- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of afatinib.
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.
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
Wearing of contact lenses
Glucose-galactose malabsorption syndrome
History of keratitis
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
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.
Alanine aminotransferase increased
Aspartate aminotransferase increased
Interstitial lung disease
Palmar-Plantar Erythrodysaesthesia syndrome
Respiratory distress syndrome
Toxic epidermal necrolysis
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: July 2019
Summary of Product Characteristics: Giotrif 20mg, 30mg, 40mg, 50mg film-coated tablets. Boehringer Ingelheim Ltd. Revised June 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 July 2019
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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.