What is it and how is it used?
TYSABRI is used to treat multiple sclerosis (MS).
The symptoms of MS vary from patient to patient, and you may experience some or none of them. Symptoms can include; walking problems, numbness in the face, arms or legs, problems seeing things, tiredness, feeling off-balance or light headed, bladder and bowel problems, difficulty in thinking and concentrating, depression, acute or chronic pain, sexual problems, and stiffness and muscle spasms. When the symptoms flare up, it is called a relapse (also known as an exacerbation or an attack). When a relapse occurs, you may notice the symptoms suddenly, within a few hours, or slowly progressing over several days. Your symptoms will then usually improve gradually (this is called a remission).
MS causes inflammation in the brain that damages the nerve cells. In TYSABRI the active ingredient is natalizumab, a protein similar to your own antibodies. It stops the cells that cause inflammation from going into your brain. This reduces nerve damage caused by MS.
In clinical trials, TYSABRI approximately halved the progression of the disabling effects of MS and also decreased the number of MS attacks by about two-thirds. However, TYSABRI cannot repair the damage that has already been caused by MS. When you receive TYSABRI you might not notice any improvement, but TYSABRI may still be working to prevent your MS becoming worse.
It is important to continue with your medicine for as long as you and your doctor decide that it is helping you.
What do you have to consider before using it?
Before you start treatment with TYSABRI, it is important that you and your doctor have discussed the benefits you would expect to receive from this treatment and the risks that are associated with it.
Do not use TYSABRI
Take special care with TYSABRI
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 risk of PML increases the longer that you are on treatment especially if you have been on treatment for more than two years. It is not known if the chance of getting PML continues to rise, remains the same, or falls after you have been on TYSABRI for more than three years. The risk of PML is also greater if you have previously taken a medicine that weakens your immune system.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 your body. IRIS may lead to your condition getting worse, including worsening of brain function.
The symptoms of PML may be similar to an MS relapse (e.g. weakness or visual changes). Therefore, if you believe your MS is getting worse or if you notice any new symptoms, it is very important that you speak to your doctor as soon as possible.
Speak with your partner or caregivers and inform them about your treatment. Symptoms might arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML.
You will also find this information in the Patient Alert Card you have been given by your doctor. It is important that you keep this Alert Card and show it to your partner or caregivers.
Serious infections may occur with TYSABRI. If you develop any infection, or if you develop symptoms like an unexplained fever, severe diarrhoea, prolonged dizziness / headache / stiff neck, weight loss, or listlessness, or other symptoms potentially associated with an infection whilst receiving TYSABRI, speak to your doctor as soon as possible and show the Patient Alert Card and this package leaflet to him.
You will also find this information in the Patient Alert Card you have been given by your doctor. It is important that you keep this Alert Card.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines you may have obtained without a prescription. You may not be able to use TYSABRI with some medicines that affect your immune system.
Pregnancy and breast-feeding
You should not use TYSABRI if you are pregnantunless you have discussed this with your doctor. Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Do not breast-feed whilst using TYSABRI. You should discuss with your doctor whether you choose to breast-feed or to use TYSABRI.
Ask your doctor or pharmacist for advice before taking any other medicine with TYSABRI.
Driving and using machines
TYSABRI is not expected to have an effect on your ability to drive or to operate machines. If you are concerned, discuss this with your doctor.
How is it used?
TYSABRI will be prepared and given to you by a doctor.
Information for medical or healthcare professionals on how to prepare and administer TYSABRI is provided at the end of this leaflet.
The adult dose is 300 mg given once every 4 weeks.
TYSABRI must be diluted before it is given to you. It is given as a drip into a vein (by intravenous infusion), usually in your arm. This takes about 1 hour.
A few patients have had an allergic reaction to TYSABRI. Your doctor will check for allergic reactions during the infusion and for 1 hour afterwards.
It is important to continue with your medicine for as long as you and your doctor decide that it is helping you. Continuous dosing with TYSABRI is important, especially during the first few months of treatment. This is because patients who received one or two doses of TYSABRI and then had a gap in treatment of three months or more, were more likely to have an allergic reaction when resuming treatment.
If you miss your dose of TYSABRI
If you miss your usual dose of TYSABRI, arrange with your doctor to receive it as soon as you can. You can then continue to receive your dose of TYSABRI every 4 weeks.
If you have any further questions on TYSABRI, ask your doctor.
What are possible side effects?
Like all medicines, TYSABRI can cause side effects, although not everybody gets them.
If you have any worrying side effects, including any not listed in this leaflet, please tell your doctor, nurse or pharmacist as soon as possible.
Speak to your doctor or nurse immediately if you notice any of the following:
Signs of allergy to TYSABRI, during or shortly after your infusion:
Signs of a possible liver problem:
TYSABRI can also have other side effects.
Side effects are listed below by how commonly they have been reported in clinical trials:
Common side effects that may occur in less than 10 in 100 patients:
Uncommon side effects that may occur in less than 1 in 100 patients:
Rare side effects that may occur in less than 1 in 1000 patients :
What to do if your MS gets worse or you notice new symptoms
There have been reports of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI. PML usually leads to severe disability or death.
The symptoms of PML may be similar to an MS relapse.
Serious infections may occur with TYSABRI. The symptoms of infections include:
You will also find this information in the Patient Alert Card you have been given by your doctor.
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). Your doctor can decide whether TYSABRI is not working properly for you by testing your blood and will stop TYSABRI, if necessary.
How should it be stored?
Keep out of the reach and sight of children.
Unopened vial:
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Do not use TYSABRI after the expiry date stated on the label and carton.
Diluted solution:
After dilution, immediate use is recommended. If not used immediately, the diluted solution must be stored at 2-C - 8-C and infused within 8 hours of dilution.
Do not use TYSABRI if you notice particles in the liquid and/or the liquid in the vial is discoloured.
