Vizimpro

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 
 



2 

This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions.  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vizimpro 15 mg film-coated tablets 
Vizimpro 30 mg film-coated tablets 
Vizimpro 45 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION  
 
Vizimpro 15 mg film-coated tablets 
Each film-coated tablet contains dacomitinib monohydrate equivalent to 15 mg dacomitinib. 
 
Excipients with known effect 
Each film-coated tablet contains 40 mg of lactose monohydrate. 
 
Vizimpro 30 mg film-coated tablets  
Each film-coated tablet contains dacomitinib monohydrate equivalent to 30 mg dacomitinib. 
 
Excipients with known effect 
Each film-coated tablet contains 81 mg of lactose monohydrate. 
 
Vizimpro 45 mg film-coated tablets  
Each film-coated tablet contains dacomitinib monohydrate equivalent to 45 mg dacomitinib. 

 
Excipients with known effect 
Each film-coated tablet contains 121 mg of lactose monohydrate. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Vizimpro 15 mg film-coated tablets 
Blue film-coated, 6.35 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB15” 
on the other. 
 
Vizimpro 30 mg film-coated tablets  
Blue film-coated, 7.5 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on 
the other. 
 
Vizimpro 45 mg film-coated tablets  
Blue film-coated, 9.0 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on 
the other. 
 
 



3 

4. CLINICAL PARTICULARS  
 
4.1 Therapeutic indications 
 
Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally 
advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor 
(EGFR)-activating mutations.  
 
4.2 Posology and method of administration  
 
Treatment with Vizimpro should be initiated and supervised by a physician experienced in the use of 
anticancer medicinal products. 
 
EGFR mutation status should be established prior to initiation of dacomitinib therapy (see section 4.4). 
 
Posology 
 
The recommended dose of Vizimpro is 45 mg taken orally once daily, until disease progression or 
unacceptable toxicity occurs.    
 
Patients should be encouraged to take their dose at approximately the same time each day. If the 
patient vomits or misses a dose, an additional dose should not be taken and the next prescribed dose 
should be taken at the usual time the next day.  
 
Dose modifications 
Dose modifications may be required based on individual safety and tolerability. If dose reduction is 
necessary, then the dose of Vizimpro should be reduced as described in Table 1. Dose modification 
and management guidelines for specific adverse reactions are provided in Table 2 (see sections 4.4 and 
4.8). 
 
Table 1. Recommended dose modifications for Vizimpro adverse reactions  
 
Dose level Dose (once daily) 
Recommended starting dose 45 mg  
First dose reduction 30 mg 
Second dose reduction 15 mg 
 



4 

Table 2. Dose modification and management for Vizimpro adverse reactions 

 
Adverse reactions Dose modification 
Interstitial lung disease 
(ILD/Pneumonitis) 

 Withhold dacomitinib during ILD/Pneumonitis diagnostic evaluation.  
 Permanently discontinue dacomitinib if ILD/Pneumonitis is 

confirmed. 
Diarrhoea 
 

 For Grade 1 diarrhoea, no dose modification is required. Initiate 
treatment with anti-diarrhoeal medicinal products (e.g., loperamide) at 
first onset of diarrhoea. Encourage adequate oral fluid intake during 
diarrhoea. 

 For Grade 2 diarrhoea, if not improved to Grade ≤ 1 within 24 hours 
while using anti-diarrhoeal medicinal products (e.g., loperamide) and 
adequate oral fluid intake, withhold dacomitinib. Upon recovery to 
Grade ≤ 1, resume dacomitinib at the same dose level or consider a 
reduction of 1 dose level. 

 For Grade ≥ 3 diarrhoea, withhold dacomitinib. Treat with 
anti-diarrhoeal medicinal products (e.g., loperamide), and adequate 
oral fluid intake or intravenous fluids or electrolytes as appropriate. 
Upon recovery to Grade ≤ 1, resume dacomitinib with a reduction of 
1 dose level. 

Skin-related adverse 
reactions 

 For Grade 1 rash or erythematous skin conditions, no dose 
modification is required. Initiate treatment (e.g., antibiotics, topical 
steroids, and emollients). 

 For Grade 1 exfoliative skin conditions, no dose modification is 
required. Initiate treatment (e.g., oral antibiotics and topical steroids). 

 For Grade 2 rash, erythematous or exfoliative skin conditions, no dose 
modification is required. Initiate treatment or provide additional 
treatment (e.g., oral antibiotics and topical steroids).  

 If Grade 2 rash, erythematous or exfoliative skin conditions persist for 
72 hours despite treatment, withhold dacomitinib. Upon recovery to 
Grade ≤ 1, resume dacomitinib at the same dose level or consider a 
reduction of 1 dose level.  

 For Grade ≥ 3 rash, erythematous or exfoliative skin conditions, 
withhold dacomitinib. Initiate or continue treatment and/or provide 
additional treatment (e.g., broad spectrum oral or intravenous 
antibiotics and topical steroids). Upon recovery to Grade ≤ 1, resume 
dacomitinib with a reduction of 1 dose level.  

Other  For Grade 1 or 2 toxicity, no dose modification is required. 
 For Grade ≥ 3 toxicity, withhold dacomitinib until symptoms resolve 

to Grade ≤ 2. Upon recovery, resume dacomitinib with a reduction of 
1 dose level. 

 
Special populations 
 
Hepatic impairment  
No starting dose adjustments are required when administering Vizimpro to patients with mild 
(Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. Dacomitinib has not been 
studied in patients with severe (Child-Pugh class C) hepatic impairment. Treatment in this population 
is not recommended (see section 5.2).  
 
Renal impairment 
No starting dose adjustments are required when administering Vizimpro to patients with mild or 
moderate renal impairment (creatinine clearance [CrCl] ≥ 30 mL/min). Limited data are available in 
patients with severe renal impairment (CrCl < 30 mL/min). No data are available in patients requiring 
haemodialysis. Thus no dosing recommendations can be made for either patient population (see 
section 5.2).  



5 

 
Elderly population  
No starting dose adjustment of Vizimpro in elderly (≥ 65 years of age) patients is required (see section 
5.2). 
 
Paediatric population  
The safety and efficacy of Vizimpro in the paediatric population (< 18 years of age) have not been 
established. No data are available.  
 
Method of administration  
 
Vizimpro is for oral use. The tablets should be swallowed with water and can be taken with or without 
meals.  
 
4.3 Contraindications  
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  
 
4.4 Special warnings and precautions for use  
 
Assessment of EGFR mutation status 
 
When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust 
methodology is chosen to avoid false negative or false positive determinations. 
 
Interstitial lung disease (ILD)/Pneumonitis  
 
ILD/pneumonitis, which could be fatal, has been reported in patients receiving Vizimpro (see 
section 4.8). Patients with a history of ILD have not been studied. 
 
Careful assessment of all patients with an acute onset or unexplained worsening of pulmonary 
symptoms (e.g., dyspnoea, cough, fever) should be performed to exclude ILD/pneumonitis. Treatment 
with dacomitinib should be withheld pending investigation of these symptoms. If ILD/pneumonitis is 
confirmed, dacomitinib should be permanently discontinued and appropriate treatment instituted as 
necessary (see section 4.2). 
 
Diarrhoea  
 
Diarrhoea, including severe diarrhoea, has been very commonly reported during treatment with 
Vizimpro (see section 4.8). Diarrhoea may result in dehydration with or without renal impairment, 
which could be fatal if not adequately treated.  
 
Proactive management of diarrhoea should start at the first sign of diarrhoea especially within the first 
2 weeks of starting dacomitinib, including adequate hydration combined with anti-diarrhoeal 
medicinal products and continued until loose bowel movements cease for 12 hours. Anti-diarrhoeal 
medicinal products (e.g., loperamide) should be used and, if necessary, escalated to the highest 
recommended approved dose. Patients may require dosing interruption and/or dose reduction of 
therapy with dacomitinib. Patients should maintain adequate oral hydration and patients who become 
dehydrated may require administration of intravenous fluids and electrolytes (see section 4.2). 
 
Skin-related adverse reactions  
 
Rash, erythematous and exfoliative skin conditions have been reported in patients treated with 
Vizimpro (see section 4.8). 
 
For prevention of dry skin, initiate treatment with moisturizers, and upon development of rash, initiate 
treatment with topical antibiotics, emollients, and topical steroids. Start oral antibiotics and topical 



6 

steroids in patients who develop exfoliative skin conditions. Consider adding broad spectrum oral or 
intravenous antibiotics if any of these conditions worsen to greater than or equal to Grade 2 severity. 
Rash, erythematous and exfoliative skin conditions may occur or worsen in areas exposed to the sun. 
Advise patients to use protective clothing and sunscreen before exposure to the sun. Patients may 
require dosing interruption and/or dose reduction of therapy with dacomitinib (see section 4.2).  
 
Hepatotoxicity and transaminases increased  
 
Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, 
transaminases increased) have been reported during treatment with Vizimpro (see section 4.8). Among 
NSCLC patients treated with dacomitinib 45 mg daily, there have been isolated reports of 
hepatotoxicity in 4 (1.6%) patients. Across the dacomitinib program, hepatic failure led to a fatal 
outcome in 1 patient. Therefore, periodic liver function testing is recommended. In patients who 
develop severe elevations in transaminases while taking dacomitinib, treatment should be interrupted 
(see section 4.2). 
 
Medicinal products metabolised by cytochrome P450 (CYP)2D6 
 
Vizimpro may increase exposure (or decrease exposure of active metabolites) of other medicinal 
products metabolised by CYP2D6. Concomitant use of medicinal products predominantly metabolised 
by CYP2D6 should be avoided unless such products are considered necessary (see section 4.5). 
 
Other forms of interactions 
 
Concomitant use of proton pump inhibitors (PPIs) with dacomitinib should be avoided (see 
section 4.5). 
 
Lactose 
 
This medicinal product contains lactose. Patients with rare hereditary problems of galactose 
intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal 
product.  
 
Sodium 
 
This medicinal product contains < 1 mmol sodium (23 mg) per tablet, that is to say essentially 
“sodium-free”. 
 
4.5 Interaction with other medicinal products and other forms of interaction  
 
Co-administration of dacomitinib with agents that increase gastric pH 
 
The aqueous solubility of dacomitinib is pH dependent, with low (acidic) pH resulting in higher 
solubility. Data from a study in 24 healthy subjects indicated that co-administration of a single 45 mg 
dacomitinib dose with the PPI rabeprazole 40 mg once daily for 7 days decreased dacomitinib Cmax, 
AUC0-96h (area under the concentration-time curve from time 0 to 96 hours), and AUCinf (AUC from 
time 0 to infinity) (n=14) by approximately 51%, 39%, and 29%, respectively, when compared to a 
single 45 mg dose of dacomitinib administered alone. PPIs should be avoided while receiving 
treatment with dacomitinib (see section 4.4).  
 
Based on data from observations in 8 patients in Study A7471001, there was no apparent effect of 
local antacid administration on Cmax and AUCinf of dacomitinib. Based on pooled data in patients, there 
was no apparent effect of histamine-2 (H2) receptor antagonists on steady-state trough concentration 
of dacomitinib (geometric mean ratio of 86% (90% CI: 73; 101). Local antacids and H2 receptor 
antagonists may be used if needed. Dacomitinib should be administered 2 hours before or at least 
10 hours after taking H2 receptor antagonists. 
 



7 

Co-administration of dacomitinib and CYP2D6 substrates  
 
Co-administration of single 45 mg oral dose of dacomitinib increased the mean exposure (AUClast and 
Cmax) of dextromethorphan, a probe CYP2D6 substrate, 855% and 874%, respectively, compared with 
administration of dextromethorphan alone. These results suggest that dacomitinib may increase 
exposure of other medicinal products (or decrease exposure to active metabolites) primarily 
metabolised by CYP2D6. Concomitant use of medicinal products predominantly metabolised by 
CYP2D6 should be avoided (see section 4.4). If concomitant use of such medicinal products is 
considered necessary, they should follow their respective labels for dose recommendation regarding 
co-administration with strong CYP2D6 inhibitors. 
 
Effect of dacomitinib on drug transporters  
 
Based on in vitro data, dacomitinib may have the potential to inhibit the activity of P-glycoprotein 
(P-gp) (in the gastrointestinal [GI] tract), Breast Cancer Resistance Protein (BCRP) (systemically and 
GI tract), and organic cation transporter (OCT)1 at clinically relevant concentrations (see section 5.2).  
 
4.6 Fertility, pregnancy and lactation 
 
Woman of childbearing potential/Contraception 
 
Women of childbearing potential should be advised to avoid becoming pregnant while receiving 
Vizimpro. Women of childbearing potential who are receiving this medicinal product should use 
adequate contraceptive methods during therapy and for at least 17 days (5 half-lives) after completing 
therapy.  
 
Pregnancy 
 
There are no data on the use of dacomitinib in pregnant women. Studies in animals have shown 
limited effects on reproductive toxicity (lower maternal body weight gain and food consumption in 
rats and rabbits, and lower foetal body weight and higher incidence of unossified metatarsals in rats 
only) (see section 5.3). Based on its mechanism of action, dacomitinib may cause foetal harm when 
administered to a pregnant woman. Dacomitinib should not be used during pregnancy. Female patients 
taking dacomitinib during pregnancy or who become pregnant while taking dacomitinib should be 
apprised of the potential hazard to the foetus. 
 
Breast-feeding  
 
It is not known whether dacomitinib and its metabolites are excreted in human milk. Because many 
medicinal products are excreted in human milk, and because of the potential for serious adverse 
reactions in breast-fed infants from exposure to dacomitinib, mothers should be advised against 
breast-feeding while receiving this medicinal product. 
 
Fertility 
 
Fertility studies have not been performed with dacomitinib. Non-clinical safety studies showed 
reversible epithelial atrophy in the cervix and vagina of rats (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Vizimpro has minor influence on the ability to drive and use machines. Patients experiencing fatigue 
or ocular adverse reactions while taking dacomitinib should exercise caution when driving or 
operating machinery. 
 



8 

4.8 Undesirable effects  
 
Summary of safety profile 
 
The median duration of treatment with Vizimpro across the pooled data set was 66.7 weeks. 
 
The most common (> 20%) adverse reactions in patients receiving dacomitinib were diarrhoea 
(88.6%), rash (79.2%), stomatitis (71.8%), nail disorder (65.5%), dry skin (33.3%), decreased appetite 
(31.8%), conjunctivitis (24.7%), weight decreased (24.3%), alopecia (23.1%), pruritus (22.4%), 
transaminases increased (22.0%), and nausea (20.4%). 
 
Serious adverse reactions were reported in 6.7% of patients treated with dacomitinib. The most 
frequently (≥ 1%) reported serious adverse reactions in patients receiving dacomitinib were diarrhoea 
(2.0%), interstitial lung disease (1.2%), rash (1.2%), and decreased appetite (1.2%). 
 
Adverse reactions leading to dose reductions were reported in 52.2% of patients treated with 
dacomitinib. The most frequently reported (> 5%) reasons for dose reductions due to any adverse 
reactions in patients receiving dacomitinib were rash (32.2%), nail disorder (16.5%), and diarrhoea 
(7.5%). 
 
Adverse reactions leading to permanent discontinuation were reported in 6.7% of patients treated with 
dacomitinib. The most common (> 0.5%) reasons for permanent discontinuations associated with 
adverse reactions in patients receiving dacomitinib were: rash (2.4%), interstitial lung disease (2.0%), 
and diarrhoea (0.8%). 
 
Tabulated list of adverse reactions 
 
Table 3 presents adverse reactions for Vizimpro. Adverse reactions are listed according to system 
organ class (SOC). Within each SOC, the adverse reactions are ranked by frequency, with the most 
frequent reactions first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to 
< 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000). Within each frequency 
grouping, adverse reactions are presented in order of decreasing seriousness. 
 



9 

 
Table 3.       Adverse reactions reported in dacomitinib clinical studies (N=255) 
 
System organ class Very common Common 

Metabolism and nutrition disorders Decreased appetite 
Hypokalaemiaa 

Dehydration 

Nervous system disorders   Dysgeusia 
Eye disorders  Conjunctivitisb Keratitis 
Respiratory, thoracic and mediastinal 
disorders  

 Interstitial lung disease*c 

Gastrointestinal disorders  Diarrhoea* 
Stomatitisd 
Vomiting 
Nausea 

 

Skin and subcutaneous tissue disorders  Rashe 

Palmar-plantar 
erythrodysaesthesia 
syndrome 
Skin fissures 
Dry skinf 

Pruritusg 

Nail disorderh 
Alopecia 

Skin exfoliationi 
Hypertrichosis 
 

General disorders and administration site 
conditions  

Fatigue 
Asthenia 

 

Investigations  Transaminases increasedj 
Weight decreased 

 

Data based on pool of 255 patients who received Vizimpro 45 mg once daily as starting dose for first-line 
treatment of NSCLC with EGFR-activating mutations across clinical studies. 
 
* Fatal events were reported. 
a Hypokalaemia includes the following preferred terms (PTs): Blood potassium decreased, Hypokalaemia. 
b Conjunctivitis includes the following PTs: Blepharitis, Conjunctivitis, Dry eye, Noninfective 
 conjunctivitis. 
c Interstitial lung disease includes the following PTs: Interstitial lung disease, Pneumonitis. 
d Stomatitis includes the following PTs: Aphthous ulcer, Cheilitis, Dry mouth, Mucosal inflammation, 
 Mouth ulceration, Oral pain, Oropharyngeal pain, Stomatitis. 
e Rash (also referred to as Rash and erythematous skin conditions) includes the following PTs: Acne, 
 Dermatitis acneiform, Erythema, Erythema multiforme, Rash, Rash erythematous, Rash generalised, Rash 
 macular, Rash maculo-papular, Rash papular. 
f Dry skin includes the following PTs: Dry skin, Xerosis. 
g Pruritus includes the following PTs: Pruritus, Rash pruritic. 
h Nail disorder includes the following PTs: Ingrowing nail, Nail bed bleeding, Nail bed inflammation, Nail 
 discolouration, Nail disorder, Nail infection, Nail toxicity, Onychoclasis, Onycholysis, Onychomadesis, 
 Paronychia. 
i Skin exfoliation (also referred to as Exfoliative skin conditions) includes the following PTs: Exfoliative 
 rash, Skin exfoliation. 
j Transaminases increased includes the following PTs: Alanine aminotransferase increased, Aspartate 

aminotransferase increased, Transaminases increased. 
 
Description of selected adverse reactions 
 
Very common adverse reactions in patients occurring in at least 10% of patients in Study ARCHER 
1050 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in 
Table 4. 
 



10 

Table 4.        Very common adverse reactions in Phase 3 Study ARCHER 1050 (N=451) 
 
 Dacomitinib 

(N=227) 
Gefitinib 
(N=224) 

Adverse Reactionsa All Grades 
% 

Grade 3 
% 

Grade 4 
% 

All Grades 
% 

Grade 3 
% 

Grade 4 
% 

Metabolism and nutrition disorders 
Decreased appetite 30.8 3.1 0.0 25.0 0.4 0.0 
Hypokalemiab 10.1 4.0 0.9 5.8 1.8 0.0 

Eye disorders 
Conjunctivitisc 23.3 0.0 0.0 8.9 0.0 0.0 

Gastrointestinal disorders 
Diarrhoead 87.2 8.4 0.0 55.8 0.9 0.0 
Stomatitise 69.6 4.4 0.4 33.5 0.4 0.0 
Nausea 18.9 1.3 0.0 21.9 0.4 0.0 

Skin and subcutaneous tissue disorders 
Rashf 77.1 24.2 0.0 57.6 0.9 0.0 
Palmar-plantar 
erythrodysaesthesia 
syndrome 

14.5 0.9 0.0 3.1 0.0 0.0 

Dry sking 29.5 1.8 0.0 18.8 0.4 0.0 
Pruritush 20.3 0.9 0.0 14.3 1.3 0.0 
Nail disorderi 65.6 7.9 0.0 21.4 1.3 0.0 
Alopecia 23.3 0.4 0.0 12.5 0.0 0.0 

General disorders and administration site conditions 
Asthenia 12.8 2.2 0.0 12.5 1.3 0.0 

Investigations 
Transaminases 
increasedj 

23.8 0.9 0.0 40.2 9.8 0.0 

Weight decreased 25.6 2.2 0.0 16.5 0.4 0.0 
a  Only adverse reactions with ≥ 10% incidence in the dacomitinib arm are included.  
b Hypokalaemia includes the following preferred terms (PTs): Blood potassium decreased, Hypokalaemia.  
c Conjunctivitis includes the following PTs: Blepharitis, Conjunctivitis, Dry eye, Noninfective conjunctivitis. 
d 1 fatal event was reported in the dacomitinib arm. 
e Stomatitis includes the following PTs: Aphthous ulcer, Cheilitis, Dry mouth, Mucosal inflammation, Mouth 

ulceration, Oral pain, Oropharyngeal pain, Stomatitis.  
f Rash includes the following PTs: Acne, Dermatitis acneiform, Erythema, Rash, Rash erythematous, Rash 

generalised, Rash macular, Rash maculo-papular, Rash papular. 
g Dry skin includes the following PTs: Dry skin, Xerosis.  
h Pruritus includes the following PTs: Pruritus, Rash pruritic. 
i Nail disorder includes the following PTs: Ingrowing nail, Nail discolouration, Nail disorder, Nail infection, Nail 

toxicity, Onychoclasis, Onycholysis, Onychomadesis, Paronychia. 
j Transaminases increased includes the following PTs: Alanine aminotransferase increased, Aspartate 

aminotransferase increased, Transaminases increased. 
 
Interstitial lung disease (ILD)/Pneumonitis 
ILD/pneumonitis adverse reactions were reported in 2.7% of patients receiving Vizimpro, and 
Grade ≥ 3 ILD/pneumonitis adverse reactions were reported in 0.8%, including a fatal event (0.4%) 
(see section 4.4).  
 
The median time to the first episode of any grade ILD/pneumonitis was 16 weeks and the median time 
to the worst episode of ILD/pneumonitis was 16 weeks in patients receiving dacomitinib. The median 
duration of any grade and Grade ≥ 3 ILD/pneumonitis was 13 weeks and 1.5 weeks, respectively (see 
section 4.4).  



11 

 
Diarrhoea 
Diarrhoea was the most frequently reported adverse reaction in patients receiving Vizimpro (88.6%) 
and Grade ≥ 3 diarrhoea adverse reactions were reported in 9.4% of patients. In a clinical study, one 
patient (0.4%) had a fatal outcome (see section 4.4).  
 
The median time to the first episode of any grade diarrhoea was 1 week and the median time to the 
worst episode of diarrhoea was 2 weeks in patients receiving dacomitinib. The median duration of any 
grade and Grade ≥ 3 diarrhoea was 20 weeks and 1 week, respectively (see section 4.4).  
 
Skin-related adverse reactions  
Rash, erythematous and exfoliative skin condition adverse reactions were reported in 79.2% and 5.5%, 
respectively, of patients receiving Vizimpro. Skin-related adverse reactions were Grades 1 to 3. 
Grade 3 rash and erythematous skin condition adverse reactions were the most frequently reported 
Grade 3 adverse reactions (25.5%). Grade 3 exfoliative skin conditions were reported in 0.8% of 
patients (see section 4.4).  
 
The median time to the first episode of any grade rash and erythematous skin conditions was 
approximately 2 weeks and the median time to the worst episode of rash and erythematous skin 
conditions was 7 weeks in patients receiving dacomitinib. The median duration of any grade and 
Grade ≥ 3 rash and erythematous skin conditions was 53 weeks and 2 weeks, respectively. The median 
time to the first episode of any grade exfoliative skin conditions was 6 weeks and the median time to 
the worst episode of exfoliative skin conditions was 6 weeks. The median duration of any grade and 
Grade ≥ 3 exfoliative skin conditions was 10 weeks and approximately 2 weeks, respectively. 
 
Transaminases increased  
Transaminases increased (alanine aminotransferase increased, aspartate aminotransferase increased, 
transaminases increased) were reported in 22.0% of patients receiving Vizimpro and were Grades 1 to 
3, with the majority Grade 1 (18.4%) (see section 4.4).  
 
The median time to the first episode of any grade of transaminases increased was approximately 
12 weeks and the median time to the worst episode of transaminases increased was 12 weeks in 
patients receiving dacomitinib. The median duration of any grade and Grade ≥ 3 transaminases 
increased was 11 weeks and 1 week, respectively. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
The adverse reactions observed at doses greater than 45 mg once daily were primarily gastrointestinal, 
dermatological, and constitutional (e.g., fatigue, malaise, and weight loss).  
 
There is no known antidote for dacomitinib. The treatment of dacomitinib overdose should consist of 
symptomatic treatment and general supportive measures.  
 
 



12 

5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Anti-neoplastic agents, protein kinase inhibitors, ATC code: L01XE47 
 
Mechanism of action  
 
Dacomitinib is a pan-human epidermal growth factor receptor (HER) (EGFR/HER1, HER2, and 
HER4) inhibitor, with activity against mutated EGFR with deletions in exon 19 or the L858R 
substitution in exon 21. Dacomitinib binds selectively and irreversibly to its HER family targets 
thereby providing prolonged inhibition.  
 
Clinical efficacy  
 
Vizimpro in first-line treatment of NSCLC patients with EGFR-activating mutations (ARCHER 1050) 
The efficacy and safety of Vizimpro was studied in a Phase 3 trial (ARCHER 1050) conducted in 
patients with locally advanced, not amenable to curative surgery or radiotherapy, or metastatic 
NSCLC harbouring activating mutations of EGFR, to demonstrate the superiority of dacomitinib 
versus gefitinib. A total of 452 patients were randomised 1:1 to dacomitinib or gefitinib in a 
multicentre, multinational, randomised, open-label Phase 3 study.  
 
Treatment was administered orally on a continuous daily basis until disease progression, institution of 
new anticancer therapy, intolerable toxicity, withdrawal of consent, death, or investigator decision 
dictated by protocol compliance, whichever occurred first. Stratification factors at randomisation were 
race (Japanese versus mainland Chinese versus other East Asian versus non-East Asian, as stated by 
the patient), and EGFR mutation status (exon 19 deletion versus the L858R mutation in exon 21). 
EGFR mutation status was determined by a standardised and commercially available test kit.  
 
The primary endpoint of the study was progression-free survival (PFS) as determined by blinded 
Independent Radiology Central (IRC) review. Key secondary endpoints included objective response 
rate (ORR), duration of response (DoR), and overall survival (OS). 
 
The demographic characteristics of the overall study population were 60% female; median age at 
enrolment was 62 years with 10.8% being ≥ 75 years old. Thirty percent had baseline Eastern 
Cooperative Oncology Group (ECOG) performance status (PS) 0 and 70% had ECOG PS 1; 59% had 
an exon 19 deletion, and 41% had a L858R mutation in exon 21. Race was 23% White, 77% Asian, 
and < 1% Black. Patients with brain metastases or leptomeningeal disease or ECOG PS ≥ 2 were 
excluded from the trial. 
 
A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients 
randomised to dacomitinib compared with those randomised to gefitinib, see Table 5 and Figure 1. 
Subgroup analyses of PFS per IRC review based on baseline characteristics were consistent with those 
from the primary analysis of PFS. In particular, the hazard ratios (HRs) for PFS per IRC review in 
Asian and non-Asian patients were 0.509 (95% CI: 0.391, 0. 662) and 0.889 (95% CI: 0.568, 1.391), 
respectively. In Asian patients, median PFS was 16.5 months for dacomitinib arm and 9.3 months for 
gefitinib arm. In non-Asian patients, median PFS was 9.3 months for dacomitinib arm and 9.2 months 
for gefitinib arm. 
 
OS results from the final analysis (data cut-off date of 17-Feb-2017) when 48.7% of events had 
occurred showed a HR of 0.760 (95% CI: 0.582, 0.993) and a gain of 7.3 months in median OS 
(median OS: 34.1 months [95% CI: 29.5, 37.7] and 26.8 months [95% CI: 23.7, 32.1] in the 
dacomitinib and gefitinib arm, respectively). However, according to the hierarchical testing approach, 
the analysis was stopped with the testing of ORR as the statistical significance was not reached. 
Therefore, the statistical significance of OS improvement could not be formally assessed. 
 



13 

Table 5.       Efficacy results from ARCHER 1050 in patients with previously untreated 
NSCLC with EGFR-activating mutations – ITT population ⃰ 

 

 Dacomitinib 
N=227 

Gefitinib 
N=225 

Progression-Free Survival (per IRC)   
Number of patients with event, n (%) 136 (59.9%) 179 (79.6%) 
Median PFS in months (95% CI) 14.7 (11.1, 16.6) 9.2 (9.1, 11.0) 
HR (95% CI)a 0.589 (0.469, 0.739) 
2-sided p-valueb < 0.0001 

Objective Response Rate (per IRC)  
Objective Response Rate % (95% CI) 74.9% (68.7, 80.4) 71.6% (65.2, 77.4) 
2-sided p-valuec 0.3883 

Duration of Response in Responders (per IRC)  
Number of responders per IRC review, n 
(%) 

170 (74.9) 161 (71.6) 

Median DoR in months (95% CI) 14.8 (12.0, 17.4) 8.3 (7.4, 9.2) 
HR (95% CI)a 0.403 (0.307, 0.529) 
2-sided p-valueb < 0.0001 

⃰ Data based on data cut-off date of 29 July 2016.  
Abbreviations: CI=confidence interval; EGFR=epidermal growth factor receptor; HR=hazard ratio; 
IRC=independent radiologic central; ITT=Intent-to-treat; IWRS=interactive web response system; N/n=total 
number; NSCLC=non-small cell lung cancer; PFS=progression-free survival; DoR=Duration of Response. 
a. From stratified Cox Regression. The stratification factors were Race (Japanese vs mainland Chinese and 

other East Asian vs non-East Asian) and EGFR mutation status (exon 19 deletion vs the L858R mutation 
in exon 21) at randomisation per IWRS.  

b. Based on the stratified log-rank test. The stratification factors were Race (Japanese vs mainland Chinese 
and other East Asian vs non-East Asian) and EGFR mutation status (exon 19 deletion vs the L858R 
mutation in exon 21) at randomisation per IWRS. 

c. Based on the stratified Cochran-Mantel-Haenszel test. The stratification factors were Race (Japanese vs 
mainland Chinese and other East Asian vs non-East Asian) and EGFR mutation status (exon 19 deletion vs 
the L858R mutation in exon 21) at randomisation per IWRS. 

 
Figure 1. ARCHER 1050 - Kaplan-Meier curve for PFS per IRC review – ITT population 
 

 
Abbreviations: CI=confidence interval; HR=hazard ratio; IRC=independent radiologic central; 
ITT=Intent-To-Treat; N=total number; PFS=progression-free survival. 
 



14 

Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
dacomitinib in all subsets of the paediatric population in NSCLC indication (see section 4.2 for 
information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption  
 
Following the administration of a single 45 mg dose of dacomitinib tablets, the mean oral 
bioavailability of dacomitinib is 80% (range: 65% to 100%) compared to intravenous administration, 
with Cmax occurring 5 to 6 hours after oral dosing. Following dacomitinib 45 mg daily dosing, 
steady-state was reached within 14 days. Food does not alter bioavailability to a clinically meaningful 
extent. Dacomitinib is a substrate for the membrane transport proteins P-gp and BCRP. However, 
based on the oral bioavailability of 80%, these membrane transport proteins are unlikely to have any 
impact on dacomitinib absorption. 
 
Distribution  
 
Dacomitinib is extensively distributed throughout the body with a mean steady-state volume of 
distribution of 27 L/kg (patient of 70 kg) [coefficient of variation (CV%): 18%] following intravenous 
administration. In plasma, dacomitinib binds to albumin and 1-acid glycoprotein and the fraction 
unbound is approximately 2% in vitro and ex vivo in healthy volunteers. 
 
Biotransformation  
 
In humans, dacomitinib undergoes oxidation and glutathione conjugation as the major metabolic 
pathways. Following oral administration of a single 45-mg dose of [14C] dacomitinib, the most 
abundant circulating metabolite was O-desmethyl dacomitinib. This metabolite exhibited in vitro 
pharmacologic activity that was similar to that of dacomitinib in the in vitro biochemical assays. In 
faeces, dacomitinib, O-desmethyl dacomitinib, a cysteine conjugate of dacomitinib, and a 
mono-oxygenated metabolite of dacomitinib were the major drug-related components. In vitro studies 
indicated that CYP2D6 was the major CYP isozyme involved in the formation of O-desmethyl 
dacomitinib, while CYP3A4 contributed to the formation of other minor oxidative metabolites. 
O-desmethyl dacomitinib accounted for 16% of human plasma radioactivity and is formed mainly by 
CYP2D6 and to a lesser extent CYP2C9. The inhibition of CYP2D6 translated into approximately a 
90% reduction in metabolite exposure and an approximate 37% increase in dacomitinib exposure. 
 
Other information on drug-drug interactions  
 
Effect of dacomitinib and O-desmethyl dacomitinib on CYP enzymes  
In vitro, dacomitinib and its metabolite O-desmethyl dacomitinib have a low potential to inhibit the 
activities of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP3A4/5 at clinically relevant 
concentrations. In vitro, dacomitinib has a low potential to induce CYP1A2, CYP2B6, or CYP3A4 at 
clinically relevant concentrations. 
 
Effect of dacomitinib on drug transporters  
In vitro, dacomitinib has a low potential to inhibit the activities of drug transporters P-gp 
(systemically), organic anion transporters (OAT)1 and OAT3, OCT2, organic anion transporting 
polypeptide (OATP)1B1, and OATP1B3, but may inhibit the activity of P-gp (in the GI tract), BCRP 
(systemically and GI tract), and OCT1 at clinically relevant concentrations.  
 
Effect of Dacomitinib on UGT Enzymes  
In vitro, dacomitinib has a low potential to inhibit uridine-diphosphate glucuronosyltransferase 
(UGT)1A4, UGT1A6, UGT1A9, UGT2B7, and UGT2B15. 
 



15 

Elimination  
 
The plasma half-life of dacomitinib ranges from 54 to 80 hours. Dacomitinib showed a clearance of 
20.0 L/hr with an inter-individual variability of 32% (CV%). In 6 healthy male subjects given a 
single-oral dose of [14C] radiolabeled dacomitinib, a median of 82% of the total administered 
radioactivity was recovered in 552 hours; faeces (79% of dose) was the major route of excretion, with 
3% of the dose recovered in urine, of which < 1% of the administered dose was unchanged 
dacomitinib.  
 
Special populations  
 
Age, race, gender, body weight 
Based on population pharmacokinetic analyses, patient age, race (Asian and non-Asian), gender, and 
body weight do not have a clinically relevant effect on predicted steady-state exposure of dacomitinib. 
Approximately 90% of patients included in this analysis were Asian or White. 
 
Hepatic impairment  
In a dedicated hepatic impairment trial, following a single-oral dose of 30 mg Vizimpro, dacomitinib 
exposure (AUCinf and Cmax) was unchanged in mild hepatic impairment (Child-Pugh A; N=8) and 
decreased by 15% and 20%, respectively in moderate hepatic impairment (Child-Pugh B; N=9) when 
compared to subjects with normal hepatic function (N=8). Dacomitinib pharmacokinetics has not been 
studied in subjects with severe hepatic impairment (Child-Pugh class C). In addition, based on a 
population pharmacokinetic analysis using data from 1381 patients, that included 158 patients with 
mild hepatic impairment defined by National Cancer Institute (NCI) criteria [total bilirubin ≤ Upper 
Limit of Normal (ULN) and Aspartate Aminotransferase (AST) > ULN, or total bilirubin > 1.0 to 
1.5 × ULN and any AST; N=158], mild hepatic impairment had no effect on the pharmacokinetics of 
dacomitinib. From the small number of patients in the moderate group [total bilirubin > 1.5 to 
3 × ULN and any AST; N=5], there is no evidence for a change in dacomitinib pharmacokinetics. 
 
Renal impairment  
No clinical studies have been conducted in patients with impaired renal function. Based on population 
pharmacokinetic analyses, mild (60 mL/min ≤ CrCl < 90 mL/min; N=590) and moderate 
(30 mL/min ≤ CrCl < 60 mL/min; N=218) renal impairment, did not alter dacomitinib 
pharmacokinetics, relative to subjects with normal (CrCl ≥ 90 mL/min; N=567) renal function. 
Limited pharmacokinetic data are available in patients with severe renal impairment 
(CrCl < 30 mL/min) (N=4). The pharmacokinetics in patients requiring haemodialysis have not been 
studied.  
 
Exposure response relationships 
No clear relationship between dacomitinib exposure and efficacy could be characterised over the 
exposure range studied. Significant exposure-safety relationship was defined for Grade ≥ 3 
rash/dermatitis acneiform, other skin toxicities, diarrhoea and Grade ≥ 1 stomatitis.  
 
5.3 Preclinical safety data  
 
Repeated-dose toxicity 
 
In oral repeated-dose toxicity studies for up to 6 months in rats and 9 months in dogs, the primary 
toxicities were identified in the skin/hair (dermal changes in rats and dogs, atrophy/dysplasia of hair 
follicles in rats), kidney (papillary necrosis often accompanied by tubular degeneration, regeneration, 
dilatation and/or atrophy and changes in urinary markers indicative of renal injury in rats, erosion or 
ulceration of the pelvic epithelium with associated inflammation without changes indicative of renal 
dysfunction in dogs), eye (cornea epithelial atrophy in rats and dogs, corneal ulcers/erosions with 
red/swollen conjunctiva(e), conjunctivitis, elevated third eyelid, increased squinting, partially closed 
eyes, lacrimation, and/or ocular discharge in dogs), and digestive system (enteropathy in rats and dogs, 
erosions/ulcers of the mouth with reddened mucous membranes in dogs), and atrophy of epithelial 
cells of other organs in rats. In addition, hepatocellular necrosis with transaminase increases and 



16 

hepatocellular vacuolation were observed in rats only. These effects were reversible with the exception 
of hair follicles and kidney changes. All effects occurred at systemic exposure below that in humans at 
the recommended dose of 45 mg once daily. 
 
Genotoxicity 
 
Dacomitinib was tested using a series of genetic toxicology assays. Dacomitinib was not mutagenic in 
a bacterial reverse mutation (Ames) assay, and not clastogenic or aneugenic in the in vivo bone 
marrow micronucleus assay in male and female rats. Dacomitinib was clastogenic in the in vitro 
human lymphocyte chromosome aberration assay at cytotoxic concentrations. Dacomitinib is not 
directly reactive toward DNA as evidenced by the negative response in the bacterial reverse mutation 
assay and did not induce chromosome damage in a bone marrow micronucleus assay at concentrations 
up to approximately 60-70 times the unbound AUC or Cmax at the recommended human dose. Thus, 
dacomitinib is not expected to be genotoxic at clinically relevant exposure concentrations. 
 
Carcinogenicity 
 
Carcinogenicity studies have not been performed with dacomitinib. 
 
Impairment of fertility 
 
Fertility studies have not been performed with dacomitinib. In repeat-dose toxicity studies with 
dacomitinib, effects on reproductive organs were observed in female rats given approximately 
0.3 times the unbound AUC at the recommended human dose (for 6 months) and were limited to 
reversible epithelial atrophy in the cervix and vagina. There was no effect on reproductive organs in 
male rats given ≤ 2 mg/kg/day for 6 months (approximately 1.1 times the unbound AUC at the 
recommended human dose), or in dogs given ≤ 1 mg/kg/day for 9 months (approximately 0.3 times the 
unbound AUC at the recommended human dose). 
 
Developmental toxicity 
 
In embryo-foetal development studies in rats and rabbits, pregnant animals received oral doses up to 
approximately 2.4 times and 0.3 times, respectively, the unbound AUC at the recommended human 
dose during the period of organogenesis. Maternal body weight gain and food intake were lower in 
pregnant rats and rabbits. The maternally toxic dose was foetotoxic in rats, resulting in reduced foetal 
body weights and higher incidence of unossified metatarsals.   
 
Phototoxicity 
 
A phototoxicity study with dacomitinib in pigmented rats showed no phototoxicity potential. 
 
Environmental risk assessment 
 
Environmental risk assessment studies have shown that dacomitinib has the potential to be very 
persistent, bioaccumulative and toxic to the environment (see section 6.6). 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
 
Lactose monohydrate 
Microcrystalline cellulose  
Sodium starch glycolate  
Magnesium stearate  



17 

 
Film coating 
 
Opadry II Blue 85F30716 containing: 
Polyvinyl alcohol – partially hydrolysed (E1203) 
Talc (E553b) 
Titanium dioxide (E171) 
Macrogol (E1521) 
Indigo Carmine Aluminium Lake (E132) 
 
6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
5 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions.  
 
6.5 Nature and contents of container  
 
Aluminium/aluminium blister containing 10 film-coated tablets. Each pack contains 30 film-coated 
tablets. 
 
6.6 Special precautions for disposal  
 
Dacomitinib has the potential to be a very persistent, bioaccumulative and toxic substance (see 
section 5.3). Any unused medicinal product or waste material should be disposed of in accordance 
with local requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1354/001 
EU/1/19/1354/002 
EU/1/19/1354/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 



19 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Pfizer Manufacturing Deutschland GmbH 
Betriebsstätte Freiburg 
Mooswaldallee 1 
79090 Freiburg 
Germany 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are 
set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequent updates published on the European medicines web-
portal. 
 
The marketing authorisation holder shall submit the first periodic safety update report for this product 
within 6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
 Risk Management Plan (RMP) 

 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



22 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vizimpro 15 mg film-coated tablets 
dacomitinib 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 15 mg dacomitinib (as dacomitinib monohydrate). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



23 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Dispose unused medicinal product in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG  
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1354/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Vizimpro 15 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  
 
 



24 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER STRIPS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vizimpro 15 mg tablets 
dacomitinib 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG (as MA holder logo) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER  
 
Lot 
 
 
5. OTHER 
 
 



25 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vizimpro 30 mg film-coated tablets 
dacomitinib 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 30 mg dacomitinib (as dacomitinib monohydrate). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



26 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Dispose unused medicinal product in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1354/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Vizimpro 30 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  
 
 



27 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER STRIPS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vizimpro 30 mg tablets 
dacomitinib 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG (as MA holder logo) 
 
 
3. EXPIRY DATE 

 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



28 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vizimpro 45 mg film-coated tablets 
dacomitinib 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 45 mg dacomitinib (as dacomitinib monohydrate). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



29 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Dispose unused medicinal product in accordance with local requirements. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG  
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/19/1354/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Vizimpro 45 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  
 
 



30 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER STRIPS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Vizimpro 45 mg tablets 
dacomitinib 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG (as MA holder logo) 
 
 
3. EXPIRY DATE 

 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



32 

Package leaflet: Information for the patient 
 

Vizimpro 15 mg film-coated tablets 
Vizimpro 30 mg film-coated tablets 
Vizimpro 45 mg film-coated tablets 

dacomitinib 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.  
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Vizimpro is and what it is used for  
2. What you need to know before you take Vizimpro 
3. How to take Vizimpro 
4. Possible side effects  
5. How to store Vizimpro 
6. Contents of the pack and other information 
 
 
1. What Vizimpro is and what it is used for 
 
Vizimpro contains the active substance dacomitinib, which belongs to a group of medicines called 
protein tyrosine kinase inhibitors which are used to treat cancer.  
 
Vizimpro is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer’. If a test 
has shown that your cancer has certain changes (mutations) in a gene called ‘EGFR’ (epidermal 
growth factor receptor) and has spread to your other lung or other organs, your cancer is likely to 
respond to treatment with Vizimpro. 
 
Vizimpro can be used as your first treatment once your lung cancer has spread to your other lung or 
other organs. 
 
 
2. What you need to know before you take Vizimpro 
 
Do not take Vizimpro: 

 if you are allergic to dacomitinib or any of the other ingredients of this medicine (listed in 
section 6).  

 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before taking Vizimpro: 

 if you ever had any other lung problems. Some lung problems may get worse during treatment 
with Vizimpro, as Vizimpro may cause inflammation of the lungs during treatment. 
Symptoms may be similar to those from lung cancer. Tell your doctor right away if you have 



33 

any new or worsening symptoms including difficulty in breathing, shortness of breath, or 
cough with or without phlegm (mucous), or fever.  

 If you are being treated with any of the medicines listed in section Other medicines and 
Vizimpro. 
 

Tell your doctor immediately while taking this medicine: 
 if you develop diarrhoea. Immediate treatment of diarrhoea is important.  
 if you develop skin rash. Early treatment of skin rash is important. 
 if you have any symptoms of a liver problem which may include: yellowing of your skin or 

the white part of your eyes (jaundice), dark or brown (tea coloured) urine, light-coloured 
bowel movements (stools). 

 
Children and adolescents 
Vizimpro has not been studied in children or adolescents and it must not be given to patients under the 
age of 18 years.  
 
Other medicines and Vizimpro 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
In particular, the effects of some medicines may increase when taken with Vizimpro. These include, 
among others: 

 Procainamide, used to treat heart arrhythmias 
 Pimozide and thioridazine, used to treat schizophrenia and psychosis 

 
You should not take these medicines during your treatment with Vizimpro. 
 
The following medicines may reduce how well Vizimpro works: 

 Long-acting medicines for reducing stomach acid, such as proton pump inhibitors (for ulcers, 
indigestion and heartburn). 

 
You should not take these medicines during your treatment with Vizimpro. As an alternative, you can 
take a short-acting medicine, such as an antacid, or an H2 blocker medicine. If you take H2 blocker 
medicine take your dose of Vizimpro at least 2 hours before or 10 hours after taking the H2 blocker 
medicine.  
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Pregnancy 
You should not become pregnant during treatment with Vizimpro because this medicine could harm 
the baby. If there is any possibility that you may become pregnant you must use effective 
contraception during treatment, and for at least 17 days afterwards. If you become pregnant while 
taking this medicine, you should immediately talk to your doctor. 
 
Breast-feeding 
Do not breast-feed while taking this medicine because it is not known if it can harm your baby.  
 
Driving and using machines 
Tiredness and eye irritation can occur in patients taking Vizimpro. If you feel tired or your eyes are 
irritated, you should use caution when driving or using machines. 
 
Vizimpro contains lactose and sodium 
This medicine contains lactose (found in milk or dairy products). If you have been told by your doctor 
that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
 



34 

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 
“sodium-free”. 
 
 
3. How to take Vizimpro 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.  
 

 The recommended dose is 45 mg taken by mouth each day.  
 Take the tablet at about the same time each day.  
 Swallow the tablet whole with a glass of water. 
 You can take the tablet with or without meals.  

 
Your doctor may decrease the dose of your medicine depending on how well you tolerate it. 
 
If you take more Vizimpro than you should 
If you have taken too much Vizimpro, see a doctor or go to a hospital immediately.  
 
If you forget to take Vizimpro 
If you miss a dose or vomit, take your next dose as scheduled. Do not take a double dose to make up 
for a forgotten tablet. 
 
If you stop taking Vizimpro 
Do not stop taking Vizimpro unless your doctor tells you to. If you have any further questions on the 
use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Contact your doctor immediately if you notice any of the following side effects – you may need urgent 
medical treament: 

 Inflammation of the lungs (common, may affect up to 1 in 10 people) 
Difficulty in breathing, shortness of breath, possibly with a cough or fever. This may mean 
that you have an inflammation of the lungs called interstitial lung disease and can be fatal.  

 Diarrhoea (very common, may affect more than 1 in 10 people)  
Diarrhoea may lead to fluid loss (common), low blood potassium (very common), and 
worsening kidney function and can be fatal. At first signs of increased frequency of bowel 
movements, contact your doctor immediately, drink plenty of fluids, and start antidiarrhoea 
treatment as soon as possible. You should have an anti-diarrhoeal medicine available before 
you start taking Vizimpro.  

 Skin rash (very common) 
It is important to treat the rash early. Tell your doctor if a rash starts. If treatment for rash is 
not working or the rash is getting worse (for example, you have peeling or cracking of the 
skin) you should tell your doctor immediately, since your doctor may decide to stop your 
treatment with Vizimpro. Rash may occur or worsen in areas exposed to sun. Sun protection 
with protective clothing and sunscreen is recommended. 

 



35 

Tell your doctor as soon as possible if you notice any of the other following side effects: 
 
Very common (may affect more than 1 in 10 people): 

 Inflammation of the mouth and lips 
 Nail problems 
 Dry skin 
 Loss of appetite 
 Dry, red, or itchy eyes 
 Weight loss 
 Hair loss 
 Itching 
 Abnormal liver enzyme blood tests 
 Nausea or vomiting 
 Flushed or painful palms or soles 
 Tiredness 
 Weakness 
 Cracks in the skin 

 
Common (may affect up to 1 in 10 people): 

 Alteration in taste 
 Peeling skin 
 Eyes inflammation 
 Abnormal amount of body hair growth 

 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Vizimpro 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. 
The expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
This medicine may pose a risk for the environment. Do not throw away any medicines via wastewater 
or household waste. Ask your pharmacist how to throw away medicines you no longer use. These 
measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Vizimpro contains  
- The active substance is dacomitinib (as dacomitinib monohydrate). Vizimpro tablets come in 

different strengths. 
Vizimpro 15 mg tablet: each tablet contains 15 mg dacomitinib 
Vizimpro 30 mg tablet: each tablet contains 30 mg dacomitinib 
Vizimpro 45 mg tablet: each tablet contains 45 mg dacomitinib 



36 

- The other ingredients are:  
Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, 
magnesium stearate (see section 2 Vizimpro contains lactose and sodium). 
Film coating: Opadry II Blue 85F30716 containing polyvinyl alcohol – partially hydrolysed 
(E1203), talc (E553b), titanium dioxide (E171), macrogol (E1521), Indigo carmine aluminium 
lake (E132). 

 
What Vizimpro looks like and contents of the pack 
- Vizimpro 15 mg film-coated tablets are supplied as blue film-coated, round biconvex tablets, 

debossed with “Pfizer” on one side and “DCB15” on the other. 
 
- Vizimpro 30 mg film-coated tablets are supplied as blue film-coated, round biconvex tablet, 

debossed with “Pfizer” on one side and “DCB30” on the other. 
 
- Vizimpro 45 mg film-coated tablets are supplied as blue film-coated, round biconvex tablet, 

debossed with “Pfizer” on one side and “DCB45” on the other. 
 
It is available in blister packs of 30 film-coated tablets (tablets). 
 
Marketing Authorisation Holder  
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
Manufacturer  
Pfizer Manufacturing Deutschland GmbH 
Betriebsstätte Freiburg 
Mooswaldallee 1 
79090 Freiburg 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/ België /Belgien 
Pfizer S.A. / N.V. 
Tél/Tel: +32 (0)2 554 62 11 

Lietuva 
Pfizer Luxembourg SARL filialas Lietuvoje 
Tel. + 370 52 51 4000 

България 
Пфайзер Люксембург САРЛ, Клон България 
Тел.: +359 2 970 4333 

Luxembourg/Luxemburg 
Pfizer S.A. 
Tél/Tel: +32 (0)2 554 62 11 

Česká republika 
Pfizer PFE, spol. s r.o. 
Tel.: +420 283 004 111 

Magyarország 
Pfizer Kft. 
Tel.: +36-1-488-37-00 

Danmark 
Pfizer ApS 
Tlf: +45 44 20 11 00 
 

Malta 
Vivian Corporation Ltd. 
Tel: + 35621 344610 

Deutschland 
Pfizer Pharma GmbH 
Tel: +49 (0)30 550055 51000 
  

Nederland 
Pfizer BV 
Tel: +31 (0)10 406 43 01 



37 

Eesti 
Pfizer Luxembourg SARL Eesti filiaal  
Tel.: +372 666 7500 

Norge 
Pfizer Norge AS 
Tlf: +47 67 52 61 00 
 

Ελλάδα 
Pfizer Ελλάς A.E. 
Τηλ.: +30 210 6785 800 

Österreich 
Pfizer Corporation Austria Ges.m.b.H. 
Tel: +43 (0)1 521 15-0 

España 
Pfizer, S.L. 
Tel: +34 91 490 99 00 

Polska 
Pfizer Polska Sp. z o.o. 
Tel.:+48 22 335 61 00 
 

France 
Pfizer  
Tél: +33 (0)1 58 07 34 40 

Portugal 
Pfizer Biofarmacêutica, Sociedade Unipessoal Lda 
Tel: +351 21 423 5500 

Hrvatska 
Pfizer Croatia d.o.o. 
Tel: +385 1 3908 777 

România 
Pfizer Romania S.R.L. 
Tel: +40 (0) 21 207 28 00 

Ireland 
Pfizer Healthcare Ireland 
Tel: 1800 633 363 (toll free) 
+44 (0)1304 616161 

Slovenija 
Pfizer Luxembourg SARL 
Pfizer, podružnica za svetovanje s področja 
farmacevtske dejavnosti, Ljubljana 
Tel.: + 386 (0)1 52 11 400 
 

Ísland 
Icepharma hf. 
Sími: +354 540 8000 

Slovenská republika 
Pfizer Luxembourg SARL, organizačná zložka  
Tel.: + 421 2 3355 5500 

Italia 
Pfizer S.r.l. 
Tel: +39 06 33 18 21 

Suomi/Finland 
Pfizer Oy 
Puh./Tel: +358 (0)9 43 00 40 

Kύπρος 
Pfizer Ελλάς Α.Ε. (Cyprus Branch)  
Τηλ: +357 22 817690 

Sverige  
Pfizer Innovations AB 
Tel: +46 (0)8 550 520 00 

Latvija 
Pfizer Luxembourg SARL filiāle Latvijā 
Tel.: + 371 670 35 775 

United Kingdom 
Pfizer Limited 
Tel: +44 (0) 1304 616161 

 
 
This leaflet was last revised in MM/YYYY 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET