Nuedexta in the Nursing Home
Nuedexta® (dextromethorphan hydrobromide and quinidine) was the first medication approved by the FDA for the treatment of pseudobulbar affect (PBA). Pseudobulbar affect is a specific neurological disorder characterized by sudden, uncontrollable laughing and/or crying that does not represent the patient’s true emotions at the moment of outburst. Patients may present with PBA secondary to many neurological disorders including: dementia, Alzheimer’s disease, stroke, traumatic brain injury, Parkinson’s disease, multiple sclerosis, and amyotrophic lateral sclerosis (ALS). PBA is often misdiagnosed as depression due to the frequent outbursts of crying, so many patients are placed on antidepressants.
Nuedexta® is manufactured by Avanir Pharmaceuticals and is available as 20/10 mg capsules at a cost of over $600 for a one-month supply. The usual dosage is once capsule every 12 hours, following a one capsule daily titration period of 7 days. It is important for patients, prescribers, and nurses (in the LTC setting) to observe for signs and symptoms of adverse effects during the titration period. (see below)
To date, there have been 25 clinical trials completed. The results of several clinical trials have been clinically insignificant due to small sample size. In one clinical trial, Nuedexta® showed statistically significant improvement in reducing PBA symptoms after 12 weeks in patients with ALS and MS but, its safety and efficacy has yet to be established in patient with any other neurological disorders. It is worth noting that in this “pivotal” trial, even the placebo group had a remission rate of 30%, which may suggest the symptoms of PBA may be more transient and less chronic.
There is some concern to the long-term and off-label use of Nuedexta® in the elderly for other neurological or psychological conditions with affective instability. Nuedexta® is not indicated and has not been studied as a treatment for the behavioral and psychological symptoms of dementia (BPSD). In clinical trials, only 2% of participants were 75 years old or older. More data from head-to-head clinical trials and post-marketing adverse event reporting is needed to know how safe and effective Nuedexta® will be in other neurological conditions as well as in the older population. As with all new medications, healthcare providers should exercise caution when initiating Nuedexta® and monitor closely for adverse effects.
Common Adverse Events |
Contraindications |
Concerns for LTCFs |
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• Diarrhea • Dizziness • Cough • Vomiting • Asthenia • Peripheral edema • Urinary Tract Infection • Influenza • Elevated liver enzymes • Gas
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• Hypersensitivity to either component• Use with Quinidine, Quinine, or Mefloquine• MAOIs (must discontinue use 14 days before initiating Nuedexta®)• Prolonged QT interval
• Congential long QT syndrome • History of torsades de pointes • Heart failure • Hepatitis • Use with CYP2D6 drugs that prolong QT interval • AV block w/o pacemaker and high risk for complete AV block
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• Increased fall risk • Anticholinergic effects of quinidine • Drug-drug interactions with current psychoactive treatment o Serotonin syndrome o QTc prolongation • Drug-disease interactions o AV block • Long-term use has not been studied
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References:
- Pioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar aff ect. Ann Neurol 2010; 68: 693–702.
- Nuedexta [package insert]. Aliso Viejo, CA: Avanir Pharmaceuticals, Inc.; Revised January 2015.
This article was originally published in our monthly issue of From the Front Lines – a monthly publication that shares best practices and medication-related challenges faced by “front line” staff in long-term care and post-acute (LTCPAC) facilities.
