Zelboraf

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Vemurafenib 240mg (as a co-precipitate with hypromellose acetate succinate (800 mg total));  ;  

Available from:

Roche Products (NZ) Ltd

INN (International Name):

Vemurafenib 240 mg (as a co-precipitate with hypromellose acetate succinate (800 mg total))

Dosage:

240 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Vemurafenib 240mg (as a co-precipitate with hypromellose acetate succinate (800 mg total))     Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Iron oxide red Macrogol 3350 Magnesium stearate Polyvinyl alcohol Purified talc Titanium dioxide

Units in package:

Blister pack, OPA/Al/PVC, 56 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Micro-Macinazione SA

Therapeutic indications:

Indicated for the treatment of unresectable stage IIIC or stage IV metastatic melanoma positive for the BRAF V600 mutation.

Product summary:

Package - Contents - Shelf Life: Blister pack, OPA/Al/PVC - 56 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture. Store in the original package

Authorization date:

2011-05-20

Patient Information leaflet



Zelboraf 200605
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ZELBORAF
®
VEMURAFENIB
240 MG FILM-COATED TABLETS
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


Zelboraf 200605
2

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 ex

Summary of Product characteristics

1
Zelboraf 200605
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
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
Zelboraf film-coated 240 mg tablets are oval, biconvex, pinkish white
to orange white tablets
with “VEM” engraved on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zelboraf is indicated for the treatment of unresectable stage IIIC or
stage IV metastatic
melanoma positive for the BRAF V600 mutation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Before taking Zelboraf, patients must have BRAF V600 mutation-positive
tumour status
confirmed by a validated molecular pathology laboratory.
RECOMMENDED DOSAGE
The recommended dose of Zelboraf is 960 mg (four 240 mg tablets) twice
daily (equivalent
to a total daily dose of 1920 mg). The first dose should be taken in
the morning and the
second dose should be taken in the evening approximately 12 hours
later. Both doses of
Zelboraf should be taken either 1 hour before or 2 hours after a meal.
It is recommended that treatment with Zelboraf continue until disease
progression or the
development of unacceptable toxicity (see Table 1).
MISSED DOSES
If a planned 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 Zelboraf administration the patient should
not take an additional
dose of the medicine but the treatment should be continued as usual.
2
Zelboraf 200605
DOSE MODIFICATIONS
Management of symptomatic adverse events or prolongation of QTc may
require dose
reduction, temporary interruption or treatment discontinuation of
Zelboraf (see section 4.4).
Dose modifications or interruptions are not recommended for cutaneous
squamous cell
carcinoma (cuSCC). Dose reductions resulting in a dose below 480 mg
twice daily are