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.
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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.
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The Tysabri TOUCH Prescribing Program
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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).
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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 |
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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 |
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TYSABRI must be administered only to patients who are
enrolled in and meet all the conditions of the TOUCH Prescribing Program |
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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 |
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Enrollment in TOUCH (the REMS program) is required to
prescribe, receive, administer, or distribute TYSABRI |
Tysabri®
and TOUCH® are registered trademarks of Biogen
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