Tagrisso

As monotherapy for the adjuvant treatment after complete tumour resection in adults w/ stage IB-IIIA NSCLC whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. As monotherapy for the treatment of adults w/ locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations & whose disease has not progressed during or following platinum-based chemoradiation therapy. As monotherapy for the 1st-line treatment of adults w/ locally advanced or metastatic NSCLC w/ activating EGFR mutations. As monotherapy for the treatment of adults w/ locally advanced or metastatic EGFR T790M mutation +ve NSCLC. In combination w/ pemetrexed & platinum-based chemotherapy for the 1st-line treatment of adults w/ advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

80 mg once daily. Reduce to 40 mg once daily if dose reduction is necessary based on individual safety & tolerability.

May be taken with or without food: Swallow whole w/ water; do not crush/split/chew. If unable to swallow whole tab, disperse in 50 mL of non-carbonated water, w/o crushing, & immediately drink, then rinse w/ additional ½ glass of water to ensure that no residue remains; alternatively, administer via nasogastric tube using 15 mL for initial dispersion & 15 mL for residue rinses, w/in 30 min of adding tab to water.

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

Determine EGFR mutation status using a validated test method. Risk of ILD or ILD-like adverse reactions eg, pneumonitis; radiation pneumonitis; severe cutaneous adverse reactions eg, SJS & TEN; QTc interval prolongation; changes in cardiac contractility eg, decreased left ventricular ejection fraction (LVEF); keratitis; aplastic anaemia. Avoid use in patients w/ congenital long QT syndrome. Consider cardiac monitoring including LVEF assessment at baseline & during treatment in patients w/ cardiac risk factors & those w/ conditions that can affect LVEF. Not recommended in patients w/ severe hepatic impairment. Caution in patients w/ severe & end-stage renal impairment. Women of childbearing potential should avoid becoming pregnant while on treatment. Female patients should use effective contraception for at least 2 mth after completion of treatment. Male patients should use effective contraception for at least 4 mth after completion of treatment. May cause foetal harm when administered to a pregnant woman. Should not be used during pregnancy unless necessary. Breast-feeding should be discontinued during treatment. Safety & efficacy in childn or adolescents <18 yr have not been established. Elderly patients (>65 yr) or patients w/ low body wt (<50 kg) may be at increased risk of developing adverse events of grade ≥3.

Monotherapy: Diarrhoea, rash, paronychia, dry skin, stomatitis. Combination therapy: Rash, diarrhoea, decreased appetite, stomatitis, paronychia, dry skin.

Decreased exposure w/ strong CYP3A4 inducers (eg, phenytoin, rifampicin, carbamazepine); moderate CYP3A4 inducers (eg, bosentan, efavirenz, etravirine, modafinil). Increased exposure of BCRP substrates (eg, rosuvastatin); P-gp substrates (eg, fexofenadine). Risk for decreased exposure of hormonal contraceptives.

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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