NUEDEXTA®

NUEDEXTA

PseudoBulbar Affect {PBA) is a neurologic condition that can occur when certain neurologic conditions or brain injuries damage areas of the brain involved in crying and/or laughing. This damage may interrupt brain signaling and result in sudden, frequent and involuntary episodes of crying and/or laughing that are exaggerated or do not match what the person is feeling inside.

An estimated 2 million people in the US with neurologic conditions have PBA. It can affect men and women, old and young. Some conditions or injuries that can lead to PBA include:

  • Alzheimer's disease or other dementias
  • Stroke
  • Traumatic brain injury (TBI)
  • Multiple sclerosis (MS)
  • Parkinson's disease
  • ALS (Amyotrophic Lateral Sclerosis)/ Lou Gehrig's Disease

NUEDEXTA is the first and only FDA approved treatment for PBA-sudden, frequent, uncontrollable crying and/or laughing. NUEDEXTA contains two components: dextromethorphan and quinidine, medicines that have been used separately to treat conditions other than PBA but that work uniquely together to treat PBA. NUEDEXTA has been clinically proven to help reduce involuntary crying and laughing episodes caused by PBA. In a 12 week study:

  • Many patients experienced fewer PBA episodes after the first week of taking NUEDEXTA.
  • On average, patients taking NUEDEXTA experienced 82% fewer PBA episodes (versus 45% with placebo) at week 12.
  • 51% of patients were completely free of PBA episodes in the final two weeks of the study, versus 29% on placebo.

As with any medicine, the effects of NUEDEXTA may vary from person to person. The most common side effects of NUEDEXTA are diarrhea, dizziness cough, vomiting, weakness and swelling of the feet and ankles. Patients are encouraged to talk with their doctor about the risks and benefits of taking NUEDEXTA, and to read the Important Safety lnformation below.

For more information please visit the NUEDEXTA Website.

What is NUEDEXTA® approved for?

  • NUEDEXTA® is approved for the treatment of PseudoBulbar Affect (PBA). PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain injury. PBA episodes are typically exaggerated or don't match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury.
  • NUEDEXTA is only available by prescription.

Important Safety Information

Before you take NUEDEXTA, tell your doctor:

  • If you are taking monoamine oxidase inhibitors (MAOls), quinidine, or quinidine-related drugs. These can interact with NUEDEXTA causing serious side effects. MAOls cannot be taken within 14 days before or after taking NUEDEXTA.
  • If you have previously had an allergic reaction to dextromethorphan, quinidine or quinidine-like drugs.
  • About all medicines, herbal supplements, and vitamins you take as NUEDEXTA and certain other medicines can interact causing side effects.
  • If you have had heart disease or have a family history of heart rhythm problems. NUEDEXTA may cause serious side effects, including changes in heart rhythm. If you have certain heart problems, NUEDEXTA may not be right for you. Your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA.
  • If you have myasthenia gravis.

While taking NUEDEXTA, call your doctor right away:

  • If you feel faint or lose consciousness.
  • If you experience lightheadedness, chills, fever, nausea, or vomiting as these may be signs of an allergic reaction to NUEDEXTA. Hepatitis has been seen in patients taking quinidine, an ingredient in NUEDEXTA.
  • If you have unexplained bleeding or bruising. Quinidine, an ingredient in NUEDEXTA, can cause a reduction in the number of platelets in your blood which can be severe and, if left untreated, can be fatal.
  • If you feel dizzy, since it may increase your risk of falling.
  • If you have muscle twitching, confusion, high blood pressure, fever, restlessness, sweating, or shivering, as these may be signs of a potential drug interaction called serotonin syndrome.

The most common side effects of NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, and swelling of feet and ankles. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

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

For additional Important Safety Information about NUEDEXTA, please see the full Prescribing Information, including Patient Information and Instructions for Use.

AVN-0037-WEB-0117