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Auvelity™ (dextromethorphan HBr and bupropion HCl) home page

The Auvelity Experience

symptom improvement Video

(VOICE OVER)

00:03

Auvelity is the first and only oral NMDA receptor antagonist for the treatment of major depressive disorder. Auvelity offers patients rapid symptom improvement at Week 1 that was sustained at Week 6.


00:23

Auvelity is a rapid-acting oral antidepressant with proven efficacy at Week 1.


00:29

Auvelity is indicated for the treatment of major depressive disorder in adults.

Antidepressants may increase suicidal thoughts and behaviors in pediatric and young adult patients.

Closely monitor your patients for these or new or worsening symptoms of depression, or new or sudden changes in mood, behavior, thoughts, or feelings. Auvelity is not approved for pediatric patients.

Please see additional Safety Information and Prescribing Information, including Boxed Warning for suicidal thoughts and behaviors, available by clicking on the Prescribing Information button to the right.


01:03

In the GEMINI clinical study, Auvelity demonstrated rapid and sustained symptom improvement vs placebo.


01:10

The Phase 3 GEMINI study evaluated the efficacy and safety of Auvelity vs placebo in 327 patients.


01:19

The primary endpoint was the LS mean change from baseline in the MADRS total score, measuring symptom improvement, at Week 6.

01:31
As you know, patients with MDD are living with a debilitating and chronic disorder. The GEMINI study looked at how Auvelity helped relieve depressive symptoms in patients as assessed by the MADRS total score and the CGI-I scale.


01:47

As shown here, Auvelity achieved the primary endpoint. Rapid symptom improvement on the MADRS total score was demonstrated starting at Week 1 and sustained at Week 6 vs placebo–which was statistically significant.

Furthermore, examination of demographic subgroups by age, sex, and race did not suggest differences on the primary endpoint.


02:19

Rapid and sustained results on the CGI-I scale were shown at Week 1 and sustained at Week 6. Significantly more patients taking Auvelity were very much or much improved starting at as Week 1 vs placebo. The percentage of patients increased over time to Week 6.


02:50

Symptom improvement that is rapid and sustained could make a difference for your patients with MDD.


02:57
The safety profile for Auvelity was demonstrated in the GEMINI phase 3 study. Most common adverse reactions were dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis. Mean weight loss was reported in patients taking Auvelity.


03:18

Auvelity was also studied up to 1 year in an open-label safety study and results were consistent with those observed in the controlled clinical studies.


03:30

Auvelity should not be taken with MAOIs. Do not use in patients with a seizure disorder or a history of anorexia or bulimia because of an increased risk of seizure. Do not use in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs. Do not use in patients with known allergy to the components in Auvelity due to a risk of severe allergic reaction. Concomitant use of Auvelity with migraine, psychiatric, or depression medications increases the risk of serotonin syndrome, a potentially life-threatening condition. Seizures, increased blood pressure and hypertension, manic episodes, psychosis, angle-closure glaucoma, and dizziness may occur with Auvelity. Auvelity may cause fetal harm when administered during pregnancy. Common side effects include dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis. These are not all the side effects that may occur.

Please see additional Safety Information and Prescribing Information, including Boxed Warning for suicidal thoughts and behaviors, available by clicking on the Prescribing Information button to the right.


04:58

Rapid symptom improvement is just the beginning. Patients taking Auvelity experienced meaningful relief at Week 6. What can Auvelity do for your patients with MDD?

Scroll up to see the MOA video. Scroll down to learn about remission.

[END OF TRANSCRIPT]

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Indication

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

Important Safety Information

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

  • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.
  • Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors.
  • Auvelity is not approved for use in pediatric patients.

CONTRAINDICATIONS

Seizure: Do not use Auvelity in patients with a seizure disorder.

Current or prior diagnosis of bulimia or anorexia nervosa: A higher incidence of seizure was observed in such patients treated with bupropion.

Undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs: Due to risk of seizure.

Monoamine Oxidase Inhibitors (MAOIs): Do not use Auvelity concomitantly with, or within 14 days of stopping, an MAOI due to the risk of serious and possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome. Conversely, at least 14 days must be allowed after stopping Auvelity before starting an MAOI antidepressant. Do not use Auvelity with reversible MAOIs such as linezolid or intravenous methylene blue.

Hypersensitivity: Do not use in patients with known hypersensitivity to dextromethorphan, bupropion, or any component of Auvelity. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported with bupropion. Arthralgia, myalgia, fever with rash, and other serum sickness-like symptoms suggestive of delayed hypersensitivity have also been reported with bupropion.

WARNINGS AND PRECAUTIONS

Suicidal Thoughts and Behaviors in Pediatrics and Young Adults: Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing Auvelity, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

Seizure: Bupropion, a component of Auvelity, can cause seizure and the risk is dose related. Because the risk of seizure with bupropion is dose-related, screen patients for use of other bupropion-containing products prior to initiating Auvelity. If concomitant use of Auvelity with other bupropion-containing products is clinically warranted, inform patients of the risk. Discontinue Auvelity and do not restart treatment if the patient experiences a seizure.

Increased Blood Pressure and Hypertension: Treatment with bupropion, a component of Auvelity, can cause elevated blood pressure and hypertension. The risk of hypertension is increased if Auvelity is used concomitantly with MAOIs or other drugs that increase dopaminergic or noradrenergic activity. Assess blood pressure before initiating treatment with Auvelity and monitor periodically during treatment. Monitor blood pressure, particularly in patients who receive the combination of bupropion and nicotine replacement.

Activation of Mania/Hypomania: Antidepressant treatment can precipitate a manic, mixed, or hypomanic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating Auvelity, screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). Auvelity is not approved for use in treating bipolar depression.

Psychosis and Other Neuropsychiatric Reactions: Auvelity contains bupropion and dextromethorphan. Depressed patients treated with bupropion have had a variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. In some cases, these symptoms abated upon dose reduction and/or withdrawal of treatment. Dextromethorphan overdose can cause toxic psychosis, stupor, coma, and hyperexcitability.

Because the risks of neuropsychiatric reactions are dose-related, screen patients for use of other bupropion- or dextromethorphan-containing products prior to initiating Auvelity. If concomitant use of Auvelity with other bupropion- or dextromethorphan-containing products is clinically warranted, monitor patients for neuropsychiatric reactions and instruct patients to contact a healthcare provider if such reactions occur.

Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressants, including Auvelity, may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including Auvelity, in patients with untreated anatomically narrow angles.

Dizziness: Auvelity may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls. Caution patients about operating hazardous machinery, including motor vehicles, until they are reasonably certain that Auvelity therapy does not affect them adversely.

Serotonin Syndrome: Auvelity contains dextromethorphan. Concomitant use with selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants increases the risk of serotonin syndrome, a potentially life-threatening condition. Prior to initiating therapy with Auvelity, screen patients for use of other dextromethorphan-containing products. If concomitant use of Auvelity with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome, and monitor for symptoms. Discontinue Auvelity and/or concomitant serotonergic drug(s) immediately if symptoms of serotonin syndrome occur and initiate supportive symptomatic treatment.

Embryo-fetal Toxicity: Based on animal studies, Auvelity may cause fetal harm when administered during pregnancy. Discontinue treatment in pregnant females and advise the patient about the potential risk to a fetus. Use alternative treatment for females who are planning to become pregnant.

DRUG INTERACTIONS

Strong Inhibitors of CYP2D6: Concomitant use with Auvelity increases plasma concentrations of dextromethorphan. Dosage adjustment is necessary. Monitor patients for adverse reactions potentially attributable to dextromethorphan, such as somnolence and dizziness.

Strong CYP2B6 Inducers: Concomitant use with Auvelity decreases plasma concentrations of dextromethorphan and bupropion and may decrease efficacy of Auvelity. Avoid co-administration of Auvelity.

CYP2D6 Substrates: Concomitant use with Auvelity can increase the exposures of drugs that are substrates of CYP2D6. It may be necessary to decrease the dose of CYP2D6 substrates, particularly for drugs with a narrow therapeutic index.

Digoxin: Concomitant use with Auvelity may decrease plasma digoxin levels. Monitor plasma digoxin levels in patients treated concomitantly with Auvelity.

Drugs that Lower Seizure Threshold: Concomitant use with Auvelity may increase risk of seizure. Use Auvelity with caution. Discontinue Auvelity and do not restart treatment if the patient experiences a seizure.

Dopaminergic Drugs: Concomitant use with Auvelity can result in central nervous system toxicity. Use Auvelity with caution.

USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for neurotoxicity, advise patients that breast-feeding is not recommended during treatment with Auvelity and for 5 days following final dose.

Renal Impairment: Dosage adjustment is recommended in patients with moderate renal impairment (eGFR 30 to 59 mL/minute/1.73 m2). Auvelity is not recommended in patients with severe renal impairment (eGFR 15 to 29 mL/minute/1.73 m2).

Hepatic Impairment: Auvelity is not recommended in patients with severe hepatic impairment.

ADVERSE REACTIONS

Most common adverse reactions (≥5% and twice the rate of placebo): dizziness (16%), headache (8%), diarrhea (7%), somnolence (7%), dry mouth (6%), sexual dysfunction (6%), and hyperhidrosis (5%).

Please see full Prescribing Information, including Boxed Warning for suicidal thoughts and behaviors.

AUV HCP ISI 10/2022