KOSELUGO 10 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

SELUMETINIB AS HYD-SULFATE

متاح من:

ASTRAZENECA (ISRAEL) LTD

ATC رمز:

L01EE04

الشكل الصيدلاني:

HARD CAPSULE

تركيب:

SELUMETINIB AS HYD-SULFATE 10 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ASTRA ZENECA UK LIMITED

المجال العلاجي:

SELUMETINIB

الخصائص العلاجية:

Koselugo is indicated for the treatment of pediatric patients 2 years of age and older withneurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

تاريخ الترخيص:

2021-06-29

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS( - 1986
This medicine is dispensed with a doctor’s prescription only
KOSELUGO™ 10 MG
HARD CAPSULES
Each hard capsule contains:
Selumetinib )as hyd-sulfate( 10 mg
KOSELUGO™ 25 MG
HARD CAPSULES
Each hard capsule contains:
Selumetinib )as hyd-sulfate( 25 mg
For inactive ingredients in the medicine - please see 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 any
further
questions, ask your doctor or pharmacist.
This medicine has been prescribed for you/your child. Do not pass it
on to
others. It may harm them, even if it seems to you that their ailment
is similar.
1. WHAT THE MEDICINE INTENDED FOR?
Koselugo is indicated for the treatment of pediatric patients 2 years
of age and
older with neurofibromatosis type 1 )NF1( who have symptomatic,
inoperable
plexiform neurofibromas )PN(.
THERAPEUTIC GROUP
Koselugo is protein Kinase inhibitor.
2. BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE IF:
You or your child are/is sensitive )allergic( to the active ingredient
Selumetinib or to any of the other ingredients of this medicine )see
section 6(.
SPECIAL WARNINGS REGARDING USE OF KOSELUGO
BEFORE TREATMENT WITH KOSELUGO, TELL THE DOCTOR IF:
you or your child suffers from heart problems )see section 4 "Side
effects"(.
you or your child suffers from eye problems such as: blurred vision,
sensitivity
to light, cataracts or increased intraocular pressure )see section 4
"Side
effects"(.
you or your child suffers from gastrointestinal problems such as
diarrhea )see
section 4 "Side effects"(.
you or your child suffers from skin problems such as rash )see section
4 "Side
effects"(.
you or your child suffers from muscle pain )which can be caused by
increase
creatinine phosphokinase enzyme( )see section 4 "Side effects"(.
you or your child suffers from an increased risk of bleeding .
you are pregnant or plannin

خصائص المنتج

1
1
NAME OF THE MEDICINAL PRODUCT
Koselugo 10 mg
Koselugo 25 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Selumetinib (As Hyd-Sulfate) 10 mg/capsule
Selumetinib (As Hyd-Sulfate) 25 mg/capsule
3
PHARMACEUTICAL FORM
Hard Capsules
4
THERAPEUTIC INDICATIONS
KOSELUGO is indicated for the treatment of pediatric patients 2 years
of age and older with
neurofibromatosis type 1 (NF1) who have symptomatic, inoperable
plexiform neurofibromas (PN).
5
DOSAGE AND ADMINISTRATION
5.1
RECOMMENDED DOSAGE
The recommended dosage of KOSELUGO is 25 mg/m
2
orally twice daily (approximately every 12 hours)
until disease progression or unacceptable toxicity.
Take KOSELUGO on an empty stomach. Do not consume food 2 hours before
each dose or 1 hour after
each dose
_[see Clinical Pharmacology (11)]_
. The recommended dose of KOSELUGO based on body
surface area (BSA) is shown in Table 1.
TABLE 1
RECOMMENDED DOSAGE BASED ON BODY SURFACE AREA
BODY SURFACE AREA*
RECOMMENDED DOSAGE
0.55 – 0.69 m
2
20 mg in the morning and 10 mg in the evening
0.70 – 0.89 m
2
20 mg twice daily
0.90 – 1.09 m
2
25 mg twice daily
1.10 – 1.29 m
2
30 mg twice daily
1.30 – 1.49 m
2
35 mg twice daily
1.50 – 1.69 m
2
40 mg twice daily
1.70 – 1.89 m
2
45 mg twice daily
≥ 1.90 m
2
50 mg twice daily
*
The recommended dosage for patients with a BSA less than 0.55m
2
has not been established.
Swallow KOSELUGO capsules whole with water. Do not chew, dissolve or
open capsule.
Do not administer to patients who are unable to swallow a whole
capsule.
Do not take a missed dose of KOSELUGO unless it is more than 6 hours
until the next scheduled dose.
If vomiting occurs after KOSELUGO administration, do not take an
additional dose, but continue with
the next scheduled dose.
5.2
DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS
2
The recommended dose reductions for adverse reactions are provided in
Table 2.
TABLE 2
RECOMMENDED DOSE REDUCTIONS FOR KOSELUGO FOR ADVERSE REACTIONS
*
Permanently discontinue KOSELUGO in patients unable to tolerate
KOSELUGO after two dose reductions