150 mg solution for injection in a pre-filled syringe
What Tysabri is and what it is used for
Tysabri is used to treat multiple sclerosis (MS). It contains the active substance natalizumab. It is a so-called monoclonal antibody.
MS causes inflammation in the brain that damages nerve cells. This inflammation occurs when white blood cells enter the brain and spinal cord. This medicine
prevents the white blood cells from entering the brain. This reduces the nerve damage that MS causes.
Symptoms of multiple sclerosis
The symptoms of MS can vary from patient to patient, and you may notice some of them or none at all.
They may include; difficulty walking, numbness in the face, arms, or legs, vision problems, tiredness, feeling off balance or dizziness, bowel and bladder problems, difficulty thinking and concentrating, depression, acute or chronic pain, sexual problems, stiffness, and muscle cramps.
When the symptoms flare up, it is called a relapse (can also be called exacerbation or attack). When you have a flare -up, symptoms may come on suddenly, within hours, or they may develop slowly over several days. After that, the symptoms usually gradually get better (this is called remission ).
How Tysabri can help
In clinical trials, this drug has approximately halved the rate of progression of the disabflare-upects of MS and also reduced the number of MS relapses by approximately two-thirds. While you are being treated with this medicine, you may not notice any improvement, but it may still work to keep your MS from getting worse.
What you need to know before you receive Tysabri
Before you start using this medicine, it is important that you and the doctor have discussed what benefits you can expect from the medicine and what risks 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 did you and the doctor mustML is a less common infection of the brain.
- If you have a serious problem with the immune system. This can be due to illness (such as HIV ) or be a consequence of any medicine you are using or have used in the past (see below).
- If you are taking medicines that affect the immune system including certain other medicines used to treat MS. These medicines must not be used at the same time as Tysabri.
- If you have cancer (unless it is a type of skin cancer called basal cell carcinoma ).
Warnings and precautions
You should talk to your doctor about whether Tysabri is the most appropriate treatment for you. Do this before you start taking this medicine, and when you have had it for more than two years.
Possible infection of the brain (PML)
Some people receiving this medicine (fewer than 1 in 100) have developed a less common brain infection called PML ( progressive multifocal leukoencephalopathy ). PML can lead to severe disability or death.
- Before treatment begins, blood samples are taken from all patients to clarify JC virus infection. The JC virus is a common virus that does not normally make you sick. However, PML is associated with an increase in JC virus in the brain. The reason for this increase in some patients treated with Tysabri is unknown. The doctor will take a blood test before you start the treatment and during the treatment to check if you have antibodies against the JC virus , which is a sign that you have been infected with ththe e JC virus .
- The doctor does a magnetic resonance imaging (MRI) scan that will be repeated during treatment to rule out PML.
- The symptoms of PML can be similar to an MS relapse ( see section 4, Possible side effects ). You can also get PML for p to 6 months after stopping Tysabri treatment.
- Tell your docto as soon as possible if you think your MS is getting worse or if you notice new symptoms while you are being treated with Tysabri or for up to 6 months after you stop treatment.
- Talk to your partner or caregiver about the signs to look out for (see also section 4, Possible side effects ). Some symptoms may be difficult to notice yourself, such as mood or behavior changes, confusion, and speech, and communication difficulties. If you get any of these, you may need further tests. You should be aware of symptoms that may occur for up to 6 months after the end of Tysabri treatment.
- Save the patient information card that was given to you by the doctor. It includes this information. Show it to your partner or caregiver.
Three things can increase your risk of PML associated with Tysabri treatment. If you have two or more of these risk factors, your risk increases further:
- If you have antibodies against the JC virus in your blood. These are a sign that you have the virus in your body. You will be tested before and during Tysabri treatment.
- If you are treated for a long time with Tysabri, especially if you have been treated for longer than two years.
- If you have previously taken a medicine called an immunosuppressant medicine, which can reduce the activity of your immune system.
Another condition called JCV GCN ( JC virus granule cell neuronopathy ) is also caused by the JC virus and has occurred in some patients receiving this medicine. The symptoms of JCV GCN are similar to PML.
For those at a lower risk of PML, the doctor may repeat the test regularly to check that:
- you still do not have antibodies against the JC virus in your blood.
- you still have a lower level of JC virus antibodies in your blood if you have been receiving treatment for more than 2 years.
If you get PML
PML can be treated and Tysabri treatment should be discontinued. However, some patients experience a reaction when Tysabri is removed from the body. This reaction (called IRIS or Immune Reconstitution Inflammatory Syndrome ) can lead to the worsening of your condition, including deterioration of brain function.
Be aware of other infections
Other infections besides PML can also be serious and can be caused by viruses, bacteria, and other causes.
- Tell the doctor or nurse immediately if you think you have an infection (see also section 4. Possible side effects ).
Changes in platelets
Natalizumab can reduce the number of platelets, which are responsible for blood clotting. This can lead to a condition called thrombocytopenia (see section 4) where the blood may not clot quickly enough to stop a bleed. This can lead to bruising as well as other serious problems, such as extensive bleeding. You should see a doctor immediately if you have unexplained bruising, red or purple spots on the skin (called petechiae ), bleeding from a cut that does not stop or if blood is oozing from the wound, persistent bleeding from the gums or nose, blood in the urine or stool or bleeding in the whites of the eyes.
Children and young people
Other medicines and Tysabri
Tell the doctor if you are using, have recently used, or might be using other medicines.
- You must not be given this medicine if you are currently being treated with medicines that affect your immune system, including some other medicines to treat MS.
- You may not be able to use this medicine if you have previously received medicines that affected your immune system.
Pregnancy and breastfeeding
- Do not use this medicine if you are pregnant, unless you have first discussed this with the doctor. Make sure you tell the doctor right away if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
- Do not breast-feed while being treated with Tysabri. You should discuss with the doctor whether you should choose to stop breastfeeding or stop using this medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicbreastfeedsk on the baby and the benefit to the mother will be considered by the doctor.
Driving ability and use of machinery
If you experience dizziness, which is a very common side effect, you should not drive or use machinery.
Tysabri contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 300 mg dose, i.e. it is almost “sodium-free”.
How Tysabri is given
A doctor experienced in treating MS will give you Tysabri as an injection. Your doctor may switch you directly from another medicine for MS to Tysabri if there are no signs of problems caused by your previous treatment.
- The doctor takes blood samples to test for antibodies to the JC virus and other possible problems.
- The doctor will do a magnetic resonance imaging (MRI) scan which will be repeated during the treatment.
- To switch from certain medicines used to treat MS, your doctor may advise you to wait a certain amount of time to ensure that most of the previous medicine has left your body.
- The recommended dose for adults is 300 mg once every four weeks.
- Each dose is given as two injections under the skin in the thigh, abdomen, or back of the arm. This takes up to 30 minutes.
- Information for doctors or healthcare professionals on how to prepare and inject the medicine can be found at the end of this leaflet.
If you stop using Tysabri
Regular dosing with this drug is important, especially during the first months of treatment. It is important to continue taking your medicine for as long as you and your doctor think it is helping you. Patients who received one or two doses of Tysabri and then had a break in treatment of three months or more have been more likely to have an allergic reaction when treatment was resumed.
Some patients have had allergic reactions to this medicine. The doctor may check during the injection and 1 hour afterward if you get any allergic reaction. See also section 4, Possible side effects.
If you miss your Tysabri dose
If you should miss your regular Tysabri dose, you must agree with the doctor to receive it as soon as possible. After that, you can continue to receive Tysabri every four weeks.
Does Tysabri always work?
In some patients receiving Tysabri, the body’s natural defenses may eventually prevent the drug from working as it should when the body develops antibodies against the drug. The doctor can find out if this medicine is not working properly for you by taking a blood test and will, if necessary, stop your treatment.
Ask your doctor if you have any further questions about Tysabri. Always use this medicine exactly as described in this leaflet or as directed by your doctor. Consult a doctor if you are unsure.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell the doctor or nurse straight away if you notice any of the following:
Signs of an infection in the brain
- Changes in personality and behavior, such as confusion, delirium, or loss of consciousness
- Convulsions (seizures)
- Neck stiffness
- Extreme sensitivity to bright light
- Rash (anywhere on the body)
These symptoms can be caused by an infection in the brain ( encephalitis or PML ) or the membranes around the brain ( meningitis ).
Signs of other serious infections
- Unexplained fever
- Severe diarrhea
- Shortness of breath
- Prolonged dizziness
- Weight loss
- Impaired vision
- Pain in the eye(s) or red eyes
Signs of an allergic reaction
- Itchy rash ( hives )
- Swelling of the face, lips, or tongue
- Difficulty breathing
- Pain or discomfort in the chest
- Increased or decreased blood pressure (the doctor or nurse will notice this if they check your blood pressure ).
These signs are most likely during or shortly after injection one.
Signs of possible liver problems
- Yellowing of the skin or the whites of the eyes
- Unusual darkening of the urine
- Abnormal liver function tests
Talk to a doctor or nurse straight away if you get any of the side effects listed above or if you think you have an infection.
Show the patient information card and this leaflet to all treating doctors or nurses, not just the neurologist.
Other side effects are
Very common (may affect more than 1 in 10 patients)
- Urinary tract infection
- Sore throat and runny or stuffy nose
- NauseaJoint pain
Common (may affect up to 1 in 10 patients)
- Anemia (decreased levels of red blood cells which can lead to paleness and can cause feeling short of breath or lack of energy)
- Allergy (hypersensitivity)
- Itchy rash ( hives )
- Difficulty breathing ( dyspnea )
- Flushing of the face or body ( hot flushes )
- Herpes infections
- Discomfort at the injection site. You may experience pain, bruising, redness, itching, or swelling
Uncommon (may affect up to 1 in 100 patients)
- Severe allergy ( anaphylactic reaction )
- Progressive multifocal leukoencephalopathy (PML)
- Inflammatory disorder after discontinuation of the drug
- Swelling in the face
- An increased number of white blood cells ( eosinophilia )
- Decreased number of platelets
- Easy bruising (purpura)
Rare (may affect up to 1 in 1,000 patients)
- Herpes infection in the eye
- Severe anemia (decreased levels of red blood cells which can lead to paleness and can cause feeling short of breath or lack of energy)
- Severe swelling under the skin
- High levels of bilirubin in the blood ( hyperbilirubinemia ) can cause symptoms such as yellow eyes or skin, fever or fatigue
Frequency not known (cannot be estimated from available data)
- Unusual infection in the brain and eyes
- Liver damage
Talk to the doctor as soon as possible if you think you have an infection.
You will also find this information on the patient information card given to you by the doctor.
How to store Tysabri
Keep this medicine out of sight and reach of children.
Use before the expiry date stated on the label and carton. The expiration date is the last day of the specified month.
To be kept in the refrigerator.
Do not freeze.
The syringes can be stored at room temperature (maximum 25 °C) for up to 24 hours in the original packaging. Do not put the syringes back in the refrigerator. Store the syringes in the outer carton. Light sensitive.
Do not use this medicine if you see particles in the liquid and/or the liquid in the syringe is discolored.
Contents of the packaging and other information
The active substance is natalizumab.
Each 1 ml pre-filled syringe contains 150 mg of natalizumab.
Other ingredients are:
Sodium dihydrogen phosphate monohydrate
Disodium hydrogen phosphate heptahydrate
Sodium chloride (see section 2 “Tysabri contains sodium”)
Polysorbate 80 (E433)
Appearance and package sizes of the medicine
Tysabri is a colorless to slightly yellow, slightly opalescent to opalescent liquid.
Each pack contains two syringes.
Marketing Authorisation Holder
Biogen Netherlands BV
Prins Mauritslaan 13
1171 LP Badhoevedorp
FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1
Biogen Netherlands BV
Prins Mauritslaan 13
1171 LP Badhoevedorp