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Infections: Tell the doctor immediately if the patient has, or thinks he/she has, any sort of infection (see Side Effects). Some infections other than PML may also be serious and can be due to viruses, bacteria, or other causes.
There have been cases of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI. PML may lead to severe disability or death.
The symptoms of PML may be similar to an MS relapse (e.g. weakness or visual changes). Therefore, if the patient believes the MS is getting worse or if he/she notices any new symptoms while on TYSABRI treatment or for up to 6 months after stopping TYSABRI treatment, it is very important that the patient speak to the doctor as soon as possible.
Speak with the partner or caregivers and inform them about the treatment. Symptoms might arise that the patient might not become aware of by himself/herself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which the doctor may need to investigate further to rule out PML. The patient should remain aware for symptoms that might arise for up to 6 months after stopping TYSABRI treatment.
The patient will also find this information in the Patient Alert Card he/she has been given by the doctor. It is important to keep this Alert Card and show it to the patient's partner or caregivers.
PML is associated with an uncontrolled increase of the JC virus in the brain, although the reason for this increase in some patients treated with TYSABRI is unknown. A condition called JCV GCN (JC virus granule cell neuronopathy) is also caused by JC virus and has occurred in some patients who have been given TYSABRI. The symptoms of JCV GCN are similar to PML. JC virus is a common virus which infects many people but does not normally cause noticeable illness.
The doctor may test the blood to check if the patient has antibodies to the JC virus before he/she starts treatment with TYSABRI. These antibodies are a sign that the patient has been infected by JC virus. The doctor may repeat this blood test while the patient is on TYSABRI treatment to check if anything has changed.
The risk of PML with TYSABRI is higher: If the patient has antibodies to the JC virus in the blood.
The longer that the patient is on treatment especially if he/she has been on treatment for more than two years.
If the patient has previously taken a medicine called an immunosuppressant. These medicines reduce the activity of the body's immune system.
If the patient has all three risks described previously, the chance of getting PML is higher.
If the patient has previously not been treated with immunosuppressants and has received TYSABRI for 2 years or longer, the level of the anti-JCV antibody response may be associated with the risk of getting PML.
For those with a lower risk of PML, the doctor may repeat the test regularly to check if anything has changed if: If the patient does not have antibodies to the JC virus in the blood OR; if the patient has been treated for more than 2 years and he/she has a lower level of JCV antibodies in the blood.
Discuss with the doctor if TYSABRI is the most suitable treatment for the patient before he/she starts taking TYSABRI and when he/she has been taking TYSABRI for more than two years.
In patients with PML a reaction known as IRIS (Immune Reconstitution Inflammatory Syndrome) is likely to occur after treatment for PML, as TYSABRI is removed from the body. IRIS may lead to the condition getting worse, including worsening of brain function.
Allergic reactions: A few patients have had an allergic reaction to TYSABRI. The doctor will check for allergic reactions during the infusion and for 1 hour afterwards.
Will TYSABRI always work?: In a few patients who use TYSABRI, over time the body's natural defence may stop TYSABRI from working properly (the body develops antibodies to TYSABRI). The doctor can decide whether TYSABRI is not working properly for the patient by testing the blood and will stop TYSABRI, if necessary.
TYSABRI contains sodium: Each vial of TYSABRI contains 2.3 mmol (or 52 mg) of sodium. After dilution for use, this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose. This should be considered if the patient is on a controlled sodium diet.
Driving and using machines: There are no studies on the effects of TYSABRI on the ability to drive and use machines. However, if the patient experiences dizziness, a common side effect, then the patient should not drive or use machines.
