HOW TO START YOUR PATIENTS ON NUEDEXTA

Actor portrayal of patient with PseudoBulbar Affect (PBA) after treatment

Dosing and administration1

STARTING DOSE

Days 1-7

1 capsule per day
(1 capsule PO QD)

Not actual size.

MAINTENANCE DOSE

Beginning Day 8

2 capsules per day
(1 capsule PO Q12H)

Not actual size.

Titrate to Q12H at Day 8. Efficacy beyond Week 1 in the pivotal trial was achieved with Q12H dosing.2

Following this regimen, patients on NUEDEXTA had a mean 82% reduction in pseudobulbar affect (PBA) episodes vs 45% on placebo at 12 weeks in the STAR pivotal trial.2

The need for continued treatment should be reassessed periodically as spontaneous improvement of PBA symptoms occurs in some patients. 

Specific Populations1

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.

Example of NUEDEXTA patient prescription sheet

Script pad is used for illustrative purposes only.

Document your diagnosis of PBA using ICD-10 code F48.2.3

NUEDEXTA is a central nervous system (CNS) agent that does NOT fall into the antipsychotic category.4

NUEDEXTA is categorized in the "Central Nervous System, Other" pharmacologic class in the USP model formulary.4

Script pad is used for illustrative purposes only.


This code is intended for reference only. ICD-10-CM codes submitted to the payer must be determined by the provider/physician and accurately describe PBA as the diagnosis for which the patient receives NUEDEXTA treatment.

What to know about NUEDEXTA pharmacology

Watch NUEDEXTA paharmacology
SEE THE PHARMACOLOGY OF NUEDEXTA
The exact mechanism by which NUEDEXTA exerts its therapeutic effects in patients with PBA is unknown.1

NUEDEXTA is a combination of 2 well-characterized components1

The exact mechanism by which NUEDEXTA exerts its therapeutic effects in patients with PBA is unknown.1

1

Dextromethorphan HBr (20 mg)1,5
Nuedexta molecule dextromethorphan HBr (20mg)

An uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, believed to modulate certain neurotransmitter functions

2

Quinidine sulfate (10 mg)—ultra-low dose1,6
Nuedexta molecule quinidine sulfate (10 mg)

A CYP2D6 metabolic inhibitor that increases dextromethorphan (DM) bioavailability and prolongs its elimination half-life

NUEDEXTA is believed to modulate certain neurotransmitter functions5

DM is thought to target glutamate signaling in two ways.

Portrayal of dextromethorphan (DM) targeting glutamate signaling in 2 ways

Binding of DM to sigma-1 receptors is believed to result in inhibition of glutamate release.5

Portrayal of dextromethorphan (DM) targeting glutamate signaling in 2 ways

NMDA is one of the main neurotransmitter receptors for glutamate. DM NMDA receptor antagonism reduces postsynaptic glutamate signaling.5,7

References: 1. NUEDEXTA [package insert]. Aliso Viejo, CA: Avanir Pharmaceuticals, Inc. 2. Data on File. Avanir Pharmaceuticals, Inc. 3. Centers for Disease Control and Prevention (CDC). International Classification of Diseases. Tenth Revision, Clinical Modification (ICD-10-CM). https://www.cdc.gov/nchs/icd/icd10cm.htm. Accessed April 24, 2019. 4. The United States Pharmacopeial Convention (USP). Medicare Model guidelines v7.0. USP website. http://www.usp.org/sites/default/files/usp/document/our-work/healthcare-quality-safety/uspmmg_v7_0_w_exampledrugs_rev170206.pdf. Accessed April 1, 2019. 5. Werling LL, Lauterbach EC, Calef U. Dextromethorphan as a potential neuroprotective agent with unique mechanisms of action. Neurologist. 2007;13(5):272-293. 6. Schadel M, Wu D, Otton SV, Kalow W, Sellers EM. Pharmacokinetics of dextromethorphan and metabolites in humans: influence of the CYP2D6 phenotype and quinidine inhibition. J Clin Psychopharmacol. 1995;15(4):263-269. 7. Pankevich DE, Davis M, Altevogt BM; for the Institute of Medicine Forum on Neuroscience and Nervous System Disorders. Glutamate-Related Biomarkers in Drug Development for Disorders of the Nervous System: Workshop Summary. Washington, DC: The National Academies Press; 2011.

INDICATION AND USAGE

NUEDEXTA® (dextromethorphan HBr and quinidine sulfate) 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.

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 (eg, 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 (eg, thioridazine and pimozide), patients with complete atrioventricular (AV) block without implanted pacemaker, or at high risk of complete AV block.

WARNINGS AND PRECAUTIONS

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 (eg, 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. Please see Full Prescribing Information.

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