STIVARGA regorafenib 40 mg tablet bottle

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

regorafenib, Quantity: 40 mg

Հասանելի է:

Bayer Australia Ltd

INN (Միջազգային անվանումը):

Regorafenib

Դեղագործական ձեւ:

Tablet

Կազմը:

Excipient Ingredients: polyvinyl alcohol; croscarmellose sodium; iron oxide red; microcrystalline cellulose; povidone; purified talc; magnesium stearate; titanium dioxide; macrogol 3350; colloidal anhydrous silica; iron oxide yellow; lecithin

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

28 (starter pack), 84 (3 x 28), 28

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

STIVARGA is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine,- oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.,STIVARGA is indicated for the treatment of patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.,STIVARGA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Ապրանքի ամփոփագիր:

Visual Identification: Light pink, oval tablet embossed with '40' on one side and 'BAYER' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Լիազորման կարգավիճակը:

Licence status A

Հաստատման ամսաթիվը:

2013-11-29

Տեղեկատվական թերթիկ

Stivarga CMI_VX2.0
1
STIVARGA
®
40 MG TABLETS (STI·VAR·GAH)
_regorafenib_
_ _
CONSUMER MEDICINE INFORMATION
WARNING: Liver problems
Stivarga can cause liver problems which can be serious and in rare
cases lead to death. Your doctor will
check your liver function before you start taking Stivarga and monitor
your liver function during treatment.
Your doctor may need to change your dose or advise you to stop taking
Stivarga. Please see under section
SIDE EFFECTS the possible signs of severe liver injury.
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
STIVARGA. It does not
contain all the available
information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
taking STIVARGA against
the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS, OR
ARE UNSURE ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST FOR MORE
ADVICE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it
again.
WHAT STIVARGA
IS USED FOR
STIVARGA is a medicine
used to treat cancer by
slowing down the growth and
spread of cancer cells.
STIVARGA cuts off the
blood supply that keeps
cancer cells growing.
STIVARGA is used to treat:
•
colon, rectal or bowel
cancer that has spread to
other parts of the body in
patients who have
previously received other
treatments;
•
gastrointestinal stromal
tumour (GIST) in patients
who have previously
received other treatments.
•
liver cancer in patients who
have been previously
treated with another
anticancer medicine
(sorafenib)
GIST is a cancer of the
stomach and bowel. It is
caused by the uncontrolled
growth of cells in the wall of
the stomach or bowel.
STIVARGA belongs to a
group of medicines called
antineoplastic (anti-cancer)
agents.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
reason.
STIVARGA is not addictive.
BEFORE YOU
TAKE STIVARGA
_WHEN YOU MUST NOT _

Ապրանքի հատկությունները

Stivarga PI_VX1.0, CCDS 10
Page 1 of 33
AUSTRALIAN PRODUCT INFORMATION - STIVARGA
® (REGORAFENIB)
40 MG TABLETS
WARNING: HEPATOTOXICITY
Rare cases of fatal hepatotoxicity have been observed in clinical
trials and in the post-marketing
setting, including in the absence of hepatic metastases. Monitor
hepatic function prior to and
during treatment [see section 4.4 Special warnings and precautions for
use - Hepatotoxicity].
Modify or interrupt dose if signs of liver injury emerge, depending
upon severity and persistence
[See section 4.2 Dose and method of administration, Table 1]
1
NAME OF THE MEDICINE
Regorafenib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg regorafenib (as 41.49 mg
regorafenib monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Light pink, oval tablets, marked with ‘BAYER’ on one side and
‘40’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
STIVARGA is indicated for the treatment of patients with metastatic
colorectal cancer (CRC) who have
been previously treated with fluoropyrimidine-, oxaliplatin- and
irinotecan-based chemotherapy, an
anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.
STIVARGA is indicated for the treatment of patients with unresectable
or metastatic gastrointestinal
stromal tumours (GIST) who progressed on or are intolerant to prior
treatment with imatinib and
sunitinib.
STIVARGA is indicated for the treatment of patients with
hepatocellular carcinoma (HCC) who have
been previously treated with sorafenib.
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
METHOD OF ADMINISTRATION
For oral use.
DOSAGE REGIMEN
Take four STIVARGA (40 mg) tablets daily at the same time each day for
three weeks on therapy (21
days) followed by one week off therapy (7 days) to comprise a cycle of
four weeks (28 days) (see
section 5.2 Pharmacokinetic properties – Absorption)_. _The tablets
should be swallowed whole with
water after a low-fat meal (ideally at breakfast) that contains