Boehringer Ingelheim


Concise Prescribing Info
Afatinib dimaleate
1st-line treatment of patients w/ locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ epidermal growth factor receptor (EGFR) mutations. Monotherapy for 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: Take at least 1 hr before or 3 hr after meals. Swallow whole. For patients w/ difficulty of swallowing, tab may be dispersed in approx 100 mL of plain, non-carbonated water. No other liqd should be used. Drop the tab in water & stir w/o crushing until it disperses (approx 15 min). Drink immediately. Rinse glass w/ another 100 mL of water & drink. Dispersed liqd may also be administered via nasogastric tube.
Special Precautions
Assess EGFR status. Diarrhoea including severe diarrhoea which may result in dehydration w/ or w/o renal impairment. Patients w/ prolonged or severe skin reactions may require temporary interruption of therapy. Discontinue or interrupt treatment if severe bullous, blistering or exfoliating conditions develop. Female gender, lower body wt & underlying renal impairment; interstitial lung disease; GI perforations. Interrupt or discontinue treatment if ulcerative keratitis is confirmed. Patients w/ a history of keratitis, ulcerative keratitis or severe dry eye. Cardiac monitoring including left ventricular ejection function (LVEF) assessment at baseline & during treatment in patients w/ cardiac risk factors & those w/ conditions that can affect LVEF. Consider interruption or discontinuation in patients w/ an ejection fraction below the institution’s lower limit of normal. Concomitant treatment w/ strong P-glycoprotein (P-gp) inducers. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in patients w/ eGFR <15 mL/min or on dialysis; patients w/ severe (Child Pugh C) hepatic impairment. Pregnancy. Avoid breastfeeding during therapy. Not recommended in childn & adolescents.
Adverse Reactions
Paronychia; decreased appetite; epistaxis; diarrhoea, stomatitis, nausea, vomiting; rash, dermatitis acneiform, pruritus, dry skin. Cystitis; dehydration, hypokalaemia; dysgeusia; conjunctivitis, dry eye; rhinorrhoea; dyspepsia, cheilitis; increased ALT & AST; palmar-plantar erythrodysaesthesia syndrome, nail disorders; muscle spasms; renal impairment/failure; pyrexia; decreased wt. Stevens-Johnson syndrome, toxic epidermal necrolysis.
Drug Interactions
May lead to increase exposure w/ strong P-gp inhibitors (ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir & amiodarone). Exposure may be decreased w/ strong P-gp inducers (rifampicin, carbamazepine, phenytoin, phenobarb or St. John's wort). Decreased exposure w/ high-fat meal. May increase bioavailability of BCRP substrates (rosuvastatin & sulfasalazine).
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
Giotrif FC tab 50 mg
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