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You are encouraged to report negative side effects of prescription drugs.

PML usually leads to severe disability or death.

More detailed information on Tysabri can be found by going to - medicines.org.uk

Typing Tysabri in the search box and pressing go will give you the option to view a patient information leaflet on Tysabri.

1. Tysabri Summary of Product Characteristics November 2007

2. National Institute for Heath and Clinical Excellence Natalizumab for Adults with Highly Active Relapsing Multiple Sclerosis Technology Appraisel Guidance 127 August 2007.

3. Scottish Medicines Consortium. Resubmission. Natalizumab 300 mg concentrate for solution infusion (Tysabri®, No (329/06). September 2007.

Source: biogen idec (November 22nd 2007)

Possible link to Melanoma

Almost immediately after a 46-year-old woman with multiple sclerosis received her first dose of the drug Tysabri, a mole that had been on her shoulder for years suddenly took on a dangerous new character. It turned out to be a melanoma that spread like wildfire. The woman now has just a few months to live.

At almost the same time, a 45-year-old woman who also has multiple sclerosis developed melanoma in her retina after receiving several doses of Tysabri. She had a family history of melanoma and also had atypical moles on her body; the mole on her retina went back at least nine years.

Although these are just two -- albeit dramatic -- examples, the authors of a letter in the Feb. 7 issue of the New England Journal of Medicine are cautioning doctors who care for MS patients to keep this potential risk in mind.

"Neurologists who have patients who report a family history of melanoma or have funny moles should send them to a dermatologist first. Don't just start them on drugs [Tysabri]," said Dr. John Thomas Mullen, co-author of the letter and a surgical oncologist with Beth Israel Deaconess Medical Center, in Boston.

"I can't say it's cause-and-effect definitively because it's just an observation, but the first patient had had that mole forever. She took the drug and almost instantaneously the lesion changed," added Mullen, who saw both patients.

"We don't know if the two are related right now," said Patricia O'Looney, vice president of biomedical research at the National Multiple Sclerosis Society. "There are so many people taking Tysabri, we should go forward with caution... One should always consult with their doctor and go over their personal family history and decide what is best."

Tysabri (natalizumab), a monoclonal antibody that helps treat autoimmune disorders such as MS and Crohn's disease, has had a clouded history. It first received U.S. Food and Drug Administration approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed a rare but deadly viral infection of the brain called progressive multifocal leukoencephalopathy.

In June 2006, the FDA allowed the drug back on the market but with strict conditions governing its use.

Just last month, the FDA approved Tysabri to treat people with a moderate to severe form of Crohn's disease.

But there is basic science to support Mullen's observations.

One of the participants in an earlier study of Tysabri had developed (and subsequently died of) a metastatic melanoma that appeared as soon as he got his first dose of the drug, Mullen said.

And in a study done before Tysabri received FDA approval, melanomas in mice that were given the drug had an increased tendency to detach from the primary tumor and spread.

Tysabari may have a dampening effect on the immune system that encourages the formation of the potentially deadly skin cancer, the letter stated.

“And now that Tysabri has been approved for people with Crohn's disease, more people may be at risk, although those with no family history of melanoma and no moles probably don't need to worry” Mullen said.

"Doctors should ask for a family history of melanoma and do a quick skin check," he said. "Tysabri isn't the only drug in our arsenal. You could give the patient something else if you were concerned about that."

Continued

Tysabri-Natalizumab as a treatment for Multiple Sclerosis is indicated for people with highly active relapsing remitting multiple sclerosis.

Update Autumn 2007.

Uses 1,2,3

Tysabri (natalizumab was licensed across The EU in June 2006 for use in people With highly relapsing remitting multiple sclerosis (RRMS).

Tysabri is used to treat active relapsing-remitting multiple sclerosis (RRMS). Highly active RRMS is defined by 2 or more relapses in a year and an active

MRI scan.

NICE issued guidance recommending Tysabri for use on the NHS in England and Wales in August 2007. In September 2007 SMC issued its advice on the use of Tysabri in Scotland.

As of September 2007, approximately 17,000 MS patients worldwide are currently receiving therapy with Tysabri, either in the commercial setting or in clinical trials.

Class 1

Tysabri-represents a novel class of MS treatments called selective adhesion molecule (SAM) inhibitors.

Efficacy 1

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.

Mode of Action 1.

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-beta and glatiramer acetate.)

Administration 1.

Tysabri-is administered by intravenous infusion, or drip, once every four weeks; including tests and checks, this process takes about two hours.

Contraindications 1.

Tysabri should not be given if:

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.

Note

TYSABRI is not used in people under 18 years or over 65 years due to lack of data in this population - therefore TYSABRI is currently not licensed for these age groups

Precautions and side effects 1.

Side effects which occur more often with Tysabri include urinary tract infection, sore throat and runny or blocked nose, shivering or fever, itchy rash (hives), headache, dizziness or vomiting or tiredness.

Some people may experience a hypersensitivity (allergic) reaction to Tysabri. If this is the case, Tysabri treatment will be stopped permanently.

People using Tysabri may develop neutralising antibodies. This is because Tysabri is a foreign protein and the body’s immune system naturally produces antibodies against foreign proteins. Some people continue to produce neutralising antibodies - in this case called “persistent antibodies”. If this occurs the effectiveness of Tysabri will be reduced. In trials 6% of patients developed “persistent antibodies” and therefore stopped treatment with Tysabri.
There have been very rare reports of a brain infection called Progressive Multifocal Leukoencephalopathy (PML). 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-beta. In addition Tysabri should not be given to people whose immune systems have reduced effectiveness e.g. HIV or Leukaemia.