Once-daily XADAGO

Once-daily XADAGO

Box of 50 mg XADAGO (safinamide) tablets and box of 100 mg XADAGO (safinamide) tablets.
50mg

The recommended starting dose of XADAGO is 50 mg once daily

100mg

Your healthcare provider may need to change the dose of XADAGO until the dose is right for you

Take XADAGO once daily in addition to your levodopa/carbidopa1

  • XADAGO can be taken at any time of the day, with or without food1
  • Over 87% of patients in clinical trials did not require a decrease in their levodopa—XADAGO was just added on2,3

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

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.