Zuellig Pharma
Concise Prescribing Info
1st-line treatment & adjuvant therapy after tumour resection of adult patients w/ locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. Locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR TKI therapy.
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, do not crush/split/chew. For patients w/ swallowing difficulties, tab may be dispersed in 50 mL non-carbonated water & stir w/o crushing until dispersed. Drink immediately. Rinse glass w/ another ½ 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. The tube should be flushed w/ water after administration. Administer soln w/in 30 min after prep.
Hypersensitivity. Not to be used w/ St. John's wort.
Special Precautions
Discontinue use if interstitial lung disease is diagnosed, signs & symptoms of 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 prior to treatment. 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 impairment, end-stage renal disease. May impair fertility. Women of childbearing potential must use effective contraception at least 2 mth after treatment completion & at least 4 mth for men 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. Interstitial lung disease.
Drug Interactions
Decreased exposure by strong (eg, phenytoin, rifampicin, carbamazepine) & moderate (eg, bosentan, efavirenz, etravirine, modafinil) CYP3A4 inducers. Increased exposure of BCRP & P-gp substrates (eg, digoxin, dabigatran, aliskiren). Increased AUC & Cmax of rosuvastatin, fexofenadine. Decreased AUC & Cmax of simvastatin.
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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