Treatment:

Tysabri® (natalizumab)

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The active ingredient of Tysabri® is natalizumab. Natalizumab is a humanised monoclonal antibody which locks onto certain immune cells, called T cells. Once the natalizumab is attached to the T cells, they cannot cross the blood brain barrier to attack the myelin or nerves.

Clinical trials found that Tysabri® has a significant beneficial effect in people with relapsing-remitting MS (RRMS) by reducing the accumulation of permanent physical disability, exacerbation frequency and disease activity measured by active lesions on brain magnetic resonance images (MRI).

Tysabri® is infused intravenously (into a vein) once every 28 days, usually at a hospital or infusion clinic. A nurse or other qualified health professional will monitor you before, during and after your infusion.

Tysabri® helps most people with MS, but may have side effects in some people. All medications have side effects. It is important to notify your health professional if you experience any side effects or are feeling unwell.

Common side effects of Tysabri® include urinary tract infections, sore throat, runny or blocked nose, headaches, dizziness, shivering, rash (hives), nausea, vomiting, joint pain, tiredness and fever.

A condition called Progressive Multifocal Leukoencephalopathy (PML) has been associated with taking Tysabri®. PML is a life threatening brain infection caused by the John Cunningham (JC) virus which manifests in people whose immune system has been suppressed. PML has also been associated with other immunosuppressive medications for MS. Your MS healthcare team will carefully monitor you for this condition with regular blood tests for JC virus antibodies and MRI scans.

Your neurologist will assist you to assess the risks and the expected benefit of treatment with Tysabri® prior to starting therapy and over the course of treatment. Your health professional can provide comprehensive information on the use of Tysabri®, including precautions and side effects.

There are no adequate and well-controlled studies of natalizumab therapy in pregnant women. This drug should be used during pregnancy only if the benefits outweigh the risks. If a woman becomes pregnant while taking natalizumab, discontinuation of therapy should be considered.

If you are currently pregnant or trying to become pregnant, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.

Natalizumab is excreted into breastmilk in some, but not all, women. The time of the peak level in breastmilk is variable but might be as long as 6 months. Because natalizumab is a large protein molecule, absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Some experts recommend avoiding breastfeeding with natalizumab, while others do not. Until more data become available, natalizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

If you are currently breastfeeding, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.

Tysabri® has been approved by the Therapeutic Goods Administration (TGA) for the treatment of patients with relapsing remitting MS and is available through the Pharmaceutical Benefits Scheme (PBS). Your neurologist will need to obtain an authority to prescribe the medication for you.

For details of the criteria required to receive a prescription for Tysabri® treatment through the PBS, please visit the official PBS website at: http://www.pbs.gov.au/medicine/item/9505G-9624M

You will need to click on the red Authority Required (STREAMLINED) link.

If you are eligible for medications through the PBS, you will need to pay a contribution fee each time your prescription is dispensed. The Federal Government pays for the remaining cost. The amount of the contribution fee depends upon whether or not you have a pension or concession card. The amount of this fee is set each year by the Federal Government.

Further information about the PBS, your entitlements and details regarding the PBS safety net (which protects patients and their families requiring a large number of PBS items) is available through the Medicare Australia website at: www.medicare.gov.au

If you are not eligible for Tysabri® through the PBS, for example if you are a visitor from overseas, your neurologist may write a private prescription. In this instance you will have to pay the full cost to the pharmacy that dispenses your medication. You will need to request a quote from your pharmacist for the price of any medication which is not subsidised by the PBS.

Tysabri® (natalizumab)

Forms of MS used for:
Relapsing remitting MS
Administration route:
Intravenous infusion (into vein)
Dosage and frequency:
Every 28 days
Storage:
Stored in the pharmacy or clinic at 2-8°C
TGA approval date:
November 2006
Available on PBS:
Yes
Manufacturer:
Biogen

General Information and Assistance

Generally, the clinic where you have your Tysabri® infused will take care of your prescription and order the medication for you.

If you do need to get Tysabri® dispensed at your local pharmacy, please remember they will need to place an order and have stock delivered especially for you. It is therefore important to give your pharmacist notice to organise the medication.

For more information

Speak to your neurologist about what treatment best suits your individual circumstances.

MS Nurses can also provide information, training and ongoing support in managing your immunotherapy.

MS Australia does not recommend any specific disease-modifying treatment for people living with MS. Decisions about any treatments, taking into consideration the potential benefits and side effects for each individual’s circumstances, should be made in careful consultation with the person’s neurologist.

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Tysabri®