देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
natalizumab (UNII: 3JB47N2Q2P) (natalizumab - UNII:3JB47N2Q2P)
Biogen Inc.
natalizumab
natalizumab 300 mg in 15 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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) ]
Biologic Licensing Application
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 पूरा दस्तावेज़ पढ़ें
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 पूरा दस्तावेज़ पढ़ें