One of the biggest challenges of living with multiple sclerosis (MS) is the
uncertainty you face every day. These frequently asked questions
(FAQs) about multiple sclerosis and TYSABRI may help to address some of
these concerns. If you have additional questions, your healthcare professional
is still your best source for information.
What is
multiple sclerosis?
How do
the nerves in the brain work?
How
does multiple sclerosis affect the nerves?
What
are common multiple sclerosis symptoms?
What causes
multiple sclerosis?
Who can get
multiple sclerosis?
How many
people have multiple sclerosis?
How many
forms of multiple sclerosis are there?
What form
of multiple sclerosis is most common?
Why is
multiple sclerosis treatment so important?
When
should multiple sclerosis treatment be started?
What
multiple sclerosis treatments are available?
How is
TYSABRI different?
Where do
infusions take place?
How long
does an infusion take?
What if I
miss an infusion?
What is
the Pre-infusion Patient Checklist?
Who is
TYSABRI for?
How do you
decide if you have not been helped enough by or cannot tolerate other multiple
sclerosis treatments?
How much
could TYSABRI help me?
Should I
switch from the multiple sclerosis therapy I'm taking now?
I have
relapsing multiple sclerosis and have never tried any of the disease-modifying
therapies. Will I be able to use TYSABRI?
Can I
switch to TYSABRI if I'm on another multiple sclerosis drug right now?
How can
I receive TYSABRI?
What is
the TOUCH™ Prescribing Program?
How do
I enroll in the TOUCH Prescribing Program?
Who should
not receive TYSABRI?
What are
the possible side effects of TYSABRI?
How many
cases of PML were there in clinical trials?
I read that
the FDA has given TYSABRI a "Boxed Warning." What does that
mean?
What are
the signs of PML that a person using TYSABRI should look out for?
What is
the treatment for PML?
How much
does TYSABRI cost?
Will my
insurance cover the cost of TYSABRI?
Does
Medicare cover the use of TYSABRI?
What is multiple sclerosis?
Multiple sclerosis is an autoimmune
disease affecting the central nervous system. An autoimmune disease is one
in which the immune system
attacks the body.
Normally, the immune system defends the body against foreign invaders such
as viruses or bacteria. Instead, in the case of MS, the body's immune system
attacks the nerves.
How do the nerves in the brain work?
Your brain contains nerve cells called neurons. Each neuron
is protected by a type of insulation called a myelin sheath.
The myelin also helps the neurons do their job of helping electrical impulses
travel to and from the brain.
How does multiple sclerosis affect the nerves?
In MS, the immune system
attacks the myelin sheath, damaging it. There can be so much damage that the
neuron itself is hurt or even broken. When this happens, the neuron cannot help
electrical impulses travel where they are supposed to go. This produces the
different symptoms of MS.
What are common multiple sclerosis symptoms?
Common multiple sclerosis symptoms include:
- Bladder and bowel problems
- Cognitive
difficulties
- Depression
- Fatigue
- Muscle rigidity or stiffness
- Weakness or poor coordination
- Numbness and tingling
- Pain in arms and legs
- Visual disturbances
What causes multiple sclerosis?
The exact cause of MS is unknown. However, these factors may lead to its
development: environmental elements (e.g., temperature), infectious agents
(i.e., bacteria or virus), and/or genetic
predisposition.
Who can get multiple sclerosis?
Anyone can get MS, although 2-3 times more women than men have MS. Most
patients are of northern European descent and are diagnosed between the ages of
20 and 50.
How many people have multiple sclerosis?
Worldwide, about 2.5 million people have MS. And in the US, over 400,000
people have MS.
How many forms of multiple sclerosis are there?
There are 4 different forms of MS. They are:
What form of multiple sclerosis is most common?
Relapsing-remitting is the most common. About 85% of people with MS are
first diagnosed with this form.
People have sudden, clearly defined flare-ups (also known as relapses,
attacks, or exacerbations). These flare-ups represent acute worsening of brain
function. They are followed by a time of partial or complete recovery
(remission).
Why is multiple sclerosis treatment so important?
Multiple sclerosis is like an iceberg. The part that you see above the water
is big.
- In MS, this would be relapses and other symptoms patients experience
But the part you can't see below the water is even bigger and can have an even
greater effect.
- In MS, brain
lesions can develop and permanent loss of brain tissue (atrophy) can occur
whether a person is having relapses and symptoms or not
When should multiple sclerosis treatment be started?
You should start multiple sclerosis treatment as soon as possible. Many
studies have shown that permanent nerve damage can happen during early
relapses. Limiting lesions may reduce permanent future disability for some
people with MS.
What multiple sclerosis treatments are available?
*AVONEX (Interferon beta-1a) is a registered trademark of Biogen Idec.
Betaseron® (Interferon beta-1b) is a registered trademark of Berlex. Rebif®
(Interferon beta-1a) is a registered trademark of Serono Inc and Pfizer Inc.
Copaxone® (glatiramer acetate injection) is a registered trademark of Teva
Pharmaceutical Industries Ltd. Novantrone® (mitoxantrone) is a registered
trademark of EMD Serono, Inc.
How is TYSABRI different?
TYSABRI is an antibody, not an interferon or glatiramer
acetate. It is thought to inhibit white blood
cells from getting into the brain and attacking nerves. Keeping these cells
from attacking nerves is believed to result in fewer brain lesions that cause
multiple sclerosis symptoms.
It is important to note that while the way in which TYSABRI works has been
studied, the exact way that TYSABRI works is not fully known.
TYSABRI is infused into a vein once every 4 weeks, so you don't need to self
inject.
Where do infusions take place?
TYSABRI multiple sclerosis treatment may be infused right in your doctor's
office or you may get your infusion at an infusion center. If your doctor does
not perform infusions, a Biogen Idec Case Manager can help find an authorized
infusion site that is convenient for you. This site could be in a hospital or a
separate center that only gives infusions.
How long does an infusion take?
Not counting your travel time and any administrative work needed at the site
of infusion, the actual infusion takes about 1 hour. After the infusion, you
will be observed for another hour to make sure you are not having a reaction
that may need medical help.
What if I miss an infusion?
It depends on why the infusion was missed. If it was just a mistake (for
example, you forgot your appointment), you should reschedule the infusion as
soon as possible.
If you did not qualify for the infusion according to the Pre-infusion
Patient Checklist, your doctor will need to decide if you should have another
TYSABRI infusion.
What is the Pre-infusion Patient Checklist?
This is a checklist of important questions that must be answered before each
infusion. Your answers will decide whether you can receive your TYSABRI
infusion or not. At each infusion visit, you will need to answer questions
about whether you:
1. Have any new or worsening medical problems.
2. Have a condition or are taking medicines that could weaken your immune
system.
3. Have taken steroid medicines.
Who is TYSABRI for?
TYSABRI is a prescription medicine approved for
patients with relapsing forms of multiple sclerosis to:
- Slow the worsening of disability that is
common in patients with MS
- Decrease the number of flare-ups (relapses)
Because of the chance of getting progressive multifocal leukoencephalopathy
(PML), TYSABRI is generally recommended for patients that have not been helped
enough by, or cannot tolerate other treatments for MS.
How do you decide if you have not been helped enough by or cannot tolerate
other multiple sclerosis treatments?
There's no exact way to know. You may still be having relapses even though
you are on therapy. You may find it harder to recover from your relapses. Your
disease may be progressing. You may have more MRI lesions. You may
have a hard time with the side effects of your current therapy. Or, it could be
a combination of all these things.
That's why the choice to take TYSABRI or switch to TYSABRI must be made
after talking with your doctor and carefully thinking about the benefits and
risks.
How much could TYSABRI help me?
TYSABRI is approved to slow the worsening of disability and decrease the
number of flare-ups. TYSABRI has also been proven to positively affect MRI brain lesions*. But you
should know that everyone may not get the same benefits from treatment with
TYSABRI. TYSABRI does not cure MS.
Fewer flare-ups
At the end of a 2-year study, TYSABRI reduced how often flare-ups occurred
by 67% compared with placebo.
- Of patients who took TYSABRI in the 2-year study, more than 7 out of 10 had
no flare-ups at all
Slowed disease progression
At the end of a 2-year study, TYSABRI slowed the worsening of disability
that is common in patients with multiple sclerosis.
- Of patients who took TYSABRI in the 2-year study: 8 out of 10 had no
disease progression
Fewer new lesions
At the end of the same 2-year study, TYSABRI reduced the number of lesions that
show new disease activity by 92% compared with placebo.*
*It is not known exactly how well MRI findings relate to how your multiple
sclerosis is progressing.
Go toThe
Effectiveness of TYSABRI for more information on these studies.
Should I switch from the multiple sclerosis therapy I'm taking now?
Only you can answer this question after carefully discussing with your
doctor
- How well you're doing on your current therapy
- The benefits and risks of TYSABRI
I have relapsing multiple sclerosis and have never tried any of the
disease-modifying therapies. Will I be able to use TYSABRI?
Yes, if you and your doctor decide it's right for you.
Can I switch to TYSABRI if I'm on another multiple sclerosis drug right
now?
You and your doctor will need to decide when it is the right time for you to
start TYSABRI.
How can I receive TYSABRI?
TYSABRI is only:
- Prescribed by doctors who are enrolled in the TOUCH Prescribing
Program
- Infused at infusion centers that are enrolled in the TOUCH Prescribing
Program
- Given to patients who are enrolled in the TOUCH Prescribing Program
What is the TOUCH Prescribing Program?
Most multiple sclerosis medicines offer patients support programs. The TOUCH
Prescribing Program is different for many reasons.
First, you must be enrolled in the program in order to receive TYSABRI.
Second, it was created with the Food and Drug Administration (FDA) to help
manage the risk of progressive multifocal leukoencephalopathy (PML). And third,
your doctor will provide information about your health status to the TOUCH
Prescribing Program every 6 months and will determine if you should continue to
receive TYSABRI.
How do I enroll in the TOUCH Prescribing Program?
1) Read the Patient
Medication Guide.
2) Discuss the benefits and risks of TYSABRI with your doctor.
3) Complete and sign the TOUCH Enrollment Form with your doctor.
Who should not receive TYSABRI?
Do not receive TYSABRI if you:
- Have PML
- Are allergic to TYSABRI or any of its ingredients
TYSABRI is not recommended if you:
What are the possible side effects of TYSABRI?
TYSABRI increases your chance of getting a rare brain infection that usually
causes death or severe disability. This infection is called progressive
multifocal leukoencephalopathy (PML). PML usually happens in people with
weakened immune systems.
Other serious side effects with TYSABRI include allergic reactions, serious
allergic reactions, and infections. TYSABRI may increase your chance of getting
an unusual or serious infection because TYSABRI can affect your immune
system.
Symptoms of allergic reactions can include:
- hives
- chills
- itching
- rash
- trouble breathing
- nausea
- chest pain
- flushing of skin
- dizziness
- low blood pressure
Serious allergic reactions usually happen within 2 hours of the start of the
infusion, but they can happen at any time after receiving TYSABRI.
Tell your doctor or nurse right away if you have any symptom of an allergic
reaction, even if it happens after you leave the infusion center. You may need
treatment if you are having an allergic reaction.
Common side effects of TYSABRI include:
- headache
- urinary tract infection
- lung infection
- pain in your arms and legs
- vaginitis
- feeling tired
- joint pain
- depression
- diarrhea
- rash
- stomach area pain
How many cases of PML were there in clinical trials?
PML occurred in 3 out of over 3000 patients who received TYSABRI in clinical
studies. Two of the cases occurred in MS patients. They were taking TYSABRI and
a beta interferon at the same time. The third case occurred in a patient with
Crohn's
disease who had a very weak immune system. Biogen Idec did a study of the
patients who had been in clinical
trials to try to find out what happened. An independent panel of experts
evaluated the health records of 3116 patients. The experts found no other cases
of PML.
I read that the FDA has given TYSABRI a "Boxed Warning." What does
that mean?
According to the FDA, a Boxed Warning is the most serious warning for a
prescription medication. Boxed warnings are designed to highlight important
safety information and to help doctors and nurses understand what they are and
how to deal with them.
The Boxed Warning for TYSABRI warns of the increased risk of PML and the
importance of monitoring patients using the drug for any new sign or symptoms
that may be suggestive of PML.
What are the signs of PML that a person using TYSABRI should look out
for?
You should look out for and call your doctor right away if you get any new
or worsening medical problems (such as a new or sudden change in your thinking,
eyesight, balance, or strength, or other problems) that have lasted over
several days.
Tell all of your doctors that you are getting treatment with TYSABRI.
What is the treatment for PML?
There is no known treatment, prevention, or cure for PML.
How much does TYSABRI cost?
The cost of TYSABRI will depend on what your insurance coverage is. You
should contact your health insurance plan to see what your individual coverage
is.
Elan and Biogen Idec are committed to making TYSABRI accessible to appropriate
patients who may benefit from therapy. Programs have been developed to assist
patients who are uninsured or who require financial assistance.
Patients who require financial assistance can receive more information by
calling reimbursement specialists at the TOUCH Prescribing Program at
1.800.456.2255.
Will my insurance cover the cost of TYSABRI?
Most private insurance plans currently provide coverage for TYSABRI. Because
TYSABRI is often administered in the physicians office, many insurers will
provide coverage under the "Medical Benefit." Depending on your
insurance benefits, you may or may not have some financial responsibility for
the cost of the drug or the infusion co-pay when you receive TYSABRI.
Does Medicare cover the use of TYSABRI?
TYSABRI is available to Medicare patients under the Part B benefit. Under
this benefit, patients are responsible for a portion of the cost of the drug
and office visit and Medicare covers the remaining fees. However, there are
supplemental insurance policies available, which provide coverage for
out-of-pocket expenses under Medicare Part B. Beneficiaries pay additional
premiums for this coverage. TYSABRI services can help you understand your
Medicare coverage and additional insurance options that may be available to
you.
