FOR PARKINSON’S DISEASE (PD) - XADAGO.com · (saﬁnamide) tablets GET TO KNOW XADAGO can increase your daily on time without troublesome dyskinesia (uncontrolled movement) FOR

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(safinamide) tablets

GET TO KNOW

XADAGO can increase your daily on time without troublesome dyskinesia (uncontrolled movement)

FOR PARKINSON’S DISEASE (PD)

Please see the complete Important Safety Information on pages 14-15 and the accompanying full Prescribing Information and Patient Information.

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(safinamide) tablets2 3


Introducing once-daily XADAGO

XADAGO® (safi namide) is a prescription-only monoamine oxidase type B (MAO-B) inhibitor, which is used as an “add-on” with levodopa/carbidopa for PD patients. XADAGO can help reduce your off time (or off episodes) and increase your daily on time without troublesome dyskinesia.*

It is not known if XADAGO is effective to treat PD when taken as a single medicine (monotherapy). It is not known if XADAGO is safe and effective in children.

Important Safety Information

What’s an MAO-B inhibitor?

MAO-B is an enzyme that naturally breaks down chemicals in the brain, including dopamine.

A shortage of dopamine in your brain can cause impaired movement and PD motor symptoms like stiffness (rigidity), freezing, and shaking (tremor).

XADAGO is a medication that helps prevent MAO-B from breaking down dopamine in your brain.

Adding XADAGO to your levodopa/carbidopa medicine may increase your dopamine levels—and reduce some of your PD motor symptoms.

Dopamine

Normal

With PD

TALK TO YOUR HEALTHCARE PROVIDER IF YOU WANT MORE ON TIME AND LESS OFF TIME

XADAGO HELPS BLOCK THE LOSS OF DOPAMINE IN THE BRAIN

Tell your physician if you are taking, or planning to take, any prescription or over-the-counter drugs.

Do not take XADAGO if you are taking other monoamine oxidase inhibitors (MAOIs), as it could cause a sudden severe increase in your blood pressure.

The combination of MAO-B inhibitors such as XADAGO and antidepressants has resulted in a serious and sometimes fatal condition called serotonin syndrome.

For Parkinson’s disease (PD)

*Like any medication, XADAGO may not have the same effect on every person and may cause side effects.

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Do not take XADAGO with opioid medications including meperidine, tramadol, methadone, or propoxyphene, as this could result in serious, sometimes fatal, reactions.

Also, do not take XADAGO with amphetamine, cyclobenzaprine, methylphenidate, or St. John’s wort. Taking these drugs together can also result in serotonin syndrome, which could be fatal.

Do not use XADAGO with dextromethorphan, as this has been reported to cause episodes of psychosis or abnormal behavior.

What is ON and OFF time?

During a typical day, PD patients experience on time and off time. In addition, on time can be accompanied by troublesome dyskinesia.

ON TIME is when:

OFF TIME (or off episodes) is when:

What is XADAGO?

XADAGO is a tablet you take once a day to treat the motor symptoms of PD.

Since XADAGO is an “add-on,” that means it is used along with your levodopa/carbidopa medication.

As shown in clinical trials, XADAGO can:

XADAGO IS A PD TREATMENT YOU “ADD-ON” TO YOUR LEVODOPA/CARBIDOPA MEDICINE

Increase daily on time—without troublesome dyskinesia

Reduce off time and off time symptoms

Help improve patients’ ability to move and take on their day

And, a majority of PD patients taking XADAGO were able to maintain their current levodopa/carbidopa dose

• Your oral levodopa/carbidopa medication is working well

• Your PD symptoms are at a minimum

• You are moving and able to go about your day

• Your oral levodopa/carbidopa medication isn’t working

• Your PD symptoms have re-emerged and are at or near their worst

• Symptoms like stiffness (rigidity), freezing, shaking (tremor), or diffi culty moving get in the way of your daily tasks

• Uncontrollable (involuntary), abnormal movements interfere with your daily activities

• These movements often occur as a side effect of long-term treatment with levodopa/carbidopa

TROUBLESOME DYSKINESIA is when:

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Do not use XADAGO if you have hypersensitivity to safi namide, as this can cause swelling of the tongue and mouth and trouble breathing.

You should not take XADAGO if you have severe liver disease. Do not exceed a dose of 50 mg per day of XADAGO if you have moderate liver disease.

During treatment with XADAGO you may experience increases in blood pressure. Inform your physician if you have a history of high blood pressure.

How do I take XADAGO?

XADAGO is taken once-daily in addition to your levodopa/carbidopa medicine.

The recommended starting dose of XADAGO is 50 mg once daily

After 2 weeks, your healthcare provider may decide to increase your daily dose to 100 mg once daily, if necessary

ADDING ONCE-DAILY XADAGO CAN HELP IF YOU ARE EXPERIENCING OFF TIME

If you are taking levodopa/carbidopa, XADAGO can:

• Provide more daily on time—without troublesome dyskinesia

• Reduce the amount of off time that you experience during the day

• Help improve your ability to move and take on your day

XADAGO CAN HELP YOU BE READY TO GO AND TAKE ON YOUR DAY

50 mg*

100 mg*

*Images above are not actual size of XADAGO tablets

Once-daily XADAGO can be taken with or without food—and at any time of the day. If you are experiencing side effects, or feel like you’re not getting the symptom relief you need, be sure to talk to your healthcare provider as soon as possible. Do not change your dose or stop taking XADAGO unless your healthcare provider tells you to.

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Is XADAGO right for me?

Over time, with long-term levodopa/carbidopa treatment, you may start to experience decreased on time—and may be having more off time.

If you are experiencing off time, and notice that your PD symptoms, like stiffness (rigidity), freezing, shaking (tremor), or diffi culty moving, are not controlled with your levodopa/carbidopa, ask your healthcare provider if XADAGO may be right for you.

XADAGO is a once-daily tablet that can help give you more on time (without troublesome dyskinesia), so you can get back to—and GO about—your day.

Before taking XADAGO, tell your healthcare provider about all medications and supplements you are taking and ask your healthcare provider what medications you shouldn’t take with XADAGO.

The most common side effects of XADAGO include uncontrolled, sudden movements (dyskinesia), falls, nausea, trouble sleeping or falling asleep (insomnia).

Ask your healthcare provider about which side effects are likely to occur and what PD symptoms you should watch for. Tell your healthcare provider if you have any side effects that bother you or do not go away.

These are not all of the possible side effects of XADAGO. For more information, call your healthcare providerfor medical advice about side effects.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-888-492-3246 (1-888-4XADAGO). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


What are the possible side effects of XADAGO?

TALK TO YOUR HEALTHCARE PROVIDER ABOUT HOW XADAGO CAN HELP INCREASE ON TIME

MOREON

TIMELESSOFF TIME

WITHOUTTROUBLESOME DYSKINESIA


Possible symptoms of an unsafe rise in blood pressure include severe headache, blurred vision, confusion, seizures, shortness of breath, severe anxiety, and nausea and vomiting. Contact your doctor or seek immediate medical attention if you experience any of these symptoms.

Some patients treated with XADAGO experienced drowsiness or sudden onset of sleep. Do not drive, operate heavy machinery, work in high places or do other dangerous activities until you know how XADAGO affects you.

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Restriction of foods and beverages containing tyramine is usually not required when treated with the recommended doses of XADAGO. However, it is recommended that you avoid foods containing high amounts of tyramine, such as aged cheeses, as some patients may have an increased sensitivity that could lead to an unsafe rise in blood pressure.

Is there a savings program with XADAGO?

XADAGO Prescription Savings Program

Yes—the XADAGO Prescription Savings Program is here to help you with fi nancial assistance—so you can get your prescription when you need it.*

The XADAGO Prescription Savings Program provides you with up to $125 co-pay assistance per month over 12 months.

For more information about the XADAGO Prescription Savings Program, or to fi nd a participating pharmacy, visit XADAGO.com/pharmacy.

*Patients whose prescriptions will be paid for in part or in whole by Medicare, Medicaid, or any similar federal or state healthcare program, are not eligible for savings or rebates according to federal and state law.

Here’s how it works

As a participant in the eVoucherRx™ Program powered by RelayHealth, US WorldMeds has made it possible to extend prescription savings on to you.

eVoucherRx is a paperless electronic coupon program that makes co-pay savings on your prescription for XADAGO easy for you and your healthcare provider.

Simply take your prescription for XADAGO to a participating pharmacy and the eVoucherRx savings coupon will be automatically applied to your co-pay.*

Pay as little as $25*

(save up to $125)on your XADAGO prescription

each month

Rx Rx

*Restrictions may apply. For more information, visit xadago.com

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The most common side effects seen with XADAGO are uncontrolled movements (dyskinesia), falls, nausea, and insomnia.


Together™

We’re here to help you understand and manage your care—or the care of your loved one—with once-daily XADAGO.

The XADAGO Together Program is your resource for:

• XADAGO and PD information

• XADAGO refi ll reminders

• Savings on your XADAGO prescriptions*

• Tools to help you talk to your healthcare provider about XADAGO

• Lifestyle tips for patients with PD and their care partners

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(safinamide) tabletsPlease see the complete Important Safety Information on pages 14-15 and the accompanying full Prescribing Information and Patient Information.

VISIT XADAGO.COM TODAY TO JOIN

*Eligibility restrictions may apply. For more information, visit xadago.com.

®


You should not take XADAGO if you have severe liver disease. Do not exceed a dose of 50 mg per day of XADAGO if you have moderate liver disease.

During treatment with XADAGO you may experience increases in blood pressure. Inform your physician if you have a history of high blood pressure. Possible symptoms of an unsafe rise in blood pressure include severe headache, blurred vision, confusion, seizures, shortness of breath, severe anxiety, and nausea and vomiting. Contact your doctor or seek immediate medical attention if you experience any of these symptoms.

Some patients treated with XADAGO experienced drowsiness or sudden onset of sleep. Do not drive, operate heavy machinery, work in high places or do other dangerous activities until you know how XADAGO affects you.

Restriction of foods and beverages containing tyramine is usually not required when treated with the recommended doses of XADAGO. However, it is recommended that you avoid foods containing high amounts of tyramine, such as aged cheeses, as some patients may have an increased sensitivity that could lead to an unsafe rise in blood pressure.

The most common side effects seen with XADAGO are uncontrolled movements (dyskinesia), falls, nausea, and insomnia.


Please see full Prescribing Information and Patient Information at www.xadago.com.

IndicationXADAGO (safi namide) is a type of prescription medicine known as monoamine oxidase type B (MAO-B) inhibitor used with levodopa and carbidopa to treat adults with Parkinson’s disease (PD) who are having off episodes.

It is not known if XADAGO is effective to treat PD when taken as a single medicine (monotherapy). It is not known if XADAGO is safe and effective in children.

Important Safety Information for PatientsTell your physician if you are taking, or planning to take, any prescription or over-the-counter drugs.

• Do not take XADAGO if you are taking other monoamine oxidase inhibitors (MAOIs), as it could cause a sudden severe increase in your blood pressure.

• The combination of MAO-B inhibitors such as XADAGO and antidepressants has resulted in a serious and sometimes fatal condition called serotonin syndrome.

• Do not take XADAGO with opioid medications including meperidine, tramadol, methadone, or propoxyphene, as this could result in serious, sometimes fatal, reactions.

• Also, do not take XADAGO with amphetamine, cyclobenzaprine, methylphenidate, or St. John’s wort. Taking these drugs together can also result in serotonin syndrome, which could be fatal.

• Do not use XADAGO with dextromethorphan, as this has been reported to cause episodes of psychosis or abnormal behavior.

Do not use XADAGO if you have hypersensitivity to safi namide, as this can cause swelling of the tongue and mouth and trouble breathing.


®


Once-daily XADAGO can:

• Provide more daily on time—without troublesome dyskinesia

• Reduce the amount of off time that you experience during the day

• Improve your ability to move and take on your day

TM

Under License from Newron Pharmaceuticals SpA.

US WorldMeds, LLC is the exclusive licensee and distributor of XADAGO in the United States

and Its territories. ©2017. Zambon SpA. XADAGO is a registered trademark of Zambon SpA. USWM-XAD018A-0617

Get to knowXADAGO


Visit XADAGO.COM today and learn more

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FOR PARKINSON’S DISEASE (PD) - XADAGO.com · (saﬁnamide) tablets GET TO KNOW XADAGO can increase your daily on time without troublesome dyskinesia (uncontrolled movement) FOR