उत्पाद वर्णन
उत्पाद विवरण: Afatinib 20 mg Tablets
Generic Name: Afatinib (afatinib dimaleate salt)
Brand Examples: Gilotrif, Giotrif, Afanat, Xovoltib
Dosage Form: Oral film-coated tablet; 20 mg strength
Therapeutic Use
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Indications:
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First-line treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC) with non-resistant EGFR mutations (e.g., del 19, L858R, G719X, L861Q)
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Second-line treatment for metastatic squamous NSCLC after platinum-based chemotherapy failure
Mechanism of Action
Afatinib is an irreversible inhibitor of the ErbB family of tyrosine kinases, notably EGFR (ErbB-1), HER2 (ErbB-2), and ErbB-4. It blocks signaling pathways that drive tumor cell growth and proliferation. Its effective against certain EGFR mutations resistant to first-generation TKIs but not against the T790M mutation.
Dosage & Administration
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Typically administered once daily, on an empty stomach at least 1 hour before or 2 hours after a meal, to ensure proper absorption.
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Tablets must be swallowed whole with water; do not crush or chew.
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Caution and dose adjustments are needed when co-administered with P-glycoprotein (P-gp) inhibitors or inducers.
Safety & Side Effects
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Very Common (>10%):
Diarrhea (up to 96% incidence, with 15% being severe by week 6), rash/acne-like dermatitis, stomatitis/mouth sores, paronychia (nail inflammation), decreased appetite, itching, dry skin, nosebleed.
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Other/Common (110%):
Dehydration, taste changes, conjunctivitis, dry eye, cheilitis, fever, congestion, elevated liver enzymes (ALT, AST), hand-foot syndrome, muscle spasms, kidney impairment.
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Less Common (0.11%):
Keratitis, interstitial lung disease (rare but serious) .
Warnings:
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Diarrhea may lead to dehydration and renal impairment; monitor patients closely, especially early in treatment.
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Photosensitivity: Advise protective measures (sunscreen, clothing) .
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Monitor for pulmonary symptoms, cardiac issues, and other severe adverse events; discontinue or adjust dose as needed.
Storage & Handling
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Store at room temperature (2025 C / 6877 F), protected from heat, humidity, and light. Keep in the original container with desiccant
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