COTELLIC cobimetinib 20 mg film-coated tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

cobimetinib fumarate, Quantity: 22.2 mg (Equivalent: cobimetinib, Qty 20 mg)

Saatavilla:

Roche Products Pty Ltd

INN (Kansainvälinen yleisnimi):

cobimetinib fumarate

Lääkemuoto:

Tablet, film coated

Koostumus:

Excipient Ingredients: titanium dioxide; macrogol 3350; magnesium stearate; microcrystalline cellulose; polyvinyl alcohol; purified talc; lactose monohydrate; croscarmellose sodium

Antoreitti:

Oral

Kpl paketissa:

63 tablets

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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

Tuoteyhteenveto:

Visual Identification: The tablet is round and white with COB debossed on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 60 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2016-04-06

Pakkausseloste

COTELLIC
®
_Cobimetinib_
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 TAKE COTELLIC IF YOU HAVE
AN ALLERGY TO:
�

Valmisteyhteenveto

Cotellic 190711
1
AUSTRALIAN PRODUCT INFORMATION
COTELLIC
® (COBIMETINIB FUMARATE)
1.
NAME OF THE MEDICINE
Cobimetinib fumarate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains cobimetinib hemifumarate equivalent
to 20 mg cobimetinib.
Excipients with known effect
Each film-coated tablet contains 36 mg lactose monohydrate.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round film-coated tablets of approximately 6.6 mm diameter,
with “COB” debossed
on one side.
4.
CLINICAL PARTICULARS
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
DOSAGE
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 also refer to the full Product Information for Zelboraf, which
is used in combination
with Cotellic.
Standard Dosage
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).
Each dose of three 20 mg tablets (60 mg) can be taken with or without
food (see section 5.2
Pharmacokinetic properties). Cotellic tablets should be swallowed
whole with water.
Duration of Treatment
Treatment with Cotellic should continue until the patient no longer
derives benefit or until the
development of unacceptable toxicity.
Cotellic 190711
2
Delayed or Missed Doses
If a dose is missed, it can be taken up to 12 hours prior to the next
dos