Important Safety Information
TYSABRI® (natalizumab) is a prescription infusion medication used to treat adults with multiple sclerosis or moderate to severe Crohn’s disease when other forms of treatment have failed to provide relief. It has proven effective in decreasing symptoms and preventing flare-ups. It is unknown whether the medication is effective in children under 18 years of age.
What is the most important information I should know about TYSABRI®?
TYSABRI® could increase the risk of developing progressive multifocal leukoencephalopathy (PML) — a rare brain infection that often causes severe disability or death. The risk of developing PML is higher if you undergo infusion treatment with TYSABRI® for more than two years, have taken medications that weaken your immune system in conjunction with TYSABRI®, and/or if you have been infected by the John Cunningham virus (JCV). Prior to starting treatment, your doctor should conduct a blood test to determine whether you have been infected by JCV.
Talk with your doctor about your medical history — as well as all medications you are currently taken and have taken in the past — to determine whether the benefits of undergoing infusion treatment with TYSABRI® outweigh the risks of developing PML.
It’s also crucial to tell your doctor about anything that may weaken your immune system, as this increases the risk of PML. This includes leukemia, lymphoma, being an organ transplant recipient, having HIV, or any worsening medical conditions.
It is unknown if TYSABRI® would harm an unborn baby or a child. Talk to your doctor if you’re pregnant, there’s a possibility you are pregnant, or are planning to become pregnant. Also, discuss your options if you’re breastfeeding or planning to breastfeed.
Side Effects of TYSABRI®
As with any prescription medication, TYSABRI® carries a risk of side effects. These may include:
- Urinary tract infections
- Abdominal pain
- Joint pain
- Nose and throat infections
- Lung infection
The most serious side effects of undergoing treatment with TYSABRI® include:
Progressive Multifocal Leukoencephalopathy (PML)
PML is a rare brain infection that usually leads to severe disability or death — and it has no cure. Tell your doctor immediately if you experience vision loss, trouble speaking, facial drooping, lack of coordination, personality changes, weak muscles, and/or difficulty walking.
Serious Allergic Reactions
Serious allergic reactions could occur within two hours from the start of an infusion treatment. Tell your doctor if you experience itching, breathing difficulties, chest pain, dizziness, chills, hives, rash, flushing of the skin, nausea, and/or low blood pressure.
Weakened Immune System
TYSABRI® is an immunosuppressant medication — which means it weakens the immune system. As a result, you may have an increased risk of contracting additional medical ailments. Talk to your doctor about how TYSABRI® may interact with other medications you’re taking.
Seek immediate medical care if you experience fever, severe headache, and/or confusion. TYSABRI® may also increase the risk of infection of the brain and spinal cord (encephalitis or meningitis) caused by herpes viruses.
TYSABRI® could cause liver damage within six days from the first infusion treatment. Tell your doctor if you experience yellowing of the skin and whites of the eyes, unusually dark urine, feeling weak, nausea, and/or vomiting.
Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.
TYSABRI® is used to treat adults with multiple sclerosis or moderate to severe Crohn’s disease. Each infusion treatment lasts approximately an hour, every four weeks. TYSABRI® solution must be administered within eight hours of preparation. Do not use on patients who have or have had PML or have had a hypersensitivity reaction to the medication in the past.
Please refer to the full prescribing information.