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.
- trouble sleeping (insomnia)
- dry mouth
- 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