LUXTURNA

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

VORETIGENE NEPARVOVEC

제공처:

NOVARTIS ISRAEL LTD

약제 형태:

CONCENTRATE AND SOLVENT FOR SOLUTION FOR INJECTION

구성:

VORETIGENE NEPARVOVEC 5X10^12 VECTOR GENOMES/ML

관리 경로:

SUBRETINAL INJECTION

처방전 유형:

Required

Manufactured by:

NOVA LABORATORIES LTD, UK

치료 징후:

Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

승인 날짜:

2019-11-24

환자 정보 전단

LUXTURNA
®
Concentrate and solvent for
solution for injection
RMP 2022-001-ENG
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
ACTIVE INGREDIENT:
voretigene neparvovec
Each mL of concentrate contains 5x10
12
vector
genomes (vg)
Inactive and allergenic ingredients: see section 6 “Further
information”
and section 2 “Important information about some of the ingredients
of
the medicine”.
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.
1. WHAT IS THE MEDICINE INTENDED FOR?
Luxturna is used for the treatment of adults and children with vision
loss
due to inherited retinal dystrophy caused by a genetic mutation called
biallelic RPE65, and who have a sufficient amount of live retinal
cells.
Biallelic RPE65 mutations prevent the body from producing a protein
needed for vision, and thereby lead to loss of sight and eventual
blindness.
THERAPEUTIC GROUP: Still undetermined.
Luxturna is a gene therapy product.
The active ingredient in Luxturna, voretigene neparvovec, is a
modified
virus that contains a working copy of the RPE65 gene. After injection,
it
delivers this gene into the cells of the retina, the layer at the back
of the
eye that detects light. This enables the retina to produce the
proteins
needed for vision. The virus used to deliver the gene does not cause
disease in humans.
Luxturna will only be given to you if genetic testing shows that your
vision
loss is caused by mutations in the RPE65 gene.
IN ADDITION TO THIS LEAFLET, LUXTURNA HAS A PATIENT LEAFLET PRINTED IN
LARGE FONT SIZE, AND A SAFETY INFORMATION CARD THAT CONTAIN IMPORTANT
SAFETY INFORMATION, WHICH YOU SHOULD KNOW BEFORE STARTING AND
DURING TREATMENT WITH LUXTURNA, AND ACT ACCORDINGLY. READ THE
INFORMATION CARD AND THE PATIENT LEAFLET BEFORE STARTING TO USE THE
PREPARATION. KEEP THE CARD F

제품 특성 요약

LUX API DEC23 V5
Based on EU SmPC JUL23
1
1.
NAME OF THE MEDICINAL PRODUCT
Luxturna
5
×
10
12
vector genomes/mL
Concentrate and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
General description
Voretigene neparvovec is a gene transfer vector that employs an
adeno-associated viral vector
serotype 2 (AAV2) capsid as a delivery vehicle for the human retinal
pigment epithelium 65 kDa
protein (hRPE65) cDNA to the retina. Voretigene neparvovec is derived
from wild-type AAV2
using
recombinant DNA techniques.
2.2
Qualitative and quantitative composition
Each mL of concentrate contains 5
×
10
12
vector genomes (vg).
Each vial of Luxturna contains 0.5 extractable mL of concentrate
(corresponding to 2.5 × 10
12
vector
genomes) which requires a 1:10 dilution prior to administration, see
section 6.6.
After dilution of 0.3 mL of concentrate with 2.7 mL of solvent, each
mL contains 5 × 10
11
vector
genomes. Each dose of 0.3 mL Luxturna contains 1.5
×
10
11
vector genomes.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate and solvent for solution for injection.
Following thaw from their frozen state, both the concentrate and the
solvent are clear, colourless
liquids with a pH of 7.3.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Luxturna is indicated for the treatment of adult and paediatric
patients with vision loss due to
Patient Alert Card
The arketi
g of Lu tur
a is sujet to a risk aage
et pla RMP i
ludi
g Patiet Alert Card
and a patient information leaflet - both available in a large print.
These materials emphasize 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.
Healthcare Professional Guide
This product is marketed with Healthcare Professional Guide providing
important safety information.
Please ensure you are familiar with this material as it contains
important safety information.
LUX API DEC23 V5
Based