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informed consent risk of cheese reaction
Informed ConsentRisk of Cheese Reaction
  • A possible risk of using selegiline is uncontrolled hypertension (high blood pressure), the so-called “cheese reaction”, which can occur if you eat foods containing tyramine, e.g., aged cheese, liquor, dry sausage, yogurt, raisins, liver, pickled herring, Fava beans, sauerkraut, and over-the-counter cough/cold medications. Therefore, it is important that you tellyour doctor immediately if you have any of the following symptoms: headache, heart palpitations, a sense of constriction in the throat or chest, sweating, dizziness, neck stiffness, nausea, or vomiting.

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patient information on dietary modifications
Patient Information on Dietary Modifications
    • A modified diet is not necessary when taking EMSAM 6mg/24 hours (20mg)
    • The consumption of certain foods and beverages during treatment with EMSAM 9mg/24 hours (30mg) or 12mg/24 hours (40mg) dose may lead to a sudden, large increase in blood pressure, called a ‘‘hypertensive crisis’’ (a potentially life-threatening situation). (See What are the possible side effects of EMSAM?)
  • Dietary Modifications:
    • To prevent a hypertensive crisis, the following foods and beverages should be avoided beginning on the first day of EMSAM 9mg/24 hours (30mg) or 12mg/24 hours (40mg) treatment and continue until 2 weeks after a dose reduction to EMSAM 6mg/24 hours (20mg) or stopping EMSAM 9mg/24 hours (30mg) or 12mg/24 hours (40mg):

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patient information on dietary modifications continued
Patient Information on Dietary Modifications (Continued)
  • Dietary Modifications:
    • 12mg/24 hours (40mg):
      • Air dried, aged and fermented meats, sausages and salamis (including cacciatore, hard salami and mortadella); pickled herring; and any spoiled or improperly stored meat, poultry and fish (e.g., foods that have undergone changes in coloration, odor, or become moldy)
      • Broad bean pods (fava bean pods)
      • Aged cheeses
      • All varieties of tap beer, and beers that have not been pasteurized so as to allow for ongoing fermentation should be avoided during EMSAM treatment
      • Concentrated yeast extract (e.g., Marmite), sauerkraut, all soybean products (including soy sauce and tofu)
    • All foods must be fresh or properly frozen
    • Avoid foods when you are unaware of storage conditions

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informed consent description of symptoms of hypertensive crisis
Informed ConsentDescription of Symptoms of Hypertensive Crisis
  • Severe headache, flushing, sudden elevation of blood pressure, awareness of rapid or pounding heart, nausea, vomitting, sweating, fever, and chest pain. Although rare, hypertensive crisis may be a life-threatening reaction that requires immediate medical attention.

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responder rates for mdd patients in placebo controlled studies
Responder Rates* for MDD Patients inPlacebo-Controlled Studies

% Improved

* Defined as CGI-I score of 1 or 2

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slide9
Tyramine Pressor Dose and TSF Values for Individual Subjects Challenged in the Fasted and Fed States

*Fasted - lowest value obtained during 30-90 days of EMSAM 40 mg treatment

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