Sutent

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sunitinib malate 50.1mg equivalent to 37.5mg Sunitinib;  

Available from:

Pfizer New Zealand Limited

INN (International Name):

Sunitinib malate 50.1 mg (equivalent to 37.5mg Sunitinib)

Dosage:

37.5 mg

Pharmaceutical form:

Capsule

Composition:

Active: Sunitinib malate 50.1mg equivalent to 37.5mg Sunitinib   Excipient: Croscarmellose sodium Gelatin Ink Iron oxide yellow Magnesium stearate Mannitol Povidone Sodium laurilsulfate Titanium dioxide

Prescription type:

Prescription

Manufactured by:

Pfizer Asia Pacific Pte Ltd

Therapeutic indications:

SUTENT is indicated for the treatment of advanced renal cell carcinoma.

Product summary:

Package - Contents - Shelf Life: Blister pack, Aluminium/polyvinyl chloride(PVC)/polychlorotriflouroethylene(PCTFE, Aclar) - 28 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE white opaque, 60mL, Closure: 28 mm squeeze and turn cap - 28 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2015-09-16

Patient Information leaflet

SUTENT
®
1
SUTENT
®
_Sunitinib malate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SUTENT.
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 SUTENT
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SUTENT IS USED
FOR
SUTENT is used in the treatment of
renal cell carcinoma, a type of kidney
cancer.
SUTENT is used to treat
gastrointestinal stromal tumour
(GIST). GIST is a cancer of the
stomach and bowels. It is caused by
the uncontrolled growth of cells in
the wall of the stomach or bowel.
SUTENT slows down the growth of
these cells.
SUTENT is also used to treat
pancreatic neuroendocrine tumours.
This is a rare cancer in the cells of
the pancreas that release hormones.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SUTENT HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
SUTENT is only available with a
doctor's prescription. It is not
addictive.
_USE IN CHILDREN _
The safety and efficacy of SUTENT
have not been established in children.
BEFORE YOU TAKE
SUTENT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SUTENT IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO
SUNITINIB (THE ACTIVE INGREDIENT IN
SUTENT) OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
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 USE SUTENT AFTER THE
EXPIRY DATE PRINTED ON THE PACK.
DO NOT USE SUTENT IF THE
PACKAGING SHOWS SIGNS OF
TAMPERING.
_BEFORE YOU START TO TAKE IT _
YOU MUST TELL YOUR DOCTOR IF:
•
YOU HAVE HIGH BLOOD PRESSURE
•
YOU HAVE OR HAVE HAD AN
ANEURYSM (ABNORMAL BALLOO

Summary of Product characteristics

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Page 1 of 31
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
SUTENT

(sunitinib 12.5 mg capsules)
SUTENT

(sunitinib 25 mg capsules)
SUTENT

(sunitinib 37.5 mg capsules)
SUTENT

(sunitinib 50 mg capsules)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of SUTENT is sunitinib malate. SUTENT capsules
contain sunitinib malate
equivalent to 12.5 mg, 25 mg, 37.5 mg or 50 mg sunitinib.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
SUTENT is supplied as a hard gelatin capsule for oral administration.
12.5 mg strength: Hard gelatin capsule with Swedish Orange cap and
Swedish Orange body, printed
with white ink “Pfizer” on the cap, “STN 12.5mg” on the body.
25 mg strength: Hard gelatin capsule with caramel cap and Swedish
Orange body, printed with
white ink “Pfizer” on the cap, “STN 25mg” on the body.
37.5 mg strength: Hard gelatin capsule with yellow cap and yellow
body, printed with black ink
“Pfizer” on the cap, “STN 37.5mg” on the body.
50 mg strength: Hard gelatin capsule with caramel cap and caramel
body, printed with white ink
“Pfizer” on the cap, “STN 50mg” on the body.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SUTENT is indicated for the treatment of advanced renal cell
carcinoma.
SUTENT is indicated for the treatment of gastrointestinal stromal
tumour (GIST) after failure of
imatinib mesilate treatment due to resistance or intolerance.
SUTENT
is
indicated
for
the
treatment
of
unresectable,
well-differentiated
pancreatic
neuroendocrine tumours (pancreatic NET).
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4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
For GIST and mRCC, the recommended dose of SUTENT is 50 mg taken
orally once daily for
4 consecutive weeks followed by a 2 week rest period (Schedule 4/2) to
comprise a complete cycle
of 6 weeks.
For pancreatic NET, the recommended dose of SUTENT is 37.5 mg taken
orally once daily without
a scheduled rest period.
If