Concise Prescribing Info
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.
Dosage/Direction for Use
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.
Special Precautions
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.
Adverse Reactions
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.
Drug Interactions
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 & Cmax of rosuvastatin & fexofenadine. Concomitant use w/ St. John's wort; P-gp-dependent drugs & w/ narrow therapeutic index eg, digoxin, dabigatran, aliskiren.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EB04 - osimertinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Tagrisso FC tab 40 mg
3 × 10's
Tagrisso FC tab 80 mg
3 × 10's
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