Subinit 25 mg capsules hard

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

SUNITINIB

Tillgänglig från:

Przedsiebiorstwo Farmaceutyczne LEK-AM sp. z o.o 14A Ostrzykowizna Street, 05-170 Zakroczym, , Poland

ATC-kod:

L01XE01

INN (International namn):

SUNITINIB 25 mg

Läkemedelsform:

HARD CAPSULE

Sammansättning:

SUNITINIB 25 mg

Receptbelagda typ:

POM

Terapiområde:

ANTINEOPLASTIC AGENTS

Produktsammanfattning:

Licence number in the source country: NOT APPLICAPABLE

Bemyndigande status:

Authorised

Tillstånd datum:

2021-08-09

Bipacksedel

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUBINIT 12.5 MG CAPSULES, HARD
SUBINIT 25 MG CAPSULES, HARD
SUBINIT 50 MG CAPSULES, HARD
Sunitinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Subinit is and what it is used for
2.
What you need to know before you take Subinit
3.
How to take Subinit
4.
Possible side effects
5.
How to store Subinit
6.
Contents of the pack and other information
1.
WHAT SUBINIT IS AND WHAT IT IS USED FOR
Subinit contains the active substance sunitinib, which is a protein
kinase inhibitor. It 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.
Subinit is used to treat adults with the following types of cancer:
-
Gastrointestinal stromal tumour (GIST), a type of cancer of the
stomach and bowel, where
imatinib (another anticancer medicine) no longer works or you cannot
take imatinib.
-
Metastatic renal cell carcinoma (MRCC), 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.
If you have any questions about how Subinit works or why this medicine
has been prescribed for
you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUBINIT
DO NOT TAKE
Subinit
Page 2 of 8
-
If you are allergic to sunitinib or any of the other ingredients of
Subinit (listed in section 6).
WARNINGS AND PRECAUTIONS
TALK TO YOU

Produktens egenskaper

Page 1 of 32
1.
NAME OF THE MEDICINAL PRODUCT
Subinit 12.5 mg, capsules, hard
Subinit 25 mg, capsules, hard
Subinit 50 mg, capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Subinit 12.5 mg, capsules, hard
Each capsule contains 16.70 mg of sunitinib malate, equivalent to 12.5
mg of sunitinib.
Subinit 25 mg, capsules, hard
Each capsule contains 33.40 mg of sunitinib malate, equivalent to 25
mg of sunitinib.
Subinit 50 mg, capsules, hard
Each capsule contains 66.80 mg of sunitinib malate, equivalent to 50
mg of sunitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Subinit 12.5 mg, capsules, hard
Hard gelatin capsules, opaque red cap and body, size 4, with yellow to
orange granules.
Subinit 25 mg, capsules, hard
Hard gelatin capsules, opaque yellow cap and opaque red body, size 2,
with yellow to orange
granules.
Subinit 50 mg, capsules, hard
Hard gelatin capsules, opaque yellow cap and body, size 1, with yellow
to orange granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Subinit is indicated for the treatment of unresectable and/or
metastatic malignant gastrointestinal
stromal tumour (GIST) in adults after failure of imatinib treatment
due to resistance or intolerance.
Metastatic renal cell carcinoma (MRCC)
Subinit is indicated for the treatment of advanced/metastatic renal
cell carcinoma (MRCC) in adults.
Pancreatic neuroendocrine tumours (pNET)
Subinit is indicated for the treatment of unresectable or metastatic,
well-differentiated pancreatic
neuroendocrine tumours (pNET) with disease progression in adults.
Page 2 of 32
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy with sunitinib should be initiated by a physician experienced
in the administration of
anticancer agents.
Posology
For GIST and MRCC, the recommended dose of Subinit 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 pNET, the recommended dose of S