Treatment with TAGRISSO should be initiated by a physician experienced in the use of anticancer therapies.
When considering the use of TAGRISSO, EGFR mutation status should be determined using a validated test method (see Precautions) for: exon 19 deletions or exon 21 (L858R) substitution mutations (in tumour specimens for adjuvant treatment and tumour or plasma specimens for first-line treatment); T790M mutations (in tumour or plasma specimens following progression on or after EGFR TKI therapy).
Posology: The recommended dose is 80 mg osimertinib once a day.
Duration of treatment: Patients in the adjuvant setting should receive treatment until disease recurrence or unacceptable toxicity. Treatment duration for more than 3 years was not studied.
Patients with locally advanced or metastatic lung cancer should receive treatment until disease progression or unacceptable toxicity.
Missed dose: If a dose of TAGRISSO is missed, the dose should be made up unless the next dose is due within 12 hours.
TAGRISSO can be taken with or without food at the same time each day.
Dose adjustments: Dosing interruption and/or dose reduction may be required based on individual safety and tolerability. If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.
Dose reduction guidelines for adverse reactions toxicities are provided in Table 10. (See Table 10.)
Click on icon to see table/diagram/image
Special populations: No dosage adjustment is required due to patient age, body weight, gender, ethnicity and smoking status (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Based on clinical studies, no dose adjustments are necessary in patients with mild hepatic impairment (Child Pugh A) or moderate hepatic impairment (Child Pugh B). Similarly, based on population pharmacokinetic (PK) analysis, no dose adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤upper limit of normal (ULN) and aspartate aminotransferase (AST) >ULN or total bilirubin >1.0 to 1.5x ULN and any AST) or moderate hepatic impairment (total bilirubin between 1.5 to 3 times ULN and any AST) but caution should be used when administering TAGRISSO to these patients. The safety and efficacy of this medicinal product has not been established in patients with severe hepatic impairment. Until additional data become available, use in patients with severe hepatic impairment is not recommended (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Based on clinical studies and population PK analysis, no dose adjustments are necessary in patients with mild, moderate, or severe renal impairment. The safety and efficacy of this medicinal product has not been established in patients with end-stage renal disease [Creatinine clearance (CLcr) less than 15 mL/min, calculated by the Cockcroft and Gault equation], or on dialysis. Caution should be exercised when treating patients with severe and end-stage renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of TAGRISSO in children or adolescents aged less than 18 years have not been established. No data are available.
Method of administration: This medicinal product is for oral use. The tablet should be swallowed whole with water and it should not be crushed, split or chewed.
If the patient is unable to swallow the tablet, the tablet may first be dispersed in 50 mL of non-carbonated water. It should be dropped in the water, without crushing, stirred until dispersed and immediately swallowed. An additional half a glass of water should be added to ensure that no residue remains and then immediately swallowed. No other liquids should be added.
If administration via nasogastric tube is required, the same process as previously mentioned should be followed but using volumes of 15 mL for the initial dispersion and 15 mL for the residue rinses. The resulting 30 mL of liquid should be administered as per the naso-gastric tube manufacturer's instructions with appropriate water flushes. The dispersion and residues should be administered within 30 minutes of the addition of the tablets to water.