Cotellic

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

cobimetinib hemifumarate

Saatavilla:

Roche Registration GmbH

ATC-koodi:

L01XE38

INN (Kansainvälinen yleisnimi):

cobimetinib

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Melanoma

Käyttöaiheet:

Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Tuoteyhteenveto:

Revision: 14

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2015-11-20

Pakkausseloste

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COTELLIC 20 MG FILM-COATED TABLETS
cobimetinib
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Cotellic is and what it is used for
2.
What you need to know before you take Cotellic
3.
How to take Cotellic
4.
Possible side effects
5.
How to store Cotellic
6.
Contents of the pack and other information
1.
WHAT COTELLIC IS AND WHAT IT IS USED FOR
WHAT COTELLIC IS
Cotellic is an anti-cancer medicine that contains the active substance
cobimetinib.
_ _
WHAT COTELLIC IS USED FOR
Cotellic is used to treat adult patients with a type of skin cancer
called melanoma, that has spread to
other parts of the body or cannot be removed by surgery.
•
It is used in combination with another anti-cancer medicine called
vemurafenib.
•
It can only be used in patients whose cancer has a change (mutation)
in a protein called
“BRAF”. Before starting treatment, your doctor will test for this
mutation. This change may
have led to the development of melanoma.
HOW COTELLIC WORKS
Cotellic targets a protein called “MEK” that is important in
controlling cancer cell growth. When
Cotellic is used in combination with vemurafenib (which targets the
changed “BRAF” protein), it
further slows down or stops the growth of your cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COTELLIC
DO NOT TAKE COTELLIC:
•
if you are allergic to cobimetinib or any of the other ingredients of
this medicine (listed in
section 6).
If you are not su

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cotellic 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains cobimetinib hemifumarate equivalent
to 20 mg cobimetinib.
Excipient with known effect
Each film-coated tablet contains 36 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
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 vemurafenib for the
treatment of adult patients with
unresectable or metastatic melanoma with a BRAF V600 mutation (see
sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Cotellic in combination with vemurafenib should only be
initiated and supervised by a
qualified physician experienced in the use of anticancer medicinal
products.
Before starting this treatment, patients must have BRAF V600
mutation-positive melanoma tumour
status confirmed by a validated test (see sections 4.4 and 5.1).
Posology
The recommended dose of Cotellic is 60 mg (3 tablets of 20 mg) once
daily.
Cotellic is taken on a 28 day cycle. Each 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
(Days 22 to 28-treatment break). Each subsequent Cotellic treatment
cycle should start after the 7-day
treatment break has elapsed.
For information on the posology of vemurafenib, please refer to its
SmPC.
_ _
_Duration of treatment _
_ _
Treatment with Cotellic should continue until the patient no longer
derives benefit or until the
development of unacceptable toxicity (see Table 1 below).
3
_Missed doses _
_ _
If a dose 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 administration of Cotellic, the patien