Osimertinib (Specialist drug)

Treatment should be initiated by a physician experienced in the use of anticancer therapies, and EGFR mutation status must be determined by a validated test before use. The same 80 mg once-daily dose applies as monotherapy and when given with pemetrexed and platinum-based chemotherapy (cisplatin and/or carboplatin for up to 4 cycles - refer to their own SPCs). DOSE REDUCTION: if required, reduce to 40 mg once daily. Withhold for up to 3 weeks for a Grade 3 or higher adverse reaction; if it improves to Grade 0-2, restart at 80 mg or 40 mg; if it does not improve within 3 weeks, discontinue permanently. Permanently discontinue for ILD/pneumonitis, QTc prolongation with signs or symptoms of serious arrhythmia, Stevens-Johnson syndrome or toxic epidermal necrolysis, or aplastic anaemia. For QTc greater than 500 msec on at least 2 ECGs, withhold until QTc is less than 481 msec or back to baseline, then restart at 40 mg. Missed dose: make up the dose unless the next dose is due within 12 hours. DURATION: adjuvant setting - until disease recurrence or unacceptable toxicity (treatment beyond 3 years not studied); locally advanced or metastatic disease - until disease progression or unacceptable toxicity. If the patient cannot swallow the tablet it may be dispersed (not crushed) in 50 mL of non-carbonated water, stirred until dispersed and swallowed immediately, followed by a rinse; for nasogastric administration use 15 mL for the dispersion and 15 mL for the rinse and administer within 30 minutes. Not established in patients under 18 years - no data available.