Giotrif標必達

Giotrif

afatinib

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Afatinib dimaleate
Indications/Uses
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
Administration
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.
Contraindications
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.
Presentation/Packing
Form
Giotrif FC tab 20 mg
Packing/Price
28's
Form
Giotrif FC tab 30 mg
Packing/Price
28's
Form
Giotrif FC tab 40 mg
Packing/Price
28's
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