Sunitinib Krka 12.5 mg hard capsules

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Sunitinib

Tilgængelig fra:

KRKA, d.d., Novo mesto

ATC-kode:

L01XE04

INN (International Name):

Sunitinib

Dosering:

12.5 milligram(s)

Lægemiddelform:

Capsule, hard

Terapeutisk område:

sunitinib

Autorisation status:

Not marketed

Autorisation dato:

2021-07-09

Indlægsseddel

1.3.1
Sunitinib
SPC, Labeling and Package Leaflet
IE-Ireland
PI_Text006560_1
- Updated:
Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUNITINIB KRKA 12.5 MG HARD CAPSULES
SUNITINIB KRKA 25 MG HARD CAPSULES
SUNITINIB KRKA 50 MG HARD CAPSULES
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 Sunitinib Krka is and what it is used for
2.
What you need to know before you take Sunitinib Krka
3.
How to take Sunitinib Krka
4.
Possible side effects
5.
How to store Sunitinib Krka
6.
Contents of the pack and other information
1.
WHAT SUNITINIB KRKA IS AND WHAT IT IS USED FOR
Sunitinib Krka 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.
Sunitinib Krka 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 Sunitinib Krka works or why this
medicine has been
prescribed for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB KRKA

Produktets egenskaber

Health Products Regulatory Authority
12 July 2021
CRN009PVN
Page 1 of 25
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sunitinib Krka 12.5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains sunitinib malate, equivalent to 12.5 mg of
sunitinib.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule (capsule).
Hard gelatine capsule with orange cap and orange body, printed with
white imprint "SNB" and "12.5" on the body. The capsule
is filled with orange powder. Capsule size: 4 (length of approximately
14 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Sunitinib Krka 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)
Sunitinib Krka is indicated for the treatment of advanced/metastatic
renal cell carcinoma (MRCC) in adults.
Pancreatic neuroendocrine tumours (pNET)
Sunitinib Krka 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
Therapy with Sunitinib Krka should be initiated by a physician
experienced in the administration of anticancer agents.
Posology
For GIST and MRCC, the recommended dose of Sunitinib Krka 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 Sunitinib Krka 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 individual safety and tolerability. Daily dose
should not exceed 75 mg nor be decreased below 25 mg.
For pNET, dose modification in 12.5 mg steps may be applied based on