EMSAM® (selegiline transdermal system)
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 EMSAM or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. EMSAM is not approved for use in pediatric patients and should not be used in children under the age of 12, even when administered with dietary modifications.

It's Time to Chart a Different Course

With EMSAM, the First and Only FDA-Approved Transdermal System for the Treatment of MDD1-4

Learn More

Learn about EMSAM and how transdermal delivery works

References: 1. EMSAM Prescribing Information. Dey Pharma, L.P. January 2010. 2. Marplan® (isocarboxazid) Tablets Prescribing Information. Validus Pharmaceuticals, Inc. August 2007. 3. Nardil® (phenelzine sulfate tablets, USP) Prescribing Information. Parke-Davis. February 2009. 4. Parnate® (tranylcypromine sulfate) Prescribing Information. GlaxoSmithKline. May 2010.

Indication

EMSAM Transdermal System is indicated for the treatment of major depressive disorder.

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 EMSAM 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 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 for the need for close observation and communication with the prescriber. EMSAM is not approved for use in pediatric patients. Furthermore, EMSAM at any dose should not be used in children under the age of 12, even when administered with dietary modifications.

Contraindications

  • To reduce the risk of hypertensive crisis, which is potentially life-threatening, 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.
    • EMSAM Transdermal System should not be used in combination with tyramine-containing nutritional supplements
  • Due to potential for serotonin syndrome, which is sometimes fatal, EMSAM Transdermal System should not be used with the following: selective serotonin reuptake inhibitors (SSRIs); dual serotonin and norepinephrine reuptake inhibitors (SNRIs); tricyclic antidepressants (TCAs); monoamine oxidase inhibitors (MAOIs); cyclobenzaprine; mirtazapine; bupropion; meperidine and analgesics such as tramadol, methadone, propoxyphene, and pentazocine; dextromethorphan or St. John’s Wort. EMSAM Transdermal System should not be used with oral selegiline or other MAO inhibitors (MAOIs e.g., isocarboxazid, phenelzine, and tranylcypromine)
    • Stop use of these agents approximately 1 week (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 buspirone or a drug contraindicated with EMSAM Transdermal System
  • EMSAM Transdermal System is also contraindicated for use with sympathomimetic amines, including amphetamines, cold products and weight-reducing products containing vasoconstrictors (e.g., pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine)
  • EMSAM Transdermal System is also contraindicated for use with carbamazepine and oxcarbazepine
  • Patients taking EMSAM Transdermal System should not undergo elective surgery requiring general anesthesia or be given cocaine or local anesthesia containing sympathomimetic vasoconstrictors
  • EMSAM Transdermal System is contraindicated in patients with known hypersensitivity to selegiline or to any other component of the transdermal system
  • EMSAM Transdermal System should not be used in the presence of pheochromocytoma

Warnings and Precautions

  • Risk of bipolar disorder should be ruled out prior to initiating antidepressant therapy. EMSAM Transdermal System is not approved for the treatment of bipolar depression
  • EMSAM Transdermal System should be used cautiously in patients with a history of mania and in patients with concomitant systemic illnesses that can produce altered metabolism or hemodynamic responses
  • Due to the potential for elevated blood pressure, use of EMSAM Transdermal System with buspirone is not recommended. Buspirone should be stopped about 1 week before starting EMSAM Transdermal System
  • Postural hypotension can occur with EMSAM Transdermal System therapy. Dose increases in patients with pre-existing orthostasis should be made with caution and elderly patients should be observed closely for postural changes in blood pressure throughout treatment
  • EMSAM Transdermal System is not approved for use in pediatric patients
  • Pregnancy Category C. EMSAM Transdermal System should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when administering EMSAM Transdermal System to a nursing mother

Treatment Considerations

  • EMSAM Transdermal System may have the potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until they are certain EMSAM Transdermal System does not impair their ability to engage in such activities
  • The use of alcohol is not recommended while using EMSAM Transdermal System

Adverse Events

  • 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%)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

Please see full Prescribing Information, including Boxed Warning and Medication Guide.