TYSABRI FAQs

These frequently asked questions (FAQs) about TYSABRI may help address some of your own questions. If you have additional questions, your healthcare professional is your best source for information.

TYSABRI Basics

How is TYSABRI different?

Who is TYSABRI for?

How much could TYSABRI help me?

How much does TYSABRI cost?

Does Medicare cover the use of TYSABRI?

Switching therapies

How do you decide if you have not been helped enough by or cannot tolerate another MS treatment?

Should I consider switching from the MS 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 MS drug right now?

About the TOUCH® Prescribing Program

What is the TOUCH^® Prescribing Program?

How do I enroll in the TOUCH Prescribing Program?

The infusion process

Where do TYSABRI infusions take place?

How long does an infusion take?

What if I miss an infusion?

Risks

Who should not receive TYSABRI?

What are possible TYSABRI side effects?

How many cases of PML have there been?

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?

Are there any treatments for PML?

TYSABRI Basics

How is TYSABRI different?

TYSABRI is an antibody, not an interferon (AVONEX^®(interferon beta-1a), Betaseron^® (interferon beta-1b), Extavia^® (interferon beta-1b), Rebif^® (interferon beta-1a))* or glatiramer acetate (Copaxone^®).* TYSABRI 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.

**Changes in MRI often do not relate to how your MS is progressing.

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.

*AVONEX is a registered trademark of Biogen Idec. All other trademarks are the property of their respective owners.

Who is TYSABRI for?

• TYSABRI is a prescription medicine approved for adult patients with relapsing forms of MS to slow the worsening of physical disability that is common in patients with MS and decrease the number of flare-ups (relapses).
• Because TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection that usually causes death or severe disability, TYSABRI is generally recommended for patients that have not been helped enough by, or cannot tolerate, another treatment for MS.
• TYSABRI does not cure MS and has not been studied for longer than two years or in patients with chronic progressive MS.

How much could TYSABRI help me?

TYSABRI is approved to slow the worsening of physical disability and decrease the number of flare-ups.

TYSABRI has also been proven to reduce the number of new MRI brain lesions. However, changes in MRI often do not relate to how your MS is progressing.

But you should know that everyone's experience is unique and you 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. The average number of flare-ups a patient had each year was 0.22 for TYSABRI and 0.67 for placebo.

• Of people who took TYSABRI in the 2-year study, more than 6 out of 10 had no flare-ups at all

Slowed physical disability progression

At the end of a 2-year study, TYSABRI slowed the worsening of physical disability that is common in people with multiple sclerosis by 42% compared with placebo (17% of people on TYSABRI had their physical disability worsen, versus 29% on placebo).

• Of people who took TYSABRI in the 2-year study: more than 8 out of 10 had no physical disability progression

Fewer new, or newly active lesions*

At the end of the same 2-year study:

• 97% of people taking TYSABRI had no new lesions that showed disease activity compared with 72% of people taking placebo
• This means that 9 out of 10 people taking TYSABRI had no new lesions or new disease activity

*Changes in MRI often do not relate to how your MS is progressing.

How much does TYSABRI cost?

If you have insurance, the cost of TYSABRI will depend on the extent of your insurance coverage. You can contact Biogen Idec Patient Services to speak with a MS Support Specialist, who can assist you with contacting your health insurance plan to see what your individual coverage is.

Most private insurance plans currently provide coverage for TYSABRI. Because TYSABRI is often administered in the physician's 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.

Elan and Biogen Idec are committed to making TYSABRI accessible to appropriate, qualified patients who may benefit from therapy. If you do not have insurance or you have insurance but the cost is still too much, programs have been developed to assist eligible patients.

Whatever your financial situation, you can receive more information by calling Biogen Idec MS Support Specialists at 1-800-456-2255. Note that you do not have to be a TYSABRI patient to speak with an MS Support Specialist.

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. An MS Support Specialist can help you understand your Medicare coverage and additional insurance options that may be available to you.

Switching therapies

How do you decide if you have not been helped enough by, or cannot tolerate, another MS treatment?

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.

Should I consider switching from the MS 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 potential 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 MS drug right now?

You and your doctor will need to decide when it is the right time for you to start TYSABRI.

About the TOUCH^® Prescribing Program

What is the TOUCH Prescribing Program?

The TOUCH Prescribing Program makes your safety a priority. TOUCH monitors every patient who has been prescribed TYSABRI treatment. The goal of the program is to minimize the risk of PML.

• Because of the risk of PML, TYSABRI is available only through the TOUCH Prescribing Program, which is a restricted distribution program focused on safety
• TOUCH was developed with the help of the Food and Drug Administration (FDA)
• Only prescribers and patients enrolled in the TOUCH Prescribing Program can prescribe and receive TYSABRI
• Only certain pharmacies and infusion sites authorized by the TOUCH Prescribing Program can dispense and infuse TYSABRI
• TOUCH assigns you your own specially trained Case Manager to help:
  • Get you started on therapy and answer questions about your therapy
  • Find an authorized infusion site in your area
  • Provide information about insurance coverage and possible sources of financial assistance, if necessary
• TOUCH requires more interaction with doctors and nurses. Your treatment is closely monitored to help make sure TYSABRI continues to be right for you:
  • Once every 4 weeks at each infusion visit
  • Plan to see your doctor 3 months after the first infusion, 6 months after the first infusion and as frequently as every 6 months thereafter

How do I enroll in the TOUCH Prescribing Program?

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

Therefore, you need to speak with your doctor about whether or not TYSABRI is right for you. Ask your doctor about the potential risks and benefits of each MS therapy.

1. Read the Patient Medication Guide.
2. Discuss the benefits and risks of TYSABRI with your doctor.
3. Agree to all the requirements of the TOUCH Prescribing Program.
4. Complete and sign the TOUCH Enrollment Form with your doctor.

The infusion process

Where do TYSABRI 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 at an infusion clinic within a hospital or at a separate center that only gives infusions.

How long does an infusion take?

Not counting your travel time and any administrative work required at the infusion center (including reviewing the Patient Medication Guide (PDF) and the Pre-infusion Patient Checklist), 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 attention.

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.

As part of TOUCH^® 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.

Risks

Who should not receive TYSABRI?

Do not receive TYSABRI if you:

• Have PML
• Are allergic to TYSABRI

TYSABRI is not recommended if you:

• Have a medical condition that can weaken your immune system such as HIV infection or AIDS, leukemia or lymphoma, or an organ transplant, and others
• Are taking medicines that can weaken your immune system. Talk with your doctor about all of the medicines you take or have taken

What are possible TYSABRI side effects?

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
• wheezing

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.

TYSABRI may cause liver damage. Symptoms can include:

• Yellowing of the skin and eyes (jaundice)
• Nausea
• Vomiting
• Unusual darkening of the urine
• Feeling tired or weak

Blood tests can be done to check for liver damage. Call your doctor right away if you have symptoms of liver damage.

Common TYSABRI side effects include:

• headache
• urinary tract infection
• lung infection
• pain in your arms and legs
• vaginitis
• feeling tired
• joint pain
• depression
• diarrhea
• rash
• stomach area pain
• nose and throat infections

These are not all the side effects with TYSABRI. Ask your doctor for more information.

How many cases of PML have there been?

• For more information about the cases of PML, ask your healthcare provider.

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, not just your neurologist.

Are there any treatments for PML?

• There is no known treatment, prevention, or cure for PML.
• 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. However, there is no evidence that plasma exchange has any benefit in the treatment of opportunistic infections such as PML.
• There are potential side effects of plasma exchange such as a drop in blood pressure or accumulation of fluid in the lungs. You should discuss plasma exchange with your prescriber if you have additional questions.
• If you get PML, your doctor will monitor you for certain new or worsening symptoms that can happen suddenly after you get PML. Contact your doctor right away if you think your general health status is getting worse.