TYSABRI medication guide TYSABRI medication guide TYSABRI medication guide FDA

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Specifications	TYSABRI medication guide TYSABRI medication guide TYSABRI medication guide FDA
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27 MEDICATION GUIDE TYSABRI® (tie-SA-bree) (natalizumab) Read the Medication Guide given to you before you start TYSABRI

Specifications	TYSABRI medication guide TYSABRI medication guide TYSABRI medication guide FDA
Outline	HIGHLIGHTS OF PRESCRIBING INFORMATION FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Multiple Sclerosis (MS) 1.2 Crohn’s Disease (CD) 2 DOSAGE AND ADMINISTRATION 2.1 Multiple Sclerosis (MS) 2.2 Crohn’s Disease (CD) 2.3 Dilution Instructions 2.4 Administration Instructions 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 5.1 Progressive Multifocal Leukoencephalopathy (PML) 5.2 Distribution Program for TYSABRI 5.3 Hypersensitivity/Antibody Formation 5.4 Immunosuppression/Infections 5.5 Hepatotoxicity 5.6 Laboratory Test Abnormalities 5.7 Immunizations 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 4 CONTRAINDICATIONS 6 ADVERSE REACTIONS 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 13 NONCLINICAL TOXICOLOGY 14 CLINICAL STUDIES Clinical Endpoints Relative Risk Reduction 42% (95% CI 23%, 57%) MRI Endpoints Clinical Endpoints Relative Risk Reduction 24% (95% CI 4%, 39%) MRI Endpoints 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION General information about the safe and effective use of TYSABRI
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Content	27 MEDICATION GUIDE TYSABRI® (tie-SA-bree) (natalizumab) Read the Medication Guide given to you before you start TYSABRI and before each infusion. 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. Ask your doctor or nurse if you have any questions. What is the most important information I should know about TYSABRI? x TYSABRI increases your chance of getting a rare brain infection that usually causes death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). If PML happens, it usually happens in people with weakened immune systems. x No one can predict who will get PML. x There is no known treatment, prevention, or cure for PML. x 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 the 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. o Your chance of getting PML increases if you have been exposed to 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 exposed to JCV do not know it or have any symptoms. This exposure usually happens in childhood. o If you have been exposed to JCV, your chance of getting PML increases even more if: you have received TYSABRI for a long time, especially longer than 2 years you have received certain medicines that can weaken your immune system before you start receiving TYSABRI Your doctor may do a blood test to check if you have been exposed to JCV before you start receiving TYSABRI or during your treatment. There may be other risk factors for getting PML during Tysabri treatment that we do not know about yet.
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