Giotrif

Giotrif

afatinib

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Afatinib dimaleate
Indications/Uses
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
Administration
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.
Contraindications
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).
ATC Classification
L01XE13 - afatinib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Giotrif FC tab 50 mg
Packing/Price
28's
Form
Giotrif FC tab 40 mg
Packing/Price
28's
Form
Giotrif FC tab 30 mg
Packing/Price
28's
Form
Giotrif FC tab 20 mg
Packing/Price
28's
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