Package leaflet: Information for the patient
TYSABRI 300 mg concentrate for solution for infusion
natalizumab
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
In addition to this leaflet you will be given a Patient Alert Card, which contains important safety information that you need to know before you are given TYSABRI (pronounced tie-SA-bree) and during treatment with TYSABRI.
1. What TYSABRI is and what it is used for
2. What you need to know before you use TYSABRI
3. How to use TYSABRI
4. Possible side effects
5. How to store TYSABRI
6. Contents of the pack and other information
1. What TYSABRI is and what it is used for
TYSABRI contains the active substance (natalizumab). This active ingredient is called a monoclonal antibody. These antibodies work by binding to proteins in the body so that the harmful effect of that protein is removed.
TYSABRI is used to treat multiple sclerosis (MS). MS causes inflammation in the brain that damages the nerve cells. TYSABRI stops the cells that cause inflammation from going into your brain. This reduces nerve damage caused by 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).
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. When you receive TYSABRI you might not notice any improvement, but TYSABRI may still be working to prevent your MS becoming worse.
2. What you need to know before you use TYSABRI
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.
Talk to your doctor before using TYSABRI.
Tell your doctor immediately if you have, or think you have, 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.
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.
Your doctor may test your blood to check if you have antibodies to the JC virus before you start treatment with TYSABRI. These antibodies are a sign that you have been infected by JC virus. Your doctor may repeat this blood test while you are on TYSABRI treatment to check if anything has changed.
If you have all three risks described above your chance of getting PML is higher.
If you have previously not been treated with immunosuppressants and have received TYSABRI for 2 years or longer, the level of your anti-JCV antibody response may be associated with the risk of getting PML.
For those with a lower risk of PML, your doctor may repeat the test regularly to check if anything has changed if:
You should discuss with your doctor if TYSABRI is the most suitable treatment for you before you start taking TYSABRI and when you have 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 your body. IRIS may lead to your condition getting worse, including worsening of brain function.
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.
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.
Tell your doctor if you are taking or have recently taken or might take any other medicines.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine
There are no studies on the effects of TYSABRI on the ability to drive and use machines. However, if you experience dizziness, a very common side effect, then you should not drive or use machines.
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 you are on a controlled sodium diet.
3. How to use TYSABRI
TYSABRI will be given to you by a doctor experienced in the treatment of MS. Your doctor may switch you directly from another medicine for MS to TYSABRI if there are no signs of abnormalities caused by your previous treatment. Your doctor should do a blood test in order to test for abnormalities and whether you have antibodies to the JC virus. To switch from some MS medicines, your doctor may advise you to wait for a certain time to ensure that most of the previous medicine has left your body. Initiating treatment with TYSABRI after alemtuzumab is generally not recommended. If you have been treated with alemtuzumab, a thorough evaluation and discussion with your doctor is required to decide if a switch to TYSABRI is appropriate for you.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
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.
Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor if you are not sure.
If you have any further questions on TYSABRI, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Symptoms of serious infections including:
A group of symptoms caused by a serious infection of the brain including:
These symptoms may be caused by an infection of the brain (encephalitis) or its covering layer (meningitis).
Signs of allergy to TYSABRI, during or shortly after your infusion:
Signs of a possible liver problem:
Side effects are listed below by how commonly they have been reported in clinical trials:
Very common side effects that may affect more than 1 in 10 people:
Common side effects that may affect up to 1 in 10 people:
Uncommon side effects that may affect up to 1 in 100 people:
Rare side effects that may affect up to 1 in 1,000 people:
Speak to your doctor as soon as possible if you think you have an infection.
Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
You will also find this information in the Patient Alert Card you have been given by your doctor.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Ireland
United Kingdom
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store TYSABRI
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.
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.
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 this medicine if you notice particles in the liquid and/or the liquid in the vial is discoloured.
6. Contents of the pack and other information
The active substance is natalizumab. Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ml). When diluted, the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
The other ingredients are:
Sodium phosphate, monobasic, monohydrate,
Sodium phosphate, dibasic, heptahydrate,
Sodium chloride (see section 2 ‘TYSABRI contains sodium’),
Polysorbate 80 (E433)
Water for injections
TYSABRI is a clear, colourless to slightly cloudy liquid.
Each carton contains one glass vial.
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.