Giotrif 20 mg, 30 mg, 40 mg, 50 mg Film-coated tablets (tablets).

    Giotrif 20 mg, 30 mg, 40 mg, 50 mg Film-coated tablets (tablets).

    S4
    PDF Leaflet Revision Date: 8 August 2025


    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Treatment of locally advanced or metastatic NSCLC with EGFR mutations.

    Dosage (summary)

    40 mg once daily, can escalate to 50 mg if tolerated.

    Special Populations

    • Renal impairment
    • Hepatic impairment

    Pregnancy & Breastfeeding

    Contraindicated in pregnancy and breastfeeding; potential fetal harm.

    Key Drug Interactions

    • P-glycoprotein inhibitors
    • Strong P-glycoprotein inducers

    Contraindications

    • Hypersensitivity to afatinib
    • Severe hepatic impairment
    • Severe ocular conditions

    Common side effects

    • Diarrhoea
    • Rash
    • Stomatitis
    • Nausea
    • Vomiting

    Counselling Points

    • Take without food; avoid pregnancy; monitor for diarrhoea and skin reactions.

    Serious warnings

    • Interstitial Lung Disease
    • Severe skin reactions
    • Gastrointestinal perforations
    Important Disclaimer

    The Giotrif 20 mg, 30 mg, 40 mg, 50 mg Film-coated tablets (tablets). professional information leaflet below is the property of Ingelheim Pharmaceuticals and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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