# Presentation: 207110

## Informed ConsentRisk 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 tell****your 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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## Proposed Label for 30-40 mg Diet (excerpt)

| Class | Tyramine Foodsto Avoid | Safe, No or Low Tyramine |
| --- | --- | --- |
| Meat, Poultry, Fish | Aged & Spoiled | Fresh & Fresh processed |
| Vegetables | Fava bean pods | All others |
| Dairy | Aged cheeses | Processed cheeses, yogurt |
| Beverages | Tap beersUnpasteurized beers | Alcohol not recommendedBottled & canned beer |
| Miscellaneous | Marmite, sauerkraut, soy products | Brewer’s & Baker’s yeastCommercial chain restaurant pizza |

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## 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)

**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

**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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## Transdermal SelegilinePivotal Trial II: P0052 Acute MDD

**HAMD-28:**

- p < 0.03                 p <0.04

**Dosage**

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## Transdermal SelegilinePivotal Trial II: P0052 Acute MDD

**HAMD-28**

**p < 0.03                  p <0.04**

**Dosage**

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## Responder Rates* for MDD Patients inPlacebo-Controlled Studies

| Study | EMSAM | Placebo |
| --- | --- | --- |
| E-106 | 42 | 27 |
| P0052 | 46 | 35 |
| P9804 | 42 | 30 |

- * Defined as CGI-I score of 1 or 2

**% Improved**

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

|  | Tyramine Pressor Dose (mg) |  |  |
| --- | --- | --- | --- |
| Subject | Fasted* | Fed | Fed/Fasted |
| 1 | 37.5 | 100 | 2.7 |
| 2 | 37.5 | 100 | 2.7 |
| 3 | 50 | 200 | 4.0 |
| 4 | 75 | 300 | 4.0 |
| 5 | 25 | 75 | 3.0 |
| 6 | 25 | 100 | 4.0 |
| 7 | 75 | 200 | 2.7 |
| 8 | 75 | 300 | 4.0 |

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

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