This site is intended only for healthcare professionals resident in India
Menu
Close
Menu
Close
Start With Proven First-line Efficacy1-3
Dacomitinib is a kinase inhibitor indicated for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.3
DACOPLICE®-related adverse events1
In the ARCHER 1050 study, the most commonly reported adverse events (of any grade) in patients given DACOPLICE® were1:
Diarrhoea* (198 [87%]), paronychia (140 [62%]), dermatitis acneiform (111 [49%]) and stomatitis (99 [44%]).
The most commonly reported adverse events (of any grade) in patients given gefitinib were1:
Diarrhoea (125 [56%]), alanine aminotransferase increase (88 [39%]) and aspartate aminotransferase increase (81 [36%]).
Adverse events occurring in ≥10% of DACOPLICE®-treated patients in the ARCHER 1050 study (n=227)1
Adapted from Wu YL, et al. 2017.
DACOPLICE®-related serious adverse events1
Serious adverse reactions
The most commonly reported Grade 3 and 4 adverse events were dermatitis acneiform (31 [14%] of 227 patients given DACOPLICE® vs. 0 of 224 patients given gefitinib), diarrhoea (19 [8%] vs. 2 [1%]) and raised alanine aminotransferase levels (2 [1%] vs. 19 [8%]).1
Treatment-related serious adverse events were reported in 21 (9%) patients given DACOPLICE® and in 10 (4%) patients given gefitinib. Treatment-related serious adverse events were gastrointestinal disorders (10 [4%] patients given DACOPLICE® vs. 0 given gefitinib), skin and subcutaneous disorders (3 [1%] vs. 0), respiratory disorders (2 [1%] vs. 3 [1%]), hepatobiliary disorders (3 [1%] vs. 2 [1%]), elevated liver enzymes (0 vs. 3 [1%]), metabolism and nutrition disorders (2 [1%] vs. 0), infections (2 [1%] vs. 1 [<1%]), keratitis (1 [<1%] vs. 0), acute kidney injury (1 [<1%] vs. 0) and chronic myeloid leukemia (1 [<1%] vs. 0).1
Permanent discontinuation because of adverse events related to study drug occurred in 22 (10%) of 227 patients in the DACOPLICE® group and in 15 (7%) of 224 patients in the gefitinib group. The most frequent of these in the DACOPLICE® group were skin and subcutaneous tissue disorders (n=7), gastrointestinal disorders (n=4) and ILD or pneumonitis (n=3), whereas in the gefitinib group, they were alanine aminotransferase or aspartate aminotransferase increase (n=6) and ILD or pneumonitis (n=3).1
Dose reductions occurred in 150 (66%) of 227 patients in the DACOPLICE® group; 87 (38%) patients received a lowest dose of 30 mg/day and 63 (28%) patients received a lowest dose of 15 mg/day.1
Two treatment-related deaths occurred in the DACOPLICE® group (1 related to untreated diarrhoea and 1 to untreated cholelithiases/liver disease) and 1 in the gefitinib group (related to sigmoid colon diverticulitis/rupture complicated by pneumonia).1
*Fatal events were reported.1
For special warnings and precautions for use, please see the DACOPLICE® prescribing information.3
ALT, alanine aminotransferase; ARCHER, Adolescent Rural Cohort on Hormones, Education, Environment, Health and Relationships; AST, aspartate aminotransferase; ILD, interstitial lung disease.
References:
Please click the Prescribing Information link to view the safety and adverse events information of DACOPLICE®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
PP-DAC-IND-0147 June 2022
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim…
DACOPLICE® is a second-generation EGFR TKI
Learn more
DACOPLICE® is recommended by clinical practice guidelines
Learn more
Start with proven first-line efficacy
Learn more
First-line use of DACOPLICE® was studied in a Phase III, head-to-head trial with gefitinib
Review efficacy profile
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim…
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Hac habitasse platea dictumst quisque sagittis purus sit amet volutpat. Lectus magna fringilla urna porttitor rhoncus. Venenatis urna cursus eget nunc scelerisque viverra. Id donec ultrices tincidunt arcu non sodales.
Sagittis aliquam malesuada bibendum arcu vitae elementum curabitur. Pellentesque elit ullamcorper dignissim cras tincidunt. Orci ac auctor augue mauris augue neque. Dui vivamus arcu felis bibendum ut tristique et egestas quis. Sed vulputate mi sit amet mauris commodo.
Nunc eget lorem dolor sed viverra ipsum. Sed ullamcorper morbi tincidunt ornare.
These pages are not intended for patients or for members of the general public. The web pages contain promotional content.
If you select 'No', you will be redirected to Pfizer.co.in
For more details on, Who is a Registered medical practitioner*, please visit https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf , Page No. 39, Rule 2 part (ee), last accessed on 26th April 2021.
Address: The Capital, A Wing, 1802, 18th Floor, Plot No. C-70, 'G' Block, Bandra Kurla Complex, Bandra East, Mumbai - 400051.