Waylivra

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

Volanesorsen sodium

Dostupné z:

Akcea Therapeutics Ireland Limited

ATC kód:

C10AX18

INN (Medzinárodný Name):

volanesorsen

Terapeutické skupiny:

Other lipid modifying agents

Terapeutické oblasti:

Hyperlipoproteinemia Type I

Terapeutické indikácie:

Waylivra is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.,

Prehľad produktov:

Revision: 6

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2019-05-03

Príbalový leták

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
WAYLIVRA 285 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
volanesorsen
▼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 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 Waylivra is and what it is used for
2.
What you need to know before you use Waylivra
3.
How to use Waylivra
4.
Possible side effects
5.
How to store Waylivra
6.
Contents of the pack and other information
1.
WHAT WAYLIVRA IS AND WHAT IT IS USED FOR
Waylivra contains the active substance volanesorsen, which helps to
treat a condition called familial
chylomicronemia syndrome (FCS). FCS is a genetic disease which gives
rise to abnormally high
levels of fats called triglycerides in the blood. This can lead to
inflammation of your pancreas, causing
severe pain. Together with a controlled low-fat diet, Waylivra helps
to lower the levels of triglycerides
in your blood.
Waylivra may be given after you have already received other medicines
used to lower the levels of
triglycerides in blood without them having much effect.
You will only be given Waylivra if genetic testing has confirmed you
have FCS and your risk for
pancreatitis is considered very high..
You should continue the very low-fat diet that your doctor has
prescribed during treatment with
Waylivra.
This medicine is inten

Súhrn charakteristických

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
Waylivra 285 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 200 mg volanesorsen sodium, equivalent to 190 mg
volanesorsen.
Each single-dose pre-filled syringe contains 285 mg of volanesorsen in
1.5 ml solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to slightly yellow solution with a pH of
approximately 8 and osmolarity of 363-
485 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Waylivra is indicated as an adjunct to diet in adult patients with
genetically confirmed familial
chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in
whom response to diet and
triglyceride lowering therapy has been inadequate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment should be initiated by and remain under the supervision of a
physician experienced in the
treatment of patients with FCS. Prior to initiating Waylivra,
secondary causes of hypertriglyceridemia
(e.g. uncontrolled diabetes, hypothyroidism) should be excluded or
appropriately addressed.
The recommended starting dose is 285 mg in 1.5 ml injected
subcutaneously once weekly for 3
months. Following 3 months, dose frequency should be reduced to 285 mg
every 2 weeks.
However, treatment should be discontinued in patients with a reduction
in serum triglycerides <25%
or who fail to achieve serum triglycerides below 22.6 mmol/L after 3
months on volanesorsen 285 mg
weekly.
After 6 months of treatment with volanesorsen, increase of dose
frequency to 285 mg weekly should
be considered if response has been inadequate in terms of serum
triglyceride reduction as evalua