TAGRISSO 80 MG

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

OSIMERTINIB AS MESYLATE

Mevcut itibaren:

ASTRAZENECA (ISRAEL) LTD

ATC kodu:

L01XE35

Farmasötik formu:

TABLETS

Kompozisyon:

OSIMERTINIB AS MESYLATE 80 MG

Uygulama yolu:

PER OS

Reçete türü:

Required

Tarafından üretildi:

ASTRA ZENECA AB, SWEDEN

Terapötik alanı:

OSIMERTINIB

Terapötik endikasyonlar:

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 NSCLCTAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations.

Yetkilendirme tarihi:

2021-04-30

Bilgilendirme broşürü

PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
TAGRISSO
®
40 MG
TAGRISSO
®
80 MG
TABLETS
COMPOSITION:
Each tablet contains:
Osimertinib (as mesylate) 40 mg
Osimertinib (as mesylate) 80 mg
For inactive ingredients please refer to Section 6 – “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
Keep this leaflet, you may need it again.
This leaflet contains concise information about the medicine. If you
have further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to
others. It may harm them, even if it seems to you that their ailment
is similar.
This medicine is not intended for children under the age of 18.
1.
WHAT IS TAGRISSO AND WHAT IS IT USED FOR?
TAGRISSO is indicated as adjuvant therapy after tumor resection in
adult patients with
non-small cell lung cancer (NSCLC) whose tumors have epidermal growth
factor
receptor (EGFR) exon 19 deletions or exon 21 L858R mutations.
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
(epidermal growth factor receptor) T790M mutation-positive NSCLC.
THERAPEUTIC GROUP
Anticancer medicine, protein kinase inhibitor.
This medicine will be prescribed by a doctor with experience in
anticancer therapies.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
you are hypersensitive to the active ingredient or any of the other
ingredients of
this medicine (see section 6 below – “Further Information”).
•
you are using St. John’s Wort (
hypericum perforatum
) concomitantly
.
SPECIAL WARNINGS REGARDING USE OF TAGRISSO:
BEFORE TREATMENT WITH THIS MEDICINE, TELL YOUR DOCTOR IF:
•

Ürün özellikleri

1
1.
NAME OF THE MEDICINAL PRODUCT
TAGRISSO 40mg
film-coated tablets
TAGRISSO 80mg
film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAGRISSO 40 mg tablets
Each tablet contains osimertinib 40mg (equivalent to 47.7mg of
osimertinib mesylate)
TAGRISSO 80 mg tablets
Each tablet contains osimertinib 80mg (equivalent to 95.4mg of
osimertinib 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, 9mm, 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 is indicated as adjuvant therapy after tumor resection in
adult patients with non-small cell
lung cancer (NSCLC) whose tumors have epidermal growth factor receptor
(EGFR) exon 19 deletions
or exon 21
L858R mutations.
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.
2
-
the treatment of adult patients with locally advanced or metastatic
EGFR T790M mutation-positive
NSCLC.
4.2 Posology and method of administration
Select patients with resectable tumors for the adjuvant treatment of
NSCLC with TAGRISSO based on
the presence of EGFR exon 19 deletions or exon 21 L858R mutations in
tumor specimens.
Treat patients in the adjuvant setting until disease recurrence, or
unacceptable toxicity, or for up to 3
years. Treat patients with metastatic lung cancer until disease
progression or unacceptable toxicity.
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