Onpattro

البلد: الاتحاد الأوروبي

اللغة: الإنجليزية

المصدر: EMA (European Medicines Agency)

العنصر النشط:

patisiran sodium

متاح من:

Alnylam Netherlands B.V.

ATC رمز:

N07

INN (الاسم الدولي):

patisiran

المجموعة العلاجية:

Other nervous system drugs

المجال العلاجي:

Amyloidosis, Familial

الخصائص العلاجية:

Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

ملخص المنتج:

Revision: 11

الوضع إذن:

Authorised

تاريخ الترخيص:

2018-08-27

نشرة المعلومات

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ONPATTRO 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
patisiran
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Onpattro is and what it is used for
2.
What you need to know before you are given Onpattro
3.
How Onpattro is given
4.
Possible side effects
5.
How to store Onpattro
6.
Contents of the pack and other information
1.
WHAT ONPATTRO IS AND WHAT IT IS USED FOR
The active substance in Onpattro is patisiran.
Onpattro is a medicine that treats an illness which runs in families
called hereditary
transthyretin-mediated amyloidosis (hATTR amyloidosis).
hATTR amyloidosis is caused by problems with a protein in the body
called ‘transthyretin’ (TTR).
•
This protein is made mostly in the liver and carries vitamin A and
other substances around the
body.
•
In people with this illness, abnormally shaped TTR proteins clump
together to make deposits
called ‘amyloid’.
•
Amyloid can build up around the nerves, heart, and other places in the
body, preventing them
from working normally. This causes the symptoms of the illness.
Onpattro works by lowering the amount of TTR protein that the liver
makes.
•
This means there is less TTR protein in the blood that can form
amyloid.
•
This can help to reduce the effects of this illness.
Onpattro is used in adults only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ONPATTRO
YOU MUST NOT BE GIVEN ONPATTRO
•
if you have ever had a severe allergic reaction to patisiran, or any
of the other ingredients of this
medicine (listed in section 6). If you are not sure, talk to your
doctor or nurse before you are given
Onpattro.
27
WARNINGS AND

خصائص المنتج

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Onpattro 2 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains patisiran sodium equivalent to 2 mg patisiran.
Each vial contains patisiran sodium equivalent to 10 mg patisiran
formulated as lipid nanoparticles.
Excipients with known effect
Each mL of concentrate contains 3.99 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
White to off-white, opalescent, homogeneous solution (pH approximately
7).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Onpattro is indicated for the treatment of hereditary
transthyretin-mediated amyloidosis (hATTR
amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated under the supervision of a physician
knowledgeable in the management of
amyloidosis.
Posology
The recommended dose of Onpattro is 300 micrograms per kg body weight
administered via
intravenous (IV) infusion once every 3 weeks.
Dosing is based on actual body weight. For patients weighing ≥ 100
kg, the maximum recommended
dose is 30 mg.
Treatment should be initiated as early as possible after symptom onset
(see section 5.1). The decision
to continue treatment in those patients whose disease progresses to
stage 3 polyneuropathy should be
taken at the discretion of the physician based on the overall benefit
and risk assessment
(see section 5.1).
Vitamin A supplementation at approximately 2 500 IU vitamin A per day
is advised for patients
treated with Onpattro (see section 4.4).
_ _
3
_Required premedication _
_ _
All patients should receive premedication prior to Onpattro
administration to reduce the risk of
infusion-related reactions (IRRs) (see section 4.4). Each of the
following medicinal products should be
given on the day of Onpattro infusion at least 60 minutes prior to the
start of infusion:
•
Intravenous