Tegsedi

国: 欧州連合

言語: 英語

ソース: EMA (European Medicines Agency)

有効成分:

inotersen sodium

から入手可能:

Akcea Therapeutics Ireland Limited

ATCコード:

N07

INN（国際名）:

inotersen

治療群:

Other nervous system drugs

治療領域:

Amyloidosis

適応症:

Treatment of stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

製品概要:

Revision: 14

認証ステータス:

Authorised

承認日:

2018-07-06

情報リーフレット

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEGSEDI 284 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
inotersen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Tegsedi is and what it is used for
2.
What you need to know before you use Tegsedi
3.
How to use Tegsedi
4.
Possible side effects
5.
How to store Tegsedi
6.
Contents of the pack and other information
1.
WHAT TEGSEDI IS AND WHAT IT IS USED FOR
Tegsedi contains the active substance inotersen. Inotersen is used to
treat adults with hereditary
transthyretin amyloidosis. Hereditary transthyretin amyloidosis is a
genetic disease, which causes
build-up of small fibres of a protein called transthyretin in the
organs of your body stopping them from
working properly. Tegsedi is used when the disease is causing symptoms
of polyneuropathy (nerve
damage).
Inotersen, is a type of medicine called an antisense oligonucleotide
inhibitor. It works by reducing
production of transthyretin by the liver and so lowers the risk of
fibres of transthyretin being deposited
in body organs and causing symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TEGSEDI
_ _
DO NOT USE TEGSEDI IF:
-
You are allergic to inotersen or any of the other ingredients of this
medicine (listed in section 6).
-
Tests show you have excessively low numbers of platelets, the cells in
your blood which stick
together helping it clot.
-
Tests of kidney function or protein in the urine show signs of severe
kidney problems.
-
You have severe reduction in liver

製品の特徴

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tegsedi 284 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 189 mg inotersen (as inotersen sodium).
Each pre-filled syringe contains 284 mg inotersen (as inotersen
sodium) in 1.5 mL of solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to pale yellow solution (pH 7.5 – 8.8).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tegsedi is indicated for the treatment of stage 1 or stage 2
polyneuropathy in adult patients with
hereditary transthyretin amyloidosis (hATTR).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by and remain under the supervision of a
physician experienced in the
treatment of patients with hereditary transthyretin amyloidosis.
Posology
The recommended dose is 284 mg inotersen by subcutaneous injection.
Doses should be administered
once every week. For consistency of dosing, patients should be
instructed to receive the injection on
the same day every week.
_Dose adjustment in case of reduction in platelet count _
Inotersen is associated with reductions in platelet count, which may
result in thrombocytopenia.
Dosing should be adjusted according to laboratory values as follows:
TABLE 1 . INOTERSEN MONITORING AND DOSING RECOMMENDATIONS ACCORDING TO
PLATELET COUNT
PLATELET COUNT (X 10
9
/L)
MONITORING FREQUENCY
DOSING
> 100
Every 2 weeks
Weekly dosing should be
continued.
≥ 75 to < 100*
Every week
Dosing frequency should be
reduced to 284 mg every
2 weeks.
3
< 75*
Twice weekly until 3
successive values above 75
then weekly monitoring.
Dosing should be paused until
3 successive values > 100.
On reinitiation of treatment
dose frequency should be
reduced to 284 mg every 2
weeks.
< 50‡†
Twice weekly until 3
successive values above 75
then weekly monitoring.
More frequent monitoring
should be considered if
additional risk factors for
bleeding are p