INDICATION and IMPORTANT SAFETY INFORMATION for NUEDEXTA® (dextromethorphan HBr and quinidine
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.
IMPORTANT SAFETY INFORMATION
- Quinidine and Related Drugs: NUEDEXTA contains quinidine and
should not be used concomitantly with other drugs containing quinidine, quinine, or
- 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
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
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).
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