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If you have experienced any adverse side effects from a medication or therapy -
Natalizumab -
Tysabri -
A monoclonal antibody which inhibits the migration of white cells into the central nervous system, thus reducing inflammation. It is licensed for the treatment of very active relapsing – remitting multiple sclerosis in those cases where interferon treatment has failed. The medication is given intravenously once every four weeks.
In MS, white blood cells attack the nervous system because the body mistakes its own nerves for a foreign cell. Tysabri works by reducing the number of white blood cells which can leave the blood and enter the nervous system, therefore reducing the damage to the nervous system.
This mechanism of action is different to that used by treatments that have been used
in treating MS (interferon-
Side effects may occur
- Dizziness .
- Nausea.
- Fatigue.
- Headaches.
- Hypersensitivity (allergic) -
If this is the case, Tysabri treatment will be stopped permanently. - Itchy rash (hives).
- Joint pains.
- Skin reactions.
- Sore throat and runny or blocked nose.
- Shivering or fever.
- Tiredness.
- Urinary tract infection.
- Vomiting.
Adverse side effects may occur
The very nature of the drugs mechanism of action has led to the detection of a number of cases of Progressive Multifocal Leukoencephalopathy (PML is a rare and usually fatal viral disease that is characterized by progressive damage or inflammation of the white matter of the brain at multiple locations. It occurs almost exclusively in people with severe immune deficiency).
This very serious disease of the brain is more likely to occur when taking Tysabri
and so regular MRI scanning needs to be undertaken in all such patients. For this
reason the medication is only to be prescribed in major neuroscience centres, by
specially experienced neurologists. To date, PML has only been reported in patients
taking Tysabri together with other drugs which affect the immune system or in people
whose immune system is not as strong as it should be. Therefore Tysabri is given
as a ‘monotherapy’ i.e. On its own. This means that a person should not take medicines
which affect the immune system at the same time as Tysabri including drugs like interferon-
PML usually leads to severe disability or death.
Source: biogen idec (November 22nd 2007)
Tysabri Summary of Product Characteristics November 2007
National Institute for Heath and Clinical Excellence Natalizumab for Adults with Highly Active Relapsing Multiple Sclerosis Technology Appraisel Guidance 127 August 2007.
Scottish Medicines Consortium. Resubmission. Natalizumab 300 mg concentrate for solution infusion (Tysabri®, No (329/06). September 2007.
Efficacy
In clinical trials, Tysabri has been shown to approximately halve the progression of the disabling effects of MS and also decrease the number of MS relapses by approximately two thirds.
Contraindications -
- A patient is allergic (hypersensitive) to any of the ingredients of Tysabri.
- A patient has a serious problem with their immune system (due to a disease, e.g. Leukaemia / HIV, or due to a medicine they are taking or have previously taken.)
- A patient is taking medicines that cannot be used with Tysabri.
- A patient has cancer (unless it is a type of skin cancer called basal cell carcinoma.)
- A patient is / are under 18 years of age.
- A patient is over 65 years of age.
- Clinicians need to consider the occurrence of infusion reactions, with especially delayed reactions occurring more frequently than previously assumed.
- Delayed infusion reactions occurred in 4 of 40 relapse-
remitting multiple sclerosis patients treated with natalizumab. [1] Archives of Neurology