Bupropiondosage

Prior to initiating treatment with AUVELITY: assess blood pressure; screen patients for history of bipolar disorder, mania, or hypomania; and determine if patients are receiving any other medications that contain bupropion or dextromethorphan. For MDD, the starting dosage is AUVELITY 45 mg/105 mg once daily in the morning. On day 4, increase to the maximum recommended dosage of AUVELITY 45 mg/105 mg twice daily, separated by at least 8 hours. Do not exceed two doses within the same day. For agitation associated with dementia due to Alzheimer’s disease, the starting dosage is AUVELITY 30 mg/105 mg once daily in the morning. On day 8, increase to AUVELITY 30 mg/105 mg twice daily, separated by at least 8 hours, based on tolerability. On day 15, increase to the maximum recommended dosage of AUVELITY 45 mg/105 mg twice daily, separated by at least 8 hours, based on tolerability. Do not exceed two doses within the same day. Swallow tablets whole, do not crush, divide, or chew.

Moderate renal impairment: For patients with MDD or agitation associated with dementia due to Alzheimer’s disease, the maximum recommended dosage is one tablet of 45 mg/105 mg by mouth once daily in the morning.

CYP2D6 poor metabolizers: For patients with MDD or agitation associated with dementia due to Alzheimer’s disease, the maximum recommended dosage is one tablet of 45 mg/105 mg by mouth once daily in the morning.

2.1 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. screen patients for a personal or family history of bipolar disorder, mania, or hypomania. screen patients to determine if they are receiving any other medications that contain bupropion or dextromethorphan.

2.2 Recommended

Dosage for the Treatment of Major Depressive Disorder The recommended starting dosage ofis AUVELITY (45 mg of dextromethorphan hydrobromide and /105 mg of bupropion hydrochloride) is one tablet once daily in the morning. After 3 daysOn day 4, 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. Swallow tablets whole, do not crush, divide, or chew.

2.3 Recommended

Dosage for Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease The recommended titration schedule is as follows: The recommended starting dose is AUVELITY 30 mg/105 mg once daily, in the morning. On day 8, increase to AUVELITY 30 mg/105 mg twice daily, given at least 8 hours apart, based on tolerability. On day 15, after starting AUVELITY, increase to the maximum recommended dosage of 45 mg/105 mg twice daily, given at least 8 hours apart, based on tolerability. Do not exceed two doses within the same day. Administer AUVELITY orally with or without food. Swallow tablets whole, do not crush, divide, or chew.

2.4 Dosage Recommendations in

Patients with Renal Impairment For patients with moderate renal impairment (eGFR 30 to 59 mL/minute/1.73 m²), the dosing recommendations for AUVELITY are as follows: For patients with MDD, the recommended starting and maximum dosage is 45 mg/105 mg once daily in the morning. For patients with Agitation Associated with Dementia due to Alzheimer’s Disease, the recommended starting dosage is 30 mg/105 mg once daily in the morning. On day 8, increase to the maximum recommended dosage of 45 mg/105 mg once daily in the morning, based on tolerability.

2.5 Dosage Recommendations for

Concomitant Use with Strong CYP2D6 Inhibitors When AUVELITY is co-administered with strong CYP2D6 inhibitors, the dosing recommendations for AUVELITY are as follows: For MDD, the recommended starting and maximum dosage is 45 mg/105 mg once daily in the morning. For Agitation Associated with Dementia due to Alzheimer’s Disease, the recommended starting dosage is 30 mg/105 mg once daily in the morning. On day 8, increase to the maximum recommended dosage of 45 mg/105 mg once daily in the morning, based on tolerability.

2.6 Dosage Recommendations for

Known CYP2D6 Poor Metabolizers (PMs) For patients who are known CYP2D6 poor metabolizers, the dosing recommendations are as follows: For MDD, the recommended starting and maximum dosage is 45 mg/105 mg once daily in the morning. For Agitation Associated with Dementia due to Alzheimer’s Disease, the recommended starting dosage is 30 mg/105 mg once daily in the morning. On day 8, increase to the maximum recommended dosage of 45 mg/105 mg once daily in the morning, based on tolerability.

2.7 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.