SUTENT 12.5 MG

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

SUNITINIB AS MALATE

Tillgänglig från:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC-kod:

L01XE04

Läkemedelsform:

CAPSULES

Sammansättning:

SUNITINIB AS MALATE 12.5 MG

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

PFIZER INC, USA

Terapeutisk grupp:

SUNITINIB

Terapiområde:

SUNITINIB

Terapeutiska indikationer:

Sutent is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. Sutent is indicated for the treatment of advanced renal cell carcinoma.Treatment of unresectable or metastatic, well differentiated pancreatic neuroendocrine tumours (pNET) with disease progression.

Tillstånd datum:

2022-06-30

Bipacksedel

Sutent, PIL, Israel, CC 310522
2022-0078783
1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
SUTENT
® 12.5 MG
SUTENT
® 25 MG
SUTENT
® 50 MG
CAPSULES
SUNITINIB (AS MALATE) 12.5 MG, 25 MG, 50 MG
For a list of inactive ingredients and allergens in the preparation:
See section 2 under
'Important information about some of this medicine's ingredients' and
section 6
'Further
information’
.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the doctor or
pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar
to yours.
This medicine is intended for adults above the age of 18.
1. WHAT IS THE MEDICINE INTENDED FOR?
•
For treatment of gastrointestinal stromal tumor (GIST).
•
For treatment of advanced renal cell carcinoma (aRCC).
•
For treatment of differentiated pancreatic neuroendocrine tumors
(pNET), that have
progressed or cannot be removed with surgery.
THERAPEUTIC GROUP:
Targeted tyrosine kinase receptor inhibitor.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients in this medicine (listed in section 6).
Before treatment with Sutent, tell the doctor:
•
If you are pregnant or planning to become pregnant, breastfeeding or
planning to
breastfeed.
•
If you have had a cerebral or cardiac event (e.g., any sort of heart
attack, including
myocardial infarction, heart failure, bypass surgery, heart muscle
disease
(cardiomyopathy), unstable angina pectoris) and/or pulmonary embolism
during the 12
months before commencing treatment with the medicine.
•
If you suffer, or have suffered in the past, from impaired function
of: the liver, the
kidney/urinary tract, the pancreas, the

Produktens egenskaper

Sutent 12.5 mg, 25 mg, 50 mg, LPD, Israel, CC 310522
2021-0069992, 2022-0078783
1
SUTENT
® 12.5 MG
SUTENT
® 25 MG
SUTENT
® 50 MG
1.
NAME OF THE MEDICINAL PRODUCT
Sutent 12.5 mg, capsules
Sutent 25 mg, capsules
Sutent 50 mg, capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains sunitinib malate, equivalent to 12.5, 25, 50 mg
of sunitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
12.5
mg capsules
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
gelatin capsule with caramel cap and orange body, printed with white
ink “Pfizer” on the cap and
“STN 25 mg” on the body.
50 mg capsules
gelatin capsule with caramel top and caramel body, printed with white
ink “Pfizer” on the cap and
“STN 50 mg” on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GASTROINTESTINAL STROMAL TUMOR
SUTENT is indicated for the treatment of gastrointestinal stromal
tumor after disease progression on
or intolerance to imatinib mesylate.
ADVANCED RENAL CELL CARCINOMA
SUTENT is indicated for the treatment of advanced renal cell
carcinoma.
PANCREATIC NEUROENDOCRINE TUMORS (PNET)
Treatment of unresectable or metastatic, well differentiated
pancreatic neuroendocrine tumours (pNET)
with disease progression.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy with sunitinib should be initiated by a physician experienced
in the administration of anti-
cancer agents.
Posology
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.
Sutent 12.5 mg, 25 mg, 50 mg, LPD, Israel, CC 310522
2021-0069992, 2022-0078783
2
For pNET, the recommended dose of Sutent is 37.5 mg taken orally once
daily without a scheduled
rest period.
_Dose adjustments _
_Safety and tolerability _
For GIST and MRCC, dose modifications in 12.5 mg steps may be applied
based on