非小細胞肺癌 Non-small cell lung carcinoma:
1. EGFR-TK mutation
2. metastatic squamous (previously treated)

#仿單變更2020 #仿單變更2021

Antineoplastic Agent, Epidermal Growth Factor Receptor (EGFR) Inhibitor:
Afatinib is a potent and selective, irreversible ErbB Family Blocker. It covalently binds to and irreversibly blocks signaling from all homo-and heterodimers formed by the ErbB family members EGFR (ErbB1), HER 2 (ErbB2), ErbB3 and ErbB4.

Absorption:
Decreased with high-fat meals
Distribution:
Protein binding: ~95%
Bioavailability: Tablets: 92% (as compared to an oral solution)
Metabolism:
1. Covalently adducted to proteins and nucleophilic small molecules (minimal enzymatic metabolism); ~2% of a dose is metabolized by FMO3
2. Half-life elimination: 37 hours
3. Time to peak: 2 to 5 hours
Excretion:
Feces (85%); urine (4%); primarily as unchanged drug

hypersensitivity to afatinib or to any of the excipients

D
1. Based on animal reproduction studies and on the mechanism of action, afatinib may cause fetal harm if used during pregnancy.
2. Women of reproductive potential should use highly effective contraception during therapy and for at least 2 weeks after the last afatinib dose.<20221123>

Not recommended.
Available animal data have shown excretion of afatinib in milk.
It is not known whether afatinib is excreted in human milk.
The manufacturer recommends against breastfeeding during therapy and for at least 2 weeks after the last afatinib dose.<20221123>

Common:
diarrhea, rash or acne, stomatitis, nail effect, decreased appetite, epistaxis, pruritus, decreased serum potassium<2021/8/10>
Serious:
Acute renal function, respiratory failure <2021/8/10>, bullous rash, gastrointestinal perforation<2020/10/8>, local skin exfoliation, pancreatitis, physical health deterioration, sepsis, skin blister, Stevens-Johnson syndrome, toxic epidermal necrolysis

NSCLC, metastatic or squamous:
40 mg once daily until disease progression or unacceptable toxicity
Administration:
The medication should be taken without food at the same time every morning.(at least 1 hour before or 2 hours after a meal)

Not recommended for children. <20221123>