Tysabri may cause a serious brain infection that can lead to disability or death, especially if you use natalizumab longer than 2 years, if you've used an immunosuppressant drug before, or if you've been infected with John Cunningham Virus (JCV). Call your doctor right away if you have a sudden fever, severe headache, confusion, memory problems, vision changes, eye pain, weakness on one side of your body, or problems with using your arms or legs. These symptoms may start gradually and get worse quickly.
Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.
Call your doctor at once if you develop any symptoms of liver damage, such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
You should also call your doctor right away if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination.
Before taking this medicine
Tysabri may cause a serious brain infection called progressive multifocal leukoencephalopathy (PML). This infection may be more likely if you use Tysabri for longer than 2 years, if you have used an immunosuppressant drug in the past, or if you have been infected with John Cunningham Virus (JCV).
You should not receive Tysabri if you are allergic to natalizumab, or if you have ever had PML.
Tysabri is available only from a certified pharmacy under a special program called the TOUCH Prescribing Program. You must be registered in the program and understand the risks and benefits of taking this medicine.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
fever, or an active infection;
herpes or shingles;
leukemia or lymphoma;
HIV, AIDS, or other condition that can weaken your immune system;
liver disease;
an organ transplant; or
hives, itching, or trouble breathing after a dose of Tysabri.
It is not known whether Tysabri will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It may not be safe to breastfeed while using Tysabri. Ask your doctor about any risk.
Tysabri is not approved for use by anyone younger than 18 years old.
How is Tysabri given?
Tysabri given as an IV infusion into a vein, usually once every 4 weeks. A healthcare provider will give you this injection. Tysabri is usually given once every 4 weeks.
Tysabri must be given slowly and the IV infusion can take at least 1 hour to complete. You will be watched closely for at least 1 hour after receiving the infusion, to make sure you do not have an allergic reaction to the medication. An allergic reaction can occur up to 2 hours or longer after your infusion.
Before your first dose, your doctor may recommend an MRI to make sure you do not have any signs of a brain infection.
Tysabri can weaken your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent blood tests. You may also need a brain scan or spinal tap (lumbar puncture) if you develop signs of a brain infection.
It is extremely important that your doctor check you every 3 to 6 months for signs of serious infection. Your doctor may also want to check you for several weeks after you stop using this medicine.
Tell any doctor who treats you that you are using Tysabri.
