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.

Grade 1	Grade 2	Grade 3	Grade 4
Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline	Increase of 4–6 stools per day over baseline; IV fluids indicated <24hrs; moderate increase in ostomy output compared to baseline; not interfering with ADL	Increase of ≥7 stools per day over baseline; incontinence; IV fluids ≥24hrs; hospitalisation; severe increase in ostomy output compared to baseline; interfering with ADL	Life-threatening consequences (e.g. haemodynamic collapse)

Grade 1	Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline
Grade 2	Increase of 4–6 stools per day over baseline; IV fluids indicated <24hrs; moderate increase in ostomy output compared to baseline; not interfering with ADL
Grade 3	Increase of ≥7 stools per day over baseline; incontinence; IV fluids ≥24hrs; hospitalisation; severe increase in ostomy output compared to baseline; interfering with ADL
Grade 4	Life-threatening consequences (e.g. haemodynamic collapse)

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.

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