Amvuttra
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
10-01-2023
Summary of Product characteristics
(SPC)
10-01-2023
Public Assessment Report
(PAR)
12-10-2022
Active ingredient:
vutrisiran sodium
Available from:
Alnylam Netherlands B.V.
ATC code:
N07XX18
INN (International Name):
vutrisiran
Therapeutic group:
Other nervous system drugs
Therapeutic area:
Amyloid Neuropathies, Familial
Therapeutic indications:
Treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
Product summary:
Revision: 1
Authorization status:
Authorised
Authorization date:
2022-09-15
Patient Information leaflet
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMVUTTRA 25 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
vutrisiran
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 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, pharmacist, or
nurse.
•
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 Amvuttra is and what it is used for
2.
What you need to know before you are given Amvuttra
3.
How Amvuttra is given
4.
Possible side effects
5.
How to store Amvuttra
6.
Contents of the pack and other information
1.
WHAT AMVUTTRA IS AND WHAT IT IS USED FOR
The active substance in Amvuttra is vutrisiran.
WHAT AMVUTTRA IS USED FOR
Amvuttra is used for the treatment of an illness called ‘hereditary
ATTR’ or ‘hATTR amyloidosis’.
This is an illness which runs in families. 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, small fibres of TTR protein clump
together to make deposits called
‘amyloid’. Amyloid can build up around or within the nerves,
heart, and other places in the body,
stopping them from working normally. This causes the symptoms of the
illness.
HOW AMVUTTRA WORKS
Amvuttra works by lowering the amount of TTR protein made by the liver
which means there is less
TTR protein in the blood that can form amyloid. This can help to
reduce the effects of this illness.
Amvuttra is used in adults only.
2.
WHAT YOU NEED TO KNOW BEF
Read the complete document
Summary of Product characteristics
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
Amvuttra 25 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains vutrisiran sodium equivalent to 25 mg
vutrisiran in 0.5 mL solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless-to-yellow solution (pH of approximately 7;
osmolality 210 to 390 mOsm/kg).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amvuttra 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. Treatment should be started as early as possible in the
disease course to prevent the
accumulation of disability.
Posology
The recommended dose of Amvuttra is 25 mg administered via
subcutaneous injection once every
3 months.
Vitamin A supplementation at approximately, but not exceeding, 2 500
IU to 3 000 IU vitamin A per
day is advised for patients treated with Amvuttra (see section 4.4).
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.
_Missed dose _
If a dose is missed, Amvuttra should be administered as soon as
possible. Dosing should be resumed
every 3 months, from the most recently administered dose.
Special populations
_ _
_ _
_Elderly patients _
No dose adjustment is required in patients ≥ 65 years of age (see
section 5.2).
3
_Hepatic impairment _
No dose
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