Stivarga 40mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Regorafenib

Inapatikana kutoka:

Bayer Plc

ATC kanuni:

L01XE21

INN (Jina la Kimataifa):

Regorafenib

Kipimo:

40mg

Dawa fomu:

Tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 08010500; GTIN: 5010605750014

Taarifa za kipeperushi

1
Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ _
_ _
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:
2
-
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

Tabia za bidhaa

OBJECT 1
STIVARGA 40 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 18-Jun-2018 | Bayer plc
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 2.427 mmol (or 55.8 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 occ