Dosing and administration1
1 capsule per day
(1 capsule PO QD)
Not actual size.
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.
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.
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
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
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
Dextromethorphan HBr (20 mg)1,5
An uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, believed to modulate certain neurotransmitter functions
Quinidine sulfate (10 mg)—ultra-low dose1,6
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.
Binding of DM to sigma-1 receptors is believed to result in inhibition of glutamate release.5
NMDA is one of the main neurotransmitter receptors for glutamate. DM NMDA receptor antagonism reduces postsynaptic glutamate signaling.5,7