Adverse event management: diarrhoea
Management recommendations1,2
Approach to management depends on which grade is identified in each patient. A breakdown of the management guidelines is displayed below.
Grade 1–2:
- GIOTRIF® (afatinib) treatment is continued at the same dose
- Patients should be followed closely to avoid dehydration
- Patients should stop taking laxatives and drink 8–10 glasses of water or clear fluids per day
- Patients should make dietary changes, as described in the “Advice for Patients” subsection below
- Start immediately on loperamide. Initially with a dose of 4 mg, then 2 mg after each episode of diarrhoea
(up to 20 mg/day) until bowel movements cease for 12 hours
If Grade 2 diarrhoea persists longer than 48 hours or is intolerable:
- Continue loperamide treatment
- Interrupt GIOTRIF® (afatinib) treatment, restarting once diarrhoea symptoms have resolved to Grade ≤1 at a dose reduced by 10 mg to a minimum of 20 mg/day
- Assess patients for dehydration and electrolyte imbalance and consider intravenous fluids and electrolyte replacement
Grade 3–4:
- Continue loperamide treatment
- Interrupt GIOTRIF® (afatinib) treatment, restarting once diarrhoea symptoms have resolved to Grade ≤1 at a dose reduced by 10 mg to a minimum of 20 mg/day
- Admit patient to hospital to monitor progress and to take stool specimen for microbiologic examination
- Initiate intravenous fluid replacement for ≥24 hours, noting that substantial fluid loss may have occurred
- Consider prophylactic antibiotics if the patient is neutropenic
If diarrhoea symptoms do not resolve to grade ≤1 within 14 days, despite optimal supportive care and treatment interruption:
- Permanently discontinue GIOTRIF® (afatinib) treatment
Advice for patients1
- Drink ≥2 L of clear fluids daily to avoid dehydration; some fluids should contain sugar or salt to avoid electrolyte loss
- Incorporate bananas, rice, apple sauce and toast into their diet (BRAT diet)
- Avoid food that exacerbates symptoms (e.g. greasy, spicy and fried foods) are difficult to digest or contain lactose/caffeine
Grading3
The diarrhoea grade can be used to guide the management strategy.
Adapted from CTCAE version 3.3
ADL=activities of daily living, CTCAE=Common Terminology Criteria for Adverse Events
References
- 1
- Yang JC, et al. Expert Rev Anticancer Ther 2013;13(6):729–736.
- 2
- GIOTRIF® (afatinib) Summary of Product Characteristics, 2018.
- 3
- Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.