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Vital sign changes
Laboratory and ECG changes
Other reactions observed during the premarketing evaluation of EMSAM
Dosage and Administration
EMSAM® Transdermal Patch is Available in 3 Different
24-Hour Dosage Strengths1
When to apply?
IMPORTANT SAFETY INFORMATION AND INDICATION
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WARNING: SUICIDAL THOUGHTS AND BEHAVIOR
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 for emergence of suicidal thoughts and behaviors. EMSAM is contraindicated in patients less than 12 years of age because of an increased risk of hypertensive crisis.
- EMSAM Transdermal System is contraindicated with selective serotonin reuptake inhibitors (SSRIs); serotonin and norepinephrine reuptake inhibitors (SNRIs); the tricyclic antidepressants clomipramine and imipramine, the opiate analgesics meperidine, tramadol, methadone, pentazocine, and propoxyphene; and the antitussive agent dextromethorphan because of a risk of serotonin syndrome when EMSAM Transdermal System is used with these agents.
- Carbamazepine is contraindicated with EMSAM because of a possible increased risk of hypertensive crisis.
- Stop the use of these agents 1 week (at least 5 weeks for fluoxetine) before starting therapy with EMSAM Transdermal System. EMSAM Transdermal System should be stopped at least 2 weeks before starting therapy with any drug that is contraindicated with EMSAM.
- EMSAM is contraindicated in patients less than 12 years of age because of the potential for a hypertensive crisis.
- EMSAM is contraindicated in patients with pheochromocytoma because MAOIs may precipitate a hypertensive crisis in such patients.
WARNINGS and PRECAUTIONS
Suicidal Thoughts and Behaviors in Adolescents and Young Adults: In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. Monitor all antidepressant-treated patients 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.
Consider changing the therapeutic regimen, including possibly discontinuing EMSAM, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
- Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with concomitant use of MAOIs, such as EMSAM, with serotonergic drugs. These reactions have also been reported in patients who have discontinued serotonergic drugs and then subsequently started an MAOI. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome. Treatment with EMSAM and any concomitant serotonergic agents should be discontinued immediately and supportive treatment should be initiated.
- Blood Pressure Elevation:
Tyramine-Induced Hypertensive Crisis: EMSAM inhibits the catabolism of dietary amines, such as tyramine, and has the potential to produce a hypertensive crisis following the ingestion of tyramine-rich foods or beverages. Hypertensive crises, which in some cases may be fatal, are characterized by some or all of the following symptoms: occipital headache which may radiate frontally, palpitation, neck stiffness or soreness, nausea, vomiting, sweating (sometimes with fever and sometimes with cold, clammy skin), dilated pupils, and photophobia. Either tachycardia or bradycardia may be present and can be associated with constricting chest pain. Intracranial bleeding has been reported in association with the increase in blood pressure. Patients should be instructed as to the signs and symptoms of severe hypertension and advised to seek immediate medical attention if these signs or symptoms are present. If a hypertensive crisis occurs, EMSAM should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling. Patients must be closely monitored until symptoms have stabilized.
To prevent a hypertensive crisis, foods and beverages high in tyramine must be avoided while on EMSAM 9 mg/24hr or 12 mg/24hr, and for 2 weeks following discontinuation of EMSAM Transdermal System at these doses, or after reducing the dose to 6 mg/24hr.
Blood Pressure Elevation Related to Concomitant Medication: Carbamazepine is contraindicated with EMSAM because carbamazepine has been shown to significantly elevate selegiline levels, which may increase the risk of a hypertensive crisis. The use of EMSAM with adrenergic drugs or buspirone may produce substantial increases in blood pressure. Therefore, monitor blood pressure if EMSAM is used with any of the following drugs: buspirone, amphetamines, cold products or weight-reducing preparations that contain sympathomimetic amines (e.g., pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine).
- Activation of Mania/Hypomania: In patients with bipolar disorder, treating a depressive episode with EMSAM or another antidepressant may precipitate a mixed/manic episode. Prior to initiating treatment with EMSAM, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.
- External Heat: Heat may result in an increase in the amount of selegiline absorbed from EMSAM and produce elevated serum levels of selegiline. Patients should be advised to avoid exposing the EMSAM application site to external sources of direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds and prolonged direct sunlight.
- Treatment-emergent adverse events (at ≥2% incidence with EMSAM Transdermal System and greater than placebo, respectively) in short-term clinical trials: application site reactions (24% vs 12%), headache (18% vs 17%), insomnia (12% vs 7%), diarrhea (9% vs 7%), dry mouth (8% vs 6%), dyspepsia (4% vs 3%), rash (4% vs 2%), pharyngitis (3% vs 2%), and sinusitis (3% vs 1%).
- Serotonergic Drugs: Serious, sometimes fatal, central nervous system (CNS) toxicity referred to as the “serotonin syndrome” has been reported with the combination of nonselective MAOIs and serotonergic drugs. Use of EMSAM with these drugs is contraindicated.
- Tyramine: EMSAM has the capacity to inhibit intestinal MAO, which is responsible for the catabolism of tyramine in food and beverages. As a result of this inhibition, large amounts of tyramine may enter the systemic circulation and precipitate a sudden, large rise in blood pressure or hypertensive crisis. To prevent a hypertensive crisis, foods and beverages high in tyramine must be avoided while on EMSAM 9 mg/24hr, and for 2 weeks following discontinuation of EMSAM Transdermal System at these doses, or after reducing the dose to 6 mg/24hr.
- Sympathomimetic Amines and Buspirone: The use of EMSAM with sympathomimetic amines or buspirone may produce substantial elevations in blood pressure. Therefore, monitor blood pressure if EMSAM is used with any of the following drugs: buspirone, amphetamines, and cold products or weight-reducing preparations that contain sympathomimetic amines.
- Effect of Other Drugs on EMSAM: Carbamazepine is contraindicated with MAOIs, including selegiline.
- Effect of EMSAM on Other Drugs: Use of alcohol while taking EMSAM is not recommended, even though EMSAM has not been shown to increase the impairment of mental and motor skills caused by alcohol (0.75 mg per kg). Monitor blood pressure if sympathomimetic agents (e.g., phenylpropanolamine (PPA) or pseudoephedrine) are used with EMSAM, even though selegiline does not appear to affect the pharmacokinetics of PPA or pseudoephedrine.
USE IN SPECIFIC POPULATIONS
- Pregnancy: When treating a pregnant woman with EMSAM, the physician should carefully consider both the potential risks of taking an MAOI, particularly the risk of hypertensive crisis during pregnancy, along with the established benefits of treating depression with an antidepressant.
- Lactation: Because of the potential for serious adverse reactions in breastfed infants from EMSAM, including the potential for hypertensive crisis, advise a woman that breastfeeding is not recommended during treatment with EMSAM and for 5 days after the final dose.
EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with depressive disorder (MDD).
Please click here for full Prescribing Information including Boxed WARNING and Medication Guide.
Reference: 1. Emsam [prescribing information]. Morgantown, WV: Somerset Pharmaceuticals Inc.; 2020.