Cometriq

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

cabozantinib

Saatavilla:

Ipsen Pharma

ATC-koodi:

L01XE

INN (Kansainvälinen yleisnimi):

cabozantinib

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Thyroid Neoplasms

Käyttöaiheet:

Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.

Tuoteyhteenveto:

Revision: 28

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-03-21

Pakkausseloste

47
B. PACKAGE LEAFLET
48
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COMETRIQ 20 MG HARD CAPSULES
COMETRIQ 80 MG HARD CAPSULES
cabozantinib
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 or pharmacist.
-
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. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What COMETRIQ is and what it is used for
2.
What you need to know before you take COMETRIQ
3.
How to take COMETRIQ
4.
Possible side effects
5.
How to store COMETRIQ
6.
Contents of the pack and other information
1.
WHAT COMETRIQ IS AND WHAT IT IS USED FOR
WHAT COMETRIQ IS
COMETRIQ is a cancer medicine that contains the active substance
cabozantinib (
_S_
)-malate.
It is a medicine used to treat medullary thyroid cancer, a rare type
of thyroid cancer, that cannot be removed
by surgery or that has spread to other parts of the body.
HOW COMETRIQ WORKS
COMETRIQ blocks the action of proteins called receptor tyrosine
kinases (RTKs), which are involved in the
growth of cells and the development of new blood vessels that supply
them. These proteins can be present in
high amounts in cancer cells, and by blocking their action COMETRIQ
can slow down the rate at which the
tumour grows and help to cut off the blood supply that the cancer
needs.
COMETRIQ may slow or stop the growth of medullary thyroid cancer. It
may help shrink tumours
associated with this type of cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COMETRIQ
DO NOT TAKE COMETRIQ
-
if you are allergic to cabozantinib or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking COMETRIQ if you:
-
ha

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
COMETRIQ 20 mg hard capsules
COMETRIQ 80 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One hard capsule contains cabozantinib (
_S_
)-malate equivalent to 20 mg or 80 mg cabozantinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
The hard capsules are grey with “XL184 20mg” printed in black on
the body of the capsule. The capsule
contains an off-white to white powder.
The hard capsules are orange with “XL184 80mg” printed in black on
the body of the capsule. The capsule
contains an off-white to white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COMETRIQ is indicated for the treatment of adult patients with
progressive, unresectable locally advanced
or metastatic medullary thyroid carcinoma.
For patients in whom rearranged during transfection (RET) mutation
status is not known or is negative, a
possible lower benefit should be taken into account before individual
treatment decision (see important
information in section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy with COMETRIQ should be initiated by a physician experienced
in the administration of anticancer
medicinal products.
Posology
COMETRIQ (cabozantinib) capsules and CABOMETYX (cabozantinib) tablets
are not bioequivalent and
should not be used interchangeably (see section 5.2).
The recommended dose of COMETRIQ is 140 mg once daily, taken as one 80
mg orange capsule and three
20 mg grey capsules. Treatment should continue until the patient is no
longer clinically benefiting from
therapy or until unacceptable toxicity occurs.
It should be expected that a majority of patients treated with
COMETRIQ will require one or more dose
adjustments (reduction and/or interruption) due to toxicity. Patients
should therefore be closely monitored
during the first eight weeks of therapy (see section 4.4).
Management of suspected adverse drug reactions may require temporary
interruption and/or dose reduction
o