Giotrif

Giotrif

afatinib

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH

Marketer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Afatinib dimaleate
Indications/Uses
Monotherapy treatment of epidermal growth factor receptor (EGFR) TKI-naive adult patient w/ locally advanced or metastatic non-small cell lung cancer w/ activating EGFR mutation(s); squamous histology progressing on or after platinum-based chemotherapy.
Dosage/Direction for Use
40 mg once daily, may escalate dose up to max: 50 mg daily if tolerated.
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 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 a nasogastric tube.
Contraindications
Special Precautions
Discontinue use if interstitial lung disease; severe bullous, blistering or exfoliating conditions; GI perforation developed. Interrupt & reduce dose or discontinue therapy in patients w/ severe diarrhoea. Assess EGFR mutation status. Cardiac risk factors & conditions affecting left ventricular ejection fraction. Patients w/ severe skin reactions may require temporary interruption, dose reduction & additional therapeutic intervention. History of keratitis, ulcerative keratitis or severe dry eye. Lower body wt. Female patients. Avoid excessive sun exposure. Concomitant use w/ P-gp inducers. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Severe renal impairment. Not recommended in severe hepatic impairment (Child-Pugh C) & in patients w/ eGFR <15 mL/min/1.73 m2 or on dialysis. Women of childbearing potential should use adequate contraceptives during & at least 1 mth after treatment. Pregnancy & lactation. Not recommended in childn or 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 or AST; palmar-plantar erythrodysaesthesia syndrome, nail disorders; muscle spasms; renal impairment/failure; pyrexia; decreased wt.
Drug Interactions
Increased exposure w/ strong P-gp inhibitors eg, ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir & amiodarone. Decreased exposure w/ strong P-gp inducers eg, rifampicin, carbamazepine, phenytoin, phenobarb or St. John's wort & high-fat meal. Increased bioavailability of BCRP substrates eg, 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 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
Form
Giotrif FC tab 50 mg
Packing/Price
28's
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