Auvelity: Indications and Contraindications

Indication

Auvelity is indicated exclusively for the treatment of major depressive disorder (MDD) in adults. 1

This fixed-dose combination contains dextromethorphan hydrobromide (45 mg) and bupropion hydrochloride (105 mg) in an extended-release formulation. 1
Dextromethorphan acts as an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, while bupropion functions as a CYP2D6 inhibitor that increases dextromethorphan bioavailability. 1, 2
Auvelity is NOT approved for use in pediatric patients. 1

Auvelity must not be used in the following clinical scenarios:

Current seizure disorder of any type. 1
Current or prior diagnosis of bulimia nervosa or anorexia nervosa (higher seizure incidence observed with bupropion in these populations). 1
Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs (precipitates seizure risk). 1

Concurrent use with MAOIs or within 14 days of stopping an MAOI (risk of hypertensive crisis and serotonin syndrome). 1
Starting Auvelity in patients currently treated with reversible MAOIs such as linezolid or intravenous methylene blue. 1
At least 14 days must elapse after stopping Auvelity before initiating any MAOI. 1

Known hypersensitivity to bupropion, dextromethorphan, or any component of Auvelity. 1
Previous anaphylactoid/anaphylactic reactions, Stevens-Johnson syndrome, or serum sickness-like symptoms (arthralgia, myalgia, fever with rash) with bupropion exposure. 1

Antidepressants, including Auvelity, increase the risk of suicidal thoughts and behaviors in patients under age 25. 1
The highest risk occurs in patients younger than 18 years (14 additional cases per 1,000 patients) and ages 18-24 (5 additional cases per 1,000 patients). 1
Close monitoring is mandatory during initial treatment months and at dosage changes. 1

Before initiating Auvelity, clinicians must: 1

Assess baseline blood pressure and monitor periodically during treatment
Screen for personal or family history of bipolar disorder, mania, or hypomania
Verify patients are not receiving other medications containing bupropion or dextromethorphan

Do not prescribe Auvelity to patients with eating disorders even if they are in remission, as the seizure risk remains elevated. 1
Do not combine with other bupropion-containing products (e.g., Wellbutrin, Zyban, Contrave) to avoid overdose and seizure risk. 1
Do not use in patients tapering off benzodiazepines or alcohol until withdrawal is complete and stabilized. 1
Ensure the 14-day washout period with MAOIs in both directions to prevent potentially fatal interactions. 1