COTELLIC

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

COBIMETINIB AS HEMIFUMARATE

Available from:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

Pharmaceutical form:

FILM COATED TABLETS

Composition:

COBIMETINIB AS HEMIFUMARATE 20 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

HOFFMANN LA ROCHE, SWITZERLAND

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.Cotellic as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.

Authorization date:

2021-05-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a
doctor’s prescription only
Cotellic
®
20 mg
Film-coated tablets
Composition:
Each film-coated tablet contains:
Cobimetinib 20 mg
For information on the inactive ingredients, see section
6 - “Further Information”.
Read this leaflet carefully in its entirety before using
the medicine.
∙ This leaflet contains concise information about the
medicine. If you have further questions, refer to the
doctor or pharmacist.
∙ Keep this leaflet. You may need to read it again.
∙ This medicine has been prescribed for the treatment
of your ailment. Do not pass it on to others. It may
harm them, even if it seems to you that their ailment
is similar.
∙ In addition to the leaflet, there is a patient safety
information card for Cotellic. This card includes
important safety information, that you should know,
and act upon it accordingly, before starting and
during treatment with Cotellic. Read the patient
safety information card and the patient leaflet before
starting use of this preparation. Keep the card for
additional reference, if necessary.
Cotellic is intended for treatment in adults over the
age of 18.
1)
What is the medicine intended for?
Cotellic is intended for the treatment of a type of skin
cancer called metastatic melanoma, or melanoma which
can not be surgically removed, in combination with
vemurafenib in patients with the V600 mutation in the
protein called BRAF.
Cotellic as a single agent, is intended for the treatment
of adult patients with histiocytic neoplasms.
How does the medicine work?
The medicine targets a protein called “MEK” that is
important in regulating the development of the cancer cell.
When Cotellic is given in combination with vemurafenib
)a medicine which targets the mutated “BRAF” protein(,
it further slows down or stops the development of the
cancer.
Therapeutic group
Anti-neoplastics - protein kinase inhibitors
2)
Before using the medicine
Do not use t

Summary of Product characteristics

1
Cotellic PI_Version 7
COTELLIC
®
COBIMETINIB
FILM-COATED TABLETS 20 MG
PATIENT SAFETY INFORMATION CARD
The marketing of Cotellic is subject to a risk management plan (RMP)
including a 'Patient safety
information card'. The 'Patient safety information card', emphasizes
important safety information that
the patient should be aware of before and during treatment. Please
explain the patient the need to
review the card before starting treatment.
PRESCRIBER GUIDE
This product is marked with prescriber guide providing important
safety information. Please ensure
you are familiar with this material as it contains important safety
information.
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
Unresectable or Metastatic Melanoma
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).
Histiocytic Neoplasms
Cotellic as a single agent, is indicated for the treatment of adult
patients with histiocytic neoplasms.
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.
2
For Treatment of Melanoma
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 ta