Rahika 150mg Film-coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Capmatinib

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Capmatinib

Unit dalam pakej:

60 Tablets

Dikeluarkan oleh:

NOVARTIS PHARMA PRODUKTIONS GMBH

Risalah maklumat

_CUSTOMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RAHIKA
® FILM-COATED TABLET
Capmatinib dihydrochloride monohydrate (150mg, 200mg)
1
WHAT IS IN THIS LEAFLET
1.
What Rahika is used for
2.
How Rahika works
3.
Before you use Rahika
4.
How to use Rahika
5.
While you are using Rahika
6.
Side Effects
7.
Storage and Disposal of
Rahika
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT RAHIKA IS USED FOR
Rahika is a prescription medicine
used to treat adults with a kind of
lung cancer called non-small cell
lung cancer (NSCLC) that:
•
has spread to other parts of
the body or cannot be
removed by surgery
(metastatic), and
•
whose tumors have an
abnormal mesenchymal
epithelial transition (MET)
gene
HOW RAHIKA WORKS
Rahika helps to slow down or
stop the growth and spread of
your lung cancer if it is caused by
a change (mutation) in a gene that
makes an enzyme called MET.
BEFORE YOU USE RAHIKA
_-When you must not use it _
Do not take Rahika if you are
allergic to Capmatinib or any of
the ingredients in Rahika.
_- Before you start to use it _
Before you take Rahika, tell your
doctor about all of your medical
conditions, including if you:
•
have or have had lung or
breathing problems other
than your lung cancer
•
have or have had liver
problems
•
are pregnant or plan to
become pregnant. Rahika
can harm your unborn
baby.
•
are breastfeeding or plan to
breastfeed.
_- Taking other medicines _
Tell your doctor about all the
medicines you take or start taking,
including prescription and over-
the-counter medicines, vitamins,
and herbal supplements.
_- Females who are able to become _
_pregnant _
•
Your doctor should do a
pregnancy test before you
start your treatment with
Rahika.
•
You should use effective
birth control during treatment
and for 1 week after your last
dose of Rahika. Talk to your
doctor about birth control
choices that might be right
for you during this time.
•
Tell your doctor right away if
you become pregnant or think
you may be pregnant during
trea

Ciri produk

FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
RAHIKA is indicated for the treatment of adult patients with
metastatic non-small cell lung cancer (NSCLC) whose
tumors have a mutation that leads to mesenchymal-epithelial transition
(MET) exon 14 skipping.
2
DOSAGE AND ADMINISTRATION
2.1
PATIENT SELECTION
Select patients for treatment with RAHIKA based on the presence of a
mutation that leads to MET exon 14 skipping in
tumor specimens
_[see Clinical Studies (14)]_
.
2.2
RECOMMENDED DOSAGE
The recommended dosage of RAHIKA is 400 mg orally twice daily with or
without food.
Swallow RAHIKA tablets whole. Do not break, crush or chew the tablets.
If a patient misses or vomits a dose, instruct the patient not to make
up the dose, but to take the next dose at its scheduled
time.
2.3
DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
The recommended dose reductions for the management of adverse
reactions are listed in Table 1.
TABLE 1: RECOMMENDED RAHIKA DOSE REDUCTIONS FOR ADVERSE REACTIONS
DOSE REDUCTION
DOSE AND SCHEDULE
First
300 mg orally twice daily
Second
200 mg orally twice daily
Permanently discontinue RAHIKA in patients who are unable to tolerate
200 mg orally twice daily.
The recommended dosage modifications of RAHIKA for adverse reactions
are provided in Table 2.
TABLE 2: RECOMMENDED RAHIKA DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
ADVERSE REACTION
SEVERITY
DOSAGE MODIFICATION
Interstitial Lung Disease
(ILD)/Pneumonitis
_[see Warnings and Precautions (5.1)]_
Any grade
Permanently discontinue RAHIKA.
Increased ALT and/or AST without
increased total bilirubin
_[see Warnings and Precautions (5.2)]_
Grade 3
Withhold RAHIKA until recovery
to baseline ALT/AST.
If recovered to baseline within 7
days, then resume RAHIKA at the
same dose; otherwise resume
RAHIKA at a reduced dose.
Grade 4
Permanently discontinue RAHIKA.
Increased ALT and/or AST with
increased total bilirubin in the absence
of cholestasis or hemolysis
_[see Warnings and Precautions (5.2)]_
ALT and/or AST greater than 3 times
ULN with total bilirubin greate