FREQUENTLY ASKED QUESTIONS

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• What is Axona?
• How does Axona work?
• Does Axona require a prescription?
• What is the main ingredient of Axona?
• Is Axona FDA approved?
• What is a medical food?
• Is Axona a drug or a dietary supplement?
• How many calories are contained in Axona?
• Is Axona effective?
• Is Axona safe?
• Are there any side effects?
• What can be done to minimize side effects from Axona?
• Who should not use Axona?
• What is the nutritional content of Axona?
• Can I take Axona if I am allergic to milk or lactose-intolerant?
• Can I take Axona if I am allergic to soy products?
• Is there any gluten in Axona?
• Is Axona kosher?
• Can Axona be taken with other medications for Alzheimer’s disease?
• How often should Axona be administered?
• Can Axona be mixed with something other than water?
• Can an electric blender be used to mix Axona?
• Can you change your daily dose of Axona?
• How far in advance can Axona be prepared?

• Axona is a medical food containing a proprietary formulation of medium-chain triglycerides (MCTs), specifically caprylic triglyceride, for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease.

• Glucose (a type of sugar) is used to fuel the cells of the healthy brain. For people with Alzheimer’s disease, glucose is not converted into energy as efficiently as it would be in a healthy brain, which can lead to a decrease in cognitive function. Axona works to bypass this problem by providing an alternative energy source that is metabolized in the liver and used by the brain.

• Yes, the use of Axona must be under the supervision of a physician; therefore, it is only available by prescription. Axona is available at most retail pharmacies; however, if your pharmacy does not carry Axona, please call 1-877-649-0004, then press 4.

• The main ingredient of Axona is caprylic triglyceride.

• While Axona is strictly regulated by the FDA, a prescription medical food does not go through the same approval process as a traditional pharmaceutical product. Accera has conducted all of the necessary safety and efficacy studies, and Axona has been developed, manufactured, and labeled in accordance with both the statutory and FDA regulatory definition of a medical food. In addition, Axona is subject to manufacturing facility inspections, including product and label reviews by the FDA.

• A medical food, such as Axona, is intended for the dietary management of a specific disease or condition. In the case of Axona, a distinctive nutritional requirement has been established through medical evaluation to help manage mild to moderate Alzheimer’s disease. Axona is intended for use under the supervision of a physician.

• Axona is a medical food product and not a drug or a dietary supplement. Medical food products are regulated by the FDA, but are in a unique category separate from drugs and dietary supplements.

• One packet contains 217 calories.

• In clinical trials, Axona has been shown to improve cognitive function in certain patients with mild to moderate Alzheimer’s disease.

• The ingredients in Axona are GRAS (Generally Recognized As Safe) or have achieved self-affirmed GRAS status according to strict FDA standards. The requirements for an ingredient to achieve GRAS status require not only technical demonstration of nontoxicity and safety, but also general recognition and agreement on that safety by experts in the field.

• Overall, Axona was well tolerated in clinical trials. The most common side effects were diarrhea, nausea, flatulence (gas), and stomach discomfort, which were generally considered mild to moderate. These side effects may be reduced if Axona is taken shortly after a meal.(see "Tips for Reducing Possible Side Effects")

• Each dose of Axona contains 20 grams of medium chain triglycerides (MCTs). Due to the rapid digestion of MCTs, some patients may experience diarrhea, bloating, or stomach upset after taking Axona.  Since it is difficult to determine in advance which patients might experience these side effects, we are recommending the following Tips for Reducing Possible Side Effects:
  
  
• Take Axona after eating a full meal (preferably breakfast or lunch). Taking Axona between 15 and 30 minutes after a meal may reduce potential side effects.



• Start Axona using a Graduated Dosing Plan beginning with 1 Tablespoon daily for 2 days and increasing the dose by 1 Tablespoon every other day.




Graduated Dosing Plan

	Daily dose
Days 1 & 2	1 Tablespoon
Days 3 & 4	2 Tablespoons
Days 5 & 6	3 Tablespoons
Days 7 & 8	4 Tablespoons
Day 9 + ongoing	1 Full Packet (approximately 5 Tablespoons)




Add Axona to 4 – 8 ounces of water, hot or cold liquids, or soft foods as preferred
Blend until fully mixed

In addition, these suggestions may also be helpful:

(1) If lunch is generally a bigger meal than breakfast, take Axona after lunch instead of after breakfast.

(2) Meals containing fat and protein (such as meat, cheese, and eggs) may prevent developing an upset stomach.

(3) Sip the drink over a period of 30 minutes instead of drinking it all at once.

(4) You can also try adding ice to the Axona drink, as this may also slow digestion and lessen potential side effects.

(5) Axona is a highly stable product and may be mixed with water or other hot or cold liquids, as well as with soft foods. For example: you might want to try mixing Axona with coffee, tea, fruit juice, milk, ice cream, pudding, yoghurt, oatmeal, meal replacement drinks, or adding flavorings such as chocolate syrup.

(6) Over-the-counter medications such as simethicone (for gas), antacids (for heart burn), and antidiarrheals can be useful. Patients with persistent adverse effects should seek the advice of their healthcare provider.

• Axona should be used with caution in patients who are at risk for developing ketoacidosis, or have a history of inflammation of the gastrointestinal system, metabolic syndrome, and/or renal dysfunction. Axona contains caseinate and whey, and lecithin. Thus, CONTAINS MILK AND SOY
  
  As no formal studies among the following patient groups have been carried out, Axona is not recommended if you:
  
  
  • Are under the age of 18
  • Have a history of diabetes that is not well-controlled
  • Have liver or kidney dysfunctions
  • Are pregnant or lactating
  
  It is important to discuss your complete medical history with your physician before taking Axona.

• For product with an expiration date BEFORE January 25, 2014 the nutritional content for each 40 g packet of Axona is: total calories (217), protein (6.8 g), carbohydrate (8 g)*, caprylic triglyceride (20 g), vitamin A (3820 IU), vitamin B6 (1.36 mg), vitamin C (94 mg), vitamin E (16.68 IU), folic acid (0.37 mg), chromium (0.038 mg), zinc (3.89 mg), calcium (240 mg), potassium (255 mg), sodium (58 mg), phosphorus (363 mg), magnesium (116 mg).
  
  For product with an expiration date WITH or AFTER January 25, 2014 the nutritional content for each 40 g packet of Axona is: total calories (217), protein (7 g), carbohydrate (8 g),* caprylic triglyceride (20 g), calcium (240 mg), potassium (255 mg), sodium (58 mg), phosphorus (363 mg), magnesium (116 mg).
  
  *Total carbohydrates include 2.4 g sugar and negligible amount of lactose.

• Axona contains caseinate and whey, both of which are derived from milk. Axona should not be used by patients who are allergic either to milk or to these component ingredients.
  
  A single 40-gram dose of Axona contains less than 0.04 grams of lactose. As a comparison, one cup of cow’s milk (whole, 2%, or skim) contains about 10 to 14 grams of lactose. Therefore, Axona contains less than one percent of the amount of lactose contained in milk.
  
  Thus far, Axona has not been studied in lactose-intolerant patients. Since the sensitivity to lactose can vary widely among individuals diagnosed with lactose intolerance, we recommend that lactose-intolerant patients consult with their physicians before taking Axona.

• Each 40 gram packet of Axona contains 0.22 grams of lecithin derived from soybeans. Therefore, Axona should not be used in patients with known allergies to either soy or soy lecithin. The majority of soy lecithin is purified from soybean oil that has been processed to eliminate most, if not all, allergenic proteins. Since trace amounts of soy proteins may still be present in Axona, we provide the cautionary statement on our packaging for patients who are allergic to soy.
  
  We recommend that this information be reviewed with patients’ healthcare providers. The healthcare provider should be able to make an informed decision, based on an individual patient's medical history and known hypersensitivities, and determine if Axona might be appropriate for the patient.

• Axona is gluten-free.

• Axona is certified kosher by the Orthodox Union.

• Axona can be taken with commonly prescribed medications for Alzheimer’s disease.
  
  No restrictions are required regarding dietary intake or the use of nutritional supplements such as multivitamins and omega-3 products.

• You should take Axona as prescribed by your physician. For most people, 40 grams (one packet of Axona powder) should be consumed once daily following a meal, preferably breakfast or lunch.

• In clinical trials, the current formulation of Axona was only studied when it was mixed with water. However, additional blending studies indicate that Axona is a highly stable product and may be mixed with other foods and liquids (such as ice cream, pudding, oatmeal, milk, fruit juice, chocolate syrup, and meal replacement drinks). In addition, mixing Axona with foods or liquids that contain additional fats and proteins may also reduce the likelihood of developing side effects such as nausea, indigestion, and diarrhea.

• In clinical trials, Axona was mixed by adding the powder to 4-8 ounces of water in a shaker cup, and shaking until fully blended. We have now evaluated mixing Axona by using an electric blender, both with water as well as other liquids, such as fruit juice and coffee. Using a blender results in a uniform mixture which is comparable or superior to using a shaker cup.

• Some patients appear to require starting at a lower dose for a period of time before they can tolerate a full dose of Axona (see “how to minimize side effects”). You should not take more than one packet per day of Axona without first consulting your physician. (see "Tips for Reducing Possible Side Effects")

• In clinical trials, Axona was consumed immediately after mixing. If for some reason the Axona mixture cannot be consumed right away, it may be stored in the refrigerator for up to 24 hours. The Axona mixture should be mixed thoroughly again (shaken or blended) before being consumed.