How to take NUEDEXTA

PBA (Pseudobulbar Affect) 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.

Take NUEDEXTA exactly as your doctor prescribes in order to see results.

For

Week 1

take ONE CAPSULE each morning.

This dose introduces NUEDEXTA to your body.

Starting

Week 2

on day eight, increase your dose to TWO CAPSULES per day—one in the morning, one in the evening, 12 hours apart.

This is your daily dose for the rest of your treatment.

Important dosing guidelines

  • You can take NUEDEXTA with or without food.
  • If you miss a dose, do not take a double dose. Take your next dose of NUEDEXTA at your usual time.
  • Do not take more than 2 capsules in a 24-hour period. Make sure that you have approximately 12 hours in between your doses.

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What to expect with NUEDEXTA
fewer-episodes

When you start NUEDEXTA, you might experience fewer PBA episodes after the first week. You should expect to see your best results by about 90 days.*

In a 12-week clinical trial, patients had an average of 44% fewer episodes after the first week of taking NUEDEXTA, compared to 19% on placebo* and an average of 82% fewer episodes after 12 weeks, compared to 45% on placebo.*

82% fewer episodes

During the final two weeks of the study, 51% of patients taking NUEDEXTA were completely episode-free, compared to 29% on placebo.*

*Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68:693-702.

What may happen if you stop treatment

To continue the benefits of NUEDEXTA, take daily as directed by your physician. In a clinical trial, at the beginning of the second week of treatment, patients increased their NUEDEXTA dosage to 2 capsules each day. After the clinical trial was over, many patients were monitored for another 3 months. During the transition between trials, some patients had a gap in treatment. Many of those who stopped taking NUEDEXTA saw their PBA symptoms increase after a 48-hour break in treatment.

From time to time, your doctor may want to determine if you still need to take NUEDEXTA. For some patients, PBA symptoms may improve on their own.

Patients with ALS or MS who stopped NUEDEXTA treatment after the initial 12-week trial had their final CNS-LS scores compared to their scores at the beginning of a 12-week open-label extension trial. An increase in CNS-LS scores indicated a return of PBA symptoms.

Follow your doctor’s directions
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Give it time

NUEDEXTA is meant to work over time. You should expect to see your best results by about 90 days,* so give it time to work. Taking your medication as prescribed can give you the best chance to start seeing a reduction in episodes.

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Stay consistent

When you take the prescribed dose at the same time each day, you are keeping the right amount of medicine in your system which allows it to work properly.

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Report your results

While taking NUEDEXTA, tell your doctor if your PBA episodes continue or get worse. Your doctor should periodically reassess the need for treatment as PBA symptoms may sometimes improve on their own.

*Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68:693-702.

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Robert
Patient with Traumatic Brain Injury and PBA, taking NUEDEXTA

“I tell everybody to be open and receptive – to talk it out as best you can. Advocate for your own well-being, in a way that you’re most comfortable.”

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Safety and Side Effects

Before taking NUEDEXTA:
  • Tell your doctor about all medications and supplements you are taking before taking NUEDEXTA.
  • Ask your doctor what medications you cannot use with NUEDEXTA.
  • Tell your doctor if you have heart disease, or if you or a family member have ever had any heart rhythm problems.
The most common side effects of NUEDEXTA include:
  • diarrhea
  • dizziness
  • cough
  • vomiting
  • weakness
  • swelling of feet and ankles

These are not all the possible risks of NUEDEXTA. Tell your doctor if you think you are experiencing a medication side effect.

Please see Important Safety Information and full Prescribing Information.

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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 (MAOIs), quinidine, or quinidine-related drugs. These can interact with NUEDEXTA causing serious side effects. MAOIs 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.

IMPORTANT SAFETY INFORMATION (Continued)

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.