Bonspri 20mg0.4mL Solution for Injection in Pre-filled syringe

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

OFATUMUMAB

可用日期:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN（国际名称）:

OFATUMUMAB

每包单位数:

1 Units

厂商:

NOVARTIS PHARMA STEIN AG

资料单张

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
BONSPRI
™
_ _
Ofatumumab (20 mg) Solution for Injection in pre-filled syringe
1
WHAT IS IN THIS LEAFLET
1. What Bonspri is used for
2. How it works
3. Before you use Bonspri
4. How to use Bonspri
5. While you are using it
6. Side effects
7. Storage and Disposal of product
8. Product description
9. Manufacturer
10. Product registration holder
11. Date of revision
12. Serial number
WHAT BONSPRI IS USED FOR
Bonspri is used for the treatment of
adult with relapsing forms of multiple
sclerosis includes relapsing-remitting
disease, and active secondary
progressive disease.
Multiple sclerosis (MS) is a long-
term condition that affects the central
nervous system (CNS), particularly
how the brain and spinal cord work.
In MS, the immune system (the
body’s defense system) works
incorrectly: inflammation destroys
the protective sheath (called myelin)
around the nerves in the CNS and
stops the nerves from working
properly. This process is called
demyelination.
People with relapsing MS experience
repeated attacks of nervous system
symptoms that reflect inflammation
within the CNS. These attacks are
typically called relapses or flare ups.
Symptoms vary from patient to
patient but typically involve problems
with walking or balance, weakness,
numbness, vision problems (double
vision and blurring), poor
coordination and bladder problems.
The symptoms of a relapse may
disappear completely when the
relapse is over but some problems
may remain. Patients accumulate
disability as a result of incomplete
recovery from acute relapses and/or
gradual disease progression.
HOW BONSPRI WORKS
The active substance in Bonspri,
ofatumumab is a type of protein
called a monoclonal antibody
designed to recognize and attach to a
target called CD20 on the surface of
certain types of white blood cells
which are part of the immune system
(so called B-cells).
Once an abnormal response by the
body’s immune system is triggered,
these white blood cells play a role in
multiple sclerosis by attacking

产品特点

Novartis
Page 2
Malaysia Package Leaflet
23-Jan-2020
Bonspri
TM
1
INDICATIONS AND USAGE
BONSPRI is indicated for the treatment of relapsing forms of multiple
sclerosis (RMS), to include
relapsing-remitting disease, and active secondary progressive disease,
in adults.
2
DOSAGE AND ADMINISTRATION
2.1
ASSESSMENTS PRIOR TO FIRST DOSE OF BONSPRI
Hepatitis B Virus Screening
Prior to initiating BONSPRI, perform Hepatitis B virus (HBV)
screening. BONSPRI is
contraindicated in patients with active HBV confirmed by positive
results for Hepatitis B surface
antigen [HBsAg] and anti-HBV tests. For patients who are negative for
HBsAg and positive for
Hepatitis B core antibody [HBcAb+] or are carriers of HBV [HBsAg+],
consult liver disease
experts before starting and during treatment with BONSPRI
_[see Warnings and Precautions (5.1)]. _
Serum Immunoglobulins
Prior to initiating BONSPRI, perform testing for quantitative serum
immunoglobulins
_[see _
_Warnings and Precautions (5.3)]. _
For patients with low serum immunoglobulins, consult
immunology experts before initiating treatment with BONSPRI.
Vaccinations
Because vaccination with live-attenuated or live vaccines is not
recommended during treatment
and after discontinuation until B-cell repletion, administer all
immunizations according to
immunization guidelines at least 4 weeks prior to initiation of
BONSPRI for live or live-attenuated
vaccines, and whenever possible, at least 2 weeks prior to initiation
of BONSPRI for inactivated
vaccines
_[see Warnings and Precautions (5.1)]. _
2.2
RECOMMENDED DOSAGE
The recommended dosage of BONSPRI is:

initial dosing of 20 mg by subcutaneous injection at Weeks 0, 1, and
2, followed by


subsequent dosing of 20 mg by subcutaneous injection once monthly
starting at Week 4.

Missed Doses
If an injection of BONSPRI is missed, it should be administered as
soon as possible without
waiting until the next scheduled dose. Subsequent doses should be
administered at the
recommended intervals.
2.3
ADMINISTRATION INSTRUCTIONS
Administer