Safety

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.

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