Four Star
Concise Prescribing Info
Osimertinib mesylate
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. 1st-line treatment of adults w/ locally advanced or metastatic NSCLC w/ activating EGFR mutations. Treatment of adults w/ locally advanced or metastatic EGFR T790M mutation +ve NSCLC.
Dosage/Direction for Use
80 mg once daily. Dose reduction may be required based on individual safety & tolerability.
May be taken with or without food: Swallow whole w/ water, or disperse in non-carbonated water & immediately swallow or administer through nasogastric tube.
Hypersensitivity. Concomitant use of St. John's wort.
Special Precautions
Perform a validated test to determine EGFR mutation status. Discontinue permanently if patients develop ILD. Interrupt or discontinue immediately w/ signs & symptoms of SJS. Discontinue permanently if QTc interval prolongation develops in combination w/ torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia. Cardiac monitoring in patients w/ cardiac risk factors; w/ conditions that can affect left ventricular ejection fraction; who develop relevant cardiac signs/symptoms. Refer promptly to ophthalmology specialist if presenting w/ signs & symptoms suggestive of keratitis. Caution in patients w/ severe or end-stage renal impairment; elderly >65 yr; body wt <50 kg. Not recommended in severe hepatic impairment. Fertility. Pregnancy & lactation.
Adverse Reactions
Decreased appetite; epistaxis; alopecia; urticaria; palmar-plantar erythrodysaesthesia syndrome; dry skin; rash; pruritus; paronychia; decreased leukocytes, lymphocytes, neutrophils, platelet count; increased blood creatinine; diarrhoea; ILD; stomatitis.
Drug Interactions
Decreased exposure w/ strong (eg, phenytoin, rifampicin, carbamazepine) & moderate (eg, bosentan, efavirenz, etravirine, modafinil) CYP3A4 inducers. Increased exposure of sensitive BCRP substrates (eg, rosuvastatin); P-gp substrates (eg, fexofenadine).
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
Tagrisso FC tab 80 mg
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