Important Recommendations Prior to Initiating and During Treatment with AUVELITY

Prior to initiating and during treatment with AUVELITY:

• assess blood pressure and monitor periodically during treatment [see Warnings and Precautions (5.3)].
• screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.4)].
• screen patients to determine if they are receiving any other medications that contain bupropion or dextromethorphan [see Warnings and Precautions (5.2, 5.5, 5.8)].

Recommended Dosage for the Treatment of Major Depressive Disorder

The recommended starting dosage of AUVELITY (45 mg of dextromethorphan hydrobromide and 105 mg of bupropion hydrochloride) is one tablet once daily in the morning. After 3 days, increase to the maximum recommended dosage of one tablet twice daily, given at least 8 hours apart. Do not exceed two doses within the same day.

Administer AUVELITY orally with or without food [see Clinical Pharmacology (12.3)]. Swallow tablets whole, do not crush, divide, or chew.

Dosage Recommendations in Patients with Renal Impairment

The recommended dosage of AUVELITY for patients with moderate renal impairment (eGFR 30 to 59 mL/minute/1.73 m2) is one tablet once daily in the morning [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Dosage Recommendations for Concomitant Use with Strong CYP2D6 Inhibitors

The recommended dosage of AUVELITY when co-administered with strong CYP2D6 inhibitors is one tablet once daily in the morning [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Dosage Recommendations for Known CYP2D6 Poor Metabolizers (PMs)

The recommended dosage for patients known to be poor CYP2D6 metabolizers is one tablet once daily in the morning [see Use in Specific Populations (8.8), Clinical Pharmacology (12.3)].

Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant

At least 14 days must elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with AUVELITY. Conversely, at least 14 days must be allowed after stopping AUVELITY before starting an MAOI antidepressant [see Contraindications (4), Drug Interactions (7.1)].