Precautions of Afatinib

1 Diarrhea

For patients who develop prolonged Grade 2 diarrhea lasting more than 48 hours or greater than or equal to  Grade 3 diarrhea, withhold Afatinib until diarrhea resolves to Grade 1 or less and resume Afatinib with  appropriate dose reduction. Provide patients with an anti-diarrheal agent (e.g., loperamide) for self-administration at the onset of diarrhea and instruct patients to continue anti-diarrheal therapy until loose bowel movements cease for 12 hours.

2 Bullous and Exfoliative Skin Disorders

Discontinue Afatinib in patients who develop life-threatening bullous, blistering, or exfoliating skin lesions. For patients who develop prolonged Grade 2 cutaneous adverse reactions lasting more than 7 days, intolerable  Grade 2 cutaneous reactions, or Grade 3 cutaneous reactions, withhold Afatinib until the adverse reaction  resolves to Grade 1 or less and resume Afatinib with appropriate dose reduction.

3 Interstitial Lung Disease  

Withhold Afatinib during evaluation of patients with suspected ILD and discontinue Afatinib in patients  with confirmed ILD.

4 Hepatic Toxicity

Obtain periodic liver testing in patients during treatment with Afatinib. Withhold Afatinib in patients who  develop worsening of liver function. In patients who develop severe hepatic impairment while taking Afatinib, discontinue treatment.

5 Gastrointestinal Perforation

Permanently discontinue Afatinib in patients who develop gastrointestinal perforation.

6 Keratitis

Withhold Afatinib during evaluation of patients with suspected keratitis, and if diagnosis of ulcerative keratitis is confirmed, interrupt or discontinue Afatinib. If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered. Afatinib should be used with caution in patients with a history of keratitis, ulcerative keratitis, or severe dry eye. Contact lens use is also a risk factor for keratitis and ulceration.

7 Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of  reproductive potential to use effective contraception during treatment and for at least 2 weeks after the last dose  of Afatinib.

from FDA，2022.04