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Drug-induced liver injury associated with dacomitinib: A case report
Xuanxuan Wang1, Anqi Huang1, Yun Lu1
1Department of Pharmacy, Zhongnan Hospital of Wuhan University, Wuhan, China.
Abstract:
Dacomitinib, the second-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), has been used as a first-line treatment in non-small cell lung cancer (NSCLC) patients harboring EGFR mutation. In this case, we report a patient with drug-induced liver injury (DILI) associated with the use of dacomitinib. A 59-year-old man with stage IV NSCLC was prescribed with dacomitinib; 37 days after dacomitinib administration, he was admitted to our hospital because of jaundice. Laboratory examinations revealed elevated serum levels of liver enzymes and bilirubin. Following the immediate discontinuation of dacomitinib, liver enzymes decreased but bilirubin continued to rise. Total bilirubin reached the peak (18-fold) on day 26 after dacomitinib termination and normalized on day 146 after dacomitinib discontinuation. A "probable" cause of DILI by dacomitinib was determined based on the Roussel Uclaf Causality Assessment Method. The severity of DILI was assessed as acute liver failure. To our knowledge, this is the first case of DILI caused by dacomitinib monotherapy in a real-world setting. Clinicians should pay particular attention to the possibility of DILI during dacomitinib treatment.
Insights
Dacomitinib, an EGFR-TKI for non-small cell lung cancer, can cause drug-induced liver injury (DILI). This case highlights the potential for dacomitinib monotherapy to lead to acute liver failure, necessitating careful monitoring.
Area of Science:
- Oncology
- Hepatology
- Pharmacology
Background:
- Dacomitinib is a second-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) used for EGFR-mutated non-small cell lung cancer (NSCLC).
- Drug-induced liver injury (DILI) is a potential adverse effect of various medications, including targeted cancer therapies.
Observation:
- A 59-year-old male with stage IV NSCLC developed jaundice 37 days after initiating dacomitinib.
- Laboratory tests showed elevated liver enzymes and bilirubin, indicative of liver damage.
- Despite dacomitinib discontinuation, bilirubin levels peaked at 18-fold the normal range before gradual normalization over 146 days.
Findings:
- The patient was diagnosed with probable dacomitinib-induced liver injury (DILI) with a severity assessment of acute liver failure.
- This represents the first reported case of DILI specifically attributed to dacomitinib monotherapy in a clinical setting.
- Causality was established using the Roussel Uclaf Causality Assessment Method.
Implications:
- Clinicians must be vigilant for DILI in patients treated with dacomitinib.
- Early recognition and discontinuation of dacomitinib may be crucial for managing dacomitinib-induced hepatotoxicity.
- This case underscores the importance of monitoring liver function during EGFR-TKI therapy.
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