of patients in ARCHER 1050:

Maintained 45-mg starting dose % 34 1/3 of patients required no dose reductions n

Reduced to 30 mg as lowest dose 38% Median time to dose reduction was 12.9 weeks n 45 mg 30 mg ees

Further reduced to 15 mg as lowest dose % Median time to ﬁrst dose reduction to 30 mg was 8.4 weeks; 28 median time to subsequent reduction to 15 mg was 12.4 weeks n3 45 mg 30 mg 15 mg ees ees

Most common adverse reactions leading to dose reductions6 n (%)

Skin toxicities* 94 (62.7)

Dermatitis acneiform 46 (30.7)

Paronychia 38 (25.3)

Diarrhea* 21 (14.0)

*Skin toxicities was a compound term consisting of two clustered terms: other skin toxicity (dry skin, nail disorder, palmar-plantar erythrodysesthesia syndrome, paronychia, skin fissures, skin ulcer, or xerosis) and rash/dermatitis acneiform (any reported preferred term within high-level term acnes plus Medical Dictionary for Regulatory Activities [MedDRA] preferred terms, including drug eruption, rash, rash erythematous, rash generalized, rash maculo-papular, or rash pruritic). Diarrhea was a clustered term encompassing acute prerenal failure, azotemia, dehydration, diarrhea, blood urea nitrogen/creatinine ratio increased, electrolyte imbalance, hypovolemia, and prerenal failure.6 EGFR=epidermal growth factor receptor; NSCLC=non-small cell lung cancer; QD=once daily. Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

15 The following data reflect a post hoc analysis that included 227 patients with EGFR mutation-positive advanced NSCLC who received VIZIMPRO 45 mg/day as first-line therapy from the ARCHER 1050 study.1,6 This analysis was conducted to evaluate the reasons for VIZIMPRO dose reductions and examine the incidence of adverse reactions and key efficacy endpoints in dose-reducing patients in the ARCHER 1050 trial and is not included in the product labeling. ARCHER 1050 was not designed to assess frequency or severity of adverse reactions in patients following dose reductions.1,6 This post hoc analysis was not prespecified and was exploratory. Since all patients started at a dose of 45 mg QD, no conclusions can be made as to the potential efficacy of starting doses of either 30 mg QD or 15 mg QD.6

EGFR=epidermal growth factor receptor; NSCLC=non-small cell lung cancer; QD=once daily.

SELECTED SAFETY INFORMATION Interstitial Lung Disease (ILD): Severe and fatal ILD/pneumonitis occurred in patients treated with VIZIMPRO and occurred in 0.5% of the 394 VIZIMPRO-treated patients; 0.3% of cases were fatal. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold VIZIMPRO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue VIZIMPRO if ILD is confirmed.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

16 Dose reduction data in ARCHER 1050 (N=227)6 In some patients, VIZIMPRO dose reductions helped to manage adverse reactions without the need for permanent discontinuation while maintaining efficacy.6 Safety data For patients with VIZIMPRO dose reductions, frequency and severity of adverse reactions of interest (diarrhea, dermatitis acneiform, stomatitis, and paronychia) before and after dose reduction from 45 mg QD were analyzed by NCI CTCAE grade. • Among patients who dose reduced, all patients (n=150) experienced all-causality adverse reactions prior to dose reduction; 37 patients who dose reduced did so due to a Grade 3 adverse reaction6

Grade 3 adverse reactions with dose reduction (n=150)6

efore dose redction fter dose redction 15.3

11.3

atients 7.3

P 6.7 4.7 4.0* 3.3 2.7

iarrhea† eratitis toatitis Paronchia cneifor

• There were no Grade 4 reactions of interest in VIZIMPRO-treated patients who had a dose reduction6 • For recurrent Grade 2 diarrhea, withhold VIZIMPRO until recovery to ≤Grade 1, then resume VIZIMPRO at a reduced dose1

*One Grade 5 event occurred after dose reduction and is not included in this percentage. †Clustered term encompassing acute prerenal failure, azotemia, dehydration, diarrhea, blood urea nitrogen/creatinine ratio increased, electrolyte imbalance, hypovolemia, and prerenal failure. NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; QD=once daily.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

17 Management Strategies for Common Adverse Reactions

The following data reflect a post hoc pooled safety analysis of 255 patients with EGFR mutation-positive advanced NSCLC who received VIZIMPRO 45 mg/day as first-line therapy. The population comprised 225* patients from ARCHER 1050 and 30 patients from a single- arm trial (Study A7471017).4 This pooled safety analysis was conducted to analyze incidence and management of key adverse drug reactions associated with VIZIMPRO and is not included in the product labeling.4

Management strategies for common adverse reactions

Diarrhea (N=255)4

Grade Definition7† Incidence4

1 Increase of <4 stools per day over baseline 51%

2 Increase of 4-6 stools per day over baseline 28%

Increase of ≥7 stools per day over baseline OR incontinence 3 OR hospitalization indicated OR limiting self-care ADLs 9%

4 Life-threatening consequences 0%

5 Death 0.4%

*Two patients in the ARCHER 1050 safety population did not receive VIZIMPRO as first-line therapy.5 †National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

• Severe and fatal diarrhea occurred in patients treated with VIZIMPRO; one case of Grade 5 diarrhea occurred in a patient who had not sought antidiarrheal management1,4

Median time to onset of first event Dose modifications4 (any grade)4,5

7 days Reduction Interruption Discontinuation (Range: 1-578) 7% 10% 0.8%

% of VIZIMPRO-treated patients experienced the onset 74 of diarrhea in the first cycle4

ADLs=activities of daily living; EGFR=epidermal growth factor receptor; NSCLC=non-small cell lung cancer. Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

18 Management Strategies for Common Adverse Reactions

The following management strategies include those found within the product labeling as well as additional management considerations not included in but consistent with the product labeling.

Management strategies for diarrhea1,7

Grade 1 Grade 2 Grade 3 Grade 4

Continue VIZIMPRO Withhold VIZIMPRO1 Withhold VIZIMPRO1 at same dose1

Start loperamide When symptoms Consider Hospitalize patient at 4 mg at first improve to Grade ≤1, hospitalization for maximal fluid and onset and increase resume VIZIMPRO at if no improvement nutritional support7 dose as necessary7 the same dose1 to Grade 2 within 24 hours and/or Stomatitis Managing presence of fever, For recurrent cases, abdominal pain, or Initiate antibiotics as withhold until recovery severe dehydration7 indicated for fever, to Grade ≤1, then leukocytosis, or resume at a reduced marked dehydration7 dose1

Consider Upon improvement to Grade ≤1, diphenoxylate 1 hydrochloride and resume VIZIMPRO at a reduced dose KEY atropine sulfate at standard doses7 Strategies from the Prescribing Information1 Strategies from a peer- Follow general For Grade 3, consider reviewed publication7 management advice7 subcutaneous octreotide7‡

‡100-150 micrograms subcutaneously twice daily with escalation to 500 micrograms three times daily.7

GENERAL MANAGEMENT STRATEGIES • Begin antidiarrheal treatment at time of symptom onset1,7; continue until 12 hours after resolution7 • If necessary, escalate antidiarrheals to the highest recommended approved dose7 • Administer intravenous fluids and electrolytes for dehydration7 • Recommend: – Eliminating lactose from diet if evidence of lactose intolerance7 – Frequent small low-fat meals to decrease stool frequency7 – 2 L clear liquids per day to combat dehydration7

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

19 Management Strategies for Common Adverse Reactions

Stomatitis (N=255)4

Grade Definition7* Incidence4

1 Asymptomatic or mild symptoms 42%

Moderate pain, not interfering with oral intake; 2 modified diet indicated 25%

3 Severe pain, interfering with oral intake 4%

Life-threatening consequences; 4 urgent intervention indicated 0.4%

*National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Median time to onset of first event Dose modifications4 (any grade)4,5

8 days Reduction Interruption Discontinuation (Range: 2-666) 5% 9% 0.4%

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

20 Management Strategies for Common Adverse Reactions

The following management strategies include those found within the product labeling as well as additional management considerations not included in but consistent with the product labeling.

Management strategies for stomatitis1,7,8

Grade 1 Grade 2 Grade 3 Grade 4

Withhold VIZIMPRO until Grade ≤21

Continue VIZIMPRO at same dose1

Resume VIZIMPRO at a reduced dose1

Apply triamcinolone Apply triamcinolone Consider nutritional consultation if there in dental paste in dental paste 2-3 is reduced caloric intake7 8 2-3 times daily times daily as needed Consider adding topical anesthetics 8 as needed AND or systemic analgesics7 Oral erythromycin Consider topical steroid rinses

8 Rash Managing 250-350 mg daily (eg, dexamethasone 0.5 mg/5 mL)7 OR KEY Apply clobetasol ointment Minocycline 2-3 times daily as needed8 Strategies from the 50 mg daily8 Prescribing Information1 AND 8 Strategies from peer- Oral erythromycin 500 mg daily reviewed publications7,8 OR and government 8 publications9,10 Minocycline 100 mg daily

GENERAL MANAGEMENT STRATEGIES Advise patients to: • Regularly rinse with warm water and nonmedicated saline, sip water during meals, and avoid chlorhexidine-containing oral products7 • Practice good mouth care, such as using a soft toothbrush to gently brush the teeth7 • Eat foods cold or at room temperature, and try to eat soft, soothing, and moist food, such as mashed potatoes or scrambled eggs9 • Avoid acidic or irritating juices and foods, spicy or salty foods, and rough or coarse foods like raw vegetables, granola, or crackers. Drink plenty of water, using a straw9,10

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

21 Management Strategies for Common Adverse Reactions

Rash (N=255)4*

Grade Definition7† Incidence4

<10% of BSA papules and/or pustules (with or without 1 symptoms of pruritus or tenderness) 20%

10% to 30% of BSA papules and/or pustules (with or without 2 symptoms of pruritus or tenderness) OR 37% psychosocial impact OR limiting instrumental ADLs

>30% of BSA papules and/or pustules (with or without symptoms of pruritus or tenderness) OR limiting self-care ADLs 3 OR associated with local superinfection with oral 26% antibiotics indicated

Papules and/or pustules covering any % BSA, which may or may not be associated with symptoms of pruritus or tenderness 4 and are associated with extensive superinfection with 0% IV antibiotics indicated; life-threatening consequences

*Group term comprised of any reported PTs within the HLT acnes or within the HLT rashes, eruptions and exanthems NEC, plus the PTs erythema, erythema multiforme, palmar-plantar erythrodysesthesia syndrome, pruritus, rash erythematous, and rash pruritic.7 †National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Median time to onset of first event Dose modifications4 (any grade)4,5

12 days Reduction Interruption Discontinuation (Range: 2-521) 33% 27% 2%

ADLs=activities of daily living; BSA=body surface area; HLT=high-level term; NEC=not elsewhere classifiable; PT=preferred term. Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

22 Management Strategies for Common Adverse Reactions

The following management strategies include those found within the product labeling as well as additional management considerations not included in but consistent with the product labeling.

Management strategies for rash1,7,11

Grade 1 Grade 2 Grade 3 Grade 4

1 Withhold VIZIMPRO Withhold VIZIMPRO Continue VIZIMPRO for persistent at same dose1 Grade 2 symptoms1 Once symptoms improve to Grade ≤1, resume VIZIMPRO at a reduced dose1 Upon recovery to Grade ≤1, resume at Add emollients and same dose1 topical antibiotic, Oral antibiotic7 Additional as appropriate7 For recurrent High-potency class management steps persistent Grade I–II topical steroids based on 7 2 events, withhold (eg, clobetasol 0.05% clinical judgment VIZIMPRO until cream, fluocinonide recovery to Grade ≤1, 0.05% cream) can be and then resume at a used for short periods 1 reduced dose of time, in combination with oral antibiotics11 If evidence of KEY infection (eg, purulent Oral antibiotic for ≥4 discharge or pain), Strategies from the weeks (stop topical)7 Prescribing Information1 switch to broad- Strategies from peer- Continue topical spectrum antibiotic 7,11 7 reviewed publications steroid with gram-negative Skin Dry Managing coverage for ≥10 days7 Consider skin swab Mild class VI-VII topical steroid (eg, desonide and referral to 0.05% cream, hydrocortisone 2.5% cream)11 dermatologist7

GENERAL MANAGEMENT STRATEGIES • An unscented emollient, such as Eucerin®, can be used prophylactically before starting VIZIMPRO and continuously throughout treatment7 • Patients should avoid excessive exposure to hot water and avoid household activities that require immersion in hot water, detergent, or solvents7 • Adverse drug reactions may be worse in sun-exposed areas. Patients should avoid prolonged sun exposure and wear protective clothing and apply an SPF ≥30 every 2 hours when outdoors7

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

23 Management Strategies for Common Adverse Reactions

Dry skin (N=255)4

Grade Definition7* Incidence4

1 <10% of BSA and no associated erythema or pruritus 22%

10% to 30% of BSA and associated with erythema or pruritus 2 OR limiting instrumental ADLs 10%

>30% of BSA and associated with pruritus OR 3 limiting self-care ADLs 2%

*National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Median time to onset of first event Dose modifications4 (any grade)4,5

50 days Reduction Interruption Discontinuation (Range: 2-673) 3% 2% 0%

ADLs=activities of daily living; BSA=body surface area. Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

24 Management Strategies for Common Adverse Reactions

The following management strategies include those found within the product labeling as well as additional management considerations not included in but consistent with the product labeling.

Management strategies for dry skin1,7

Grade 1 Grade 2 Grade 3

Continue VIZIMPRO Withhold VIZIMPRO for Withhold VIZIMPRO1 at same dose1 persistent Grade 2 symptoms1

Upon recovery to Grade ≤1, resume at same dose1 Once improved to Grade ≤1, KEY For recurrent persistent resume VIZIMPRO at Strategies from the Grade 2 events, withhold a reduced dose1 Prescribing Information1 VIZIMPRO until recovery to Strategies from peer- Grade ≤1, and then resume reviewed publications7,11 at a reduced dose1

OTC moisturizing cream for the face BID7 Moderate-/Low-strength Ammonium lactate 12% (or equivalent) cream or topical steroid‡ 2x daily to salicylic acid 6%† cream BID for the body7 any red, inflamed areas7

GENERAL MANAGEMENT STRATEGIES Measures to reduce the occurrence of dry skin should be initiated before the start of VIZIMPRO: • An unscented emollient skin cream should be used prophylactically to moisturize skin before the first dose of VIZIMPRO and continuously throughout treatment7 • Recommend patients use bland emollients and keratolytics (urea, ammonium lactate, salicylic acid, or lactic acid) and avoid abrasive soaps11 • Patients should avoid excessive exposure to hot water and avoid household activities that require 7

immersion in hot water, detergent, or solvents Nail Disorders Managing • Adverse drug reactions may be worse in sun-exposed areas. Patients should avoid prolonged sun exposure and wear protective clothing and apply an SPF ≥30 every 2 hours when outdoors7 • If accompanied by itching, manage with topical steroids and antihistamines (eg, cetirizine, fexofenadine, hydroxyzine)11

†Grade 2 only. ‡ Moderate-/Low-strength steroids include: triamcinolone acetonide 0.025%; desonide 0.05% cream or lotion; alclometasone 0.05% ointment; fluticasone propionate 0.05%.7

BID=twice daily; OTC=over-the-counter. Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

25 Management Strategies for Common Adverse Reactions

Nail disorders (N=255)4*

Grade Definition7† Incidence4

1 Nail fold edema or erythema; disruption of the cuticle 22%

Localized intervention indicated; oral intervention indicated (eg, antibiotic, antifungal, antiviral) OR nail fold edema or 2 erythema with pain OR associated with discharge or nail plate 35% separation OR limiting instrumental ADLs

Specialist intervention or IV antibiotics indicated 3 OR limiting self-care ADLs 9%

*Group term comprised of any reported PTs within the HLT nail and nail bed conditions (excluding infections and infestations), plus the PTs paronychia and nail infection.7 †National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Median time to onset of first event Dose modifications4 (any grade)4,5

48 days Reduction Interruption Discontinuation (Range: 7-812) 16% 13% 0%

ADLs=activities of daily living; HLT=high-level term; PT=preferred term.

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

26 Management Strategies for Common Adverse Reactions

The following management strategies include those found within the product labeling as well as additional management considerations not included in but consistent with the product labeling.

Management strategies for nail disorders1,7,11

Grade 1-2 Grade 3

Continue VIZIMPRO at same dose1 Withhold VIZIMPRO1

Once improved to Grade ≤2, resume VIZIMPRO at a 1 Topical or oral antibiotics7 reduced dose Potent topical steroid cream or ointment if no clear infection11 Daily soaking of fingers/toes in 10% white vinegar and water for 15 minutes every day7 Potent topical steroids11 For Grade ≥2 reactions, consider applying silver nitrate7 Systemic antimicrobials11

KEY Strategies from the Prescribing Information1 Obtain specialist consultation 7 Strategies from peer- as needed reviewed publications7,11

GENERAL MANAGEMENT STRATEGIES • For all nail disorders, consider tissue culture/swab for bacterial or fungal infection if no improvement within 1 week of treatment. Topical antibiotics include clindamycin 1% or erythromycin 1%7 Patients Resources for

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

27 Resources for Patients

VIZIMPRO® (dacomitinib) Patient Starter Kit The VIZIMPRO Patient Starter Kit contains products and information that may help patients start and stay on VIZIMPRO.

Components of the Patient Starter Kit:

Moisturizing cream for dry or rough skin

Antidiarrheal tablets

• Welcome letter • Patient brochure • Over-the-counter product information card • Educational brochure on what to expect during treatment with VIZIMPRO • Access/Financial support brochure

Please see Important Safety Information on page 30. Please see Full Prescribing Information at VIZIMPROhcp.com.

28 Important Safety Information

ogether.com † VISIT PﬁzerOncologyT ET) PM PERSONALIZED PATIENT SUPPORT PATIENT PERSONALIZED day-to-day their need support for patients When a dedicated with them provide can we challenges, experience. work has who social Champion Care patients to listen to here are Champions Care Our help may that resources to connect them and and educational, emotional, certain with practical needs. –8 29 AM T he offer will be accepted only at participating pharmacies. This offer is not riday 8

, patient support is at the core of everything we do. We’ve gathered gathered We’ve do. we everything of core the at support is , patient TM 1-877-744-5675 (Monday–F all OR LIVE, PERSONALIZED SUPPOR No membership fees apply. Pfizer reserves the right to rescind, revoke, or amend this offer without notice.Terms For full and Conditions, F C

please see PfizerOncologyTogether.com/terms. For any questions, please call 1-877-744-5675, visit PfizerOncologyTogether.com/terms or write: Pfizer Pfizer write: or PfizerOncologyTogether.com/terms visit 1-877-744-5675, pleasequestions, call any For please PfizerOncologyTogether.com/terms. see Oncology Together Co-Pay Savings Program, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan availablePuerto in Rico. Patients may receive up to $25,000 in savings annually. T health insurance.health Some services are provided through third-party organizations that operate independently and are not controlledare determined by Pfizer. solely Availability by these organizations. of services and eligibility requirements understand their insurance benefits and connect benefits and insurance their understand resources, assistance financial with them Eligible, coverage. insurance their of regardless as little pay may patients insured commercially terms, Limits, VIZIMPRO. for as month per $0 identify help also can We apply.* conditions and Medicaid, Medicare, with patients for resources who those for or insurance, government other health have insurance. don’t PATIENT FINANCIAL ASSISTANCE FINANCIAL PATIENT patients help can Together Pfizer Oncology † * Making your patients’ support needs a priority. Together. a priority. needs support patients’ your Making Together Pfizer Oncology At resources and developed tools to help patients and their loved ones throughout VIZIMPRO treatment. treatment. VIZIMPRO throughout ones loved their and patients help to tools developed and resources emotional for resources to patients connecting to options assistance financial identify to helping From priority. our are needs patients’ support, your Resources for Patients for Resources Important Safety Information

IMPORTANT SAFETY INFORMATION There are no contraindications for VIZIMPRO

Interstitial Lung Disease (ILD): Severe and fatal ILD/pneumonitis Drug Interactions: Concomitant use with a proton pump inhibitor occurred in patients treated with VIZIMPRO and occurred in 0.5% (PPI) decreases dacomitinib concentrations, which may reduce of the 394 VIZIMPRO-treated patients; 0.3% of cases were fatal. VIZIMPRO efficacy. Avoid the concomitant use of PPIs with Monitor patients for pulmonary symptoms indicative of ILD/ VIZIMPRO. As an alternative to PPIs, use locally-acting antacids pneumonitis. Withhold VIZIMPRO and promptly investigate for ILD or an H2-receptor antagonist. Administer VIZIMPRO at least 6 in patients who present with worsening of respiratory symptoms hours before or 10 hours after taking an H2-receptor antagonist. which may be indicative of ILD (e.g., dyspnea, cough, and fever). Concomitant use of VIZIMPRO increases the concentration of Permanently discontinue VIZIMPRO if ILD is confirmed. drugs that are CYP2D6 substrates which may increase the risk of toxicities of these drugs. Avoid concomitant use of VIZIMPRO Diarrhea: Severe and fatal diarrhea occurred in patients treated with CYP2D6 substrates where minimal increases in concentration with VIZIMPRO. Diarrhea occurred in 86% of the 394 VIZIMPRO- of the CYP2D6 substrate may lead to serious or life-threatening treated patients. Grade 3 or 4 diarrhea was reported in 11% of toxicities. patients and 0.3% of cases were fatal. Withhold VIZIMPRO for Grade 2 or greater diarrhea until recovery to less than or equal Lactation: Because of the potential for serious adverse reactions to Grade 1 severity, then resume VIZIMPRO at the same or a in breastfed infants from VIZIMPRO, advise women not to reduced dose depending on the severity of diarrhea. Promptly breastfeed during treatment with VIZIMPRO and for at least 17 initiate anti-diarrheal treatment (loperamide or diphenoxylate days after the last dose. hydrochloride with atropine sulfate) for diarrhea. Geriatric: Exploratory analyses suggest a higher incidence of Grade Dermatologic Adverse Reactions: Rash and exfoliative skin 3/4 adverse reactions and more frequent dose interruptions and reactions occurred in patients treated with VIZIMPRO. Rash discontinuations for adverse reactions in patients 65 years or older. occurred in 78% of the 394 VIZIMPRO-treated patients. Grade Hepatic Impairment: No dose adjustment is recommended 3 or 4 rash was reported in 21% of patients. Exfoliative skin in patients with mild or moderate hepatic impairment. The reactions of any severity were reported in 7% of patients. Grade 3 recommended dose of VIZIMPRO has not been established for or 4 exfoliative skin reactions were reported in 1.8% of patients. patients with severe hepatic impairment. Withhold VIZIMPRO for persistent Grade 2 or any Grade 3 or Renal Impairment: No dose adjustment is recommended 4 dermatologic adverse reaction until recovery to less than or for patients with mild or moderate renal impairment. The equal to Grade 1 severity, then resume VIZIMPRO at the same or recommended dose of VIZIMPRO has not been established for a reduced dose depending on the severity of the dermatologic patients with severe renal impairment. adverse reaction. The incidence and severity of rash and exfoliative skin reactions may increase with sun exposure. At the time of initiation of VIZIMPRO, initiate use of moisturizers and appropriate INDICATION measures to limit sun exposure. Upon development of Grade 1 VIZIMPRO is indicated for the first-line treatment of patients rash, initiate treatment with topical antibiotics and topical steroids. with metastatic non-small cell lung cancer (NSCLC) with Initiate oral antibiotics for Grade 2 or more severe dermatologic epidermal growth factor receptor (EGFR) exon 19 deletion or adverse reactions. exon 21 L858R substitution mutations as detected by an FDA- approved test. Embryo-Fetal Toxicity: VIZIMPRO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of Please see Full Prescribing Information for VIZIMPRO. the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with VIZIMPRO and for at least 17 days after the final dose.

Adverse Reactions: The most common (>20%) adverse reactions were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%), and pruritus (21%). The most common (≥1%) serious adverse reactions were diarrhea (2.2%) and interstitial lung disease (1.3%).

30 VIZIMPRO is indicated for the START THE TREATMENT PLAN first-line treatment of patients with metastatic non-small cell lung ® cancer (NSCLC) with epidermal WITH VIZIMPRO (dacomitinib) growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.1

START IN PROACTIVELY DOSE ADJUST FIRST LINE MONITOR If needed, modify the dose. Start with Proactively monitor patients VIZIMPRO is available in VIZIMPRO 45 mg to help manage potential 3 doses: 45 mg, 30 mg, oral tablets1 adverse reactions1 15 mg1

• The most common (>20%) adverse reactions in patients treated with VIZIMPRO were diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%), and pruritus (21%)1 • The most common (≥1%) serious adverse reactions for VIZIMPRO were diarrhea (2.2%) and interstitial lung disease (1.3%)1 • The most common (>20%) adverse reactions for gefitinib were diarrhea (56%), rash (47%), decreased appetite (25%), nausea (22%), and paronychia (21%)1

REFERENCES 1. VIZIMPRO Prescribing Information. New York, NY: Pfizer Inc.2. Wu YL, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib as first-line treatment for patients withEGFR - mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(11):1454-1466. 3. Mok TS, Cheng Y, Zhou X, et al. Improvement in overall survival in a randomized study that compared dacomitinib with gefitinib in patients with advanced non–small-cell lung cancer andEGFR -activating mutations. J Clin Oncol. 2018;36(22):2244-2250. 4. Zhou Q, Wu Y-L, Corral J, et al. Management of common adverse events related to first-line dacomitinib use inEGFR mutation- positive non-small-cell lung cancer: a pooled safety analysis [published online March 6, 2019]. Future Oncol. 2019;15(13):1481-1491. doi:10.2217/fon-2018-0944. 5. Data on file. Pfizer Inc, New York, NY.6. Corral J, Mok TS, Nakagawa K, et al. Effects of dose modifications on the safety and efficacy of dacomitinib EGFRfor mutation-positive non-small-cell lung cancer [published online July 17, 2019]. Future Oncol. 2019;15(24):2795-2805. doi:10.2217/fon-2019-0299. 7. Supplement to: Zhou Q, Wu YL, Corral J, et al. Management of common adverse events related to first-line dacomitinib use inEGFR mutation-positive non-small-cell lung cancer: a pooled safety analysis [published online March 6, 2019]. Future Oncol. 2019;15(13):1481-1491. doi:10.2217/fon-2018-0944. 8. Melosky B, Leighl NB, Rothenstein J, Sangha R, Stewart D, Papp K. Management of EGFR TKI–induced dermatologic adverse events. Curr Oncol. 2015;22(2):123-132. 9. National Cancer Institute. Chemotherapy and You. Bethesda, MD: NCI Office of Communications and Public Liaison; 2018. https://www.cancer.gov/publications/patient-education/chemotherapy-and-you.pdf. Accessed November 10, 2019. 10. National Cancer Institute. Eating hints: Before, during, and after Cancer Treatment. Bethesda, MD: NCI Office of Communications and Public Liaison; 2018. https://www.cancer.gov/publications/patient-education/ eatinghints.pdf. Accessed November 10, 2019. 11. Guggina LM, Choi AW, Choi JN. EGFR inhibitors and cutaneous complications: a practical approach to management. Oncol Ther. 2017;5(2):135-148.

SELECTED SAFETY INFORMATION There are no contraindications for VIZIMPRO Interstitial Lung Disease (ILD): Severe and fatal ILD/pneumonitis occurred in patients treated with VIZIMPRO and occurred in 0.5% of the 394 VIZIMPRO-treated patients; 0.3% of cases were fatal. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold VIZIMPRO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue VIZIMPRO if ILD is confirmed. Diarrhea: Severe and fatal diarrhea occurred in patients treated with VIZIMPRO. Diarrhea occurred in 86% of the 394 VIZIMPRO-treated patients. Grade 3 or 4 diarrhea was reported in 11% of patients and 0.3% of cases were fatal. Withhold VIZIMPRO for Grade 2 or greater diarrhea until recovery to less than or equal to Grade 1 severity, then resume VIZIMPRO at the same or a reduced dose depending on the severity of diarrhea. Promptly initiate anti-diarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea.

Please see Important Safety Information on page 30. Please see Full Prescribing Visit VIZIMPROhcp.com Information at VIZIMPROhcp.com.