Leqvio

Država: Evropska unija

Jezik: angleščina

Source: EMA (European Medicines Agency)

Aktivna sestavina:

inclisiran

Dostopno od:

Novartis Europharm Limited

Koda artikla:

C10AX

INN (mednarodno ime):

inclisiran

Terapevtska skupina:

Lipid modifying agents

Terapevtsko območje:

Hypercholesterolemia; Dyslipidemias

Terapevtske indikacije:

Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, oralone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Povzetek izdelek:

Revision: 5

Status dovoljenje:

Authorised

Datum dovoljenje:

2020-12-09

Navodilo za uporabo

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEQVIO 284 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
inclisiran
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 Leqvio is and what it is used for
2.
What you need to know before you are given Leqvio
3.
How Leqvio is given
4.
Possible side effects
5.
How to store Leqvio
6.
Contents of the pack and other information
1.
WHAT LEQVIO IS AND WHAT IT IS USED FOR
WHAT LEQVIO IS AND HOW IT WORKS
Leqvio contains the active substance inclisiran. Inclisiran lowers
levels of LDL-cholesterol (“bad”
cholesterol), which can cause heart and blood circulation problems
when levels are raised.
Inclisiran works by interfering with RNA (genetic material in body
cells) to limit the production of a
protein called PCSK9. This protein can increase LDL-cholesterol levels
and preventing its production
helps to lower your LDL-cholesterol levels.
WHAT LEQVIO IS USED FOR
Leqvio is used in addition to your cholesterol-lowering diet if you
are an adult with a high cholesterol
level in your blood (primary hypercholesterolaemia, including
heterozygous familial and non-familial,
or mixed dyslipidaemia).
Leqvio is given:
-
together with a statin (a type of medicine that treats high
cholesterol), sometimes combined with
another cholesterol-lowering treatment if the maximum dose of the
statin does not work well
enough, or
-
alone or together with other cholesterol-lowe

Lastnosti izdelka

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
Leqvio 284 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains inclisiran sodium equivalent to 284
mg inclisiran in 1.5 ml solution.
Each ml contains inclisiran sodium equivalent to 189 mg inclisiran.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
The solution is clear, colourless to pale yellow, and essentially free
of particulates.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Leqvio is indicated in adults with primary hypercholesterolaemia
(heterozygous familial and
non-familial) or mixed dyslipidaemia, as an adjunct to diet:
•
in combination with a statin or statin with other lipid-lowering
therapies in patients unable to
reach LDL-C goals with the maximum tolerated dose of a statin, or
•
alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant,
or for whom a statin is contraindicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 284 mg inclisiran administered as a single
subcutaneous injection: initially,
again at 3 months, followed by every 6 months.
_Missed doses _
If a planned dose is missed by less than 3 months, inclisiran should
be administered and dosing
continued according to the patient’s original schedule.
If a planned dose is missed by more than 3 months, a new dosing
schedule should be started –
inclisiran should be administered initially, again at 3 months,
followed by every 6 months.
_ _
_ _
3
_Treatment transition from monoclonal antibody PCSK9 inhibitors_
Inclisiran can be administered immediately after the last dose of a
monoclonal antibody PCSK9