STIVARGA

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

REGORAFENIB

Disponible desde:

BAYER ISRAEL LTD

Código ATC:

L01XE21

formulario farmacéutico:

FILM COATED TABLETS

Composición:

REGORAFENIB 40 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricado por:

BAYER AG., GERMANY

Grupo terapéutico:

REGORAFENIB

Área terapéutica:

REGORAFENIB

indicaciones terapéuticas:

Stivarga is indicated as monotherapy for the treatment of adults patients:- with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy,and if KRAS wild- type, an anti-EGFR therapy.- with locally advanced, unresectable or metastatic gastrointestinal stromal tumors (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.- hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Fecha de autorización:

2018-10-31

Información para el usuario

STIVARGA
®
FILM-COATED TABLETS
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
Each tablet contains:
Regorafenib 40 mg
Inactive ingredients and allergens in the preparation: see section 6
“Further
Information” and also see section 2 “Important information
regarding some of the
ingredients of the medicine”.
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.
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.
1) WHAT IS THE MEDICINE INTENDED FOR?
Stivarga contains the active ingredient regorafenib and is intended
for the treatment
of cancer. The medicine acts by slowing the growth and spread of
cancer cells and
cutting off the blood supply that allows cancer cells to continue
growing.
Stivarga is intended for treatment of the following conditions:
- colon or rectal cancer that has spread to other parts of the body in
patients who
have been treated in the past with fluoropyrimidine-, oxaliplatin- and
irinotecan-
based chemotherapy, who have been treated in the past with an
anti-VEGF therapy
and, in the case of KRAS-wild-type, have been treated in the past with
an anti-EGFR
therapy.
- gastrointestinal stromal tumor (GIST), which is a certain type of
cancer of the
stomach and bowel that is not amenable to surgery or has spread to
other parts
of the body, in patients who have been treated in the past with other
anti-cancer
medicines (imatinib and sunitinib).
- liver cancer (hepatocellular carcinoma - HCC) in patients who have
been treated
in the past with another anti-cancer medicine (sorafenib).
THERAPEUTIC GROUP: Stivarga belongs to the group of anti-cancer
medicines called
protein kinase inhibitors.
Protein kinase is a group of enzymes respons

Ficha técnica

1
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
fluoropyrimidine-,
oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy
and if KRAS wild-type, an
anti-EGFR therapy
.
- locally advanced, unresectable or metastatic gastrointestinal
stromal tumors (GIST) who have been
previously treated with imatinib mesylate and sunitinib malate.
- 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).
Patients with performance status (PS) 2 or higher were excluded from
clinical studies. There