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 in tumour or plasma specimens should be determined using a validated test method (see Precautions) for: exon 19 deletions or exon 21 (L858R) substitution mutations (for first-line treatment), T790M mutations (following progression on or after EGFR TKI therapy).
Posology: The recommended dose is 80 mg osimertinib once a day until disease progression or unacceptable toxicity.
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 8. (See Table 8.)
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 ≤ ULN and AST >ULN or total bilirubin between 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). The appropriate dose of TAGRISSO has not been established in patients with severe hepatic impairment (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. Limited data are available in patients with 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) <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 above 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.