Alunbrig (Brigatinib) 30mg Film-Coated Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Brigatinib

Boleh didapati daripada:

Takeda Malaysia Sdn Bhd

INN (Nama Antarabangsa):

Brigatinib

Unit dalam pakej:

2 x 14 Tablets; 30 Tablets

Dikeluarkan oleh:

PENN PHARMACEUTICAL SERVICES LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ALUNBRIG
_® _
Brigatinib (30mg, 90mg and 180mg)
WHAT IS IN THIS LEAFLET
1.
What Alunbrig
®
is used for
2.
How Alunbrig
®
works
3.
Before you use Alunbrig
®
4.
How to use Alunbrig
®
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Alunbrig
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ALUNBRIG
®
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.
BEFORE YOU USE ALUNBRIG®
-
_When you must not use it _
•
You are allergic to brigatinib or
any other ingredients in
Alunbrig®
-
_Before you start to use it _
Before you take Alunbrig
®
, tell your
doctor 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 any
new or worsening symptoms
including breathing discomfort,
shortness of breath, chest pain,
cough and fever.
•
High blood pressure
•
A slow heartbeat (bradycardia)
•
Vision disturbance. Inform your
doctor of any visual disturbance
that occurs during treatment, such
as seeing flashes of light, blurry
vision or light hurting your eyes.
•
Muscle problems. Report any
unexplained muscle pain,
tenderness or weakness to your
doctor.
•
Pancreas problems
•
Liver problems
•
High blood sugar
•
Sensitivity to sunlight
Avoid spending extended time in
the sunlight during treatment and
for at least 5 days after your
l

Ciri produk

1
NAME OF THE MEDICINAL PRODUCT
Alunbrig 30mg Film-Coated Tablet
Alunbrig 90mg Film-Coated Tablet
Alunbrig 180mg Film-Coated Tablet
NAME AND STRENGTH OF ACTIVE SUBSTANCES
Each tablet contains 30mg, 90mg or 180mg of Brigatinib.
Excipients: Lactose monohydrate, microcrystalline cellulose, sodium
starch glycolate (type A), silica colloidal hydrophobic,
magnesium stearate, talc, macrogol, polyvinyl alcohol, titanium
dioxide.
PRODUCT DESCRIPTION
Alunbrig is supplied as a film-coated tablet containing Brigatinib.
•
30mg tablet are round, white to off-white in color and are debossed
“U3” on one side and plain on the other side
•
90mg tablet are oval, white to off-white in color and are debossed
“U7” on one side and plain on the other side
•
180mg tablet are oval, white to off-white in color and are debossed
“U13” on one side and plain on the other side
INDICATION
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 ALK-positive advanced NSCLC previously treated
with crizotinib.
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 initiation of
Alunbrig therapy. A validated ALK assay is necessary for the
selection of ALK-positive NSCLC patients (see Pharmacodynamics
Section). Assessment for ALK-positive NSCLC should be
performed by laboratories with demonstrated proficiency in the
specific technology being utilised.
Posology
The recommended starting dose of Alunbrig is 90 mg once daily for the
first 7 days, then 180 mg once daily.
If Alunbrig is interrupted for 14 days or longer for reasons other
than adverse reactions, treatment should be resumed at 90 mg
once daily for 7 days before increasing to the previo