Natalizumab

What is Natalizumab?

• Natalizumab (Tysabri) is a monoclonal antibody to human alpha-4 integrin (an integrin receptor antagonist) used to treat multiple sclerosis and Crohn's disease.

Natalizumab 4IRZ

What are the uses of this medicine?

Natalizumab (Tysabri) is a prescription medicine used to treat adults with:

• relapsing forms of Multiple Sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML) . When starting and continuing treatment with Tysabri, it is important that you discuss with your doctor whether the expected benefit of Tysabri is enough to outweigh this risk.
• moderate to severe Crohn's disease (CD).

Tysabri is used:

• to reduce signs and symptoms of CD
• in people who have not been helped enough by, or cannot use the usual CD medicines and medicines called tumor necrosis factor (TNF) inhibitors.

Tysabri is only:

• prescribed by doctors who are enrolled in the TOUCH® Prescribing Program
• given at an infusion center that is enrolled in the TOUCH® Prescribing Program
• given to people who are enrolled in the TOUCH® Prescribing Program

How does this medicine work?

• Natalizumab (na" ta liz' ue mab) is a humanized monoclonal antibody to alpha-4 integrin, which binds avidly to the cellular adhesion molecule found on leukocytes which blocks their ability to migrate to inflammatory foci.
• Inhibition of alpha-4 integrin activity leads to modulation of inflammatory pathways that are activated in autoimmune disorders.
• Natalizumab was shown to improve vision and motor function in patients with multiple sclerosis and to decrease inflammation, symptoms and relapses in patients with Crohn's disease.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have progressive multifocal leukoencephalopathy (PML)
• are allergic to natalizumab or any of the ingredients in Tysabri.

What drug interactions can this medicine cause?

Tysabri should not be treated with concomitant immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α, and corticosteroids should be tapered in those patients with Crohn's disease who are on chronic corticosteroids when they start Tysabri therapy.

Is this medicine FDA approved?

• Natalizumab was approved for use in the United States in 2005 and indications included severe Crohn disease and relapsing multiple sclerosis.
• However, after its general availability, natalizumab was linked to several instances of progressive multifocal leukoencephalopathy (PML), a severe neurological condition which is believed to be due to reactivation of the JC virus in neural cells.
• Because of this severe complication (which is often fatal), natalizumab has been restricted in use and is available only by a special program that requires thorough assessment of risks and careful monitoring and reporting.

How should this medicine be used?

Recommended dosage: Multiple Sclerosis (MS):

• Only prescribers registered in the MS TOUCH® Prescribing Program may prescribe Tysabri for multiple sclerosis.
• The recommended dose of Tysabri for multiple sclerosis is 300 mg intravenous infusion over one hour every four weeks.

Crohn's Disease (CD):

• Only prescribers registered in the CD TOUCH® Prescribing Program may prescribe Tysabri for Crohn's disease.
• The recommended dose of Tysabri for Crohn's disease is 300 mg intravenous infusion over one hour every four weeks.

Administration:

• Tysabri is given 1 time every 4 weeks through a needle placed in your vein (IV infusion).
• Before each Tysabri dose you will be asked questions to make sure Tysabri is still right for you.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial for dilution prior to infusion

This medicine is available in fallowing brand namesː

• Tysabri

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• lung infection
• vaginitis
• stomach area pain
• feeling tired
• depression
• rash
• urinary tract infection
• pain in your arm and legs
• nose and throat infections
• joint pain
• diarrhea
• nausea

Tysabri may cause serious side effects, including:

• progressive multifocal leukoencephalopathy (PML).
• Herpes Infections
• Liver damage
• Allergic reactions, including serious allergic reactions
• Infections
• Low platelet counts

What special precautions should I follow?

• Life-threatening and fatal cases have occurred with herpes encephalitis and meningitis infections. Blindness has occurred in patients developing acute retinal necrosis. Discontinue Tysabri if these infections occur and treat appropriately.
• Natalizumab has been linked to rare instances of idiosyncratic acute liver injury and may be a rare cause of reactivation of hepatitis B. Significant liver injury, including liver failure requiring transplant, has occurred. Discontinue Tysabri in patients with evidence of liver injury.
• Serious hypersensitivity reactions (e.g., anaphylaxis) have occurred. Permanently discontinue Tysabri if such a reaction occurs.
• Tysabri may increase the risk for certain infections. Monitor patients for development of infections due to increased risk with use of Tysabri.
• Tysabri may cause thrombocytopenia. Monitor patients for bleeding abnormalities. Discontinue Tysabri in patients with thrombocytopenia.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate data on the risk of major birth defects, miscarriage, or other adverse maternal outcomes associated with the use of Tysabri in pregnant women.
• Adverse fetal outcomes of neonatal thrombocytopenia, at times associated with anemia, have been reported.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients with multiple sclerosis or Crohn's disease below the age of 18 years have not been established.
• Tysabri is not indicated for use in pediatric patients.

What are the active and inactive ingredients in this medicine?

What are the ingredients in Tysabri?

• Active ingredient: natalizumab
• Inactive Ingredients: sodium chloride, sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; polysorbate 80, and water for injection

Who manufactures and distributes this medicine?

Manufactured by:

• Biogen Inc.; Cambridge, MA USA

What should I know about storage and disposal of this medication?

• Tysabri is given 1 time every 4 weeks through a needle placed in your vein (IV infusion).
• Before each Tysabri dose you will be asked questions to make sure Tysabri is still right for you.

• Dailymed label info on Natalizumab
• FDA Natalizumab

Natalizumab Resources
Latest articles Most recent articles Ongoing trials	Wikipedia