Tagrisso 40mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Osimertinib mesylate

זמין מ:

AstraZeneca UK Ltd

קוד ATC:

L01XE35

INN (שם בינלאומי):

Osimertinib mesylate

כמות:

40mg

טופס פרצבטיות:

Tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 08010500; GTIN: 5000456011099

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAGRISSO
40 MG FILM-COATED TABLETS
TAGRISSO
80 MG FILM-COATED TABLETS
osimertinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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) and has spread to
your other lung or other organs, your cancer is likely to respond to
treatment with TAGRISSO.
TAGRISSO can be prescribed for you:
•
as the first medicine you receive for your cancer
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 r

מאפייני מוצר

OBJECT 1
TAGRISSO 40 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 20-Jun-2018 | AstraZeneca
UK Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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
This medicine contains 0.3 mg sodium per 40 mg tablet and 0.6 mg
sodium per 80 mg tablet.
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 first-line treatment of adult patients with locally advanced
or metastatic non-small cell lung cancer
(NSCLC) with activating epidermal growth factor receptor (EGFR)
mutations.
• 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
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 un