Koselugo

Země: Evropská unie

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktivní složka:

Selumetinib sulfate

Dostupné s:

AstraZeneca AB

INN (Mezinárodní Name):

selumetinib

Terapeutické skupiny:

Antineoplastic agents

Terapeutické oblasti:

Neurofibromatosis 1

Terapeutické indikace:

Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above

Přehled produktů:

Revision: 5

Stav Autorizace:

Authorised

Datum autorizace:

2021-06-17

Informace pro uživatele

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KOSELUGO 10 MG HARD CAPSULES
KOSELUGO 25 MG HARD CAPSULES
selumetinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Koselugo is and what it is used for
2.
What you need to know before you take Koselugo
3.
How to take Koselugo
4.
Possible side effects
5.
How to store Koselugo
6.
Contents of the pack and other information
1.
WHAT KOSELUGO IS AND WHAT IT IS USED FOR
WHAT KOSELUGO IS AND HOW IT WORKS
Koselugo contains the active substance selumetinib.
Selumetinib is a type of medicine called a MEK inhibitor. It works by
blocking certain proteins
involved in the growth of tumour cells.
Koselugo is expected to shrink tumours that grow along nerves, called
plexiform neurofibromas.
These tumours are caused by a genetic condition called
neurofibromatosis type 1 (NF1).
WHAT KOSELUGO IS USED FOR
Koselugo is used to treat children aged 3 years and above with
plexiform neurofibromas that cannot be
completely removed by surgery.
If you have any questions about how Koselugo works or why this
medicine has been prescribed for
you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KOSELUGO
DO NOT TAKE KOSELUGO:

if you are allergic to selumetinib or any of the other ingredients of
this

Charakteristika produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Koselugo 10 mg hard capsules
Koselugo 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Koselugo 10 mg hard capsules
Each hard capsule contains 10 mg of selumetinib (as hydrogen sulfate).
Koselugo 25 mg hard capsules
Each hard capsule contains 25 mg of selumetinib (as hydrogen sulfate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Koselugo 10 mg hard capsules
White to off-white, opaque, size 4 (approximately 14 mm x 5 mm), hard
capsule, which has a centre
band and is marked with “SEL 10” in black ink.
Koselugo 25 mg hard capsules
Blue, opaque, size 4 (approximately 14 mm x 5 mm), hard capsule, which
has a centre band and is
marked with “SEL 25” in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Koselugo as monotherapy is indicated for the treatment of symptomatic,
inoperable plexiform
neurofibromas (PN) in paediatric patients with neurofibromatosis type
1 (NF1) aged 3 years and
above.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Koselugo should be initiated by a physician experienced
in the diagnosis and the
treatment of patients with NF1 related tumours.
Posology
The recommended dose of Koselugo is 25 mg/m
2
of body surface area (BSA), taken orally twice daily
(approximately every 12 hours).
Dosing is individualised based on BSA (mg/m
2
) and rounded to the nearest achievable 5 mg or 10 mg
dose (up to a maximum single dose of 50 mg). Different strengths of
Koselugo capsules can be
combined to attain the desired dose (Table 1).
3
TABLE 1. RECOMMENDED DOSE BASED ON BODY SURFACE AREA
BODY SURFACE AREA (BSA)
A
RECOMMENDED DOSE
0.55 – 0.69 m
2
20 mg in the morning and 10 mg in the evening
0.70 –