TYSABRI contains the active ingredient natalizumab. TYSABRI is a type of protein used to treat relapsing remitting Multiple Sclerosis (MS).

The cause of MS is not yet known. MS affects the brain and spinal cord. In MS, the body's immune system reacts against its own myelin (the 'insulation' surrounding nerve fibres). In relapsing remitting MS, people have 'exacerbations' from time to time (e.g. blurred vision, weakness in the legs or arms, or loss of control of bowel or bladder function).

These are followed by periods of recovery. Recovery may be complete or incomplete. If it is incomplete there is 'progression of disability'.

TYSABRI decreases the inflammation in your brain that is caused by Multiple Sclerosis (MS) and thereby reduces nerve damage.

TYSABRI works by binding to white blood cells and preventing them from moving into the brain and spinal cord where they cause inflammation, an important part of the MS disease process.

TYSABRI slows down the progression of physical disability in people with relapsing remitting MS and decreases the number of flare-ups (relapses). Some people feel better when they start to take TYSABRI. However, TYSABRI cannot repair damage that has already been caused by MS.When you start on TYSABRI you might not notice any improvement, but TYSABRI may be working to help prevent your MS from becoming worse.

TYSABRI has not been tested in clinical trials in people with MS who are 65 years and over. TYSABRI has not been studied in patients with chronic progressive MS.

How much to use:

• The recommended dose of TYSABRI is 300 mg given once every 4 weeks.
• Follow all directions given to you by your doctor, nurse or pharmacist carefully.

When to use TYSABRI:

• TYSABRI is given once every 4 weeks.

How to use TYSABRI:

• TYSABRI will be prepared and given to you by a doctor or nurse.
• TYSABRI for infusion will be diluted before it is given to you. It is given as a drip through a needle placed into a vein (IV infusion), usually in your arm. This takes about 1 hour.
• TYSABRI injection in prefilled syringes requires no preparation. It is given as two injections just under the skin of your thigh, abdomen or upper arm.
• A few patients have had an allergic reaction to TYSABRI. Your doctor or nurse will check for allergic reactions during the infusion or injection and for 1 hour afterwards.
• The positive effects of TYSABRI may not be seen immediately.
• They occur with long-term treatment. It is important to continue treatment with TYSABRI unless your doctor tells you to stop.
• Do not interrupt your treatment, especially during the first few months. Patients who received up to 3 doses of TYSABRI followed by a gap in treatment of 3 months or more, were more likely to have an allergic reaction when restarting treatment.

TYSABRI is given once every 4 weeks. If you miss one of your treatments, you should have it as soon as possible, unless your doctor has told you otherwise. Then resume your regular monthly schedule.

As TYSABRI is given to you under the supervision of a doctor or nurse, it is unlikely that you will receive too much.

Nevertheless, if you think that you have been given too much TYSABRI, you may need urgent medical attention.

You should immediately:

• Phone the Australian Poisons Information Centre (by calling 13 11 26), or the New Zealand National Poisons Information Centre (by calling 0800 POISON or 0800 764 766), or
• Contact your doctor, or
• Go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

• Infusion with TYSABRI should start as soon as possible after the medicine has been diluted. If not used immediately, the solution must be stored at 2°C to 8°C and infused within 72 hours of dilution.
• The prefilled syringes can be kept in their original packaging for up to 24 hours at room temperature. The prefilled syringe should notbe returned to refrigeration. Do not use external heat sources, such as hot water, to warm the prefilled syringe.

TYSABRI helps most people with MS but it may have unwanted effects in a few people. All medicines have side effects. Sometimes they are serious, most of the time they are not.

See the information below and, if you need to, ask your doctor, nurse or pharmacist if you have any further questions about side effects.

Less serious side effects:

• Respiratory-related:
• Sore throat
• Runny or blocked nose
• Digestion system-related:
• Feeling sick (nausea)
• Being sick (vomiting)

Urine system-related:

• Pain or stinging when passing urine
• Nervous system-related:
• Headache
• Dizziness
• Tiredness

Non-specific effect on the body:

• Shivering
• Itchy rash (hives)
• Joint pain
• Fever

Serious side effects:

Infection-related:

• Unexplained fever, severe diarrhoea, prolonged dizziness, headache or stiff neck, weight loss, listlessness, impaired vision, pain or redness of the eye(s)

Liver-related:

• Yellowing of the skin or eyes (also called jaundice)

Blood-related:

• Tiredness, headaches, shortness of breath when exercising, dizziness, or looking pale, which may be signs of severe anaemia due to a decrease in red blood cells.

Allergic reaction-related:

• Itchy rash or hives
• Swelling of your face, lips, tongue or other parts of the body
• Shortness of breath, wheezing, difficulty breathing, chest pain or discomfort.
• These can be signs of very serious side effects. If you have them, you may have had a serious allergic reaction to TYSABRI.

Serious infection of the brain related:

• Psychological or intellectual changes such as changes in personality and behaviour, difficulty performing mental tasks, confusion, delirium or loss of consciousness, seizures (fits), headache, nausea/vomiting, stiff neck, extreme sensitivity to bright light, fever, rash

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

In particular, tell your doctor if you are being treated or have previously been treated with any medicine that affects immune function.

Examples of such medicines may include:

• medicines used for autoimmune diseases or after organ transplant, e.g. azathioprine
• cancer drugs, such as mitoxantrone
• steroids, e.g. for asthma, arthritis or skin disease.

You may not be able to take some medicines that affect your immune system at the same time as having treatment with TYSABRI.

There are many medicines that can affect immune function. It is a good idea to keep a list of your medicines and take it with you when you go to your doctor or treatment centre.

Check with your doctor, nurse or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect TYSABRI.

1. Why am I using TYSABRI?
   1. TYSABRI contains the active ingredient natalizumab. TYSABRI is used to treat relapsing remitting Multiple Sclerosis (MS).
2. What should I know before I use TYSABRI?
   1. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
3. What should I know while using TYSABRI?
   1. Things you should do
      • Remind any doctor, dentist, nurse or pharmacist you visit that you are using Tysabri.
      • Call your doctor straight away if you or your partner or caregiver notice any new or worsening medical problems (fever or infection, new or sudden change in your thinking, eyesight, balance or strength)
   2. Things you should not do
      • Do not stop using this medicine without checking with your doctor.
   3. Driving or using machines
      • Be careful before you drive or use any machines or tools until you know how TYSABRI affects you.
      • TYSABRI may cause dizziness in some people.
   4. Drinking alcohol
      • Tell your doctor if you drink alcohol.
   5. Looking after your medicine
      • Keep TYSABRI in the refrigerator at 2°C to 8°C.
      • TYSABRI must not be frozen.
      • Keep TYSABRI in the pack until it is time to use it.

Ace provides accurate and independent information medically reviewed on prescription medications. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.