Stivarga

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

regorafenib

Διαθέσιμο από:

Bayer Pharma AG

Φαρμακολογική κατηγορία (ATC):

L01EX05

INN (Διεθνής Όνομα):

regorafenib

Θεραπευτική ομάδα:

Antineoplastic agents, Protein kinase inhibitors

Θεραπευτική περιοχή:

Colorectal Neoplasms

Θεραπευτικές ενδείξεις:

Stivarga is indicated as monotherapy for the treatment of adult patients with:metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy;unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib;hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Περίληψη προϊόντος:

Revision: 20

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-08-26

Φύλλο οδηγιών χρήσης

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
STIVARGA 40 MG FILM-COATED TABLETS
regorafenib
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Stivarga is and what it is used for
2.
What you need to know before you take Stivarga
3.
How to take Stivarga
4.
Possible side effects
5.
How to store Stivarga
6.
Contents of the pack and other information
1.
WHAT STIVARGA IS AND WHAT IT IS USED FOR
Stivarga contains the active substance regorafenib. It is a medicine
used to treat cancer by slowing
down the growth and spread of cancer cells and cutting off the blood
supply that keeps cancer cells
growing.
Stivarga is used to treat:
-
colon or rectal cancer that has spread to other parts of the body in
adult patients who have received
other treatments or cannot be treated with other medicines
(fluoropyrimidine-based chemotherapy,
an anti-VEGF therapy and an anti-EGFR therapy)
-
gastrointestinal stromal tumours (GIST), a type of cancer of the
stomach and bowel, that has
spread to other parts of the body or is not amenable to surgery, in
adult patients who have been
previously treated with other anticancer medicines (imatinib and
sunitinib)
-
liver cancer in adult patients who have been previously treated with
another anticancer medicine
(sorafenib).
If you have any questions about how Stivarga works or why this
medicine has been prescribed for you,
please ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STIVARGA
DO NOT TAKE STIVARGA
-
if you are allergic to regorafenib or any of

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Stivarga 40 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg of regorafenib.
Excipients with known effect
Each daily dose of 160 mg contains 2.438 mmol (or 56.06 mg) of sodium
(see section 4.4).
Each daily dose of 160 mg contains 1.68 mg of lecithin (derived from
soya) (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_ _
Film-coated tablet.
Light pink film-coated tablets, oval shaped with a length of 16 mm and
a width of 7 mm marked with
‘BAYER’ on one side and ‘40’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Stivarga is indicated as monotherapy for the treatment of adult
patients with
- metastatic colorectal cancer (CRC) who have been previously treated
with, or are not considered
candidates for, available therapies. These include
fluoropyrimidine-based chemotherapy, an
anti-VEGF therapy and an anti-EGFR therapy (see section 5.1)
- unresectable or metastatic gastrointestinal stromal tumours (GIST)
who progressed on or are
intolerant to prior treatment with imatinib and sunitinib
- hepatocellular carcinoma (HCC) who have been previously treated with
sorafenib.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Stivarga should be prescribed by physicians experienced in the
administration of anticancer therapy.
Posology
The recommended dose of regorafenib is 160 mg (4 tablets of 40 mg)
taken once daily for 3 weeks
followed by 1 week off therapy. This 4-week period is considered a
treatment cycle.
_ _
If a dose is missed, then it should be taken on the same day as soon
as the patient remembers. The
patient should not take two doses on the same day to make up for a
missed dose. In case of vomiting
after regorafenib administration, the patient should not take
additional tablets.
Treatment should continue as long as benefit is observed or until
unacceptable toxicity occurs (see
section 4.4).
3
Patients with perf