Tagrisso

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Osimertinib mesilate 47.7mg equivalent to osimertinib 40mg;  

Boleh didapati daripada:

AstraZeneca Limited

INN (Nama Antarabangsa):

Osimertinib mesilate 47.7 mg (equivalent to osimertinib 40mg)

Dos:

40 mg

Borang farmaseutikal:

Film coated tablet

Komposisi:

Active: Osimertinib mesilate 47.7mg equivalent to osimertinib 40mg   Excipient: Hyprolose Iron oxide black Iron oxide red Iron oxide yellow Macrogol 3350 Mannitol Microcrystalline cellulose Polyvinyl alcohol Purified talc Sodium stearyl fumarate Titanium dioxide

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Lonza AG

Tanda-tanda terapeutik:

Tagrisso (osimertinib) as monotherapy is indicated for: - the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations. - the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer. - the adjuvant treatment after tumour resection in adult patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations. Tagrisso (osimertinib) is indicated in combination with: - pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic NSCLC whose tumours have EGFR mutations

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PVC/Al/PA laminate/Al foil blister - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Tarikh kebenaran:

2016-10-10

Risalah maklumat

Tagrisso
®
CMI 071223
Copyright
1(6)
TAGRISSO
®
OSIMERTINIB MESILATE 40 AND 80 MG TABLETS.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
TAGRISSO. It does not contain
all the information that is known about TAGRISSO.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking TAGRISSO
against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT TAGRISSO IS USED FOR
This medicine is used to treat adults with a type of cancer called
'non-small cell lung cancer' when the
tumour has a defect (mutation) in a gene called EGFR (epidermal growth
factor receptor). It is used
to help prevent your cancer from coming back after the tumour(s) have
been removed by surgery or
when your cancer is advanced and is worsening. TAGRISSO can be
prescribed for you if you test
positive for EGFR mutation.
This medicine belongs to a class of medicines called Tyrosine Kinase
Inhibitors (TKIs). It works by
stopping cancer cells with the EGFR mutation from growing and
multiplying. It may also help prevent
the tumour from coming back after removal by surgery. Ask your doctor
if you have any questions
about why this medicine has been prescribed for you.
TAGRISSO is available only with a doctor's prescription.
This medicine is not expected to affect your ability to drive a car or
operate machinery, however, if
symptoms occur that affect your ability to concentrate, do not drive
or operate machinery until the
effect subsides.
BEFORE YOU USE TAGRISSO
_WHEN YOU MUST NOT TAKE IT _
Do not take TAGRISSO if you have an allergy to:
•
any of the ingredients listed at the end of this leaflet
•
any other similar medicines, for example other Tyrosine Kinase
Inhibitors.
Some of the symptoms of an allergic reaction may include:
•

Ciri produk

T
AGRISSO
®
Data Sheet 071223
Copyright
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
T
AGRISSO
®
40 mg Film Coated Tablets
T
AGRISSO
®
80 mg Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
T
AGRISSO
40 mg Tablets: Each tablet contains 40 mg osimertinib (as mesilate)
T
AGRISSO
80 mg Tablets: Each tablet contains 80 mg osimertinib (as mesilate)
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
T
AGRISSO
40 mg Tablets: round, biconvex, beige, film-coated tablets with a
diameter of
approximately 9 mm. The tablets are debossed with ‘AZ’ over
‘40’ on 1 side and plain on the
reverse.
T
AGRISSO
80 mg Tablets: oval, biconvex, beige, film-coated tablets measuring
approximately
7.25 × 14.5 mm. The tablets are debossed with ‘AZ 80’ on 1 side
and plain on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
T
AGRISSO
(osimertinib) is indicated for:
•
The adjuvant treatment after tumour resection in adult patients with
non-small cell lung
cancer (NSCLC) whose tumours have epidermal growth factor receptor
(EGFR)
mutations. (see section 5.1 Pharmacodynamic Properties – Clinical
Efficacy and
Safety).
•
the first-line treatment of adult patients with locally advanced or
metastatic NSCLC
whose tumours have EGFR mutations.
•
the treatment of adult patients with locally advanced or metastatic
EGFR T790M
mutation-positive NSCLC.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with T
AGRISSO
should be initiated by a physician experienced in the use of
anticancer therapies.
T
AGRISSO
®
Data Sheet 071223
Copyright
2
When considering the use of T
AGRISSO
, EGFR mutation status in tumour or plasma specimens
should be determined using a validated test method (see section 4.4
Special Warnings and
Precautions for Use).
DOSAGE IN ADULTS
The recommended dose of T
AGRISSO
is 80 mg tablet once a day.
T
AGRISSO
can be taken without regard to food at the same time each day.
DURATION OF TREATMENT
Patients
in
the
adjuvant
setting
should
receive
treatment
until