This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Afatinib oral


Oral formulations of afatinib.

Drugs List

  • afatinib 20mg tablets
  • afatinib 30mg tablets
  • afatinib 40mg tablets
  • afatinib 50mg tablets
  • GIOTRIF 20mg tablets
  • GIOTRIF 30mg tablets
  • GIOTRIF 40mg tablets
  • GIOTRIF 50mg tablets
  • Therapeutic Indications


    Locally advanced/metastatic Non-Small Cell Lung Cancer (NSCLC)

    Epidermal Growth Factor Receptor (EGFR) TKI-naive patients with locally advanced or metastatic non-small lung cell cancer (NSCLC) with activating EGFR mutations.
    Locally advanced or metastatic non-small cell lung cancer (NSCLC) of squamous histology progressing on or after platinum-based chemotherapy.



    40mg once daily without food.

    A dose increase to a maximum of 50mg once daily may be considered in patients who tolerate a 40mg once daily in the first cycle of treatment (21 days for EGFR mutation positive NSCLC and 28 days for squamous NSCLC). The dose should not be increased in any patients with a prior dose reduction.

    Additional Dosage Information

    Dose adjustment for adverse reactions
    NCI Common Terminology Criteria for Adverse Events
    Grade 1 or Grade 2: No interruption. No Dose adjustment.
    Grade 2 (prolonged, more than 48 hours of diarrhoea and/or more than 7 days of rash or intolerable) or Grade greater or equal to 3: Interrupt until grade 0/1. Resume with dose reduction by 10mg decrements. If patient cannot tolerate 20mg/day, permanent discontinuation of afatinib should be considered.

    Missed doses
    If a dose is missed, it should be taken within the same day as soon as the patient remembers. However, if the next scheduled dose is due within 8 hours then the missed dose must be skipped.


    Children under 18 years
    Renal impairment - eGFR below 15ml/minute/1.73m sq
    Severe hepatic impairment - Child-Pugh score greater than or equal to 10

    Precautions and Warnings

    Underweight patients
    Wearing of contact lenses
    Glucose-galactose malabsorption syndrome
    History of keratitis
    Lactose intolerance
    Left ventricular dysfunction
    Renal impairment - eGFR below 30ml/minute/1.73m sq
    Severe dry eyes

    Refer patients with symptoms of keratitis to an ophthalmology specialist
    Advise ability to drive/operate machinery may be affected by side effects
    Anti-diarrhoeals may be required during treatment
    Confirm EGFR mutation status of tumour prior to treatment
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Advise no food for at least 3 hours pre- and 1 hour post dose
    Consult local policy on the safe use of anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Evaluate benefit of continued therapy if LVEF has decreased from baseline
    Monitor closely patient at risk of cardiovascular disorders
    Monitor closely patient with pre-existing hepatic impairment
    Monitor closely patient with pre-existing renal impairment
    Monitor females & underweight patients as increased risk of adverse effects
    Monitor for signs and symptoms of interstitial lung disease
    Monitor patients with cardiac disorders
    Advise patient to report any symptoms of interstitial lung disease
    Consider dose reduction for subsequent doses if severe diarrhoea occurs
    Discontinue / interrupt treatment if ulcerative keratitis develops
    Discontinue treatment if interstitial lung disease develops
    Suspend treatment if grade 3 or worse skin reaction occurs
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if severe hepatic changes occur
    Discontinue if severe skin reaction occurs
    Suspend treatment if grade 2 intolerable or 48 hour plus duration diarrhoea
    Suspend treatment if grade 2 intolerable or 7 day plus duration rash occurs
    Suspend treatment if grade 3 or greater diarrhoea occurs
    Advise patient not to take St John's wort concurrently
    Female: Contraception required during and for 1 month after treatment
    Advise patient on appropriate sun protection methods
    Advise patient to avoid exposure to sunlight and UV rays during treatment

    Higher exposure to afatinib has been observed in female patients, patients with lower body weight and those with underlying renal impairment. Close monitoring is recommended in patients with these risk factors.

    Symptoms such as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye should be referred promptly to an ophthalmology specialist.

    In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered.

    Early intervention (such as emollients, antibiotics) of dermatologic reactions can facilitate continuous afatinib treatment.

    Pregnancy and Lactation


    Afatinib is contraindicated during pregnancy.

    The manufacturer advises use of afatinib during pregnancy or if the patient becomes pregnant while or after receiving afatinib, she should be informed of the potential hazard to the foetus. At the time of writing there is limited amount of data from the use of this medicinal product in pregnant women. The risk for humans is unknown.

    Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity. Studies in animals have shown no signs of teratogenicity up to and including maternally lethal dose levels.


    Afatinib is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst receiving this medicinal product. Available pharmacokinetic data in animals have shown excretion of afatinib in milk. Based on this, it is likely that afatinib is excreted in human milk. A risk to the breastfeeding child cannot be excluded.

    Side Effects

    Acne-like eruptions
    Alanine aminotransferase increased
    Allergic alveolitis
    Aspartate aminotransferase increased
    Bullous reactions
    Decreased appetite
    Dry eyes
    Dry skin
    Interstitial lung disease
    Muscle spasm
    Palmar-Plantar Erythrodysaesthesia syndrome
    Pulmonary infiltration
    Renal failure
    Renal impairment
    Respiratory distress syndrome
    Skin reactions
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2019

    Reference Sources

    Summary of Product Characteristics: Giotrif 20mg, 30mg, 40mg, 50mg film-coated tablets. Boehringer Ingelheim Ltd. Revised June 2018.

    NICE Evidence Services Available at: Last accessed: 22 July 2019

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.