ZEPOSIA 0.23 MG

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

OZANIMOD AS HYDROCHLORIDE

Tillgänglig från:

BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL

ATC-kod:

L04AA38

Läkemedelsform:

CAPSULES

Sammansättning:

OZANIMOD AS HYDROCHLORIDE 0.23 MG

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

CELGENE CORPORATION, USA

Terapiområde:

OZANIMOD

Terapeutiska indikationer:

Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.ZEPOSIA is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Tillstånd datum:

2021-05-19

Bipacksedel

Patient leaflet in accordance with the Pharmacists’ Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Zeposia
®
0.23 mg
Zeposia
®
0.46 mg
Zeposia
®
0.92 mg
Active ingredient and its quantity:
Zeposia
®
0.23 mg: Each capsule contains 0.23 mg ozanimod (as hydrochloride)
Zeposia
®
0.46 mg: Each capsule contains 0.46 mg ozanimod (as hydrochloride)
Zeposia
®
0.92 mg: Each capsule contains 0.92 mg ozanimod (as hydrochloride)
Inactive ingredients - see section 6 ‘Additional information’ and
section 2 under
‘Important information about some of this medicine’s
ingredients’.
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,
ask 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 to yours.
In addition to the leaflet, Zeposia has a patient safety information
guide and a
patient pregnancy reminder card. The guide and card contain important
safety
information, which you should know, before starting and during the
treatment with
Zeposia and which you should follow. Carefully read the patient safety
information
guide, the patient pregnancy reminder card, and patient leaflet before
starting
treatment with this medicine. Keep the guide and card for further
reference if needed.
1. What is this medicine intended for?
•
Zeposia is indicated for the treatment of adult patients with
relapsing remitting
multiple sclerosis (RRMS) with active disease as defined by clinical
or imaging
features.
•
Zeposia is indicated for the treatment of moderately to severely
active ulcerative
colitis (UC) in adults.
Therapeutic group: selective immunosuppressants.
Zeposia contains the active substance ozanimod that belongs to a group
of medicines
which can reduce the number of white blood cells (lymphocytes)
circulating freely
round the bo

Produktens egenskaper

1
Zeposia_NPI_Dec2023_clean
1.
NAME OF THE MEDICINAL PRODUCT
Zeposia 0.23 mg
Zeposia 0.46 mg
Zeposia 0.92 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zeposia
0.23 mg capsules
Each capsule contains ozanimod hydrochloride equivalent to 0.23 mg
ozanimod.
Zeposia
0.46 mg capsules
Each capsule contains ozanimod hydrochloride equivalent to 0.46 mg
ozanimod.
Zeposia
0.92 mg capsules
Each capsule contains ozanimod hydrochloride equivalent to 0.92 mg
ozanimod.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule.
Zeposia
0.23 mg capsules
Size 4 opaque hard shell capsules with light grey body and light grey
cap. Imprinted in black ink with
“OZA” on the cap and “0.23 mg” on the body.
Zeposia
0.46 mg capsules
Size 4 opaque hard shell capsules with light grey body and orange cap.
Imprinted in black ink with
“OZA” on the cap and “0.46 mg” on the body.
Zeposia 0.92 mg capsules
Size 4 opaque hard shell capsules with orange body and orange cap.
Imprinted in black ink with
“OZA” on the cap and “0.92 mg” on the body.
2
Zeposia_NPI_Dec2023_clean
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Multiple sclerosis
Zeposia is indicated for the treatment of adult patients with
relapsing remitting multiple sclerosis
(RRMS) with active disease as defined by clinical or imaging features.
Ulcerative colitis
Zeposia is indicated for the treatment of moderately to severely
active ulcerative colitis (UC) in
adults.
4.2
Posology and method of administration
Treatment should be initiated under the supervision of a physician
experienced in the management of
multiple sclerosis (MS) or ulcerative colitis (UC).
Posology
The recommended dose is 0.92 mg ozanimod once daily.
The initial dose escalation regimen of ozanimod from Day 1 to Day 7 is
required and shown below in
Table 1. Following the 7-day dose escalation, the once daily dose is
0.92 mg, starting on Day 8.
Table 1:
Dose escalation regimen
Days 1 – 4
0.23 mg once daily
Days 5 – 7
0.46 mg once daily
Days 8 and thereafter
0.92 mg onc