VABYSMO

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

FARICIMAB

متاح من:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC رمز:

S01LA09

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

FARICIMAB 120 MG/ML

طريقة التعاطي:

INTRAVITREAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

HOFFMANN LA ROCHE LTD, SWITZERLAND

المجال العلاجي:

FARICIMAB

الخصائص العلاجية:

Vabysmo is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with:• Neovascular (Wet) Age-Related Macular Degeneration (nAMD) • Diabetic Macular Edema (DME)

تاريخ الترخيص:

2023-02-22

نشرة المعلومات

Vabysmo PL version 3
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor's prescription only
Vabysmo
120 mg/mL
Solution for intravitreal injection
Composition:
faricimab 120 mg/mL
For information on inactive ingredients and allergens, see section 6
‘Additional information’.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
In addition to the leaflet, Vabysmo also has a patient safety
information card. This card contains
important safety information that you need to know and that you should
follow before you start
and during treatment with Vabysmo. Carefully read the patient safety
information card and the
patient leaflet before using this medicine. Keep the card in case you
need to read it again.
1.
What is this medicine intended for?
Vabysmo is intended to treat:

Neovascular (wet) age-related macular degeneration (nAMD)

Diabetic macular edema (DME)
Therapeutic group:
Ophthalmologicals, antineovascularisation agents.
How does Vabysmo work?
Both neovascular (wet) age-related macular degeneration (nAMD) and
diabetic macular edema
(DME) affect the macula, the central part of the retina (the
light-sensitive layer at the back of the
eye). The macula is responsible for visual acuity.
nAMD is caused by the growth of abnormal blood vessels, which leak
blood and fluid into the
macula. DME is caused by leaky blood vessels that cause swelling of
the macula.
Faricimab, the active ingredient in Vabysmo, recognizes and attaches
to vascular endothelial
growth factor A (VEGF-A) and angiopoietin (Ang-2), blocking their
activity.
When these proteins are present in higher levels than normal, they can
cause the growth of
abnormal

خصائص المنتج

Vabysmo_PI_Ver 3
Vabysmo
®
Faricimab
Solution for injection
NAME OF THE MEDICINAL PRODUCT
Vabysmo 120 mg/mL solution for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
Faricimab is a humanised antibody produced in mammalian Chinese
Hamster Ovary (CHO) cell
culture by recombinant DNA technology.
One mL of solution contains 120 mg of faricimab.
Each vial contains 28.8 mg faricimab in 0.24 mL solution. This
provides a usable amount to deliver
a single dose of 0.05 mL solution containing 6 mg of faricimab.
For the full list of excipients, see section 11.
PHARMACEUTICAL FORM
Solution for injection
Clear to opalescent, colourless to brownish-yellow solution, with a pH
of 5.5 and an osmolality
of 270-370 mOsm/kg.
CLINICAL PARTICULARS
Patient safety information brochure
The marketing of VABYSMO is subject to a risk management plan (RMP)
including patient
safety information brochure. These materials emphasizes important
safety information that the
patient should be aware of before and during treatment. Please explain
to the patient the need to
review these materials before starting treatment.
1
INDICATIONS AND USAGE
VABYSMO is a vascular endothelial growth factor (VEGF)
and angiopoietin 2 (Ang-2) inhibitor
indicated for the treatment of patients with:
1.1
Neovascular (wet) Age-Related Macular Degeneration (nAMD)
1.2
Diabetic Macular Edema (DME)
2
DOSAGE AND ADMINISTRATION
2.1
General Dosing Information
For intravitreal injection. VABYSMO must be administered by a
qualified physician. Each vial
should only be used for the treatment of a single eye.
2.2
Neovascular (wet) Age-Related Macular Degeneration (nAMD)
The recommended dose for VABYSMO is 6 mg (0.05 mL of 120 mg/mL
solution) administered
by intravitreal injection every 4 weeks (approximately every 28 ± 7
days, monthly) for the first 4
doses, followed by optical coherence tomography and visual acuity
evaluations 8 and 12 weeks
later to inform whether to give a 6 mg dose via intravitreal injection
on one of the following
three regimens: 1) Weeks 28 and 44; 2) Wee