NUEDEXTA is meant to be taken in a specific way to treat PBA (PseudoBulbar Affect), a condition that causes sudden, frequent, uncontrollable episodes of crying and/or laughing that are exaggerated and/or don’t match how you feel.
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Take NUEDEXTA exactly as your doctor prescribes it in order to see results.
take one capsule each morning.
This dose introduces NUEDEXTA to your body.
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.
What to expect with NUEDEXTA
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 clinical trial, patients had an average of 44% fewer PBA episodes after the first week of taking NUEDEXTA,* and an average of 82% fewer episodes after 12 weeks.* During the final two weeks of the study, 51% of patients taking NUEDEXTA were completely episode-free.* Your results may vary.
Compared to baseline, patients taking placebo experienced 19% fewer PBA episodes at Week 1 and 45% fewer episodes at Week 12, and 29% were completely free of PBA episodes in the final 2 weeks of the 12-week study.*
*Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68:693-702.
A 12-week study saw
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 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
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.
When you take the prescribed dose at the same time each day, you are keeping the right amount of medicine in your system. This allows the medicine to work properly to help you reach your goal of fewer PBA episodes.
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.
With fewer PBA episodes, she spent less time managing her PBA symptoms.
Ross, caregiver for Karen, MS patient with PBA, taking NUEDEXTA
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:
- 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.