EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) antidepressant delivered through a skin patch, offering a novel mechanism of action for patients who have not responded adequately to other antidepressant therapies. Its transdermal delivery system bypasses first-pass metabolism, allowing for effective antidepressant dosing with significantly reduced dietary restrictions compared to oral MAOIs. This makes EMSAM a valuable option for managing major depressive disorder (MDD), particularly in cases where other treatments have failed. It represents a sophisticated approach to balancing efficacy with an improved safety and tolerability profile.

Features

• Contains selegiline, a monoamine oxidase inhibitor (MAO-I).
• Utilizes a transdermal delivery system (patch).
• Available in three dosage strengths: 6 mg/24 h, 9 mg/24 h, and 12 mg/24 h.
• Designed for once-daily application.
• Bypasses first-pass hepatic metabolism.
• At the 6 mg/24 h dose, it does not require the strict dietary tyramine restrictions necessary for oral MAOIs.

Benefits

• Provides an effective treatment option for patients with major depressive disorder who have had an inadequate response to other antidepressant classes (e.g., SSRIs, SNRIs).
• The transdermal delivery method offers a steady, controlled release of medication over 24 hours, minimizing peak-to-trough plasma level fluctuations.
• Eliminates gastrointestinal side effects commonly associated with oral medications, such as nausea.
• At the lowest dosage (6 mg/24 h), it allows for a normal diet without the stringent tyramine restrictions typically mandated for MAOI therapy, enhancing quality of life and adherence.
• Its unique mechanism of action (MAO-A and MAO-B inhibition) targets a different neurochemical pathway than first-line antidepressants, offering a new approach for treatment-resistant cases.
• The once-daily application simplifies the dosing regimen and may improve patient compliance.

Common use

EMSAM is indicated for the treatment of major depressive disorder (MDD) in adults. It is particularly considered for patients who have not achieved a satisfactory response from other antidepressant medications, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs). Its use is predicated on a confirmed diagnosis of MDD by a qualified healthcare professional.

Dosage and direction

Initial Dose: The recommended starting dose is 6 mg/24 hours, applied once daily. Dose Titration: Depending on clinical response and tolerability, the dose may be increased to 9 mg/24 hours or 12 mg/24 hours. Dose increases should not be made more frequently than every 2 weeks. Application Instructions:

1. Apply the patch to dry, intact, healthy skin on the upper torso (below the neck and above the waist), upper thigh, or the outer surface of the upper arm.
2. Do not apply to oily, hairy, irritated, broken, scarred, or calloused skin.
3. Rotate the application site with each new patch; do not apply a new patch to the same site for at least 14 days.
4. Press the patch firmly in place with the palm of the hand for approximately 30 seconds, ensuring complete contact, especially around the edges.
5. The patch is designed to be worn for 24 hours. After removal, apply a new patch to a different skin site.
6. Wash hands thoroughly with soap and water after handling the patch.
7. If a patch falls off, a new patch may be applied to a new site for the remainder of the day. Do not reapply the same patch.

Precautions

• Hypertensive Crisis: Although the risk is significantly lower with the transdermal system, particularly at the 6 mg/24 h dose, the potential for a hypertensive crisis (severe increase in blood pressure) exists if significant amounts of tyramine are consumed. Adherence to dietary guidance is essential at doses of 9 mg/24 h and 12 mg/24 h.
• Serotonin Syndrome: There is a risk of serotonin syndrome, a potentially life-threatening condition, especially when EMSAM is used concomitantly with other serotonergic drugs (e.g., other antidepressants, tramadol, triptans) or drugs that impair serotonin metabolism.
• Activation of Mania/Hypomania: Antidepressants can precipitate a manic or hypomanic episode. Use with caution in patients with a history of bipolar disorder.
• Suicidality: Antidepressants may increase the risk of suicidal thinking and behavior in children, adolescents, and young adults. All patients should be closely monitored for clinical worsening, suicidality, or unusual changes in behavior.
• Orthostatic Hypotension: MAOIs can cause a significant drop in blood pressure upon standing.
• Local Skin Reactions: Application site reactions (e.g., redness, rash, itching) are common. If a reaction persists or spreads, or if the reaction is more severe (blisters, swelling), medical advice should be sought.
• Withdrawal: Abrupt discontinuation can lead to symptoms such as dizziness, sensory disturbances, sleep disturbances, and irritability. Tapering the dose is recommended.

Contraindications

EMSAM is contraindicated in patients with:

• Pheochromocytoma (a tumor of the adrenal gland).
• Concomitant use with other MAOIs or within 14 days of stopping an MAOI.
• Concomitant use with serotonergic agents (e.g., SSRIs, SNRIs, clomipramine, imipramine, tramadol, meperidine, methadone, dextromethorphan, St. John’s Wort, triptans, cyclobenzaprine) or within 5 weeks of stopping fluoxetine.
• Concomitant use with sympathomimetic amines (e.g., amphetamines, cold products containing pseudoephedrine or phenylephrine) or within 7 days of stopping EMSAM.
• Concomitant use with bupropion or within 7 days of stopping EMSAM.
• Known hypersensitivity to selegiline or any component of the transdermal system.

Possible side effects

Common side effects may include:

• Application site reactions (redness, irritation, rash, itching)
• Headache
• Insomnia
• Diarrhea
• Dry mouth
• Dyspepsia
• Pharyngitis
• Sinusitis

Less common but more serious side effects require immediate medical attention:

• Symptoms of serotonin syndrome: agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, muscle rigidity, nausea, vomiting, diarrhea.
• Symptoms of hypertensive crisis: severe headache, blurred vision, confusion, seizures, chest pain, nausea, vomiting, stupor.
• Signs of an allergic reaction: hives, difficulty breathing, swelling of the face, lips, tongue, or throat.
• Symptoms of mania: racing thoughts, increased energy, reckless behavior, extreme happiness, being easily irritated, talking more than usual, severe sleep problems.

Drug interaction

EMSAM has numerous serious drug interactions due to its MAO-inhibiting activity. It is absolutely contraindicated with:

• Other antidepressants: SSRIs (e.g., fluoxetine, sertraline, paroxetine), SNRIs (e.g., venlafaxine, duloxetine), tricyclics (e.g., amitriptyline, imipramine), bupropion, mirtazapine, nefazodone, trazodone.
• Other MAOIs: isocarboxazid, phenelzine, tranylcypromine, linezolid, intravenous methylene blue.
• Certain opioids: meperidine (Demerol), tramadol, methadone, dextromethorphan.
• Sympathomimetics: amphetamines, cocaine, medications containing pseudoephedrine, phenylephrine, or phenylpropanolamine.
• Triptans (for migraine).
• Buspirone. A minimum washout period of 2-5 weeks (5 weeks for fluoxetine) is required before initiating EMSAM after stopping these agents. A 7-day washout period is required after stopping EMSAM before starting any contraindicated medication. Inform your doctor of all prescription, over-the-counter, and herbal products you are taking.

Missed dose

Apply the missed patch as soon as you remember. However, if it is almost time for the next application, skip the missed dose and apply the next patch at the regular time. Do not apply extra patches to make up for a missed dose.

Overdose

Overdose of EMSAM is a medical emergency that can be fatal. Symptoms may include severe anxiety, confusion, coma, dizziness, drowsiness, hyperthermia, hypertension or hypotension, rigidity, seizures, tachycardia, and respiratory depression. Symptoms of overdose may be delayed for up to 12 hours or longer. Immediately call poison control or emergency medical services.

Storage

• Store at room temperature between 20°C to 25°C (68°F to 77°F).
• Keep the patch in its sealed pouch until ready to use.
• Keep away from moisture, heat, and direct light.
• Keep out of reach of children and pets.

Disclaimer

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

• “After failing multiple SSRIs, EMSAM was a game-changer. The patch is convenient, and at the 6mg dose, I don’t have to worry about my diet. It gave me my life back with minimal side effects.” – Patient, 48
• “As a psychiatrist, EMSAM is a critical tool in my arsenal for treatment-resistant depression. The transdermal delivery mitigates many of the historical challenges of MAOI therapy, making this effective mechanism of action accessible to more patients.” – Dr. Evans, MD
• “The application site reactions were bothersome at first, but rotating sites diligently helped. The efficacy for my severe depression has been superior to any oral medication I’ve tried in the past decade.” – Patient, 52
• “The required washout periods and interaction profile demand careful clinical management, but for the right patient, the benefits of EMSAM are profound. It requires a knowledgeable prescriber and a compliant patient.” – Clinical Pharmacist