Zelboraf

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

Vemurafenib

Disponibil de la:

Roche Products Pty Ltd

Clasă:

Medicine Registered

Prospect

ZELBORAF
®

pronounced (ZEL-bor-af)
_contains the active ingredient vemurafenib_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZELBORAF tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ZELBORAF
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ZELBORAF IS
USED FOR
ZELBORAF contains the active
ingredient vemurafenib.
ZELBORAF belongs to a group of
medicines called anti-neoplastic (or
anti-cancer) agents.
ZELBORAF is used to treat
metastatic melanoma (a type of skin
cancer that has spread to other parts
of the body). It can only be used if
your melanoma has a change
(mutation) in the BRAF gene. Your
doctor will have tested you for this
gene. This change has been shown to
be involved in the development of
melanoma.
ZELBORAF works by targeting
proteins made from the BRAF gene
to slow down the development of
your cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZELBORAF
HAS BEEN PRESCRIBED FOR YOU.
ZELBORAF is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
ZELBORAF
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ZELBORAF IF:
1. YOU ARE ALLERGIC (HYPERSENSITIVE)
TO VEMURAFENIB OR ANY
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
 Some of the symptoms of an
allergic reaction may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
2. THE PACKAGE IS TORN OR SHOWS
SIGNS OF TAMPERING
 If the package is damaged, return
it to your pharmacist for disposal.
3. THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED.
 If you take this medicine after the
expiry date h

Caracteristicilor produsului

Zelboraf
®
 PI 130523

1 of 19 
CDS 2.0, EU SPC 

ZELBORAF
® 
_Vemurafenib _
CAS 918504-65-1 

Vemurafenib  is  designated  chemically  as  _N_-{3-[5-(4-chlorophenyl)-1_H_-pyrrolo[2,3-
b]pyridin-3-carbonyl]-2,4-difluorophenyl}propane-1-sulfonamide. 
The empirical formula of vemurafenib is C
23
H
18
ClF
2
N
3
O
3
S and its molecular weight is 489.9. 
Vemurafenib  is  a  white  to  off-white  crystalline  solid.    It  is  practically  insoluble  in  aqueous 
media. The pKa (acidic) is 7.9 and 11.1 and the
log P (water) is 3.0.  

DESCRIPTION 
ZELBORAF  film-coated  240  mg  tablets  are  oval,  biconvex,  pinkish  white  to  orange  white 
tablets with “VEM” engraved on one side.  Each tablet contains 240 mg of vemurafenib (as a 
co-precipitate  of  vemurafenib  and  hypromellose  acetate  succinate).  ZELBORAF  tablets 
contain  the  following  excipients:  croscarmellose  sodium,  colloidal  anhydrous  silica, 
magnesium  stearate,  and  hydroxypropylcellulose.    The  film-coating  contains  polyvinyl 
alcohol,  titanium  dioxide  CI77891,  macrogol  3350,  talc  (purified),  and  iron  oxide  red 
CI77491.  
ZELBORAF  is  a  protein  kinase  inhibitor,  selective  for  the  activating  mutation  of  the 
oncogenic BRAF serine-threonine kinase enzyme
.  

PHARMACOLOGY 
PHARMACODYNAMICS 
MECHANISM OF ACTION 
Vemurafenib is a low molecular weight, oral inhibitor of some mutated forms of the BRAF 
serine-threonine  kinase  enzyme.  In  biochemical  assays,  vemurafenib  also  inhibits  other 
kinases,  such  as  CRAF,  ARAF,  wild-type  BRAF,  SRMS,  ACK1,  MAP4K5  and  FGR  at 
higher  concentrations.  Some  mutations  in  the  BRAF  gene  result  in  constitutively  activated 
BRA