• Image of woman applying EMSAM patch to the outer surface of the upper arm
  • Image of woman with MDD
  • Image of woman applying EMSAM patch to the outer surface of the upper arm
  • Image of woman with MDD

*Study Descriptions1
The EMSAM (selegiline transdermal system) efficacy was evaluated based upon 2 separate randomized, placebo-controlled, double-blind studies. For Study 1 (N = 89 for EMSAM and N = 88 for placebo), a 20 cm2 EMSAM patch (20 mg applied once daily) was evaluated over 6 weeks in the adults with MDD. For Study 2 (N = 132 for EMSAM and N = 133 for placebo), the dose range of 6-12 mg/24 h was evaluated over 8 weeks. Primary efficacy outcomes used for evaluation were HAM-D Scale-17 for Study 1 and HAM-D Scale-28 for Study 2. In both studies, the EMSAM group showed significant improvement in the HAM-D total score vs placebo (LS mean change from baseline of -9 for EMSAM vs -6.5 for placebo in Study 1 and -10.9 for EMSAM vs -8.6 for placebo in Study 2).

In a third randomized, double-blind, placebo-controlled 52-week study in adult outpatients with MDD who responded with a 17-item HAM-D score of 10 or less, patients were randomized to EMSAM (6mg/24 h) (n = 159) or placebo (n = 163). Approximately 52% of patients in the EMSAM and placebo groups discontinued by week 12 of the double-blind phase. Patients on EMSAM experienced a significantly longer time to relapse than those in the placebo group.

*Study Description1
The EMSAM (selegiline transdermal system) efficacy was evaluated based upon 2 separate randomized, placebo-controlled, double-blind studies. For Study 1 (N = 89 for EMSAM and N = 88 for placebo), a 20 cm2 EMSAM patch (20 mg applied once daily) was evaluated over 6 weeks in the adults with MDD. For Study 2 (N = 132 for EMSAM and N = 133 for placebo), the dose range of 6-12 mg/24 h was evaluated over 8 weeks. Primary efficacy outcomes used for evaluation were HAM-D Scale-17 for Study 1 and HAM-D Scale-28 for Study 2. In both studies, the EMSAM group showed significant improvement in the HAM-D total score vs placebo (LS mean change from baseline of -9 for EMSAM vs -6.5 for placebo in Study 1 and -10.9 for EMSAM vs -8.6 for placebo in Study 2).

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About EMSAM

EMSAM®– The First and Only Monoamine Oxidase Inhibitor Patch for the Treatment of Major Depressive Disorder in Adults1

EMSAM contains selegiline, a monoamine oxidase (MAO) inhibitor antidepressant. When applied to intact skin, EMSAM is designed to transdermally deliver selegiline over a 24-hour period.1

INDICATION

EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD)

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.

Mechanism of Action1

The mechanism of action of selegiline (the drug substance of EMSAM) as an antidepressant is not fully understood, but is presumed to be linked to potentiation of monoamine neurotransmitter activity in the central nervous system (CNS) resulting from its irreversible inhibition of the enzyme MAO.

Who should not take EMSAM?

  • EMSAM is contraindicated with selective serotonin reuptake inhibitors (SSRIs, e.g., fluoxetine, sertraline, and paroxetine); serotonin and norepinephrine reuptake inhibitors (SNRIs, e.g., venlafaxine and duloxetine); 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 is used with these agents.
  • Carbamazepine is contraindicated with EMSAM because of a possible increased risk of hypertensive crisis.
  • After stopping treatment with drugs contraindicated with EMSAM, a time period equal to 4 to 5 half-lives (approximately one week) of the drug or any active metabolite should elapse before starting therapy with EMSAM. Because of the long half-life of fluoxetine and its active metabolite, at least 5 weeks should elapse between discontinuation of fluoxetine and initiation of treatment with EMSAM.
  • At least 2 weeks should elapse after stopping EMSAM 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.

What is notable about the pharmacokinetics of EMSAM?

Following dermal application of EMSAM to humans, 25% to 30% of the selegiline content on average is delivered systemically over 24 hours (range approximately 10% to 40%). Consequently, the degree of drug absorption may be 1/3 higher than the average amounts of 6 mg to 12 mg per 24 hours. Transdermal dosing results in significantly higher exposure to selegiline with significantly lower exposure for all metabolites.

Dosage Forms and Strengths1

EMSAM is supplied as 6 mg (20 mg/20 cm2), 9 mg (30 mg/30 cm2), and 12 mg (40 mg/40 cm2) doses.

EMSAM Matrix-Type 3 Layered Transdermal System1

  • Backing film: Provides occlusivity, physical integrity, and protects the adhesive/drug layer.
  • Adhesive: An adhesive layer that incorporates the active ingredient.
  • Release liner: Removable coated film or polymer-based protective layer that is peeled off by patient before applying EMSAM.

Top view of EMSAM

Image of Emsam 3 layered transdermal system

Side view of EMSAM system.
(Not to scale)

Image of Side view of Emsam 3 layered transdermal system

Efficacy Profile

EMSAM® Demonstrated Better Clinical Efficacy Than Placebo in Adult Patients with MDD1*

EMSAM Significantly Improved MDD Symptoms Versus Placebo1*

EMSAM transdermal patch was more effective than placebo on the HAM-D scale.1*

*Study Descriptions1
The EMSAM (selegiline transdermal system) efficacy was evaluated based upon 2 separate randomized, placebo-controlled, double-blind studies. For Study 1 (N = 89 for EMSAM and N = 88 for placebo), a 20 cm2 EMSAM patch (20 mg applied once daily) was evaluated over 6 weeks in the adults with MDD. For Study 2 (N = 132 for EMSAM and N = 133 for placebo), the dose range of 6-12 mg/24 h was evaluated over 8 weeks. Primary efficacy outcomes used for evaluation were HAM-D Scale-17 for Study 1 and HAM-D Scale-28 for Study 2. In both studies, the EMSAM group showed significant improvement in the HAM-D total score vs placebo (LS mean change from baseline of -9 for EMSAM vs -6.5 for placebo in Study 1 and -10.9 for EMSAM vs -8.6 for placebo in Study 2).

Bar chart showing LS mean change from baseline in HAM-D-17 and HAM-D-28 scores that are described above

HAM-D-17: 17-item Hamilton Depression Rating Scale; HAM-D-28: 28-item Hamilton Depression Rating Scale; LS Mean: Least Squares Mean.

Significantly Longer Time to Relapse with EMSAM Compared to Placebo1†

†Study Description
In a third randomized, double-blind, placebo-controlled 52-week study in adult outpatients with MDD who responded with a 17-item HAM-D score of 10 or less, patients were randomized to EMSAM (6mg/24 h) (n = 159) or placebo (n = 163). Approximately 52% of patients in the EMSAM and placebo groups discontinued by week 12 of the double-blind phase. Patients on EMSAM experienced a significantly longer time to relapse than those in the placebo group.

Line chart showing time to relapse with EMSAM vs placebo. Results discussed above.

‡Relapse during the double-blind phase was defined as: (1) a 17-item HAM-D score of 14 or greater; (2) a CGI-S† score of 3 or greater (with a least a 2-point increase from double-blind baseline); and (3) meeting DSM-IV criteria for MDD on 2 consecutive visits at least 11 days apart.

CGI-S; Clinical Global Impression-Severity Scale, MDD; Major Depressive Disorder.

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from these clinical studies

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Safety Profile

Adverse Events During Clinical Trials

Adverse Reactions: Incidence of ≥2% Among EMSAM®-Treated Patients.1

The Most Common Adverse Events Reported with EMSAM in Comparison to Placebo1*†

Body System EMSAM (N = 817) Placebo (N = 668)
Most common AEs for EMSAM in clincial trials. Also discussed in the full Prescribing Information Body as whole
Headache 18 17
Most common AEs for EMSAM in clincial trials. Also discussed in the full Prescribing Information Digestive
Diarrhea 9 7
Dyspepsia 4 3
Most common AEs for EMSAM in clincial trials. Also discussed in the full Prescribing Information Nervous
Insomnia 12 7
Dry mouth 8 6
Most common AEs for EMSAM in clincial trials. Also discussed in the full Prescribing Information Respiratory
Pharyngitis 3 2
Sinusitis 3 1
Most common AEs for EMSAM in clincial trials. Also discussed in the full Prescribing Information Skin
Application site reaction 24 12
Rash 4 2

*Excludes the following reactions, which had an incidence on placebo treatment greater or equal to EMSAM: infection, nausea, dizziness, pain, abdominal pain, nervousness, back pain, asthenia, anxiety, flu syndrome, accidental injury, somnolence, rhinitis, and palpitations.

  • Includes doses of EMSAM from 3 mg to 12 mg per 24 hours in placebo-controlled trials of up to 8 weeks in duration.

Adverse Reactions Leading to Treatment Discontinuation1†

Percentage of patients discontinued due to adverse reactions. Read more below

†Among N=817 MDD patients treated with EMSAM at doses of either 3 mg per 24 hours (n=151 patients), 6 mg per 24 hours (n=550 patients) or 6 mg per 24 hours, 9 mg per 24 hours, and 12 mg per 24 hours (n=116 patients) in placebo-controlled trials of up to 8 weeks in duration, 7.1% discontinued treatment due to an adverse reaction as compared with 3.6% of N=668 patients receiving placebo. The only adverse reaction associated with discontinuation, in at least 1% of EMSAM-treated patients at a rate at least twice that of placebo, was application site reaction (2% EMSAM vs. 0% placebo).

Other Adverse Reactions in Clinical Trials1

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Sexual dysfunction

Incidence of side effects in EMSAM-treated patients was comparable to placebo in placebo-controlled trials. There are no adequately designed studies examining sexual dysfunction with EMSAM treatment

Image of Vital signs Icon

Vital sign changes

EMSAM-treated patients experienced low systolic blood pressure compared to placebo. In a pool of short-term, placebo-controlled MDD studies, 3% of EMSAM patients and 1.5% of placebo patients experienced a low diastolic blood pressure (less than equal to 90 mmHg with a change of baseline of at least 20 mmHg)

In one study with higher mean doses of EMSAM, 6.25% of EMSAM patients and 0% of placebo patients experienced a low standing systolic blood pressure by these criteria

In the pool of short-term MDD trials, 9.8% of EMSAM-treated patients and 6.7% of placebo-treated patients experienced a notable orthostatic change in blood pressure, defined as a decrease of at least 10 mmHg in mean blood pressure with postural change.

Image of Weight changes Icon

Weight changes

Mean change in body weight: In placebo-controlled studies of 6-8 weeks duration, 2.1% of EMSAM patients (n=757) gained at least 5% compared to 2.4% of placebo patients (n=614). In these trials:

  • Mean change in body weight for EMSAM-treated patients: 1.2 lbs loss
  • Mean change in body weight for placebo-treated patients: 0.3 lbs gain
Image of Laboratory and ECG changes Icon

Laboratory and ECG changes

No clinically important changes were observed in various serum chemistry, hematology and urinalysis variables in the EMSAM vs placebo group.

No clinically significant changes in ECG parameters from baseline to final visit were observed in controlled studies with EMSAM (n=817) and placebo (n= 668) groups

Image of other reactions observed during the premarketing evaluation Icon

Other reactions observed during the premarketing evaluation of EMSAM

  • Cardiovascular system: Tachycardia
  • Digestive system: Anorexia
  • Nervous system: Agitation, amnesia, tremor, twitching
  • Skin and Appendages: Pruritus

ECG: Electrocardiogram.

This is not all the information you need to review before prescribing EMSAM. Please also review the Important Safety Information below and the EMSAM full Prescribing Information including Boxed WARNING.

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Efficacy Profile of EMSAM®

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Dosage and Administration

Image of Emsam pack shot images for 3 different dosage strength

EMSAM® Transdermal Patch is Available in 3 Different
24-Hour Dosage Strengths1

Image of Emsam pack shot images for 3 different dosage strength

Initial Treatment

6 mg/24 h

Recommended starting dose and target dose

No dietary restrictions

9 mg/24 h OR 12 mg/24 h

Based on clinical judgment, dose can be increased in increments of 3 mg/24 h at intervals of no less than 2 weeks up to a maximum dose of 12 mg/24 h.* However, trials were not designed to assess whether higher doses are more effective than the lowest effective dose of 6 mg/24h.
*Full antidepressant effect may be delayed.

For 9 mg/24 h and 12 mg/24 h doses, advise patients from the first dose of treatment, to avoid high-tyramine foods and beverages. Continue avoiding up to a period of 2 weeks after a dose reduction to 6 mg/24 h or following the discontinuation of 9 mg/24 h or 12 mg/24 h dose.
Click here to learn more about tyramine-rich food and
beverages to avoid

Maintenance Treatment1

  • Maintenance of efficacy in depressed patients on therapy with EMSAM at a dose of 6 mg per 24 hours after achieving a responder status for an average duration of about 25 days was demonstrated in a controlled trial.
  • The physician who elects to use EMSAM for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Administration of EMSAM®1

A new application site should be selected with each new transdermal system.

Where to apply?

Dry, intact skin on the upper torso (below the neck and above the waist), upper thigh or outer surface of the upper arm. Clothing and movement may make your patch rub off.

How often?

Once every 24 hours

Image showing where to apply EMSAM

When to apply?

Apply at approximately the same time each day.

Click here to learn more about how to apply EMSAM

Systemic Absorption1

  • 25% to 30% of the selegiline content on average is delivered systemically over 24 hours (range approximately 10% to 40%). Consequently, the degree of drug absorption may be 1/3rd higher than the average amounts of 6 mg to 12 mg per 24 hours.
  • Transdermal dosing results in significantly higher exposure to selegiline with significantly lower exposure for all metabolites. Following dermal application of radio-labeled selegiline to laboratory animals Selegiline is rapidly distributed to all body tissues. Selegiline rapidly penetrates the blood-brain barrier. In humans selegiline is approximately 90% bound to plasma protein over a 2 to 500 ng per mL concentration range. Selegiline does not accumulate in the skin.

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Efficacy Profile of EMSAM®

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Savings Card Program

Your Eligible, Commercially-Insured Patients May be Able to Save on Their Out-of-Pocket Costs With the EMSAM® Savings Card*

EMSAM Savings Card – Save up
to $600 on EMSAM*

EMSAM, the first and only once-daily skin patch for the treatment of adults with MDD,1 is offering a Savings Card.

MDD: Major Depressive Disorder

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EMSAM® (selegiline transdermal system) Savings Card

Eligible, commercially-insured patients may have their commercial copay amount for EMSAM® (selegiline transdermal system) reduced up to a maximum of $600 per month after the patient pays the first $20 per 30-day prescription, up to a maximum of $7,200 per calendar year.*

*Help your patients to register by clicking here to get the savings card and to see full terms and conditions. Valid prescription with Prescriber ID# is required. Mylan Specialty L.P., a Viatris Company, reserves the right to amend or end this program at any time without notice.

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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.

CONTRAINDICATIONS

  • 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.

ADVERSE REACTIONS

  • 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%).

DRUGS INTERACTIONS

  • 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.

INDICATION

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.

IMPORTANT SAFETY INFORMATION AND INDICATION

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.

CONTRAINDICATIONS

  • 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.

ADVERSE REACTIONS

  • 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%).

DRUGS INTERACTIONS

  • 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.

INDICATION

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.

EMSAM® is a registered trademark of Somerset Pharmaceuticals, Inc.
VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris Company.
VIATRIS ADVOCATE and the Viatris Advocate Logo are trademarks of Mylan Inc., a Viatris Company.
© 2022 Viatris Inc. All Rights Reserved. EMS-2021-0038

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