Cotellic 20mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Cobimetinib hemifumarate

থেকে পাওয়া:

Roche Products Ltd

এটিসি কোড:

L01XE38

INN (আন্তর্জাতিক নাম):

Cobimetinib hemifumarate

ডোজ:

20mg

ফার্মাসিউটিকাল ফর্ম:

Tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 08010500

তথ্য লিফলেট

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COTELLIC 20 MG FILM-COATED TABLETS
COBIMETINIB
▼This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
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

পণ্য বৈশিষ্ট্য

OBJECT 1
COTELLIC 20 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 26-Mar-2018 | Roche
Products Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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