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Informed Consent Risk of Cheese Reaction

Informed Consent Risk of Cheese Reaction.

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Informed Consent Risk of Cheese Reaction

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  1. 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. 1b - 83

  2. Proposed Label for 30-40 mg Diet (excerpt) 4a - 8

  3. 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): 4b - 8

  4. 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 4b - 9

  5. 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. 1b - 84

  6. Transdermal SelegilinePivotal Trial II: P0052 Acute MDD HAMD-28: p < 0.03 p <0.04 Dosage 2 - 19

  7. Transdermal SelegilinePivotal Trial II: P0052 Acute MDD p < 0.03 p <0.04 HAMD-28 Dosage 2 - 18

  8. Responder Rates* for MDD Patients inPlacebo-Controlled Studies % Improved * Defined as CGI-I score of 1 or 2 2 - 11

  9. 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 3a - 20

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