Boehringer Ingelheim


Agencia Lei Va Hong
Concise Prescribing Info
Afatinib dimaleate
Monotherapy for treatment of epidermal growth factor receptor (EGFR) TKI-naïve adult patients w/ locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ activating EGFR mutation(s); & locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.
Dosage/Direction for Use
Should be taken on an empty stomach: Food should not be consumed for at least 3 hr before or 1 hr after taking Giotrif. Swallow whole. For patients w/ swallowing difficulties, disperse tab in water. Do not use other liqd. Drink immediately.
Special Precautions
Assess EGFR mutation status. Diarrhoea w/in the 1st 6 wk of treatment. Interrupt & reduce dose or discontinue therapy in case of severe diarrhoea. Mild or moderate erythematous & acneiform rash may occur or worsen in areas exposed to the sun. Closer monitoring is recommended in female patients, patients w/ lower body wt & those w/ underlying renal impairment. Treatment should be interrupted if interstitial lung disease (ILD) is suspected; permanently discontinue if ILD is diagnosed. Periodic liver function testing is recommended in patients w/ pre-existing liver disease. Interrupt dose in patients who experience worsening of liver function; discontinue if severe hepatic impairment develops. Acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain &/or red eye should be referred promptly to an ophthalmology specialist. Interrupt or discontinue treatment if ulcerative keratitis is confirmed. Use cautiously in patients w/ history of keratitis, ulcerative keratitis or severe dry eye. Consider cardiac monitoring including left ventricular ejection fraction (LVEF) assessment in patients w/ cardiac risk factors & those w/ conditions that can affect LVEF. Rare hereditary conditions of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in patients w/ severely impaired renal function (eGFR <15 mL/min/1.73 m2 or on dialysis) & severe hepatic impairment (Child Pugh C).
Adverse Reactions
Diarrhea, rash, dermatitis acneiform, pruritus, dry skin, stomatitis, paronychia, decreased appetite, epistaxis, nausea & vomiting. Cystitis, dehydration, hypokalaemia, dysgeusia, conjunctivitis, dry eye, rhinorrhea, dyspepsia, cheilitis, ALT & AST increased, palmar-plantar erythrodysaesthesia, nail disorders, muscle spasms, renal impairment/renal failure, pyrexia & wt decreased.
Drug Interactions
Increased exposure w/ strong P-gp inhibitors. Possible decrease in exposure w/ strong P-gp inducers. May increase bioavailability of orally administered BCRP substrates. Significant decrease in exposure w/ high-fat meals.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EB03 - afatinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Giotrif FC tab 20 mg
Giotrif FC tab 30 mg
Giotrif FC tab 40 mg
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