Giotrif

Monotherapy treatment of epidermal growth factor receptor (EGFR) TKI-naive adults w/ locally advanced or metastatic NSCLC w/ activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.

40 mg once daily, may escalate dose up to max: 50 mg daily if tolerated.

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, may be dispersed in approx 100 mL of non-carbonated water. No other liqd should be used. Drop in water w/o crushing & stir for up to 15 min until it disperses. Drink immediately. Rinse glass w/ another 100 mL of water & drink. Dispersed liqd may also be administered via nasogastric tube.

Hypersensitivity.

Discontinue use if ILD is diagnosed; severe bullous, blistering or exfoliating conditions; GI perforation develops. Interrupt & reduce dose or discontinue therapy in patients w/ severe diarrhoea. May require temporary interruption, dose reduction & additional therapeutic intervention in patients w/ severe skin reactions. Cardiac risk factors & conditions affecting left ventricular ejection fraction. History of keratitis, ulcerative keratitis or severe dry eye. Lower body wt. Female patients. Avoid excessive sun exposure. Assess EGFR mutation status prior to initiation. Concomitant use w/ P-gp inducers. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not recommended in severe hepatic impairment (Child-Pugh C) & in patients w/ eGFR <15 mL/min/1.73 m² or on dialysis. Severe renal impairment. May affect fertility. Women of childbearing potential should use adequate contraception during & for at least 1 mth after last dose. Pregnancy. Not advisable during lactation. Not recommended in childn or adolescents.

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.

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, St. John's wort; high-fat meal. Increased bioavailability of BCRP substrates eg, rosuvastatin, sulfasalazine.

Targeted Cancer Therapy

L01EB03 - afatinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.

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