XADAGO resources and
frequently asked questions1

XADAGO resources and 
frequently asked questions1

What's Next For You With XADAGO? patient brochure

Learn more about XADAGO by downloading our Patient Brochure and reviewing answers to frequently asked questions.

DOWNLOAD BROCHURE

Could XADAGO be what's NEXT? patient questionnaire

Wondering if XADAGO may be a treatment option for you? Download our Patient Questionnaire, which can help you discuss options with your doctor.

DOWNLOAD QUESTIONNAIRE

Remember to always follow your healthcare provider's instructions.

XADAGO (safinamide) is a type of prescription medicine known as a monoamine oxidase type B (MAO-B) inhibitor used with levodopa/carbidopa to treat individuals with PD who are having off episodes.

The recommended starting dose of XADAGO is 50 mg once daily by mouth. After 2 weeks, your healthcare provider may decide to increase your dose to 100 mg once daily, if necessary. It is recommended to take XADAGO at the same time each day. Do not start or stop taking XADAGO without talking to your healthcare provider first.

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

No, you do not have to change your diet. Restriction of foods and beverages is usually not required when treated with the recommended doses of XADAGO.

Please talk with your healthcare provider about any changes to your PD medications. XADAGO is intended to be used with levodopa/carbidopa (monotherapy) medications to treat Parkinson’s disease. It is not known if XADAGO is effective to treat PD when taken as a single medicine.

Do not use XADAGO if you are allergic to XADAGO (safinamide), as this can cause swelling of the tongue and mouth and trouble breathing. You should not take XADAGO if you have severe liver disease. Please talk to your healthcare provider if you have concerns about taking XADAGO.

The combination of MAO-B inhibitors like 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. The combination of MAO inhibitors and dextromethorphan has been reported to cause episodes of psychosis or abnormal behavior.

If a dose of once-daily XADAGO is missed, the next dose should be taken at the same time the next day.

XADAGO should be stored at room temperature, between 68 and 77 degrees, but also allows for temperatures as low as 59 degrees and as high as 86 degrees.

Call your healthcare provider for medical advice about side effects. You may report side effects by contacting Supernus 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.

Why XADAGO?LEARN MORE

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.

Reference

1. XADAGO. Package Insert. US WorldMeds, LLC.

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.