Abbreviated Prescribing Information
Tagrisso

Presentation: 80 mg and 40 mg osimertinib tablet (as mesylate). Indications: 1. The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non- small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations; 2. The treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy; 3. First-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations; 4. Treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC; 5. In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Dosage: 80mg once daily with or without food. Swallowed whole with water, or dispersed in non- carbonated water and immediately swallowed or administered through nasogastric tube. Dose reduction may be required based on individual safety and tolerability. Contraindications: Hypersensitivity to the active substance or excipients; concomitant use of St. John’s Wort. Precautions: A validated test should be performed to determine EGFR mutation status. Discontinue permanently if patients develop interstitial lung disease (ILD); Interrupt or discontinue immediately with signs and symptoms Stevens-Johnson syndrome (SJS). Discontinue permanently if develop QTc interval prolongation in combination with: Torsade de pointes, polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia. Cardiac monitoring in patients with cardiac risk factors; those with conditions that can affect left ventricular ejection fraction; and those who develop relevant cardiac signs/symptoms. Refer promptly to ophthalmology specialist if presenting with signs and symptoms suggestive of keratitis. Caution in patients with severe or end-stage renal impairment; greater than 65 years of age; body weight less than 50 kg; pregnancy; breast- feeding; fertility. Not recommended in severe hepatic impairment. Interactions: Strong CYP3A4 inducers, moderate CYP3A4 inducers, rosuvastatin, fexofenadine. Undesirable effects: Decreased appetite; epistaxis; alopecia; urticaria; palmar-plantar erythrodysaesthesia syndrome; dry skin; rash; pruritus; paronychia; leukocytes decreased, lymphocytes decreased, neutrophils decreased, platelet count decreased; blood creatinine increased; diarrhoea; ILD; stomatitis. Full local prescribing information is available upon request. API.HK.TAG.0425

HK-12696 02/02/2026