APLENZIN (bupropion hydrobromide) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD).
IMPORTANT SAFETY INFORMATION
SUICIDALITY AND ANTIDEPRESSANT DRUGS:
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of APLENZIN or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. APLENZIN is not approved for use in pediatric patients.
NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION:
Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although APLENZIN is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur [see Warnings and Precautions in Full Prescribing Information].
- APLENZIN is contraindicated in patients with seizure disorder or conditions that increase the risk of seizures, known hypersensitivity to bupropion (anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported) and the concurrent use of monoamine oxidase (MAO) inhibitors.
- APLENZIN can cause seizure. The risk of seizure is dose-related. The dose should not exceed 522 mg once daily. Increase the dose gradually. Discontinue APLENZIN and do not restart treatment if the patient experiences a seizure (see Warnings and Precaution in Full Prescribing Information).
- Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for APLENZIN should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. Families and caregivers of adults being treated for depression should be similarly advised.
- APLENZIN is not approved for smoking cessation treatment; however, bupropion HCl sustained-release is approved for this use. Serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation. These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide [see Boxed Warning and Adverse Reactions in Full Prescribing Information]. Observe patients for the occurrence of neuropsychiatric reactions. Instruct patients to contact a healthcare professional if such reactions occur.
- Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating APLENZIN, 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). APLENZIN is not approved for the treatment of bipolar depression.
- For patients with severe hepatic impairment, the maximum APLENZIN dose is 174 mg every other day. In patients with mild to moderate impairment, consideration should be given to reducing the dose and/or frequency of dosing. Depressed patients treated with bupropion have had a variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. Some of these patients had a diagnosis of bipolar disorder. In some cases, these symptoms abated upon dose reduction and/or withdrawal of treatment. Discontinue APLENZIN if these reactions occur.
- Anaphylactoid reactions characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnea requiring medical treatment have been reported in clinical trials with bupropion. Treatment with APLENZIN can result in elevated blood pressure and hypertension. Assess blood pressure before initiating treatment with APLENZIN, and monitor periodically during treatment.
- Co-administration with drugs that are metabolized by CYP2B6 or CYP2D6 isoenzymes should be approached with caution. Please see the DRUG INTERACTIONS section in the Prescribing Information for further information.
- The most common adverse reactions reported in clinical trials were anorexia, dry mouth, rash, sweating, tinnitus, tremor, abdominal pain, agitation, anxiety, dizziness, insomnia, myalgia, nausea, palpitation, pharyngitis and urinary frequency.
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