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Tysabri Ds 300 Mg Vl 15 Ml Ds

  • Manufacturer Name : TYSABRI DIRECT
  • MFG # : 64406000801
  • NDC : 64406000801
  • Distributor Name : AmeriSource Bergen
PID UOM Price Qty
639086 1/EA
$13,446.92
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Additional Information

Product NameTysabri 300 mg/15 mL Vial
Active IngredientNatalizumab
Drug ClassMonoclonal Antibody
Mechanism of ActionSelectively inhibits the a4-integrin, preventing immune cell migration into the central nervous system and gastrointestinal tract, reducing inflammation.
Strength300 mg/15 mL
Volume15 mL
Route of AdministrationIntravenous (IV) infusion
Dosage ScheduleEvery 4 weeks
Side EffectsHeadache, fatigue, joint pain, infections, risk of progressive multifocal leukoencephalopathy (PML)
PrecautionsMonitor for signs of PML, liver dysfunction, infections, and hypersensitivity reactions
StorageStore in the refrigerator (2–8°C / 36–46°F), do not freeze
PackagingSingle-use vial in a carton
UsesTreatment of multiple sclerosis and Crohn's disease

Description

Tysabri (natalizumab) 300 mg/15 mL vial is a prescription medication used for the treatment of multiple sclerosis (MS) and Crohn's disease. It is an intravenous infusion that works by targeting and inhibiting the interaction between immune cells and the blood-brain barrier, thus preventing the inflammatory process that leads to nerve damage in MS. In Crohn’s disease, Tysabri helps reduce inflammation and prevent further flare-ups by blocking the migration of immune cells to the gastrointestinal tract.

Tysabri is indicated for patients with relapsing forms of multiple sclerosis who have had an inadequate response to, or are unable to tolerate, other disease-modifying therapies. It is also used in moderate to severe Crohn’s disease patients who have not responded to other treatments, providing a potent therapeutic option for these conditions.

The drug’s mechanism of action involves the selective inhibition of the a4-integrin, a cell adhesion molecule responsible for the migration of immune cells into the central nervous system and gastrointestinal tract. By blocking this molecule, Tysabri prevents the accumulation of inflammatory cells in affected tissues.

Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind NR
DESI2 Drug Ind NR
Drug Category -
Drug Category -
Drug Type Code S
Drug Type Code S
FDA Approval Date 12/01/2004
FDA Approval Date 12/01/2004
FDA Therap Equiv EA
FDA Therap Equiv EA
HCPCS Natalizumab inj, 1 MG
HCPCS Natalizumab inj, 1 MG
Market Entry Date -
Market Entry Date -
Medical Coverage J2323
Medical Coverage J2323
Termination Date 1
Termination Date 1
Unit 1
Unit 1
Units Per Pkg 11/23/2004
Units Per Pkg 11/23/2004
Active Ingredients 8765 natalizumab 189261107
Active Ingredients 8765 natalizumab 189261107
AHFS Class 92200000 IMMUNOMODULATORY AGENTS
AHFS Class 92200000 IMMUNOMODULATORY AGENTS
DEA Class NC
DEA Class NC
Dose Form VIAL (ML)
Dose Form VIAL (ML)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 58384 natalizumab INTRAVEN VIAL 300MG/15ML
Gen Code and Des 58384 natalizumab INTRAVEN VIAL 300MG/15ML
Inactive Ingredients 2551 polysorbates 9005645
Inactive Ingredients 2551 polysorbates 9005645
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 300MG
Strength 300MG
Common Brand Name COMMON BRAND NAME(S): Tysabri
Common Brand Name COMMON BRAND NAME(S): Tysabri
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: past or current use of other drugs that weaken the immune system/increase the risk of infection (such as azathioprine, cyclosporine, 6-mercaptopurine, methotrexate, fingolimod, TNF blockers such as adalimumab, etanercept, infliximab), long-term use of corticosteroids (such as dexamethasone, prednisone).
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: past or current use of other drugs that weaken the immune system/increase the risk of infection (such as azathioprine, cyclosporine, 6-mercaptopurine, methotrexate, fingolimod, TNF blockers such as adalimumab, etanercept, infliximab), long-term use of corticosteroids (such as dexamethasone, prednisone).
Allocation Period -
Allocation Period -
Case Quantity 36
Case Quantity 36
Drug Form Pack Size 15
Drug Form Pack Size 15
Form VIAL
Form VIAL
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Not Returnable
Returnable Status Not Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 30 Refrige./DoNot Freez
Temp Zone 30 Refrige./DoNot Freez
Unit EA
Unit EA
Unit Size 15
Unit Size 15
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using natalizumab and each time you receive another dose. If you have any questions, ask your doctor or pharmacist. This medication is given by a health care professional in an infusion center as directed by your doctor, usually every 4 weeks. This medication is usually given over 1 hour. You will be monitored for 1 hour after your treatment is finished (at least for the first 12 treatments) to make sure you do not have a serious reaction to the medication. (See also Side Effects section.) It is important to use this medication regularly to get the most benefit from it. Do not miss any doses without your doctor's approval. Tell your doctor if your condition worsens. When using this medication for Crohn's disease, if your condition does not improve after 12 weeks of treatment, your doctor will need to switch your treatment plan.
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using natalizumab and each time you receive another dose. If you have any questions, ask your doctor or pharmacist. This medication is given by a health care professional in an infusion center as directed by your doctor, usually every 4 weeks. This medication is usually given over 1 hour. You will be monitored for 1 hour after your treatment is finished (at least for the first 12 treatments) to make sure you do not have a serious reaction to the medication. (See also Side Effects section.) It is important to use this medication regularly to get the most benefit from it. Do not miss any doses without your doctor's approval. Tell your doctor if your condition worsens. When using this medication for Crohn's disease, if your condition does not improve after 12 weeks of treatment, your doctor will need to switch your treatment plan.
Missed Dose MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
Missed Dose MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
Notes NOTES: Lab and/or medical tests (such as MRI, liver function, anti-JCV antibody test) may be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details. Talk to your doctor or pharmacist about lifestyle changes that might benefit you. Examples of lifestyle changes include stress reduction programs and maintaining a healthy diet. A doctor-approved exercise program may also help MS patients maintain strength, balance, and muscle tone. Consult your doctor or pharmacist for more details.
Notes NOTES: Lab and/or medical tests (such as MRI, liver function, anti-JCV antibody test) may be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details. Talk to your doctor or pharmacist about lifestyle changes that might benefit you. Examples of lifestyle changes include stress reduction programs and maintaining a healthy diet. A doctor-approved exercise program may also help MS patients maintain strength, balance, and muscle tone. Consult your doctor or pharmacist for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (NA-ta-LIZ-ue-mab)
Phonetic Pronunciation (NA-ta-LIZ-ue-mab)
Precautions PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain virus infection (progressive multifocal leukoencephalopathy-PML), history of certain virus infections that keep coming back (such as herpes, shingles), weakened immune system (such as leukemia, lymphoma, HIV infection, organ transplant), current infections, mental/mood disorders (such as depression). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during pregnancy may have low platelet and red blood cell counts. Tell the doctor right away if your baby develops easy bruising/bleeding. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain virus infection (progressive multifocal leukoencephalopathy-PML), history of certain virus infections that keep coming back (such as herpes, shingles), weakened immune system (such as leukemia, lymphoma, HIV infection, organ transplant), current infections, mental/mood disorders (such as depression). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during pregnancy may have low platelet and red blood cell counts. Tell the doctor right away if your baby develops easy bruising/bleeding. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Headache, joint pain, redness/irritation at the injection site, swelling hands/feet/ankles, or changes in menstrual cycle may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any side effects while this drug is being given or shortly after your treatment is finished. Examples of these side effects (infusion reaction) may include chills, fever, flushing, nausea, dizziness, tiredness, and chest pain. Tell your doctor right away if you have any serious side effects, including: headache that is severe or doesn't go away, stiff/painful neck, fast/pounding heartbeat, easy bruising/bleeding, signs of infection (such as sore throat that doesn't go away, fever, breathing problems, unusual vaginal discharge, painful/frequent urination), mood changes (such as depression, suicidal thoughts), severe stomach/abdominal pain. This drug increases the risk of a rare, possibly fatal, brain infection (see Warning section for more details). This condition may occur during treatment or, in some cases, after treatment has stopped. In MS patients, the symptoms of PML can seem like an attack of worsening MS. Whether you are using this drug or have stopped using it within the last 6 months, tell your doctor right away of any new or worsening symptoms that have lasted for several days such as: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, problems with speech, vision changes. This drug may rarely cause serious liver problems. If you notice any of the following rare but very serious side effects, tell your doctor right away: nausea/vomiting that doesn't stop, dark urine, yellowing eyes/skin, feeling tired/weak. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Headache, joint pain, redness/irritation at the injection site, swelling hands/feet/ankles, or changes in menstrual cycle may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any side effects while this drug is being given or shortly after your treatment is finished. Examples of these side effects (infusion reaction) may include chills, fever, flushing, nausea, dizziness, tiredness, and chest pain. Tell your doctor right away if you have any serious side effects, including: headache that is severe or doesn't go away, stiff/painful neck, fast/pounding heartbeat, easy bruising/bleeding, signs of infection (such as sore throat that doesn't go away, fever, breathing problems, unusual vaginal discharge, painful/frequent urination), mood changes (such as depression, suicidal thoughts), severe stomach/abdominal pain. This drug increases the risk of a rare, possibly fatal, brain infection (see Warning section for more details). This condition may occur during treatment or, in some cases, after treatment has stopped. In MS patients, the symptoms of PML can seem like an attack of worsening MS. Whether you are using this drug or have stopped using it within the last 6 months, tell your doctor right away of any new or worsening symptoms that have lasted for several days such as: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, problems with speech, vision changes. This drug may rarely cause serious liver problems. If you notice any of the following rare but very serious side effects, tell your doctor right away: nausea/vomiting that doesn't stop, dark urine, yellowing eyes/skin, feeling tired/weak. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Not applicable. This medication is given in an infusion center and will not be stored at home.
Storage STORAGE: Not applicable. This medication is given in an infusion center and will not be stored at home.
Uses USES: Natalizumab is used to treat multiple sclerosis-MS. It is not a cure for MS, but it is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening symptoms and may prevent or delay disability. Natalizumab is also used to treat a bowel condition called Crohn's disease (CD). It is not a cure for CD, but it is thought to work by preventing your immune system from causing inflammation/swelling within your bowels. Natalizumab is a protein called a monoclonal antibody.
Uses USES: Natalizumab is used to treat multiple sclerosis-MS. It is not a cure for MS, but it is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening symptoms and may prevent or delay disability. Natalizumab is also used to treat a bowel condition called Crohn's disease (CD). It is not a cure for CD, but it is thought to work by preventing your immune system from causing inflammation/swelling within your bowels. Natalizumab is a protein called a monoclonal antibody.

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Tysabri Ds 300 Mg Vl 15 Ml Ds is manufactured by TYSABRI DIRECT.
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