Zelboraf 240mg film-coated tablets

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

vemurafenib

Mevcut itibaren:

ROCHE (MALAYSIA) SDN. BHD.

INN (International Adı):

vemurafenib

Paketteki üniteler:

56tablet Tablets

Tarafından üretildi:

Delpharm Milano s.r.l

Bilgilendirme broşürü

_ _
_Consumer Medication Information Leaflet (RiMUP) _
ZELBORAF
®
240 MG FILM-COATED TABLETS
_Vemurafenib 240 mg _
_ _
1
WHAT IS IN THIS LEAFLET
1. What Zelboraf is used for
2. How Zelboraf works
3. Before you use Zelboraf
4. How to use Zelboraf
5. While you are using Zelboraf
6. Side effects
7. Storage and disposal of
Zelboraf
8. Product Description
9. Manufacturer
10. Product Registration Holder
11. Date of revision
12. Serial Number
WHAT ZELBORAF IS USED FOR
Zelboraf is an anticancer medicine that
contains the active substance
vemurafenib. It is used to treat adult
patients with melanoma that has
spread to other parts of the body or
cannot be removed by surgery.
It can only be used in patients whose
cancer has a change (mutation) in the
“BRAF” gene. This change may have
led to the development of melanoma.
A validated test is required to identify
BRAF V600 mutation status.
HOW ZELBORAF WORKS
Zelboraf targets proteins made from
this modified gene and slows down or
stops the development of your cancer.
BEFORE YOU USE ZELBORAF
-
_WHEN YOU MUST NOT USE IT_
Do not take Zelboraf:
-
if you are
ALLERGIC
to vemurafenib or
any of the other ingredients of this
medicine (listed at the end of this
leaflet). Symptoms of allergic
reactions may include swelling of
the face, lips or tongue, difficulty
breathing, rash, or fainting
sensation.
-
_BEFORE YOU START TO USE IT _
Talk to your doctor before taking
Zelboraf.
You should be careful of the
following:
-
_Allergic reactions _
Allergic reactions can happen while
taking Zelboraf and may be severe.
Stop taking Zelboraf and get
medical help immediately if you
have any symptoms of an allergic
reaction such as swelling of the face,
lips or tongue, difficulty breathing,
rash, or fainting sensation.
-
_Severe skin reactions _
Severe skin reactions can happen
while taking Zelboraf. Stop taking
Zelboraf and talk to your doctor
immediately if you get a skin rash
with any of the following
symptoms: blisters on your skin,
blisters or sores in your mouth,
peeling of your skin, fever,

Ürün özellikleri

PACK INSERT FOR MALAYSIA
Zelboraf
®
Vemurafenib
1. NAME OF THE MEDICINAL PRODUCT
Zelboraf 240 mg film -coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 240 mg of vemurafenib (as a co -precipitate of vemurafenib and hypromellose acetate
succinate).
For the full list of excipients, see section 6. 1.
3. P HARMACEUTICAL FORM
Film -coated tablet (tablet).
Pinkish white to orange white, oval, biconvex film -coated tablets of approximately 19 mm, with ‘VEM’ engraved
on one side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Zelboraf is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation -positive
unresectable or metastatic melanoma (see section 5.1).
A validated test is required to identify BRAF V600 mutation status.
4.2 Posology and method of administration
Treatment with Zelboraf should be initiated and supervised by a qualified physician experienced in the use of
anticancer medicinal products.
Before taking Zelboraf , patients must have BRAF V6 00 mutation -positive tumour status confirmed by a
validated test (see sections 4.4 and 5.1).
Posology
The recommended dose of Zelboraf is 960 mg (4 tablets of 240 mg) twice daily (equivalent to a total daily dose
of 1,920 mg). Zelboraf may be taken with or without food, but consistent intake of both daily doses on an empty
stomach should be avoided (see Section 5.2).
Duration of treatment
Treatment with Zelboraf should continue until disease progression or the develo pment of unacceptable toxicity
(see tables 1 and 2 below).
Missed doses
If a dose is missed, it can be taken up to 4 hours prior to the next dose to maintain the twice daily regimen.
Both doses should not be taken at the same time.
Vomiting
In case of v omiting after Zelboraf administration the patient should not take an additional dose of the medicinal
product but the treatment should be continued as usual.
Posology adjustments
Management of adverse drug reactions or QTc prolongation may require dose reduction, temporary interruption
and