TYSABRI- natalizumab injection

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

natalizumab (UNII: 3JB47N2Q2P) (natalizumab - UNII:3JB47N2Q2P)

থেকে পাওয়া:

Biogen Inc.

INN (International Name):

natalizumab

রচনা:

natalizumab 300 mg in 15 mL

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

TYSABRI is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TYSABRI increases the risk of PML [see Warnings and Precautions (5.1) ]. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk. TYSABRI is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α. TYSABRI should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α [see Warnings and Precautions (5.1) ]. - TYSABRI is contraindicated in patients who have or have had progressive mult

পণ্য সারাংশ:

TYSABRI (natalizumab) injection, a sterile, preservative-free, colorless and clear to slightly opalescent solution for dilution prior to intravenous infusion, is supplied as one 300 mg/15 mL (20 mg/mL) single-dose vial per carton (NDC 64406-008-01). TYSABRI is available only through registered infusion centers participating in the TOUCH® Prescribing Program. To locate these infusion centers, contact Biogen at 1-800-456-2255. TYSABRI single-dose vials must be refrigerated between 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date stamped on the carton and vial label. DO NOT SHAKE OR FREEZE. Protect from light. Store diluted TYSABRI solution refrigerated at 2°C to 8°C (36°F to 46°F) [see Dosage and Administration (2.3) ]

অনুমোদন অবস্থা:

Biologic Licensing Application

তথ্য লিফলেট

TYSABRI- NATALIZUMAB INJECTION
Biogen Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised 04/2023
MEDICATION GUIDE
TYSABRI® (tie-SA-bree)
(natalizumab)
injection, for intravenous use
Read this Medication Guide before you start receiving TYSABRI and
before you receive each dose.
There may be new information. This Medication Guide does not take the
place of talking to your doctor
about your medical condition or your treatment.
What is the most important information I should know about TYSABRI?
•
TYSABRI increases your chance (risk) of getting a rare brain infection
that usually leads to death
or severe disability. This infection is called progressive multifocal
leukoencephalopathy (PML).
If PML happens, it usually happens in people with weakened immune
systems.
•
There is no known treatment, prevention, or cure for PML.
•
Your chance of getting PML may be higher if you are also being treated
with other
medicines that can weaken your immune system, including other
treatments for Multiple
Sclerosis (MS) and Crohn's disease (CD). You should not take certain
medicines that
weaken your immune system at the same time you are taking TYSABRI.
Even if you use
TYSABRI alone to treat your MS or CD, you can still get PML.
•
Your risk of getting PML is higher if you:
•
have been infected by the John Cunningham Virus (JCV). JCV is a common
virus
that is harmless in most people but can cause PML in people who have
weakened
immune systems, such as people taking TYSABRI. Most people who are
infected
by JCV do not know it or do not have any symptoms. This infection
usually
happens in childhood. Before you start receiving TYSABRI or during
your
treatment, your doctor may do a blood test to check if you have been
infected by
JCV.
•
have received TYSABRI for a long time, especially longer than 2 years
•
have received certain medicines that can weaken your immune system
before you
start receiving TYSABRI
Your risk of getting PML is greatest if you have all 3 risk facto

পণ্য বৈশিষ্ট্য

TYSABRI- NATALIZUMAB INJECTION
BIOGEN INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TYSABRI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TYSABRI.
TYSABRI (NATALIZUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2004
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
TYSABRI INCREASES THE RISK OF PROGRESSIVE MULTIFOCAL
LEUKOENCEPHALOPATHY (PML), AN
OPPORTUNISTIC VIRAL INFECTION OF THE BRAIN THAT USUALLY LEADS TO DEATH
OR SEVERE
DISABILITY (5.1)
RISK FACTORS FOR THE DEVELOPMENT OF PML INCLUDE THE PRESENCE OF
ANTI-JCV
ANTIBODIES, DURATION OF THERAPY, AND PRIOR USE OF IMMUNOSUPPRESSANTS.
THESE
FACTORS SHOULD BE CONSIDERED IN THE CONTEXT OF EXPECTED BENEFIT WHEN
INITIATING AND
CONTINUING TREATMENT WITH TYSABRI (5.1)
MONITOR PATIENTS, AND WITHHOLD TYSABRI IMMEDIATELY AT THE FIRST SIGN
OR SYMPTOM
SUGGESTIVE OF PML (4, 5.1)
BECAUSE OF THE RISK OF PML, TYSABRI IS AVAILABLE ONLY THROUGH A
RESTRICTED
DISTRIBUTION PROGRAM CALLED THE TOUCH PRESCRIBING PROGRAM (5.1, 5.2)
RECENT MAJOR CHANGES
Dosage and Administration (2.3)
10/2023
Warnings and Precautions (5.2)
04/2023
INDICATIONS AND USAGE
TYSABRI is an integrin receptor antagonist indicated for treatment of:
Multiple Sclerosis (MS)
TYSABRI is indicated as monotherapy for the treatment of relapsing
forms of multiple sclerosis, to include
clinically isolated syndrome, relapsing-remitting disease, and active
secondary progressive disease, in
adults. TYSABRI increases the risk of PML [See Warnings and
Precautions (_5.1)_]. When initiating and
continuing treatment with TYSABRI, physicians should consider whether
the expected benefit of TYSABRI is
sufficient to offset this risk. (1.1)
Crohn's Disease (CD)
TYSABRI is indicated for inducing and maintaining clinical response
and remission in adult patients with
moderately to severely active Crohn's disease with evidence of
inflammation who have had an
inadequate response t