Emsam

The active ingredient in Emsam is selegiline. Emsam is a transdermal patch (selegiline transdermal system), which means the mechanism of action is that the enzyme releases medicine slowly through your skin and into your bloodstream over 24 hours. Once the patch is in place, the medication moves through the skin layers, enters the tiny blood vessels underneath, and then circulates throughout your body. This steady delivery helps keep the medication level more consistent than a tablet that you swallow.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Emsam. However, the following is a synopsis of the general guidelines for the use of Emsam:

• Apply one transdermal patch to clean, dry, intact skin once daily.
• Apply to the upper chest, upper back, upper thigh, or outside of the upper arm. Do not place the patch on oily, irritated, or broken skin.
• Press firmly for several seconds to ensure full contact with the skin.
• Wash your hands after applying or removing the patch.
• Rotate sites to lower the chance of irritation. Do not use the same site two days in a row.
• If a patch falls off, place a new patch on another healthy area and continue your schedule.
• If you miss a dose, apply a new patch as soon as you remember and follow your normal schedule the next day.
• Do not expose the patch to direct heat sources such as heating pads or electric blankets.
• Different patch strengths may require avoiding foods high in tyramine. Your healthcare provider will explain whether these restrictions apply to your dose.

Some mild or common side effects of Emsam seen in clinical trials as compared to placebo include:

• Dry mouth.
• Nausea.
• Diarrhea or constipation.
• Trouble sleeping.
• Dizziness.
• Application site reaction.
• Fatigue.
• Increased sweating.
• Loss of appetite.
• Abdominal discomfort.

Some individuals may experience serious side effects while using Emsam. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe headache, stiff neck, or sudden rise in blood pressure (hypertensive crisis).
• Chest pain or shortness of breath.
• Signs of serotonin syndrome include agitation, fever, confusion, rapid heart rate, tremor, or muscle stiffness.
• Sudden mood changes or worsening depression.
• Suicidal thoughts or unusual behavior.
• Severe skin reactions, blistering, or swelling.
• Severe gastrointestinal symptoms.
• Fast or irregular heartbeat.
• Allergic reactions such as hives, swelling, or trouble breathing.

These are not all of the possible side effects of Emsam. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Emsam, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• High blood pressure (hypertension) or a history of hypertensive crisis.
• Bipolar disorder or a history of manic episodes.
• Heart rhythm problems or cardiovascular disease.
• A pheochromocytoma.
• Liver impairment.
• A history of severe headaches.
• Seizure disorders or a history of seizures.
• Frequent alcohol use.
• A history of suicidal thoughts or behaviors.
• Recent use of antidepressants, opioids, dextromethorphan, or migraine medication.
• A history of substance abuse.
• Avoid aged cheeses.

Boxed Warning

Emsam carries a boxed warning for increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults, especially during the early stages of treatment or during dose changes. It is not approved for use in individuals under 18 years of age.

Emsam should not be used in individuals who:

• Are allergic to selegiline or any ingredient in the patch.
• Are taking other MAOI (monoamine oxidase inhibitors).

Some people may begin noticing mood improvements within 1 to 2 weeks, but full therapeutic benefits can take 4 to 6 weeks. Your healthcare provider will monitor your progress and adjust your treatment if needed.

When Emsam is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, sertraline, and paroxetine, as there is an Increased risk of serotonin syndrome.
• SNRIs (serotonin–norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine. Increased risk of serotonin syndrome.
• Tricyclic antidepressants (clomipramine, imipramine). Risk of severe reactions and blood pressure changes.
• Bupropion. May increase the risk of hypertensive reactions.
• Tramadol, methadone, meperidine, pentazocine. Risk of life-threatening toxicity or serotonin syndrome.
• Buspirone. Dangerous blood pressure and neurologic reactions.
• Dextromethorphan. Increased risk of serotonin syndrome.
• Carbamazepine and oxcarbazepine. May cause toxicity.
• Amphetamines and sympathomimetics (ephedrine, pseudoephedrine). It can cause a hypertensive crisis.
• Tyramine-rich foods at certain patch strengths. May cause dangerous blood pressure increases.
• Phenylephrine.
• Tranylcypromine.

Emsam is available as a transdermal patch in the following dosage form strengths:

• 6 mg/24 hours.
• 9 mg/24 hours.
• 12 mg/24 hours.

Your healthcare provider will select the appropriate dose based on your condition and treatment response.

Store at room temperature and keep out of reach of children.

Emsam is manufactured by Bausch Health.

There is currently no generic version of the Emsam transdermal system available in the United States.

Do not stop using Emsam suddenly unless your healthcare provider tells you to. Stopping too quickly can lead to withdrawal symptoms or worsening depression. Your healthcare provider may gradually lower your dose or switch you to another therapy.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Be careful of the potential risks of taking an MAOI, particularly the risk of hypertensive crisis during pregnancy.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.