SUTENT 12.5MG CAPSULE

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

SUNITINIB MALATE

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

SUNITINIB MALATE

Unit dalam pakej:

30Capsule Capsules; 28 Capsule Capsules

Dikeluarkan oleh:

PFIZER ITALIA S.R.L.

Risalah maklumat

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET _
_(RIMUP) _
SUTENT
® CAPSULE
Sunitinib Malate (12.5 mg, 25 mg)
PLD Title
: Sunitinib Malate (SUTENT)
PLD Date
: 03 May 20190316 NovemberJuly 2020
Country
: Malaysia
Reference Document
: 12.5 mg and 25 mg capsules of Malaysia LPD dated 06 February 202018
July 2018
Reason for Changechange
: To Update PRH address
To add Serial NumberPfLEET Numbero- 2020-0062522 (S 1) To update as
per latest CLD
: To amend serial number
Pfizer Confidential
_ _
_ _
_ _
_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SUTENT
® CAPSULE
_ _
Sunitinib Malate (12.5 mg, 25 mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What SUTENT is used for
2.
How SUTENT works
3.
Before you use SUTENT
4.
How to use SUTENT
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
SUTENT
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT SUTENT IS USED FOR
SUTENT is used to treat adults with
the following types of cancer:
Gastrointestinal stromal tumour
(GIST), a type of cancer of the
stomach and bowel,. Aafter disease
progression on or, where imatinib
(another anticancer medicine) no
longer works or you cannot take
imatinib.
Advanced renal cell carcinoma, a
type of kidney cancer that has spread
to other parts of the body.
Pancreatic neuroendocrine tumours
(pNET), tumours of the hormone-
producing cells in the pancreas that
have progressed or cannot be
removed with surgery.
HOW SUTENT WORKS
SUTENT is used to treat cancer by
preventing the activity of a special
group of proteins which are known to
be involved in the growth and spread
of cancer cells.
BEFORE YOU USE SUTENT
-
_When you must not use it _
DO NOT TAKE SUTENT
If you are allergic to sunitinib or
any of the other ingredients of
SUTENT.
_Pregnancy and lactation _
There are no studies in pregnant
women using sunitinib. If you are
pregnant or think you may be
pregnant, tell your doctor.
SUTENT is not to be used during
pregnancy unless clearly necessary.
Your doctor

Ciri produk

Pfizer Confidential
SUTENT
SUNITINIB MALATE
1. NAME OF THE MEDICINAL PRODUCT
SUTENT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SUTENT 12.5 MG
Each capsule contains sunitinib malate equivalent to 12.5 mg of
sunitinib.
SUTENT 25 MG
Each capsule contains sunitinib malate equivalent to 25 mg of
sunitinib.
3. PHARMACEUTICAL FORM
12.5 MG CAPSULES
Hard gelatin capsule with orange cap and orange body, printed with
white ink “Pfizer” on the cap
and “STN 12.5 mg” on the body.
25 MG CAPSULES
Hard gelatin capsule with caramel cap and orange body, printed with
white ink “Pfizer” on the cap
and “STN 25 mg” on the body.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
4.1.1
GASTROINTESTINAL STROMAL TUMOR (GIST)
SUTENT
is indicated for the treatment of gastrointestinal stromal tumor after
disease progression
on or intolerance to imatinib mesylate.
4.1.2
ADVANCED RENAL CELL CARCINOMA (RCC)
SUTENT
is indicated for the treatment of advanced renal cell carcinoma.
4.1.3.
PANCREATIC NEUROENDOCRINE TUMOUR (PNET)_ _
SUTENT
is indicated for the treatment of unresectable or metastatic,
well-differentiated pancreatic
neuroendocrine tumours (pNET) with disease progression in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1
RECOMMENDED DOSE
For
_GIST _
and Advanced
_RCC_
, the recommended dose of sunitinib is 50 mg taken orally once daily
for 4 consecutive weeks, followed by a 2-week off period (Schedule
4/2) to comprise a complete
cycle of 6 weeks.
Pfizer Confidential
1
For
_pNET, _
the recommended dose of sunitinib is 37.5 mg taken orally once daily
without a
scheduled rest period.
Sunitinib may be taken with or without food.
If a dose is missed, the patient should not be given an additional
dose. The patient should take the
usual prescribed dose on the following day.
4.2.2
DOSE MODIFICATIONS
_Safety and Tolerability_
For GIST and Advanced RCC, dose modifications in 12.5 mg increments or
decrements may be
applied based on individual safety and tolerability up to 75 mg or
down to 25 mg.
For
_pNET_
, dose modificati