Zelboraf

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

vemurafenib

MAH:

Roche Registration GmbH

ATC_code:

L01EC01

INN:

vemurafenib

therapeutic_group:

Antineoplastic agents

therapeutic_area:

Melanoma

therapeutic_indication:

Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.,

leaflet_short:

Revision: 24

authorization_status:

Authorised

authorization_date:

2012-02-17

PIL

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZELBORAF 240 MG FILM-COATED TABLETS
vemurafenib
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.
●
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zelboraf is and what it is used for
2.
What you need to know before you take Zelboraf
3.
How to take Zelboraf
4.
Possible side effects
5.
How to store Zelboraf
6.
Contents of the pack and other information
1.
WHAT ZELBORAF IS AND WHAT IT 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.
Zelboraf targets proteins made from this modified gene and slows down
or stops the development of
your cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZELBORAF
DO NOT TAKE ZELBORAF:
●
If you are
ALLERGIC
to vemurafenib or any of the other ingredients of this medicine
(listed in
section 6 of this leaflet). Symptoms of allergic reactions may include
swelling of the face, lips
or tongue, difficulty breathing, rash, or fainting sensation.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Zelboraf.
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 brea

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
PHARMACEUTICAL 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
Vemurafenib is indicated in monotherapy for the treatment of adult
patients with BRAF V600 mutation-
positive unresectable or metastatic melanoma (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with vemurafenib should be initiated and supervised by a
qualified physician experienced
in the use of anticancer medicinal products.
Before taking vemurafenib, patients must have BRAF V600
mutation-positive tumour status
confirmed by a validated test (see sections 4.4 and 5.1).
Posology
The recommended dose of vemurafenib is 960 mg (4 tablets of 240 mg)
twice daily (equivalent to a
total daily dose of 1,920 mg). Vemurafenib 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 vemurafenib should continue until disease progression
or the development 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 vomiting after vemurafenib administration the patient
should not take an additional dose of
the medicinal product but the treatment should be continued as usual.
3
_Posology adjustments _
Management of adverse drug reactions or QTc prolongation may require
dose reduction, temporary
interruption and/or treatment discontinuation (see tables 1 and