Alunbrig

Šalis: Europos Sąjunga

kalba: anglų

Šaltinis: EMA (European Medicines Agency)

Veiklioji medžiaga:

brigatinib

Prieinama:

Takeda Pharma A/S

ATC kodas:

L01XE43

INN (Tarptautinis Pavadinimas):

brigatinib

Farmakoterapinė grupė:

Antineoplastic agents

Gydymo sritis:

Carcinoma, Non-Small-Cell Lung

Terapinės indikacijos:

Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase ALKpositive advanced NSCLC previously treated with crizotinib.

Produkto santrauka:

Revision: 9

Autorizacija statusas:

Authorised

Leidimo data:

2018-11-22

Pakuotės lapelis

57
B. PACKAGE LEAFLET
58
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALUNBRIG 30 MG FILM-COATED TABLETS
ALUNBRIG 90 MG FILM-COATED TABLETS
ALUNBRIG 180 MG FILM-COATED TABLETS
brigatinib
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Alunbrig is and what it is used for
2.
What you need to know before you take Alunbrig
3.
How to take Alunbrig
4.
Possible side effects
5.
How to store Alunbrig
6.
Contents of the pack and other information
1.
WHAT ALUNBRIG IS AND WHAT IT IS USED FOR
Alunbrig contains the active substance brigatinib, a type of cancer
medicine called a kinase inhibitor.
Alunbrig is used to treat adults with advanced stages of a
LUNG CANCER
called non-small cell lung
cancer. It is given to patients whose lung cancer is related to an
abnormal form of a gene called
anaplastic lymphoma kinase (
_ALK_
).
HOW ALUNBRIG WORKS
The abnormal gene produces a protein known as a kinase that stimulates
the growth of the cancer
cells. Alunbrig blocks the action of this protein and thus slows down
the growth and spread of the
cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALUNBRIG
_ _
DO NOT TAKE ALUNBRIG
•
if you are
ALLERGIC
to brigatinib or any of the other ingredients of this medicine (listed
in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Alunbrig or during treatment if you
have:
•
LUNG OR BREATHING PROBLEMS
Lung problems, some severe, are more frequent within the first 7 days
of treatment. Symptoms
may be similar to symptoms from lung cancer. Tell your doctor of

Prekės savybės

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Alunbrig 30 mg film-coated tablets
Alunbrig 90 mg film-coated tablets
Alunbrig 180 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alunbrig 30 mg film-coated tablets
Each film-coated tablet contains 30 mg of brigatinib.
_Excipient with known effect _
Each film-coated tablet contains 56 mg of lactose monohydrate.
Alunbrig 90 mg film-coated tablets
Each film-coated tablet contains 90 mg of brigatinib.
_Excipient with known effect _
Each film-coated tablet contains 168 mg of lactose monohydrate.
Alunbrig 180 mg film-coated tablets
Each film-coated tablet contains 180 mg of brigatinib.
_Excipient with known effec_
t
Each film-coated tablet contains 336 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Alunbrig 30 mg film-coated tablets
Round, white to off-white film-coated tablet of approximately 7 mm in
diameter with debossed “U3”
on one side and plain on the other side.
Alunbrig 90 mg film-coated tablets
Oval, white to off-white film-coated tablet of approximately 15 mm in
length with debossed “U7” on
one side and plain on the other side.
Alunbrig 180 mg film-coated tablets
Oval, white to off-white film-coated tablet of approximately 19 mm in
length with debossed “U13” on
one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alunbrig is indicated as monotherapy for the treatment of adult
patients with anaplastic lymphoma
kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
previously not treated with an
ALK inhibitor.
3
Alunbrig is indicated as monotherapy for the treatment of adult
patients with ALK-positive advanced
NSCLC previously treated with crizotinib.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Alunbrig should be initiated and supervised by a
physician experienced in the use of
anticancer medicinal products.
ALK-positive NSCLC status should be known prior to i