BEOVU 120 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BROLUCIZUMAB

Available from:

NOVARTIS ISRAEL LTD

ATC code:

S01LA06

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

BROLUCIZUMAB 120 MG / 1 ML

Administration route:

INTRAVITREAL

Prescription type:

Required

Manufactured by:

NOVARTIS PHARMA AG.,SWITZERLAND

Therapeutic area:

BROLUCIZUMAB

Therapeutic indications:

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

Authorization date:

2021-02-22

Patient Information leaflet

BEO-PFS APL JAN23 V3.1_IL country-specific
BEO-PFS APL JAN23 V3.1_IL country-specific
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
THE MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
BEOVU
® 120 MG/ML
Solution for Injection
Pre-filled syringe for intraocular injection (intravitreal)
ACTIVE INGREDIENT
brolucizumab 120 mg/ml
1 ml of solution for injection contains 120 mg brolucizumab.
Each pre-filled syringe contains 19.8 mg brolucizumab in 0.165 ml
solution.
This allows administration of a single dose of 0.05 ml solution
containing 6 mg
of brolucizumab.
Inactive and allergenic ingredients in the preparation – see chapter
6 ‘Further
information’.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It
may harm them, even if it seems to you that their medical condition is
similar.
In addition to the leaflet, Beovu has a patient safety information
guide (card).
This guide contains important safety information which you must know
and
adhere to before starting and during treatment with Beovu.
Read the patient safety information guide and the patient leaflet
before starting
to use the preparation.
Keep the guide for further reference, if necessary.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of neovascular (wet)
age-related
macular degeneration (AMD) in adults.
THERAPEUTIC GROUP: Eye medicines that counter the growth of new blood
vessels
(anti-neovascularisation).
Beovu is injected into the eye by your doctor to treat an eye disorder
called
neovascular (wet) age-related macular degeneration (AMD). This
condition
occurs when blood vessels form and grow abnormally underneath the
macula.
The macula, which is located at the back of the eye, is responsible
for clear vision.
The abnormal blood vessels ma

Summary of Product characteristics

BEO API JAN23 V3.1_IL country specific
Page 1 of 14
1.
NAME OF THE MEDICINAL PRODUCT
Beovu 120 mg/ml
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 (vial)
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
PATIENT SAFETY INFORMATION CARD
The marketing of Beovu is subject to a risk management plan (RMP)
including ‘Patient
safety information guide (card)’. The ‘Patient safety information
guide (card)’ emphasizes
important safety information that the patient should be aware of
before and during treatment.
Please explain to the patient the need to review the guide before
starting treatment.
4.1
THERAPEUTIC INDICATIONS
Beovu is indicated in adults for the treatment of neovascular (wet)
age-related macular degeneration
(AMD).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Beovu must be administered by a qualified ophthalmologist experienced
in intravitreal injections.
Posology
The recommended dose is 6 mg brolucizumab (0.05 ml solution)
administered by intravitreal injection
every 4 weeks (monthly) for the first 3 doses. Thereafter, the
physician may individualise treatment
intervals based on disease activity as assessed by visual acuity
and/or anatomical parameters. A
disease activity assessmen