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Symptoms: The highest dose of GIOTRIF studied in a limited number of patients in Phase I clinical trials was 160 mg once daily for 3 days and 100 mg once daily for 2 weeks. The adverse reactions observed at this dose were primarily dermatological (rash/acne) and gastrointestinal events (especially diarrhoea). Overdose in 2 healthy adolescents involving the ingestion of 360 mg each of GIOTRIF (as part of a mixed drug ingestion) was associated with adverse drug reactions of nause, vomiting, asthenia, dizziness, headache, abdominal pain and elevated amylase (<1.5 times ULN). Both subjects recovered from these adverse events.
Treatment: There is no specific antidote for overdose with GIOTRIF. In cases of suspected overdose, GIOTRIF should be withheld and supportive care instituted. If indicated, elimination of unabsorbed afatinib may be achieved by emesis or gastric lavage.
