AFATINIB 40 mg Tablets

Oral EGFR Tyrosine Kinase Inhibitor – Targeted Therapy for NSCLC

ATC Code: L01EB03 | Prescription Only | Specialty Oncology

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Product Description:

Afatinib is an irreversible tyrosine kinase inhibitor (TKI) that selectively targets the ErbB family of receptors, particularly EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4). Unlike first-generation TKIs, Afatinib covalently binds to the ATP-binding site of these receptors, resulting in sustained inhibition of signal transduction pathways involved in tumor cell proliferation and survival. It is indicated as first-line treatment for metastatic non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations, including exon 19 deletions and exon 21 (L858R) substitutions. It also has proven benefit in squamous cell carcinoma of the lung following platinum-based chemotherapy.

Available Presentation:

• Strength: 40 mg film-coated tablets
• Formulation: Oral solid dose; tablet color and imprint vary by manufacturer
• Packaging: Box with 30 tablets (HDPE bottle or blister pack)
• Route of Administration: Oral, once daily on an empty stomach
• Storage Conditions: Store below 30°C; protect from moisture and light

Uses:

• Targeted first-line therapy for patients with EGFR mutation-positive NSCLC
• Treatment of advanced or metastatic squamous cell carcinoma of the lung after platinum-based chemotherapy
• Effective in common EGFR mutations (Del19, L858R) and certain rare mutations (e.g., G719X, S768I, L861Q)
• Used as a personalized oncology treatment based on EGFR mutation testing

Indications:

• First-line treatment of patients with metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations
• Second-line treatment of squamous NSCLC progressing after platinum-based chemotherapy
• May be used in uncommon EGFR mutations in off-label or guideline-supported regimens under molecular oncology protocols

Regulatory and Safety Profile:

• ATC Code: L01EB03
• Pharmacologic Class: ErbB family blocker / Irreversible TKI
• Pregnancy Category: D – Use only if clearly necessary
• Common Adverse Effects: Diarrhea, rash, stomatitis, paronychia, decreased appetite
• Serious Risks: Interstitial lung disease (ILD), hepatotoxicity, keratitis, severe diarrhea requiring hospitalization
• Contraindications: Known hypersensitivity to afatinib or its excipients
• Monitoring Parameters: Liver function tests, renal status, dermatologic toxicity, pulmonary symptoms, and EGFR mutation status prior to initiation