Caprelsa

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Vandetanib

Saatavilla:

Sanofi B.V.

ATC-koodi:

L01XE

INN (Kansainvälinen yleisnimi):

vandetanib

Terapeuttinen ryhmä:

Antineoplastic and immunomodulating agents

Terapeuttinen alue:

Thyroid Neoplasms

Käyttöaiheet:

Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.Caprelsa is indicated in adults, children and adolescents aged 5 years and older.For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.

Tuoteyhteenveto:

Revision: 52

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-02-16

Pakkausseloste

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CAPRELSA 100 MG FILM-COATED TABLETS
CAPRELSA 300 MG FILM-COATED TABLETS
vandetanib
In addition to this leaflet you will be given the Patient Alert Card,
which contains important safety
information that you need to know before you are given Caprelsa and
during treatment with Caprelsa.
_ _
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet and the patient alert card. You may need to read it
again.
-
It is important that you keep the Alert Card with you during
treatment.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
:
1.
What Caprelsa is and what it is used for
2.
What you need to know before you take Caprelsa
3.
How to take Caprelsa
4.
Possible side effects
5.
How to store Caprelsa
6.
Contents of the pack and other information
1.
WHAT CAPRELSA IS AND WHAT IT IS USED FOR
CAPRELSA IS A TREATMENT FOR ADULTS AND CHILDREN AGED 5 YEARS AND ABOVE
WITH:
Type of medullary thyroid cancer that is called Rearranged during
Transfection (RET) mutant and
which cannot be removed by surgery or has spread to other parts of the
body.
Caprelsa works by slowing down the growth of new blood vessels in
tumours (cancers). This cuts off
the supply of food and oxygen to the tumour. Caprelsa may also act
directly on cancer cells to kill
them or slow down their growth.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CAPRELSA
DO NOT TAKE CAPRELSA:
-
if you are allergic to vandetanib or any of the other ingredients of
this medicine (listed in
Section 6).
-
if you have a heart problem that you were born with called
‘congenital long QTc syndrom

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Caprelsa 100 mg film-coated tablets
Caprelsa 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Caprelsa 100 mg tablets
Each film-coated tablet contains 100 mg of vandetanib.
Caprelsa 300 mg tablets
Each film-coated tablet contains 300 mg of vandetanib.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Caprelsa 100 mg tablets
The Caprelsa 100 mg tablet is a round, biconvex, white film-coated
tablet with ‘Z100’ impressed on
one side.
Caprelsa 300 mg tablets
The Caprelsa 300 mg tablet is an oval-shaped, biconvex, white
film-coated tablet with ‘Z300’
impressed on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Caprelsa is indicated for the treatment of aggressive and symptomatic
Rearranged during Transfection
(RET) mutant medullary thyroid cancer (MTC) in patients with
unresectable locally advanced or
metastatic disease.
Caprelsa is indicated in adults, children and adolescents aged 5 years
and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a physician
experienced in treatment of MTC and in
the use of anticancer medicinal products and experienced in the
assessment of electrocardiogram
(ECG).
Rearranged during transfection (RET) status
Since the activity of Caprelsa, based on available data, is considered
insufficient in patients with no
identified RET mutation, the presence of a RET mutation should be
determined by a validated test
prior to initiation of treatment with Caprelsa. When establishing RET
mutation status, tissue samples
should be obtained if possible at the time of initiation of treatment
rather than at the time of diagnosis.
Posology for MTC in adult patients
The recommended dose is 300 mg once a day, taken with or without food
at about the same time each
day.
3
If a dose is missed, it should be taken as soon as the patient
remembers. If it is less than 12 hours to
the next dose, the patient should not take the mi