Why XADAGO?

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Why XADAGO?

During clinical trials, physicians reported that XADAGO, when added to levodopa/carbidopa, helped control patients’ Parkinson’s disease (PD) motor symptoms such as*,1,2

More ability to speak

More freedom of facial expression

Improved balance

Less shaking (tremor)

Less stiffness (rigidity)

Less slowed movement (bradykinesia)

*As assessed by the Unified Parkinson's Disease Rating Scale (UPDRS) III scale.

How can XADAGO help you?

Studied In >1100 Adults with PD
Studied in >1100 Adults with PD

Clinical trials showed that once-daily XADAGO can1-3:

  • Increase daily ON time—without troublesome dyskinesia
  • Reduce OFF time and OFF time symptoms*
  • Help improve your ability to move during the day

* As assessed by the UPDRS III scale.

Get more ON time—up to 1 hour per day1,2

XADAGO can give you lasting ON time without troublesome dyskinesia.

2-4 weeks

Patients saw improvements in their ability to move in as early as 2-4 weeks.1,2

Patients maintained those improvements over 
2 years without troublesome dyskinesia.1,4

 

XADAGO patients reported significant improvements in their health status at 6 months1,2*

Clinical trial participants taking 100 mg of XADAGO showed significant total score improvements in PDQ-39, a questionnaire that evaluates 39 items grouped in categories of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and body discomfort.*

Improvements on mobility, activities of daily living, stigma, social support, and cognition were not statistically significant with the XADAGO 100 mg dose group

*There were no statistically significant differences between XADAGO 50-mg dose group and placebo.

How XADAGO works

Monoamine oxidase B (MAO-B) is a substance that naturally breaks down chemicals in your brain, like dopamine. Too little dopamine in your brain can cause impaired movement and PD motor symptoms like stiffness (rigidity), freezing, and shaking (tremor).3

XADAGO helps block MAO-B from breaking down dopamine in your brain3

Diagram showing the normal release of dopamine in the brain and the release of dopamine in the brain in patients with Parkinson's disease.

Adding XADAGO to levodopa/carbidopa increases dopamine levels by preserving your body’s dopamine, as well as dopamine made from levodopa.

Ask your doctor if XADAGO may be right for you

XADAGO side effects3

Before taking XADAGO, tell your healthcare provider about all the medications and supplements you are taking. While taking XADAGO, discuss with your healthcare provider any medications you may consider starting.

Most common side effects when taking XADAGO include:

  • Uncontrolled, sudden movements (dyskinesia)
  • Falls
  • Nausea
  • Trouble falling asleep or sleeping (insomnia)

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.

All PD patients should be monitored for hallucinations, impulse control, and confusion.

Please refer to the full Prescribing Information and Patient Information for all the possible side effects, and talk with your doctor.

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Pay as little as $15* on your
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*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.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Do not take XADAGO if you:

  • Take another medicine called monoamine oxidase inhibitors (MAOIs), as it could cause a sudden severe increase in your blood pressure.
  • Take an opioid drug, St. John’s wort, serotonin‐norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tetracyclic antidepressants, triazolopyridine antidepressants, cyclobenzaprine, methylphenidate, amphetamine, or similar drugs because it could be life‐threatening.
  • Take a medicine used to treat a cough or cold called dextromethorphan, as this has been reported to cause episodes of psychosis or abnormal behavior.
  • Have a history of an allergic reaction to safinamide, as this can cause swelling of the tongue and mouth and trouble breathing.
  • Have severe liver disease. Do not exceed a dose of 50mg per day of XADAGO if you have moderate liver disease.

Before taking XADAGO, tell your healthcare provider about: All the medicines that you take or plan to take. Especially tell your healthcare provider if you take selective serotonin reuptake inhibitors (SSRIs), meperidine, methadone, propoxyphene, tramadol, or metoclopramide.

While taking XADAGO you should avoid: Certain foods and beverages that are high in tyramine such as aged, fermented, cured, smoked, and pickled foods. Do not drive, operate machinery, or work in high places or do other dangerous activities until you know how XADAGO affects you.

Possible serious side effects of XADAGO:

  • High blood pressure or make your high blood pressure worse. XADAGO may raise your blood pressure or make your high blood pressure worse. 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.
  • Serotonin syndrome. Potentially life‐threatening problem called serotonin syndrome can happen when taking XADAGO with certain other medicines. Symptoms may include agitation, hallucinations, coma, changes in mental status, seizures, problems controlling your movements or muscle twitching, sweating or fever, nausea or vomiting, fast heartbeat, muscle stiffness or tightness, or diarrhea.
  • Falling asleep during normal activities.
  • Uncontrolled, sudden movements (dyskinesia) or make such movements worse.
  • Hallucinations and other psychosis. XADAGO can cause or worsen symptoms of seeing or hearing things that are not real, confusion, agitation, delusional beliefs, and disorganized thinking.
  • Unusual urges or inability to control these urges.
  • Problems with retina in your eye (retinal changes). Tell your healthcare provider if your eyesight changes.

The most common side effects of XADAGO include:

Uncontrolled, sudden movements (dyskinesia), falls, nausea, trouble sleeping or falling asleep.

Please refer to the Medication Guide for additional important patient information.

INDICATION

  • XADAGO is a prescription medicine known as a 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.

Please see full Prescribing Information and Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

References

1. Borgohain R, Szasz J, Stanzione P, et al. Randomized trial of safinamide add-on to levodopa in Parkinson’s disease with motor fluctuations. Mov Disord. 2014;29(2):229-237. 2. Schapira AHV, Fox SH, Hauser RA, et al. Assessment of safety and efficacy of safinamide as a levodopa adjunct in patients with Parkinson disease and motor fluctuations: a randomized clinical trial. JAMA Neurol. 2017;74(2):216-224. 3. XADAGO. Package Insert. US WorldMeds, LLC. 4. Borgohain R, Szasz J, Stanzionne P, et all. Two-year, randomized controlled study of safinamide as add-on to levodopa in mid to late Parkinson’s disease. Mov Disord 2014;29(10):1273-1280.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Do not take XADAGO if you:

  • Take another medicine called monoamine oxidase inhibitors (MAOIs), as it could cause a sudden severe increase in your blood pressure.
  • Take an opioid drug, St. John’s wort, serotonin‐norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tetracyclic antidepressants, triazolopyridine antidepressants, cyclobenzaprine, methylphenidate, amphetamine, or similar drugs because it could be life‐threatening.
  • Take a medicine used to treat a cough or cold called dextromethorphan, as this has been reported to cause episodes of psychosis or abnormal behavior.
  • Have a history of an allergic reaction to safinamide, as this can cause swelling of the tongue and mouth and trouble breathing.
  • Have severe liver disease. Do not exceed a dose of 50mg per day of XADAGO if you have moderate liver disease.

Before taking XADAGO, tell your healthcare provider about: All the medicines that you take or plan to take. Especially tell your healthcare provider if you take selective serotonin reuptake inhibitors (SSRIs), meperidine, methadone, propoxyphene, tramadol, or metoclopramide.

While taking XADAGO you should avoid: Certain foods and beverages that are high in tyramine such as aged, fermented, cured, smoked, and pickled foods. Do not drive, operate machinery, or work in high places or do other dangerous activities until you know how XADAGO affects you.

Possible serious side effects of XADAGO:

  • High blood pressure or make your high blood pressure worse. XADAGO may raise your blood pressure or make your high blood pressure worse. 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.
  • Serotonin syndrome. Potentially life‐threatening problem called serotonin syndrome can happen when taking XADAGO with certain other medicines. Symptoms may include agitation, hallucinations, coma, changes in mental status, seizures, problems controlling your movements or muscle twitching, sweating or fever, nausea or vomiting, fast heartbeat, muscle stiffness or tightness, or diarrhea.
  • Falling asleep during normal activities.
  • Uncontrolled, sudden movements (dyskinesia) or make such movements worse.
  • Hallucinations and other psychosis. XADAGO can cause or worsen symptoms of seeing or hearing things that are not real, confusion, agitation, delusional beliefs, and disorganized thinking.
  • Unusual urges or inability to control these urges.
  • Problems with retina in your eye (retinal changes). Tell your healthcare provider if your eyesight changes.

The most common side effects of XADAGO include:

Uncontrolled, sudden movements (dyskinesia), falls, nausea, trouble sleeping or falling asleep.

Please refer to the Medication Guide for additional important patient information.

INDICATION

  • XADAGO is a prescription medicine known as a 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.

Please see full Prescribing Information and Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.