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PML and DMTs
We are including this section due to the possible risk of contracting progressive multifocal leukoencephalopathy (PML) while taking Tysabri and other disease-modifying therapies (DMTs) that are used to specifically treat multiple sclerosis (MS).

Now let this be clearly understood. The mentioning of the following medications should in no way make your treatment choice for you, good or bad. Every medication has side effects of one kind or another, severity from mild to extreme, and some just don't work on every person. The medications that we are discussing below are extremely effective in the treatment of MS, and can work perfectly fine for many people. All we are doing here is making sure that you are aware of a possibly severe side effect, that being PML. And the best way to make a fully informed decision on a proper treatment for you, and nobody else, is to learn as much about each medication and discuss each option with your doctor.

Tysabri and PML

Tysabri increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include duration of therapy, prior use of immunosuppressants, and presence of anti-JC Virus antibodies. These factors should be considered in the context of expected benefit when initiating and continuing treatment with Tysabri.

Because of this risk of contracting PML while taking Tysabri, we are providing this you with this information. This isn't meant to make anyone's decision on which treatment to begin or end, but rather to provide any pro's or con's so whatever the decision is, it can be an informed decision. If the risk was a headache, rash, or even gas, that wouldn't be a concern. PML usually happens in individuals with weakened immune systems, however, no one can predict who will get PML. The chances may be higher if people are also being treated with medications that weaken their immune system, including other MS treatments.

Tysabri also increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses. Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in MS patients receiving Tysabri. Other serious adverse events that have occurred in Tysabri-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in patients treated with Tysabri in the post-marketing setting. A list of adverse events can be found in the full Tysabri product labeling for each country where it is approved.

If Tysabri is possibly a cause or contributor to those few who have contracted PML, then it must be mentioned. It needs to be understood that no treatment, medication, or even life in general is 100% safe, and it's important to know what one's risks are prior to making any decision. This is not saying that Tysabri should not be considered, but rather that it must be considered carefully as a treatment option and discussed with one's doctor and family. The use of any medication has a risk along with it and that specific risk is never the same in any two people.

Because of the increased risk of PML, it's generally recommended only for patients who have had an inadequate response to, or are unable to tolerate alternate MS therapies. Before you receive your first dose of Tysabri, your doctor should have an MRI taken to make sure you don't have any signs of a brain infection. During your treatment, it's extremely important that your doctor check you every 3 to 6 months to make sure you are not developing any signs of serious infection.

If Tysabri is used alone to treat MS, there is still a chance of getting PML. The chance of getting PML increases with a longer period of treatment. Tysabri may increase your chance of getting an unusual or serious infection, because it can affect your immune system. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid contact with people who have colds, the flu, or other contagious illnesses and contact your doctor immediately if you develop signs of infection.

Some doctors have also started giving patients a holiday (short period without any treatment) from Tysabri in an effort to avoid PML. In such scenarios, a patient takes Tysabri for two years before taking a break from the drug and turning to other therapies if needed for treatment.

Just know that whatever medication any patient chooses, there is always a chance that it may or may not work for them. There is also a chance of side effects associated with that medication that will more than likely differ with every person taking it. It comes down to how risk adverse each person is and the outcome they expect from each treatment.

Healthcare professionals should monitor patients on Tysabri for any new sign or symptom that may be suggestive of PML. Tysabri dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation including a gadolinium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

Gilenya and PML

Three cases of PML have been reported in people taking Gilenya (fingolimod). The risk of developing PML on Gilenya is considered very low but if you are worried, discuss your concerns with your doctor.

Before you start taking Gilenya, it's important that you have had a recent MRI scan. When you start treatment, you should be informed of the early signs and symptoms of PML. These can be similar to an MS relapse, so it's important to report any new or worsening symptoms. If PML is suspected during treatment, an MRI scan should be performed and Gilenya suspended until PML has been excluded.

Tecfidera and PML

Three cases of PML have been reported in people taking Tecfidera (dimethyl fumarate). The risk of developing PML on Tecfidera is considered very low but if you are worried, discuss your concerns again with your doctor.

Before you start taking Tecfidera, it is important that you have had a recent MRI scan. When you start treatment, you should be informed of the early signs and symptoms of PML. These can be similar to an MS relapse, so it is important to report any new or worsening symptoms. If PML is suspected during treatment, an MRI scan should be performed and Tecfidera suspended until PML has been excluded. The cases of PML have occurred in people who have had very low levels of lymphocytes (a type of white blood cell) for an extended period of time. Once you've started treatment you should have blood tests every three months to monitor your blood cell counts.

Other Medications and PML

Tysabri, Gilenya and Tecfidera are not the only drugs that has connections to PML. There have been several other drugs that have been linked to the deadly PML brain infections in recent years. The psoriasis drug Raptiva was recalled in April of 2009 due to PML infections, and the cancer drug Rituxan was recently connected to 57 cases of PML infection in a study published in the May 2009 issue of the medical journal Blood.

Safety Information
New safety information for the treatment for MS and Crohn’s disease that was posted on the FDAs Web site.

The following safety information to the below is associated with Tysabri as an effort to make sure that everyone associated with the drug is fully informed of it's possible link to PML. There is still no absolute proof that Tysabri is the reason or cause of those patients getting PML, but rather it is probably a contributing factor for some unknown reason, and because of that small possible chance this page is here.

There is a chance that Tysabri simply causes PML to arise a bit faster than it normally would in some people. Nobody knows for sure the degree of cause it has, but the odds are there and can't be ignored. There is a risk associated with any medication, the risk in this case may possibly be more severe, but that is a risk that only you and your doctor can make together.

The first three paragraphs on the "safety information" to the bottom right are there solely for PML. It's very important to understand what they are telling you and discuss this with your doctor if you are considering Tysabri as a treatment option or are already on it.

The typical symptoms associated with PML progress over days to weeks, and can include clumsiness and progressive weakness on one side of the body, disturbances of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. Changes of this kind should be reported immediately to your doctor.

There is no known treatment, prevention, or cure for PML, but doctors may try to rapidly remove Tysabri from a person's bloodstream through the use of plasma exchange (PLEX) to allow the immune system to re-establish itself. There is, however, no evidence that plasma exchange has any benefit in the treatment of opportunistic infections such as PML. Potential side effects of plasma exchange such as a drop in blood pressure or accumulation of fluid in the lungs are possible.
The Tysabri TOUCH Prescribing Program
Because of the risk of PML, Tysabri is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Tysabri Outreach: Unified Commitment to Health (TOUCH). The goal of the TOUCH Prescribing Program is to minimize the risk of PML. TOUCH was developed with the help of the Food and Drug Administration (FDA).
Because of the risk of PML, TYSABRI (natalizumab) is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH Prescribing Program
Under the TOUCH Prescribing Program (REMS program), only prescribers, infusion sites, and their associated pharmacies enrolled with the program are able to prescribe, distribute, or infuse TYSABRI
TYSABRI must be administered only to patients who are enrolled in and meet all the conditions of the TOUCH Prescribing Program
To enroll in the TOUCH Prescribing Program, prescribers and patients are required to understand the risks of treatment with TYSABRI, including PML and other opportunistic infections
Enrollment in TOUCH (the REMS program) is required to prescribe, receive, administer, or distribute TYSABRI

Tysabri® and TOUCH® are registered trademarks of Biogen