Safety
Adult patients
The most common adverse reactions (occurring in ≥20% of the patients) observed in the three trials that supported the registration of entrectinib were: fatigue, constipation, dysgeusia, oedema, dizziness, diarrhoea, nausea, dysaesthesia, dyspnoea, anaemia, increased weight, increased blood creatinine, pain, cognitive disorders, vomiting, cough, and pyrexia. The most frequent serious adverse reactions (≥2%) were lung infection (5.2%), dyspnoea (4.6%), cognitive impairment (3.8%), and pleural effusion (3.0%) and fractures (2.4%). Permanent discontinuation due to an adverse reaction occurred in 4.6% of patients [1].
Paediatric patients
The overall safety profile of entrectinib in the paediatric population is similar to the safety profile described for adults [1].
References
- ROZLYTREK (entrectinib), EMA Summary of medicinal Product Characteristics. 2022.
- Krzakowski MJ, Lu S, Cousin S, Smit EF, Springfeld C, Goto K, Garrido P, Chung CH, Lin JJ, Bray VJ, Pitcher B, Zeuner H, Patel S, Bordogna W, and Gelderblom H. Updated analysis of the efficacy and safety of entrectinib in patients (pts) with locally advanced/metastatic NTRK fusion-positive (NTRK-fp) solid tumors. Journal of Clinical Oncology 2022; 40:16_suppl, 3099-3099