Tagrisso

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

osimertinib mesilate

Available from:

AstraZeneca AB

ATC code:

L01XE

INN (International Name):

osimertinib

Therapeutic group:

Other antineoplastic agents, Protein kinase inhibitors

Therapeutic area:

Carcinoma, Non-Small-Cell Lung

Therapeutic indications:

TAGRISSO as monotherapy is indicated for:- 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- the first-line treatment of adult patients NSCLC with activating EGFR mutations.- the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.TAGRISSO as monotherapy is indicated for:- 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.- the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.- the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

Product summary:

Revision: 19

Authorization status:

Authorised

Authorization date:

2016-02-01

Patient Information leaflet

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAGRISSO 40 MG FILM-COATED TABLETS
TAGRISSO 80 MG FILM-COATED TABLETS
osimertinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What TAGRISSO is and what it is used for
2.
What you need to know before you take TAGRISSO
3.
How to take TAGRISSO
4.
Possible side effects
5.
How to store TAGRISSO
6.
Contents of the pack and other information
1.
WHAT TAGRISSO IS AND WHAT IT IS USED FOR
TAGRISSO contains the active substance osimertinib, which belongs to a
group of medicines called
protein kinase inhibitors which are used to treat cancer. TAGRISSO is
used to treat adults with a type of
lung cancer called ‘non-small cell lung cancer.’ If a test has
shown that your cancer has certain changes
(mutations) in a gene called ‘EGFR’ (epidermal growth factor
receptor) your cancer is likely to respond to
treatment with TAGRISSO. TAGRISSO can be prescribed for you:

after complete removal of your cancer as a post-surgical (adjuvant)
treatment
or

as the first medicine you receive for your cancer which has spread to
other parts of the body
or

in certain circumstances if you have been treated for your cancer
before with other protein kinase
inhibitor medicines.
HOW TAGRISSO WORKS
TAGRISSO works by blocking EGFR and may help to slow or stop your lung
cancer from growing. It
may also help to reduce the size of the tumour and prevent the tumour
from coming back after removal by
surgery.

If you are receiving TAGRISSO

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
TAGRISSO 40 mg film-coated tablets
TAGRISSO 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAGRISSO 40 mg tablets
Each tablet contains 40 mg osimertinib (as mesylate).
TAGRISSO 80 mg tablets
Each tablet contains 80 mg osimertinib (as mesylate).
Excipient with known effect
_TAGRISSO 40 mg tablets_
Each tablet contains 0.3 mg sodium.
_TAGRISSO 80 mg tablets_
Each tablet contains 0.6 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
TAGRISSO 40 mg tablets
Beige, 9 mm, round, biconvex tablet, debossed with “AZ” and
“40” on one side and plain on the reverse.
TAGRISSO 80 mg tablets
Beige, 7.25 x 14.5 mm, oval, biconvex tablet, debossed with “AZ”
and “80” on one side and plain on the
reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TAGRISSO as monotherapy is indicated for:

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 (see
section 5.1).

the first-line treatment of adult patients with locally advanced or
metastatic NSCLC with activating
EGFR mutations.
3

the treatment of adult patients with locally advanced or metastatic
EGFR T790M mutation-positive
NSCLC.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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
specimens for adjuvant
treatment and tumour or plasma specimens for locally advanced or
metastatic setting) should be
determined using a validated test method (see section 4.4).
Posology
The recommended dose is 80 mg osimertinib once a day.
Patients in the adjuvant setting should receive treatment until
disease recurrence or unacceptable toxicity.
Treatme