Tagrisso

Osimertinib

1st-line treatment of patients w/ locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ activating epidermal growth factor receptor (EGFR) mutations. Locally advanced or metastatic EGFR T790M mutation-positive NSCLC. Adjuvant therapy after tumour resection in patients w/ NSCLC whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations.

80 mg once daily, may be reduced to 40 mg once daily if necessary.

May be taken with or without food: Take at the same time each day. Swallow whole w/ water, do not crush/split/chew. For patients w/ swallowing difficulties, disperse tab in 50 mL non-carbonated water & stir w/o crushing then, drink w/in 30 min. Rinse glass w/ another 1/2 glass of water & drink. Dispersed liqd may also be administered via nasogastric tube by using 15 mL for initial dispersion & 15 mL for residue rinses. Flush tube w/ water after administration.

Hypersensitivity. Concomitant use w/ St. John's wort.

Discontinue use if interstitial lung disease is diagnosed, erythema multiforme & Stevens-Johnson syndrome appears & QTc interval prolongation in combination w/ Torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia develop. Avoid use in patients w/ congenital long QT syndrome. Keratitis. Determine EGFR mutation positive status. Closely monitor signs & symptoms of erythema multiforme. Periodically monitor ECG & electrolytes in patients w/ CHF, electrolyte abnormalities or those taking QTc prolonging medicinal products. Cardiac monitoring & LVEF assessment in patients w/ cardiac risk factors & conditions affecting LVEF. Severe hepatic & renal (CrCl 15-<30 mL/min) impairment, end-stage renal disease. May impair fertility. Women of childbearing potential should use effective contraception at least 2 mth after treatment completion & at least 4 mth for males after treatment completion. Not to be used during pregnancy & lactation. Childn or adolescents <18 yr.

Diarrhoea, stomatitis; rash, dry skin, paronychia, pruritus; decreased platelet count, leucocytes, lymphocytes & neutrophils. Epistaxis, interstitial lung disease; palmar-plantar erythrodysaesthesia syndrome, alopecia, urticaria; increased blood creatinine.

Increased exposure of breast cancer resistance protein & P-glycoprotein substrates. Reduced steady-state AUC w/ rifampicin. Decreased exposure w/ strong & moderate CYP3A4 inducers. Increased AUC & C_max of rosuvastatin & fexofenadine. Concomitant use w/ St. John's wort; P-gp-dependent drugs & w/ narrow therapeutic index eg, digoxin, dabigatran, aliskiren.

Targeted Cancer Therapy

L01EB04 - osimertinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.

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