Cotellic

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Cobimetinib hemifumarate 22.2mg equivalent to cobimetinib 20 mg

Tilgængelig fra:

Roche Products (NZ) Ltd

INN (International Name):

Cobimetinib hemifumarate 22.2 mg (equivalent to cobimetinib 20 mg)

Dosering:

20 mg

Lægemiddelform:

Film coated tablet

Sammensætning:

Active: Cobimetinib hemifumarate 22.2mg equivalent to cobimetinib 20 mg Excipient: Croscarmellose sodium Lactose monohydrate Macrogol 3350 Magnesium stearate Microcrystalline cellulose Polyvinyl alcohol Purified talc Purified water Titanium dioxide

Recept type:

Prescription

Fremstillet af:

F Hoffmann-La Roche Ltd

Terapeutiske indikationer:

COTELLIC is indicated for use in combination with ZELBORAF (vemurafenib) for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation.

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 63 dose units - 60 months from date of manufacture stored at or below 30°C

Autorisation dato:

2016-04-21

Indlægsseddel

COTELLIC 221027
1
COTELLIC
®
_Cobimetinib _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about COTELLIC. 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 COTELLIC
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 COTELLIC IS
USED FOR
COTELLIC contains the active
ingredient cobimetinib.
COTELLIC belongs to a group of
medicines called anti-neoplastic (or
anti-cancer) agents.
COTELLIC is used to treat a type of
skin cancer called melanoma that has
spread to other parts of the body and
cannot be removed by surgery.
COTELLIC is used in combination
with another medicine called
ZELBORAF
®
(containing the active
ingredient vemurafenib).
COTELLIC can only be used if your
melanoma has a change (mutation) in
the BRAF gene. Your doctor will
have tested you for this gene
mutation to make sure COTELLIC is
suitable for you. The gene mutation
has been shown to be involved in the
development of melanoma.
COTELLIC targets the “MEK”
protein and ZELBORAF targets the
changed “BRAF” protein. Both
proteins are important in controlling
cancer cell growth.
When used together, these medicines
slow down the growth of your
cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY COTELLIC
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
COTELLIC is not addictive.
This medicine is available only with
a doctor's prescription.
Safety and effectiveness of
COTELLIC in children younger than
18 years have not been established.
BEFORE YOU TAKE
COTELLIC
AS COTELLIC IS TAKEN TOGETHER
WITH ZELBORAF, ALSO READ THE
CONSUMER MEDICINE INFORMATION
FOR ZELBORAF BEFORE YOU TAKE
THESE MEDICINES.
_WHEN YOU MUST NOT TAKE IT _
1.
DO NOT TAK

Produktets egenskaber

Cotellic 221027
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Cotellic 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg cobimetinib (22mg of
cobimetinib as a hemifumarate salt).
Excipient with known effect:
Each film-coated tablet contains 36 mg lactose monohydrate.
For the full list of excipients, see section List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablets
4.
CLINICAL PARTICULAR
4.1
THERAPEUTIC INDICATIONS
Cotellic is indicated for use in combination with Zelboraf
(vemurafenib) for the treatment of
patients with unresectable or metastatic melanoma with BRAF V600
mutation.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
Cotellic therapy should only be initiated and supervised by a
healthcare professional experienced
in the treatment of patients with cancer.
Patients treated with Cotellic in combination with Zelboraf must have
BRAF V600 mutation-
positive melanoma tumour status confirmed by a validated test.
PLEASE REFER TO THE FULL PRESCRIBING INFORMATION OF THE COMBINATION
PRODUCT(S).
DOSE
The recommended dose of Cotellic is 60 mg (three 20 mg tablets) once
daily for 21 days in a
28 day cycle.
Each Cotellic dose consists of three 20 mg tablets (60 mg) and should
be taken once daily for 21
consecutive days (days 1 to 21 - treatment period); followed by a 7
day break in Cotellic treatment
(days 22 to 28 - treatment break).
Duration of Treatment
Treatment with Cotellic should continue until the patient no longer
derives benefit or until the
development of unacceptable toxicity.
Cotellic 221027
2
Delayed or Missed Doses
If a planned dose of Cotellic is missed, it can be taken up to 12
hours prior to the next dose to
maintain the once-daily regimen.
Vomiting
In case of vomiting after Cotellic administration, the patient should
not take an additional dose of
Cotellic on that day, and treatment should be continued as prescribed
the following day.
DOSE MODIFICATION
General
Cotellic dose modification should be based on the prescriber’s
assessment of in