Carol, patient living with PBA Carol, patient living with PBA

Dosing & Treatment

Follow the recommended
dosing schedule1

Carol, patient living with PBA

At day 8, titrate up to 2 capsules a day1

Efficacy beyond week 1 in the pivotal trial was achieved with q12h dosing.1

A timeline that portrays the starting dose from days 1-7 (with one capsule a day) to the maintenance dose beginning on day 8 (with two capsules a day)

NUEDEXTA is a combination of dextromethorphan HBr (20 mg) and quinidine sulfate (10 mg) in a capsule. It can be taken with or without food.1

The need for continued treatment should be reassessed periodically, as spontaneous improvement of Pseudobulbar Affect (PBA) symptoms occurs in some patients.1

HBr=hydrobromide; po=orally; q12h=every 12 hours; qd=once daily.

Dosage and administration in specific populations

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. No dose adjustments are required in patients with mild to moderate renal or hepatic impairment. NUEDEXTA has not been evaluated in patients with severe renal or hepatic impairment; however, increases in dextromethorphan and/or quinidine levels are likely to be observed.1

NUEDEXTA can help reduce PBA episodes.1 Hear stories from some patients

A white woman with wavy brunette hair is seen from the waist up, facing the camera. The caption on screen says “Carol, living with PBA.”
Sample script pad for NUEDEXTA Sample script pad for NUEDEXTA
[On NUEDEXTA, my mom] is living her life with fewer PBA episodes.
Liyah, Caregiver of a patient living with PBA
Drug classification of NUEDEXTA

NUEDEXTA is a central nervous system (CNS) agent that is categorized in the “Central Nervous System, Other” pharmacologic class in the United States Pharmacopeia and National Formulary (USP–NF). NUEDEXTA is not an antipsychotic medication or a controlled substance.1

Document your diagnosis of PBA using ICD-10 code F48.2
nuedexta-card

Script pad is used for illustrative purposes only.

PBA is a separate neurologic diagnosis, and the right diagnosis can lead to the right treatment.2

ICD-10 diagnosis codes are provided for informational purposes only and do not guarantee that billing codes will be appropriate or that coverage and reimbursement will result.3

Providers should consult with their payers for all relevant coverage, coding, and reimbursement requirements. It is the sole responsibility of the provider to select proper codes and ensure the accuracy of all claims used in seeking reimbursement.

This resource is not intended as legal advice or as a substitute for a provider’s independent professional judgment.

nuedexta-card

Script pad is used for illustrative purposes only.

  • References: 1.

    Nuedexta. Package insert. Otsuka America Pharmaceutical, Inc.; 2022.

  • 2.

    Brooks BR, Crumpacker D, Fellus J, Kantor D, Kaye RE. PRISM: a novel research tool to assess the prevalence of pseudobulbar affect symptoms across neurological conditions. PLoS One. 2013;8(8):e72232. doi:10.1371/journal.pone.0072232

  • 3.

    Centers for Disease Control and Prevention. ICD-10-CM tabular list of diseases and injuries. Accessed June 10, 2024. https://ftp.cdc.gov/pub/health_statistics/nchs/publications/ICD10CM/2022/icd10cm-tabular-2022-April-1.pdf

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Copay savings card

Share this card with your eligible patients to help them save on their NUEDEXTA prescription and refills.

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10-day sample

Eligible healthcare providers can request a free 10-day sample of NUEDEXTA for appropriate patients.

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IMPORTANT SAFETY INFORMATION and INDICATION for NUEDEXTA® (dextromethorphan HBr and quinidine sulfate)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

  • Quinidine and Related Drugs: NUEDEXTA contains quinidine and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine.
  • Hypersensitivity: NUEDEXTA is contraindicated in patients with a history of NUEDEXTA-, quinine-, mefloquine-, or quinidine-induced thrombocytopenia, hepatitis, bone-marrow depression, lupus-like syndrome, or known hypersensitivity to dextromethorphan (e.g., rash, hives).
  • MAOIs: NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), or in patients who have taken MAOIs within the preceding 14 days, due to the risk of serious and possibly fatal drug interactions, including serotonin syndrome. Allow at least 14 days after stopping NUEDEXTA before starting an MAOI.
  • Cardiovascular: NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, heart failure, patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide), patients with complete atrioventricular (AV) block without implanted pacemaker, or at high risk of complete AV block.

Thrombocytopenia and Other Hypersensitivity Reactions: Quinidine can cause immune-mediated thrombocytopenia that can be severe or fatal. Non-specific symptoms, such as lightheadedness, chills, fever, nausea, and vomiting, can precede or occur with thrombocytopenia. NUEDEXTA should be discontinued immediately if thrombocytopenia occurs.

Hepatotoxicity: Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy. Discontinue immediately if this occurs.

Cardiac Effects: NUEDEXTA causes dose-dependent QTc prolongation. QT prolongation can cause torsades de pointes-type ventricular tachycardia, with the risk increasing as the degree of prolongation increases. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3 to 4 hours after the first dose. Some risk factors include use with CYP3A4 inhibitors or drugs that prolong QT interval, electrolyte abnormalities, bradycardia, or left ventricular hypertrophy or dysfunction. If patients taking NUEDEXTA experience symptoms that could indicate the occurrence of cardiac arrhythmias (e.g., syncope or palpitations), NUEDEXTA should be discontinued, and the patient further evaluated.

Concomitant Use of CYP2D6 Substrates: NUEDEXTA inhibits CYP2D6 and may interact with other drugs metabolized by CYP2D6. Adjust dose of CYP2D6 substrates as needed.

Dizziness: NUEDEXTA may cause dizziness. Take precautions to reduce the risk of falls.

Serotonin Syndrome: Use of NUEDEXTA with selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants increases the risk of “serotonin syndrome.”

Anticholinergic Effects of Quinidine: Monitor for worsening in myasthenia gravis.

Adverse Reactions: The most common adverse reactions (incidence of ≥3% and two-fold greater than placebo) in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence.

These are not all the risks for use of NUEDEXTA.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/‌medwatch).

INDICATION

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).

PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurologic disease or injury.

Please see FULL PRESCRIBING INFORMATION.