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I thought I knew all the treatment options for my depression.
But then I learned about EMSAM®.

EMSAM is the first and only once-daily skin patch approved to treat major depressive disorder (MDD).

Eligible patients can save up to $500 on each prescription* with the EMSAM Instant Savings Card.

 *Certain terms and conditions apply. You can find the complete terms and conditions of this offer, as well as other information about the EMSAM Instant Savings Card, at the link below.

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IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

  • Antidepressants may increase suicidal thoughts or actions in children, teenagers and young adults.
  • Depression and other serious mental illnesses are the most important cause of suicidal thoughts and actions. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is very important when an antidepressant is started or when the dose is changed. Call a health care professional right away to report any new or sudden changes in mood, behavior, thoughts or feelings. Keep follow-up visits with your health care professional, as scheduled, and call if you have concerns about symptoms.
  • EMSAM® (selegiline transdermal system) is not for children less than 12 years of age as it may cause a severe decrease in blood pressure.
What is EMSAM Transdermal System?

EMSAM Transdermal System is a skin patch used to treat major depressive disorder.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about EMSAM?
  • Antidepressants may increase suicidal thoughts or actions in children, teenagers and young adults.
  • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions.
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is very important when an antidepressant is started or when the dose is changed.
    • Call a health care professional right away to report any new or sudden changes in mood, behavior, thoughts or feelings.
    • Keep follow-up visits with your health care professional, as scheduled, and call if you have concerns about symptoms.
  • EMSAM Transdermal System is not for children less than 12 years of age as it may cause a severe decrease in blood pressure.

Call a health care professional right away if you, or someone you care for, have any of the following symptoms, especially if they are new, worse or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated, restless, angry or irritable
  • panic attacks
  • trouble sleeping
  • new or worse irritability
  • acting aggressive, being angry or violent
  • acting on dangerous impulses
  • an extreme increase in activity or talking (mania)
  • other unusual changes in behavior or mood
Who should not use EMSAM?

Using EMSAM with certain antidepressants and certain pain, cold and cough symptom medicines may cause a potentially life-threatening problem called serotonin syndrome (See “What are the possible side effects of EMSAM?”).

Do not use EMSAM if you:

  • take certain medicines including: selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, or paroxetine; serotonin and norepinephrine reuptake inhibitors (SNRI) such as venlafaxine or duloxetine; clomipramine or imipramine (tricyclic antidepressants); meperidine, tramadol, methadone, pentazocine, propoxyphene (opioid medicines); dextromethorphan; or carbamazepine
  • are less than 12 years of age
  • have a tumor on your adrenal gland called a pheochromocytoma

Ask your health care professional or pharmacist if you are not sure if you take these medicines.

What should I tell my doctor before starting EMSAM Transdermal System?

Tell your health care professional if you:

  • have high blood pressure
  • have or had mania or bipolar disorder (manic depression)
  • have or had seizures or convulsions
  • drink alcohol
  • have any other medical conditions
  • are or intend to become pregnant
  • are breastfeeding or intend to breastfeed

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. EMSAM and some medicines may interact with each other, may not work as well or may cause serious side effects when taken together.

In particular, tell your health care professional if you take:

  • other medicines to treat depression (antidepressants) including other MAOI medicines
  • decongestant medicines to treat cold or cough symptoms
  • over-the-counter diet pills or herbal weight-loss products
  • any herbal or dietary supplement that contains tyramine and/or
    medicines called stimulants or uppers (amphetamines)
  • buspirone, an anxiety medicine

Some of these medicines need to be stopped for at least 1 week before you can start using EMSAM and for 2 weeks after you stop using EMSAM. Ask your health care professional or pharmacist if you are not sure if you take these medicines. Know the medicines you take. Keep a list of them to show your health care professional or pharmacist when you get a new medicine.

What should I avoid while using EMSAM?
  • 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.
  • Do not eat foods or drink beverages that contain high amounts of tyramine (e.g. aged and fermented meats, broad bean pods, aged cheese, all tap beers, most soybean products and over-the-counter supplements containing tyramine) while using EMSAM 9 mg or EMSAM 12 mg or for 2 weeks after you stop using EMSAM 9 mg or EMSAM 12 mg. You do not have to make any diet changes when you use EMSAM 6 mg. Ask your health care professional or see the Medication Guide for a complete list of foods and drinks that must be avoided.
  • Do not drive, operate heavy machinery or do other dangerous activities until you know how EMSAM affects you.
  • You should not drink alcohol while using EMSAM.
What are the possible side effects of EMSAM? EMSAM may cause serious side effects, including:
  • See “What is the most important information I should know about EMSAM?”
  • Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you use EMSAM while you take certain medicines called MAOIs. Symptoms of serotonin syndrome include: agitation; seeing things that are not there (hallucinations); confusion; coma; rapid pulse; low blood pressure; dizziness; sweating; flushing; fever; seizures; tremors; stiff muscles; muscle twitching; become unstable; nausea; vomiting; and diarrhea.
  • If you suddenly have these symptoms, go to the nearest hospital emergency room right away.
  • A sudden, severe increase in blood pressure (hypertensive crisis). A hypertensive crisis can happen when you eat certain foods and drink certain beverages while you use EMSAM. A hypertensive crisis can lead to stroke and death. See “What should I avoid while using EMSAM?
  • A hypertensive crisis can also happen if you use EMSAM with certain other medicines. See “Who should not use EMSAM?” 
  • Symptoms of a hypertensive crisis include: sudden, severe headache; nausea; vomiting; stiff or sore neck; a fast heartbeat (palpitations) or a change in the way your heart beats; excessive sweating sometimes with fever or cold, clammy skin; the pupils in your eyes increase in size; light bothers your eyes; fast or slow heart beat with chest pain; and bleeding in your brain. If you suddenly have these symptoms, go to the nearest hospital emergency room right away.
  • Mania or hypomania (manic episodes) in people who have a history of mania. Symptoms of manic episodes include: greatly increased energy; severe problems sleeping; racing thoughts; reckless behavior; excessive happiness or irritability; talking more or faster than usual; and unusually grand ideas

Common side effects in people who use EMSAM include:

  • a skin reaction where the patch is placed. You may see mild redness at the site when a patch is removed. This redness should go away within several hours after removing the patch. If irritation or itching continues, tell your health care professional.
  • headache
  • diarrhea
  • indigestion
  • trouble sleeping (insomnia)
  • dry mouth
  • rash
  • sore throat
  • sinus infection

Tell your health care professional if you have any side effect that bothers you or does not go away. These are not all the side effects of EMSAM. For more information, ask your health care professional or pharmacist.

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

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

SEE MORE SEE LESS

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

  • Antidepressants may increase suicidal thoughts or actions in children, teenagers and young adults.

  • Depression and other serious mental illnesses are the most important cause of suicidal thoughts and actions. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is very important when an antidepressant is started or when the dose is changed. Call a health care professional right away to report any new or sudden changes in mood, behavior, thoughts or feelings. Keep follow-up visits with your health care professional, as scheduled, and call if you have concerns about symptoms.

  • EMSAM® (selegiline transdermal system) is not for children less than 12 years of age as it may cause a severe decrease in blood pressure.

What is EMSAM Transdermal System?
EMSAM Transdermal System is a skin patch used to treat major depressive disorder.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about EMSAM?
  • Antidepressants may increase suicidal thoughts or actions in children, teenagers and young adults.
  • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions.
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is very important when an antidepressant is started or when the dose is changed.
    • Call a health care professional right away to report any new or sudden changes in mood, behavior, thoughts or feelings.
    • Keep follow-up visits with your health care professional, as scheduled, and call if you have concerns about symptoms.
  • EMSAM Transdermal System is not for children less than 12 years of age as it may cause a severe decrease in blood pressure.

Call a health care professional right away if you, or someone you care for, have any of the following symptoms, especially if they are new, worse or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated, restless, angry or irritable
  • panic attacks
  • trouble sleeping
  • new or worse irritability
  • acting aggressive, being angry or violent
  • acting on dangerous impulses
  • an extreme increase in activity or talking (mania)
  • other unusual changes in behavior or mood
Who should not use EMSAM?

Using EMSAM with certain antidepressants and certain pain, cold and cough symptom medicines may cause a potentially life-threatening problem called serotonin syndrome (See “What are the possible side effects of EMSAM?”).

Do not use EMSAM if you:

  • take certain medicines including: selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, or paroxetine; serotonin and norepinephrine reuptake inhibitors (SNRI) such as venlafaxine or duloxetine; clomipramine or imipramine (tricyclic antidepressants);  meperidine, tramadol, methadone, pentazocine, propoxyphene (opioid medicines); dextromethorphan; or carbamazepine
  • are less than 12 years of age
  • have a tumor on your adrenal gland called a pheochromocytoma

Ask your health care professional or pharmacist if you are not sure if you take these medicines.

What should I tell my doctor before starting EMSAM Transdermal System?

Tell your health care professional if you:

  • have high blood pressure
  • have or had mania or bipolar disorder (manic depression)
  • have or had seizures or convulsions
  • drink alcohol
  • have any other medical conditions
  • are or intend to become pregnant
  • are breastfeeding or intend to breastfeed

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. EMSAM and some medicines may interact with each other, may not work as well or may cause serious side effects when taken together.

In particular, tell your health care professional if you take:

  • other medicines to treat depression (antidepressants) including other MAOI medicines
  • decongestant medicines to treat cold or cough symptoms
  • over-the-counter diet pills or herbal weight-loss products
  • any herbal or dietary supplement that contains tyramine and/or

    medicines called stimulants or uppers (amphetamines)
  • buspirone, an anxiety medicine

Some of these medicines need to be stopped for at least 1 week before you can start using EMSAM and for 2 weeks after you stop using EMSAM. Ask your health care professional or pharmacist if you are not sure if you take these medicines. Know the medicines you take. Keep a list of them to show your health care professional or pharmacist when you get a new medicine.

What should I avoid while using EMSAM?
  • 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.
  • Do not eat foods or drink beverages that contain high amounts of tyramine (e.g. aged and fermented meats, broad bean pods, aged cheese, all tap beers, most soybean products and over-the-counter supplements containing tyramine) while using EMSAM 9 mg or EMSAM 12 mg or for 2 weeks after you stop using EMSAM 9 mg or EMSAM 12 mg. You do not have to make any diet changes when you use EMSAM 6 mg. Ask your health care professional or see the Medication Guide for a complete list of foods and drinks that must be avoided.
  • Do not drive, operate heavy machinery or do other dangerous activities until you know how EMSAM affects you.
  • You should not drink alcohol while using EMSAM.
What are the possible side effects of EMSAM? EMSAM may cause serious side effects, including:
  • See “What is the most important information I should know about EMSAM?”
  • Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you use EMSAM while you take certain medicines called MAOIs. Symptoms of serotonin syndrome include: agitation; seeing things that are not there (hallucinations); confusion; coma; rapid pulse; low blood pressure; dizziness; sweating; flushing; fever; seizures;  tremors; stiff muscles; muscle twitching; become unstable; nausea; vomiting; and diarrhea.
  • If you suddenly have these symptoms, go to the nearest hospital emergency room right away.
  • A sudden, severe increase in blood pressure (hypertensive crisis). A hypertensive crisis can happen when you eat certain foods and drink certain beverages while you use EMSAM. A hypertensive crisis can lead to stroke and death. See “What should I avoid while using EMSAM?
  • A hypertensive crisis can also happen if you use EMSAM with certain other medicines. See “Who should not use EMSAM?” 
  • Symptoms of a hypertensive crisis include: sudden, severe headache; nausea; vomiting; stiff or sore neck; a fast heartbeat (palpitations) or a change in the way your heart beats; excessive sweating sometimes with fever or cold, clammy skin; the pupils in your eyes increase in size; light bothers your eyes; fast or slow heart beat with chest pain; and bleeding in your brain. If you suddenly have these symptoms, go to the nearest hospital emergency room right away.
  • Mania or hypomania (manic episodes) in people who have a history of mania. Symptoms of manic episodes include: greatly increased energy; severe problems sleeping; racing thoughts; reckless behavior; excessive happiness or irritability; talking more or faster than usual; and unusually grand ideas

Common side effects in people who use EMSAM include:

  • a skin reaction where the patch is placed. You may see mild redness at the site when a patch is removed. This redness should go away within several hours after removing the patch. If irritation or itching continues, tell your health care professional.
  • headache
  • diarrhea
  • indigestion
  • trouble sleeping (insomnia)
  • dry mouth
  • rash
  • sore throat
  • sinus infection

Tell your health care professional if you have any side effect that bothers you or does not go away. These are not all the side effects of EMSAM. For more information, ask your health care professional or pharmacist.



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

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

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INDICATION

EMSAM is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD).

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients age 65 and older.

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

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
  • Clinical Worsening and Suicide Risk: All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for MDD as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Families and caregivers of patients being treated with antidepressants for MDD 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 professionals. Such monitoring should include daily observation by families and caregivers.
  • Screening Patients for Bipolar Disorder: 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.
  • 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. 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. 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: 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: EMSAM should be used cautiously in patients with a history of mania.
  • External Heat: 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 3%), pharyngitis (3% vs 2%), and sinusitis (3% vs 1%).
TREATMENT CONSIDERATIONS
  • Use of alcohol while taking EMSAM is not recommended.
  • Pregnancy Category C: There are no adequate and well-controlled studies of EMSAM in pregnant women. EMSAM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Pediatric Use: Efficacy has not been established in pediatric patients ages 12 to 17 years with MDD and EMSAM is not recommended for use in this age range.