Patient leaflet - Tysabri 150 mg solution for injection in Pre-filled syringe
1. What Tysabri is and what it is used for
Tysabri is used to treat multiple sclerosis (MS) in adults. It contains the active substance natalizumab. This is called a monoclonal antibody.
MS causes inflammation in the brain that damages the nerve cells. This inflammation happens when white blood cells get into the brain and spinal cord. This medicine stops the white blood cells getting through to the brain. This reduces nerve damage caused by MS.
Symptoms of multiple sclerosis
The symptoms of MS vary from patient to patient, and you may experience some or none of them.
They may include: walking problems; numbness in the face, arms or legs; problems with vision; tiredness; feeling off-balance or lightheaded; bladder and bowel problems; difficulty in thinking and concentrating; depression; acute or chronic pain; sexual problems; 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).
How Tysabri can help
In trials, this medicine approximately halved the build-up of disability caused by MS, and decreased the number of MS attacks by about two-thirds. While you are treated with this medicine you might not notice any improvement, but it may still be working to prevent your MS becoming worse.
2. What you need to know before you receive Tysabri
Before you start treatment with this medicine, it is important that you and your doctor have discussed the benefits you could expect to receive from this treatment and the risks that are associated with it.
You must not be given Tysabri
If you are allergic to natalizumab or
any of the other ingredients of this medicine (listed in section 6).
If you have been diagnosed
with PML (progressive multifocal leukoencephalopathy). PML is an uncommon infection of the brain.
If your immune system has a serious
problem. This may be due to disease (such as HIV), or to a medicine you are taking, or have taken in the past (see below).
If you are taking medicines that affect
your immune system, including certain other medicines used to treat MS. These medicines cannot be used with Tysabri.
If you have cancer (unless it is a
type of skin cancer called basal cell carcinoma).
Warnings and precautions You need to discuss with your doctor
whether Tysabri is the most suitable treatment for you. Do this before you start taking this medicine and when you have been receiving it for more than two years.
Keeping a record
In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future.
Possible brain infection (PML)
Some people receiving this medicine (fewer than 1 in 100) have had
an uncommon brain infection
called PML (progressive multifocal leukoencephalopathy). PML can lead to severe disability or death.
Before starting treatment, all patients
will have blood tests arranged by the doctor for JC virus infection. JC virus is a common virus that does not normally make you ill. However, PML is linked to an increase of JC virus in the brain. The reason for this increase in some patients treated with Tysabri is not clear. Before and during treatment, your doctor will test your blood to check if you have antibodies to the JC virus, which are a sign that you have been infected by the JC virus.
Your doctor will arrange a Magnetic
Resonance Imaging (MRI) scan, which will be repeated during treatment to rule out PML.
The symptoms of PML may be similar
to an MS relapse (see section 4, Possible side effects). You can also get PML up to 6 months after stopping Tysabri treatment.
Tell your doctor as soon as possible if you notice your MS getting worse or if you notice any new symptoms, while you are on Tysabri treatment or for up to 6 months afterwards.
Tell your partner or caregivers about
what to look out for (see also section 4, Possible side effects). Some symptoms might be difficult to spot by yourself, such as changes in mood or behaviour, confusion, speech and communication difficulties. If you get any of these, you may need further tests. Keep looking out for symptoms in the 6 months after stopping Tysabri.
Keep the Patient Card you have been
given by your doctor. It includes this information. Show it to your partner or caregivers.
If you or your caregiver administer the
treatment, review the Pre-Administration Checklist before each dose.
Three things can increase your risk of PML with Tysabri. If you have two or more of these risk factors, the risk is increased further:
If you have antibodies to the JC
virus in your blood. These are a sign that the virus is in your body. You will be tested before and during Tysabri treatment.
If you are treated for a long time with
Tysabri, especially if it is more than two years.
If you have taken a medicine called
an immunosuppressant, that reduces the activity of your immune system. Another condition, called JCV GCN (JC virus granule cell neuronopathy), is also caused by JC virus and has occurred in some patients receiving this medicine. The symptoms of JCV GCN are similar to PML.
For those with a lower risk of PML, your doctor may repeat the test regularly to check that:
You still do not have antibodies to the
JC virus in your blood.
If you have been treated for more than
2 years, you still have a lower level of JC virus antibodies in your blood.
If someone gets PML
PML can be treated, and Tysabri treatment will be stopped. However, some people get a reaction as Tysabri is removed from the body. This reaction (known as IRIS, or immune reconstitution inflammatory syndrome) may lead to your condition getting worse, including worsening of brain function.
Look out for other infections
Some infections other than PML may also be serious and can be due to viruses, bacteria, and other causes.
Tell a doctor or nurse immediately if you think you have an infection (see also section 4, Possible side effects).
Changes in blood platelets
Natalizumab may reduce platelets in the blood which are responsible for clotting. This may result in a condition called thrombocytopenia (see section 4) in which your blood may not clot quickly enough to stop bleeding. This can lead to bruising as well as other more serious problems such as excessive bleeding. You should talk to your doctor immediately if you have unexplained bruising, red or purple spots on the skin (called petechiae), bleeding from skin cuts that does not stop or oozes, prolonged bleeding from the gums or nose, blood in urine or stools, or bleeding in the whites of your eyes.
Children and adolescents
Do not give this medicine to children or adolescents under the age of 18 years.
Other medicines and Tysabri
Tell your doctor if you are taking, have recently taken or might take any other medicines.
You must not be given this medicine
if you are now being treated with medicines that affect your immune system, including certain other medicines to treat your MS.
You might not be able to use this
medicine if you have previously had any medicines that affect your immune system.
Pregnancy and breast-feeding
Do not use this medicine if you are
pregnant, unless you have discussed this with your doctor. Be sure to tell your doctor immediately if you get pregnant, think you may be pregnant, or if you are planning to become pregnant.
Do not breast-feed whilst using
Tysabri. Your doctor will help you decide whether you should stop breast-feeding, or stop using the medicine.
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. The risk to the baby and benefit to the mother will be taken into consideration by your doctor.
Driving and using machines
Dizziness is a very common side effect. If you are affected, do not drive or use machines.
Tysabri contains polysorbate 80 (E 433)
This medicine contains 0.4 mg of polysorbate 80 in each pre-filled syringe, which is equivalent to 0.8 mg per dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
Tysabri contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 300 mg dose, so it is essentially ‘sodium-free’.
3. How Tysabri is given
Tysabri injections will be prescribed to you by a doctor experienced in the treatment of MS. Your doctor may switch you directly from another medicine to Tysabri if there are no signs of problems caused by your previous treatment.
Your doctor will order blood tests for
antibodies to the JC virus and other possible problems.
Your doctor will arrange an MRI
scan, which will be repeated during treatment.
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.
If your condition allows, your doctor
may discuss with you the option of receiving injections outside a clinic (e.g. at home). These injections can be administered by a healthcare professional, by yourself or a caregiver, provided you meet certain criteria. You will still need to attend the clinic or hospital for appointments including those for regular blood tests and MRI scans.
If your doctor decides that you are
suitable for self-administration (or administration by your caregiver), a healthcare professional will supervise you for the administration of the first two doses (2 injections each).
Your healthcare professional will
give you or your caregiver detailed instructions and will show you how to prepare and inject the medicine before using the syringes the first time.
If your doctor decides that you are
suitable for administration by yourself or a caregiver, make sure you read the Patient Card to review the list of PML symptoms and you review the Pre-Administration Checklist before each dose. If any symptoms appear or worsen, do not administer the dose and contact your doctor immediately.
For adults the recommended dose is
300 mg, given once every 4 weeks.
Each dose is given as two injections
under the skin, in your thigh, abdomen (at least 6 centimetres away from the belly button) or back of your arm (the latter only in case of injection by a healthcare professional or a caregiver). This takes up to 30 minutes.
Information on how to prepare and
inject the medicine is provided at the end of this leaflet.
If you stop using Tysabri
Regular dosing with this medicine is important, especially in the first few months of treatment. It is important to continue with your medicine for as long as you and your doctor decide that it is helping you. Do not stop using your medicine without your doctor’s advice. Patients who received one or two doses of Tysabri, and then had a gap in treatment of 3 months or more, were more likely to have an allergic reaction when restarting treatment.
Checking for allergic reactions
A few patients have had an allergic reaction to this medicine. Your doctor may check for allergic reactions during the injections and for 1 hour afterwards. In case of self-administration or administration by a caregiver, if you experience an allergic reaction stop the injection and seek medical attention immediately. See also section 4, Possible side effects.
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.
Two syringes need to be administered to give the full dose. It is important that both syringes are administered and that you have them at the prescribed dosing schedule. If you or your caregiver are administering the injections and you have missed a dose or you have injected only one syringe, contact your doctor as soon as possible for advice.
Will Tysabri always work?
In a few patients receiving Tysabri, the body’s natural defences may stop the medicine from working properly over time, as the body develops antibodies to the medicine. Your doctor can decide whether this medicine is not working properly for you from blood tests and will stop the treatment, if necessary.
If you have any further questions on Tysabri, ask your doctor. 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. Subcutaneous is abbreviated as SC on the syringe label.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Speak to your doctor or nurse immediately if you notice any of the following.
Signs of a brain infection
Changes in personality and behaviour
such as confusion, delirium or loss of consciousness,
- Seizures (fits)
- Headache
- Nausea / vomiting
- Stiff neck
- Extreme sensitivity to bright light
- Fever
- Rash (anywhere on the body) These symptoms may be caused by an infection of the brain (encephalitis or PML) or its covering layer (meningitis).
Signs of other serious infections
- An unexplained fever
- Severe diarrhoea
- Shortness of breath
- Prolonged dizziness
- Headache
- Weight loss
- Listlessness
- Impaired vision
- Pain or redness of the eye(s)
Signs of an allergic reaction
- Itchy rash (hives)
- Swelling of your face, lips or tongue
- Difficulty breathing
- Chest pain or discomfort
Increase or decrease in your blood
pressure (your doctor or nurse will notice this if they are monitoring your blood pressure)
These are most likely during or shortly after the injection.
Signs of a possible liver problem
Yellowing of your skin or the whites of
your eyes
- Unusual darkening of the urine
Abnormal liver function test
Speak to a doctor or nurse immediately if you get any of the side effects listed above, or if you think you have an infection. Show your Patient Card and this package leaflet to any doctor or nurse who treats you, not only to your neurologist.
Other side effects
Very common (may affect more than 1 in 10 people)
- Urinary tract infection
Sore throat and runny or blocked up
nose
- Headache
- Dizziness
- Feeling sick (nausea)
- Joint pain
Tiredness
Common (may affect up to 1 in 10 people)
- Anaemia (decrease in your red blood cells which can make your skin pale and can make you feel breathless or lacking energy)
- Allergy (hypersensitivity)
- Shivering
- Itchy rash (hives)
- Being sick (vomiting)
- Fever
- Difficulty breathing (dyspnoea)
Reddening of the face or body
(flushing)
- Herpes infections
- Discomfort around the place you have been injected. You could experience pain, bruising, redness, itching or swelling
Uncommon (may affect up to 1 in 100 people)
- Severe allergy (anaphylactic reaction)
Progressive multifocal
leukoencephalopathy (PML)
- Inflammatory disorder after discontinuation of the medicinal product
- Facial swelling
- An increase in the number of white blood cells (eosinophilia)
- Reduction in blood platelets
- Easy bruising (purpura)
Rare (may affect up to 1 in 1000 people)
- Herpes infection in the eye
- Severe anaemia (decrease in your red blood cells which can make your skin pale and can make you feel breathless or lacking energy)
- Severe swelling under the skin
High levels of bilirubin in the blood
(hyperbilirubinaemia) which may cause symptoms such as yellowing of your eyes or skin, fever and tiredness Not known (frequency cannot be estimated from the available data)
- Unusual infections of brain and eyes
Damage to your liver
Speak to your doctor as soon as possible if you think you have an infection. You will also find this information in the Patient Card you have been given by your doctor.
Reporting of side effects
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 the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.
Store in a refrigerator (2 °C - 8 °C). Do not freeze.
Keep the syringes in the outer carton in order to protect from light.
The pre-filled syringes can be kept at room temperature (up to 30° C) for a maximum of a combined period of up to 24 hours, including the time to allow warming to room temperature for administration. The syringes can be returned to the refrigerator and used before the expiry date stated on the label and carton. Date and time of removal of the pack from the refrigerator must be recorded on the carton. Discard the syringes if left out of the refrigerator for more than 24 hours. Do not use external heat sources such as hot water to warm the pre-filled syringes.
Do not use this medicine if you notice particles in the liquid and/or the liquid in the syringe is discoloured.
6. Contents of the pack and other information
What Tysabri contains
The active substance is natalizumab. Each 1 mL pre-filled syringe contains 150 mg natalizumab.
The other ingredients are:
Sodium phosphate, monobasic, monohydrate,
Sodium phosphate, dibasic, heptahydrate, Sodium chloride (see section 2 ‘Tysabri contains sodium’),
Polysorbate 80 (E 433)
Water for injections
What Tysabri looks like and contents of the pack
Tysabri is a colourless to slightly yellow, slightly opalescent to opalescent (pearly) liquid.
Each carton contains two syringes. Tysabri is available in packs containing 2 pre-filled syringes.
Marketing Authorisation Holder
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
This leaflet was last revised in May 2026.
solution for injection in pre-filled syringe
natalizumab
150 mg
Instructions for administration overleaf
ART13456
Choose the 2nd Injection Site.
a. Choose another area to inject. You may use one of
the following injection sites:
Abdomen (at least 6 centimetres away from the
belly button)
- Front of the thigh
Upper outer arm (this is for caregiver
administration only)
b. Do not inject into an area of the body where the skin
is tender, red, infected, bruised or has scars.
c. Change (rotate) injection sites between injections.
d. If using the same area of the body, make sure your
2nd injection site is at least 3 centimetres from your
first injection site.
12
Disposing Tysabri
Do not dispose of your used sharps
disposal container or any used syringes
in your household trash.
Dispose of Both Syringes.
15
Do not touch, fan or blow on the clean area.
Clean the 2nd Injection Site.
a. Wipe the skin with an alcohol wipe.
b. Let the injection site air dry before injecting the
dose.
13 14
Put both used syringes in a sharps disposal
container right away after use. If you do not have a sharps disposal container, you can ask your healthcare professional for one or you may use a household container that is:
- made of heavy-duty plastic,
- can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labelled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. There may be state or local laws about how you should dispose of used syringes. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
= Caregiver = Self- injection
FIRST injection
SECOND injection
If injecting into the same area, at least 3 cm apart
Plunger rod
Finger flange
Needle cap
Needle Needle guard
Before use:
Do not remove the finger flange. The finger flange will allow you to hold the syringe more firmly during the injection process.
This “Instructions for Use” contains information on how to inject using the Tysabri pre-filled syringe. Read these Instructions for Use before you start using the Tysabri pre-filled syringe (called “syringe” in these instructions) and each time you get a refill. There may be new information.
This information does not take the place of talking to your healthcare professional about your medical condition or your treatment.
Full dose = Two pre-filled syringes
Important information you need to know before injecting Tysabri Storing Tysabri Tysabri Device Parts
subcutaneous use
INSTRUCTIONS FOR USE
Tysabri is provided in a pre-filled syringe (called “syringe” in these instructions). Each Tysabri carton contains two syringes. You will need to use both syringes, within 30 minutes of each other, to get your full dose.
In case of self-administration or administration by a caregiver, your healthcare
professional should show you or your caregiver how to prepare and inject the syringes before you use them the first time. If you or your caregiver are administering the injections and have missed a dose or have injected only one syringe, contact your pharmacist or treating physician.
The syringes are for subcutaneous injection only (inject directly into the fatty layer under
the skin).
- Each syringe can only be used one time (single use). They cannot be reused.
Do not share your syringes with other people, even if their illness is the same as yours.
You may give an infection to them or get an infection from them.
Note for healthcare professionals:
Patients should be observed during the subcutaneous injections and for 1 hour after for signs and symptoms of injection reactions including hypersensitivity. After the first six Tysabri doses, regardless of route of administration, patients should be observed after subcutaneous injection according to clinical judgement.
- Keep the syringe and all medicines out of sight and reach of children.
- Store the syringes in the refrigerator (2 °C to 8 °C).
If needed, syringes may be stored at room temperature (up to 30 °C) and up to
24 hours in total. If the syringes have been out of refrigerator for more than 24 hours, do not use them.
- Keep the syringes in the original carton to protect them from sunlight.
- Do not freeze the syringes or expose to temperatures above 30 °C.
- The syringes can be returned to the refrigerator and used before the expiry date stated on the label and carton.
solution for injection in pre-filled syringe natalizumab
Do not use external heat sources, such as hot water, to warm
the syringes.
Do not touch, fan or blow on the clean area.
Collect the Supplies.
Collect the supplies and place them on a clean,
flat surface in a well-lit area.
1 Remove 2 Syringes from the
Refrigerator and Wait 30 Minutes.
Take the carton, containing TWO syringes, out of the refrigerator and let
them come to room temperature (up to 30 °C) for at least 30 minutes.
2 Wash and Dry Hands.
Wash your hands well with soap and water.
Then dry your hands.
3 Check the Syringes.
4 Choose the 1st Injection Site.
a. Use one of the following injection sites:
Abdomen (at least 6 centimetres away from the
belly button)
- Front of the thigh
Upper outer arm (this is for caregiver
administration only)
b. Do not inject into an area of the body where the skin
is tender, red, infected, bruised or has scars.
c. Change (rotate) injection sites between injections. 5
a. Wipe the skin with an alcohol wipe.
b. Let the injection site air dry before injecting the dose.
6
Preparing to Inject Tysabri
Do not use the syringe if the expiration date has passed.
a. Check the expiration date on both syringes (callout a).
Do not use the syringe if it is damaged or cracked.
b. Check the syringes to see if they are damaged or cracked (callout b).
Do not use the syringe if the liquid has visible particles.
Do not use the syringe if it has been dropped prior to using it. Notify your healthcare professional if you have any of these issues with the syringes.
c. Check that the medicine in both syringes is colourless to slightly yellow, slightly
opalescent to opalescent (pearly), and free of visible particles (callout c).
You may see bubbles in the medicine. This is normal.
Note: The appearance of the medicine may change after it is removed from the
refrigerator. This is normal.
Clean the
1st Injection Site.
30 min
Sharps Disposal Container
Alcohol
Wipe Gauze Pad Adhesive
Bandage
LOT
EXP YYYY-MM
a
b c
= Self- injection = Caregiver
90°
OK 45°
If the needle guard does not activate to cover the needle, do
not recap the syringe. Place it in the sharps disposal container
and contact your healthcare professional for assistance.
Do not touch or re-cap the needle. You could get a
needle stick injury.
Do not pull on the plunger rod.
When the syringe is empty, begin releasing the plunger and remove
the syringe from the injection straight out until the entire needle is
covered by the needle guard.
- Apply a gauze pad or adhesive bandage to your injection site, if needed.
Injecting Your 1st Syringe
Remove the Needle Cap.
a. Hold the syringe body with one hand with the needle pointing up.
b. With your other hand, firmly hold the needle cap and pull it straight off
the needle.
c. Dispose of the needle cap right away after removing it.
Note: you may see a drop of liquid on the needle tip. This is normal.
7 Insert the Needle into the 1st Site.
a. Pinch the skin around the cleaned
injection site.
b. With your other hand, hold the syringe
like a pencil and use a quick, dart-like
motion to insert the needle at an angle
of 45 to 90 degrees until the needle is
fully under the skin.
8 Give Your 1st Injection.
a. After the needle is in the skin, release the
pinched skin.
b. Slowly push the plunger all the way down as
far as it will go to inject all of the medicine.
9 Remove the Needle from the Injection Site.
10 11
Make sure you push the plunger rod all the
way down to get all your medicine and
engage the needle guard.
Check and Care for Your Injection Site.
plunger rod
Injecting Your 2nd Syringe
After use:
Once the syringe is empty and the plunger
is released, the needle guard is designed to
cover the entire needle.
INSTRUCTIONS FOR USE
Give Your 2nd Injection.
a. Repeat steps 7-11 to inject the SECOND syringe to get your full dose.
Administer injections one after the other without significant delay. The second injection should be administered no later than 30 minutes after the first injection.
SYRINGES FOR YOUR FULL DOSE
USE
FULL D O SE YOUR