Formulation and specifications: Tablets: 30mg, 40mg
Indications:
1. Locally advanced or metastatic NSCLC with EGFR-sensitive mutations, not previously treated with EGFR tyrosine kinase inhibitors (EGFR-TKI).
2. Locally advanced or metastatic squamous histologic type NSCLC with disease progression during or after platinum-containing chemotherapy.
Key points for rational drug use:
1. Patients with advanced NSCLC with EGFR gene-sensitive mutations in first-line therapy must clearly have EGFR gene-sensitive mutations detected by EGFR gene testing methods approved by the State Drug Administration prior to dosing.
2. Although the drug insert indicates that afatinib does not require genetic testing for use in patients with advanced squamous cell carcinoma of the lung who progress during or after second-line treatment with platinum-containing chemotherapy, it is still not recommended for use in patients with negative EGFR mutations.
3. Afatinib is preferred for patients with uncommon EGFR gene mutations.
4. The recommended dose is 40 mg once daily, with dose adjustment based on patient tolerability; see Table 2 for the dose adjustment regimen.
Table 2 Recommended Dose Adjustment Regimen for Afatinib
| CTCAEa(version 4.0) drug-related adverse events | Recommended dosing of afatinib | |
| Grade 1 to 2 | No interruptionb | No dose adjustment |
| Interruption until recovery to level 0/1 b | Continue in 10mg decrementsd | |
a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 4.0.
b When diarrhea occurs, an antidiarrheal drug (eg, loperamide) should be administered immediately and should be continued until the diarrhea stops in cases of persistent diarrhea.
cDiarrhea >48 hours and/or rash >7 days.
dIf the patient cannot tolerate 20 mg daily, permanent discontinuation of this product should be considered.
5. 30 mg may be used as the recommended dose for patients evaluated by the clinician as poorly tolerated.
6. Afatinib should not be taken with food and should be taken at least 3 hours after eating or at least 1 hour before eating.
7. Adverse events such as diarrhea, skin-related adverse reactions, and interstitial pneumonia must be noted during administration.
8. if P-glycoprotein inhibitors are required, they should be administered in staggered doses, as far apart from afatinib as possible. p-glycoprotein inhibitors should be administered 6 hours (P-glycoprotein inhibitors administered twice daily) or 12 hours (P-glycoprotein inhibitors administered once daily) apart from afatinib administration.
9. Afatinib is not metabolized by the CYP enzyme system and in vitro experimental studies have shown no significant effect on afatinib exposure when combined with CYP inhibitors or inducers.
10. This product contains lactose and should not be administered to patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.