BEOVU brolucizumab (rbe) 120 mg/mL solution for injection in pre-filled syringe

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

brolucizumab, Quantity: 120 mg/mL

Disponível em:

Novartis Pharmaceuticals Australia Pty Ltd

Forma farmacêutica:

Injection, solution

Composição:

Excipient Ingredients: water for injections; polysorbate 80; sucrose; sodium citrate

Via de administração:

Intravitreal-Within The Vitreous Cavity Of The Eye

Unidades em pacote:

1 unit pack contains 1 pre-filled syringe

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Beovu is indicated for the treatment of: ? Neovascular (wet) age-related macular degeneration (AMD). ? Diabetic macular oedema (DME).

Resumo do produto:

Visual Identification: Sterile, clear to slightly opalescent, colourless to slightly brownish yellow and preservative free aqueous solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure and restricted flow insert

Status de autorização:

Registered

Data de autorização:

2020-01-16

Folheto informativo - Bula

BEOVU
®
B
E
O
V
U
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I RECEIVING BEOVU?
Beovu contains the active ingredient brolucizumab. Beovu is used to
treat eye conditions in adults 1) neovascular (wet) age-related
macular degeneration (AMD) or wet AMD, 2) diabetic macular oedema
(DME).
For more information, see Section 1. Why am I receiving Beovu? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN BEOVU?
Do not use if you have ever had an allergic reaction to Beovu or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Beovu? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Beovu and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW WILL I BE GIVEN BEOVU?
•
Beovu is given by an ophthalmologist (eye doctor) as an injection into
the eye under a local anaesthetic.
•
The recommended dose is 6 mg (0.05 mL) of brolucizumab.
More instructions can be found in Section 4. How will I be given
Beovu? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE I AM GIVEN BEOVU?
THINGS YOU MUST DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Beovu.
•
Tell your doctor if you experience signs of inflammation or infection
or you become pregnant.
DRIVING OR USING
MACHINES
•
Do not drive or operate machinery if your vision is poor, either
because of your disease or because
of the treatment.
DRINKING ALCOHOL
•
There are no known interactions between Beovu and alcohol.
LOOKING AFTER YOUR
MEDICINE
•
Your opht

Características técnicas

1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – BEOVU
® (BROLUCIZUMAB)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Brolucizumab (_rbe_)
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 with a molecular
weight of ~26 kDa, 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 containing 6 mg of
brolucizumab.
Beovu 120 mg/mL solution for injection in vial
Each vial contains 27.6 mg brolucizumab in 0.230 mL solution. This
provides a usable amount to
deliver a single dose of 0.05 mL containing 6 mg of brolucizumab.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
Sterile, clear to slightly opalescent, colourless to slightly
brownish-yellow and preservative-free
aqueous solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Beovu is indicated for the treatment of:
•
Neovascular (wet) age-related macular degeneration (AMD),
•
Diabetic macular oedema (DME).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Beovu must be administered by a qualified ophthalmologist experienced
in administering intravitreal
injections.
▼

2
DOSAGE
_WET AMD _
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 assessment is sugg