Tysabri®
Drug class
- Biologic/biosimilar
- Integrin receptor angonist
Generic name
Natalizumab
Safety
Efficacy
Convenience
Box warning
Natalizumab can cause a rare, deadly brain infection called PML. The risk goes up if patients have had other immune treatments or have certain antibodies. PML can cause serious disability or death. Patients must be monitored for any new neurological problems during treatment.
Indications
Approved for inducing and maintaining remission in patients with moderate to severe Crohn's disease.
How it works
By inhibiting specific proteins that cause inflammation, biologic medications reduce disease activity and severity.
Drug interactions
Should not be used in combination with immunosuppressants, for example 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate or TNF-α inhibitors.
Pre-treatment screening tests
Hepatic panel, tuberculosis infection, viral hepatitis panel, hepatitis B panel (core, antigen, antibody), complete blood count, and comprehensive metabolic panel.
Tests during screening
Blood count, liver enzymes, kidney function, tuberculosis infection TB Hepatitis B, antibodies to natalizumab (Testing is recommended if persistent antibodies are suspected. If positive, repeat/confirm test in 3 months), JCV antibody (detects antibodies to the John Cunningham (JC) virus, which can help identify risk factors for progressive multifocal leukoencephalopathy (PML)). For PML, monitor for diverse symptoms that progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Route of administration
Frequency
Every 4 weeks
Side effects
Headache, fatigue, joint pain, upper respiratory tract infections, nausea or upset stomach, rash, intestinal obstruction, and infections including Progressive Multifocal Leukoencephalopathy (PML).
Contraindications
Hypersensitivity to natalizumab or any component of the formulation and current or history of progressive multifocal leukoencephalopathy (PML).
Safety information
Signs of an allergic reaction, like face swelling, fainting, dizziness, hives, shortness of breath. Signs of infection. Signs of a UTI. Signs of liver problems. Thoughts of hurting yourself or suicide or depression. Flushing, chest pain, swelling in arms or legs, changes in menstruation (period), and changes in eyesight.