Briumvi

국가: 유럽 연합

언어: 영어

출처: EMA (European Medicines Agency)

유효 성분:

Ublituximab

제공처:

Neuraxpharm Pharmaceuticals S.L.

ATC 코드:

L04

INN (국제 이름):

ublituximab

치료 그룹:

Immunosuppressants

치료 영역:

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

치료 징후:

Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

제품 요약:

Revision: 01

승인 상태:

Authorised

승인 날짜:

2023-05-31

환자 정보 전단

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRIUMVI 150 MG CONCENTRATE FOR SOLUTION FOR INFUSION
ublituximab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Briumvi is and what it is used for
2.
What you need to know before you are given Briumvi
3.
How Briumvi is given
4.
Possible side effects
5.
How to store Briumvi
6.
Contents of the pack and other information
1.
WHAT BRIUMVI IS AND WHAT IT IS USED FOR
WHAT BRIUMVI IS
Briumvi contains the active substance ublituximab. It is a type of
protein called a monoclonal
antibody. Antibodies work by attaching to specific targets in your
body.
WHAT BRIUMVI IS USED FOR
Briumvi is used to treat adults with relapsing forms of multiple
sclerosis (RMS), where the patient has
flare-ups (relapses) followed by periods with milder or no symptoms.
WHAT IS MULTIPLE SCLEROSIS
Multiple Sclerosis (MS) affects the central nervous system, especially
the nerves in the brain and
spinal cord. In MS, white blood cells called B cells that are part of
the immune system (the body’s
defence system) work incorrectly and attack a protective layer (called
myelin sheath) around nerve
cells, causing inflammation and damage. Breakdown of the myelin sheath
stops the nerves from
working properly and causes symptoms of MS. Symptoms of MS depend on
which part of the central
nervous system is affected and can include problems with walking and
balance, muscle weakness,
numbness, double vision and blurr

제품 특성 요약

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Briumvi 150 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 150 mg of ublituximab in 6 ml at a concentration of
25 mg/ml. The final
concentration after dilution is approximately 0.6 mg/ml for the first
infusion and 1.8 mg/ml for the
second infusion and all subsequent infusions.
Ublituximab is a chimeric monoclonal antibody produced in a clone of
the rat myeloma cell line YB2/0
by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion [sterile solution]
Clear to opalescent, and colourless to slightly yellow solution.
The pH of the solution is 6.3 to 6.7, and the osmolality is 340 to 380
mOsm/kg.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Briumvi is indicated for the treatment of adult patients with
relapsing forms of multiple sclerosis
(RMS) with active disease defined by clinical or imaging features (see
section 5.1).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by specialised physicians
experienced in the diagnosis
and treatment of neurological conditions and who have access to
appropriate medical support to
manage severe reactions such as serious infusion-related reactions
(IRRs).
Premedication for infusion-related reactions
The following two premedications must be administered (orally,
intravenously, intramuscular, or
subcutaneously) prior to each infusion to reduce the frequency and
severity of IRRs (see section 4.4
for additional steps to reduce IRRs):
•
100 mg methylprednisolone or 10-20 mg dexamethasone (or an equivalent)
approximately
30-60 minutes prior to each infusion;
•
diphenhydra