Stivarga

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Regorafenib monohydrate 41.49mg equivalent to regorafenib 40 mg

Available from:

Bayer New Zealand Limited

INN (International Name):

Regorafenib monohydrate 41.49 mg (equivalent to regorafenib 40 mg)

Dosage:

40 mg

Pharmaceutical form:

Tablet

Composition:

Active: Regorafenib monohydrate 41.49mg equivalent to regorafenib 40 mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry pink 85G35294 Povidone

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

Stivarga is indicated 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.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE white opaque with a child resistant screw cap PP white with sealing insert and desiccant - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture 7 weeks opened stored at or below 25°C protect from moisture - Bottle, plastic, HDPE white opaque with a child resistant screw cap PP white with sealing insert and desiccant - 84 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture 7 weeks opened stored at or below 25°C protect from moisture

Authorization date:

2013-12-12

Patient Information leaflet

170927 Stivarga CMI
1
STIVARGA
®
Sti-VAR-gah
_regorafenib _
CONSUMER MEDICINE INFORMATION
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.
STIVARGA is a prescription
medicine. It should only be
used under medical
supervision.
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 used to treat:
•
Colon, rectal or bowel cancer
that has spread to other parts
of the body in adult patients
who have received other
treatments or cannot be
treated with other regimens;
•
Gastrointestinal stromal
tumours (GIST) in adult
patients who have been
previously treated with other
anticancer medicines
(imatinib and sunitinib).
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 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 TAKE _
_IT _
DO NOT TAKE STIVARGA IF
YOU HAVE AN ALLERGY TO:
• regorafenib, the active
ingredient in STIVARGA
• any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
• shortness of breath
• wheezing or difficulty
breathing
• swelling of the face, lips,
tongue or other parts of the
body
• rash, itching or hives on the
skin
DO NOT TAKE THIS MEDICINE IF
YOU ARE PREGNANT OR THINK
YOU MIGHT BE PREGNANT.
DO NOT

Summary of Product characteristics

1801 Stivarga dDS
Page 1 of 26
DATA SHEET
1.
STIVARGA
® (REGORAFENIB)
Stivarga 40 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Regorafenib 40 mg
Each daily dose of 160 mg contains 2.427 mmol (or 55.8 mg) of sodium.
To be taken into
consideration by patients on a controlled sodium diet. Each daily dose
of 160 mg contains
1.68 mg of lecithin (derived from soya).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
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 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 5.1.3).
•
unresectable or metastatic gastrointestinal stromal tumours (GIST) who
progressed on or
are intolerant to prior treatment with imatinib and sunitinib.
4.2
DOSE AND METHOD OF ADMINISTRATION
4.2.1
DOSE
Stivarga should be prescribed by doctors experienced in the
administration of anticancer
therapy.
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.
1801 Stivarga dDS
Page 2 of 26
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
is limited data in patients with PS ≥2.
4.2.1.1
DOSE ADJUST