TAGRISSO Film-coated tablet Ref.[9022] Active ingredients: Osimertinib

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 section 4.4).

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 1.

Table 1. Recommended dose modifications for TAGRISSO:

^a Note: The intensity of clinical adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
ECGs: Electrocardiograms; QTc: QT interval corrected for heart rate

Special populations

No dosage adjustment is required due to patient age, body weight, gender, ethnicity and smoking status (see section 5.2).

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 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). 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 section 5.2).

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 section 5.2).

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.

In TAGRISSO clinical trials a limited number of patients were treated with daily doses of up to 240 mg without dose limiting toxicities. In these studies, patients who were treated with TAGRISSO daily doses of 160 mg and 240 mg experienced an increase in the frequency and severity of a number of typical EGFR TKI-induced AEs (primarily diarrhoea and skin rash) compared to the 80 mg dose. There is limited experience with accidental overdoses in humans. All cases were isolated incidents of patients taking an additional daily dose of TAGRISSO in error, without any resulting clinical consequences.

There is no specific treatment in the event of TAGRISSO overdose. In case of suspected overdose, TAGRISSO should be withheld and symptomatic treatment initiated.

Shelf life: 3 years.

This medicinal product does not require any special storage conditions.

Al/Al perforated unit dose blisters. Cartons of 30 × 1 tablets (3 blisters).

Al/Al perforated unit dose blisters. Cartons of 28 × 1 tablets (4 blisters).

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.