Beovu

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

brolucizumab

Tillgänglig från:

Novartis Europharm Limited 

ATC-kod:

S01

INN (International namn):

brolucizumab

Terapeutisk grupp:

Ophthalmologicals

Terapiområde:

Wet Macular Degeneration

Terapeutiska indikationer:

Beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Produktsammanfattning:

Revision: 10

Bemyndigande status:

Authorised

Tillstånd datum:

2020-02-13

Bipacksedel

33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BEOVU 120 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
brolucizumab
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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Beovu is and what it is used for
2.
What you need to know before you are given Beovu
3.
How Beovu is given
4.
Possible side effects
5.
How to store Beovu
6.
Contents of the pack and other information
1.
WHAT BEOVU IS AND WHAT IT IS USED FOR
WHAT BEOVU IS
Beovu contains the active substance brolucizumab, which belongs to a
group of medicines called
antineovascularisation agents. Beovu is injected into the eye by your
doctor to treat eye conditions
which may impact your vision.
WHAT BEOVU IS USED FOR
Beovu is used to treat
eye conditions
in adults which occur when abnormal blood vessels form and
grow underneath the macula. The macula, which is at the back of the
eye, is responsible for clear
vision. The abnormal blood vessels may leak fluid or blood into the
eye and interfere with the
macula’s function, resulting in diseases which may cause decreased
vision such as:
•
wet age-related macular degeneration (wet AMD)
•
diabetic macular oedema (DME)
HOW BEOVU WORKS
Beovu may slow down disease progression and thereby maintain, or even
improve, your vision.
Abnormal blood vessels
that leak fluid or blood
into the macula
35
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BEOVU
YOU MUST NOT BE GIVEN BEOVU:
-
if you are allergic to brolucizumab or any of the other ingr

Produktens egenskaper

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
Beovu 120 mg/ml solution for injection in pre-filled syringe
Beovu 120 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution for injection contains 120 mg of brolucizumab*.
* Brolucizumab is a humanised monoclonal single-chain Fv (scFv)
antibody fragment produced in
_Escherichia coli_
cells by recombinant DNA technology.
Beovu 120 mg/ml solution for injection in pre-filled syringe
Each pre-filled syringe contains 19.8 mg brolucizumab in 0.165 ml
solution. This provides a usable
amount to deliver a single dose of 0.05 ml solution containing 6 mg of
brolucizumab.
Beovu 120 mg/ml solution for injection
Each vial contains 27.6 mg brolucizumab in 0.23 ml solution. This
provides a usable amount to deliver
a single dose of 0.05 ml solution containing 6 mg of brolucizumab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear to slightly opalescent, colourless to slightly brownish-yellow
aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Beovu is indicated in adults for the treatment of
•
neovascular (wet) age-related macular degeneration (AMD) (see section
5.1),
•
visual impairment due to diabetic macular oedema (DME) (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Beovu must be administered by a qualified ophthalmologist experienced
in intravitreal injections.
Posology
_Wet AMD _
_Treatment initiation – loading _
The recommended dose is 6 mg brolucizumab (0.05 ml solution),
administered by intravitreal
injection every 4 weeks (monthly) for the first 3 doses. A disease
activity assessment is suggested
16 weeks (4 months) after treatment start.
3
Alternatively,