Mood disorders:

Indications for: AUVELITY

Major depressive disorder (MDD).

Adult Dosage:

Swallow whole. ≥18yrs: initially 1 tab once daily in the AM for 3 days, then increase to 1 tab twice daily (given at least 8hrs apart). Max 2 doses daily. Moderate renal impairment (eGFR 30–59mL/min/1.73m2), concomitant strong CYP2D6 inhibitors, poor CYP2D6 metabolizers: reduce to 1 tab once daily in the AM.

Children Dosage:

<18yrs: not established.

AUVELITY Contraindications:

Seizure disorders. Bulimia. Anorexia nervosa. Undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptics. During or within 14 days of discontinuing MAOIs. Concomitant linezolid or IV methylene blue.

Boxed Warning:

Suicidal thoughts and behavior.

AUVELITY Warnings/Precautions:

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor all patients closely for clinical worsening and emergence of suicidal thoughts and behaviors (esp. during the initial few months and at times of dosage changes). Consider alternative regimen including discontinuing treatment if depression worsens or if suicidal thoughts/behaviors occur. Increased risk of seizure with severe head injury, arteriovenous malformation, CNS tumor or CNS infection, severe stroke, metabolic disorders. Discontinue and do not restart treatment if seizure occurs. Risk of dose-related neuropsychiatric reactions (eg, delusions, hallucinations, psychosis, concentration disturbance, paranoia, confusion). Angle-closure glaucoma. Avoid use in those with untreated anatomically narrow angles. Monitor BP prior to initiation and periodically during treatment. Screen for a history of bipolar disorder, mania, or hypomania. Screen for other medications containing bupropion or dextromethorphan. Severe renal (eGFR 15–29mL/min/1.73m2) or hepatic (Child-Pugh C) impairment: not recommended. Embryo-fetal toxicity. Use alternative treatment for females who are planning to become pregnant. Pregnancy: not recommended; discontinue if occurs during treatment. Nursing mothers: not recommended (during and for 5 days after the last dose).

AUVELITY Classification:

Uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist + aminoketone.

AUVELITY Interactions:

See Contraindications. Increased risk of hypertensive crisis and serotonin syndrome during or within 14 days of discontinuing MAOIs (eg, linezolid or IV methylene blue). Increased risk of serotonin syndrome with other serotonergic drugs; discontinue Auvelity and/or concomitant drug if occurs. Caution with drugs that lower seizure threshold (eg, bupropion products, antipsychotics, tricyclic antidepressants, theophylline, systemic corticosteroids, CNS stimulants) or factors that lower seizure threshold (eg, opiate or cocaine addiction, excessive use of alcohol or sedative/hypnotics). Potentiated by strong CYP2D6 inhibitors; monitor and adjust dose. Antagonized by strong CYP2B6 inducers; avoid. May potentiate CYP2D6 substrates; consider decreasing dose of substrates esp. for drugs with a narrow therapeutic index. May antagonize drugs that require metabolic activation by CYP2D6; consider increasing the dose of these drugs. May antagonize digoxin; monitor. Caution with dopaminergic drugs (eg, levodopa, amantadine). Avoid or minimize consumption of alcohol during treatment. May cause false (+) urine immunoassay test results for amphetamine.

Adverse Reactions:

Dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, hyperhidrosis; hypertension.

Generic Drug Availability:


How Supplied: