Pamlab A PATIENT GUIDE. For people with Type 2 Diabetes experiencing numbness, tingling and burning pain in the hands and feet.

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1 understanding diabetic neuropathy For people with Type 2 Diabetes experiencing numbness, tingling and burning pain in the hands and feet. A PATIENT GUIDE This publication provided by: Pamlab

2 What is diabetic neuropathy? 1-4 diabetic neuropathy... A Progressive Disease 1,5 Diabetic neuropathy develops gradually and you may not notice problems until the damage has already occurred. You can prevent diabetic neuropathy or slow its progress with tight blood sugar control and a healthy lifestyle. Diabetic neuropathy is nerve damage caused by diabetes. High blood sugar can reduce blood flow and injure nerve fibers throughout your body, but most often the damage occurs in your legs and feet. At least 6 out of 10 people with diabetes have some degree of neuropathy making it the most common complication of diabetes. Diabetic neuropathy with loss of feeling in your feet is one of the most frequent causes of foot ulceration and amputation.! - + Mild/Moderate Pain Burning, shooting, stabbing pains Severe Pain Severe burning, shooting, stabbing pains; increased sensitivity Sensory Loss Numbness/deadness Painless injury Reduced thermal sensation Late Complications Ulceration, foot deformity, non-traumatic amputation *Staging does not imply automatic progression to the next stage. The aim is to prevent or at least delay progression to the next stage. Reduced Nerve Fiber Density & Increased Symptoms of Diabetic Neuropathy 2,6 Decreased Nerve Fiber Density* Increased Symptoms Burning Pain Stabbing Pain Numbness Tingling Shooting Pain Reduced blood flow leads to a progressive loss of nerve fibers in the legs and feet. *This image represents a patient with diabetic neuropathy with reduced nerve fibers in the skin. = Nerve Fiber Loss of nerve fibers correlates with increased diabetic neuropathy symptoms. 2 Metanx is an orally administered medical food for use only under medical supervision for the dietary management of endothelial dysfunction in patients with diabetic peripheral neuropathy. 3

3 What causes diabetic neuropathy? 7 How diabetes leads to nerve damage is a subject of intense research, but two main factors are likely involved: A. Elevated blood sugar levels damage the blood vessels and reduce blood flow to the nerves, starving them of the oxygen and nutrients they need to survive. B. Elevated blood sugar levels directly damage the nerves resulting in reduced nerve fiber density. To learn more visit How Does Metanx Work in Diabetic Neuropathy? If you have diabetic neuropathy, there is a good chance that you have reduced blood flow to the nerves in your hands and feet. As a result, your nerves may become damaged and lose the ability to repair themselves. Metanx provides the nutritional requirements needed by diabetes patients to restore the metabolic processes associated with diabetic neuropathy to do the following: 8-10 C. Maintain blood flow in the vessels that carry the nutrients and oxygen to your nerves. D. Provide the required nutrients to help facilitate nerve repair. A. Reduced Blood Flow C. Restored Blood Flow B. Reduced Nerve Fiber Density The majority of diabetes patients with symptomatic neuropathy have reduced nerve fibers. 11 D. Increased Nerve Fiber Density Nutritional management of endothelial dysfunction with Metanx has been shown to increase nerve fibers in patients with diabetic neuropathy. 9,12 = Nerve Fiber 4 Metanx is an orally administered medical food for use only under medical supervision for the dietary management of endothelial dysfunction in patients with diabetic peripheral neuropathy. 5

4 What is Metanx? Metanx is a medical food available by prescription designed to nutritionally manage the metabolic processes that regulate blood vessel and nerve health in patients with diabetic neuropathy. How is Metanx different than over-the-counter vitamins? The folic acid, B 12 and B 6 found in most over-the-counter vitamins are man-made and need to be broken down by the body before they can be used. Did You Know? Up to 50% of individuals are unable to fully convert folic acid into the active form of folate, L-methylfolate. 13 B Vitamin Folic acid Vitamin B 6 Vitamin B 12 Active Dietary Form L-methylfolate Pyridoxal 5 -phosphate Methylcobalamin Metanx features the active, naturally occurring forms of these B vitamins used by your body. DPN TOTAL SYMPTOMS Each Metanx tablet contains: L-methylfolate Calcium (as Metafolin ) 3 mg Pyridoxal-5 -Phosphate 35 mg Methylcobalamin 2 mg Metanx is immediately available to provide a nutritional benefit for your blood vessels and nerves. 6 Metanx is an orally administered medical food for use only under medical supervision for the dietary management of endothelial dysfunction in patients with diabetic peripheral neuropathy. 7

5 What are Medical Foods? A medical food is a specially formulated food that must be used under the supervision of a physician. All components of a medical food must have GRAS status (Generally Recognized as Safe) as designated by the FDA or independent review and the product must also comply with general food safety and manufacturing standards. 14 Medical Foods are intended to manage a specific disease or condition for which medical evaluation, based on recognized scientific principles, has established distinctive nutritional requirements. Metanx as a Medical Food Metanx is indicated for the distinct nutritional requirements of diabetes patients with endothelial dysfunction associated with symptomatic diabetic neuropathy (DN). Diabetes Metanx metabolic process metabolic process blood flow nerve fiber density blood flow nerve fiber density DN symptoms DN symptoms For example, diabetes causes an imbalance in the metabolic processes responsible for vascular and nerve repair. As a result, blood flow is reduced to the peripheral nerves, causing more severe diabetic neuropathy (DN) symptoms. 11 Metanx provides the nutritional requirements to restore the metabolic processes responsible for vascular and nerve repair. 8 Metanx is an orally administered medical food for use only under medical supervision for the dietary management of endothelial dysfunction in patients with diabetic peripheral neuropathy. 9

6 What Should I Expect From Metanx? When Should I Feel the Difference With Metanx? Most diabetic neuropathy therapies have a variety of side effects and are effective at covering up the painful symptoms, but your nerve damage continues to get worse. Once you have addressed your nutritional needs with Metanx, you may begin to feel the difference in one or more of the following: 15,16 Numbness Burning Pain Shooting Pain Tingling Improved Sleep Give Metanx A Chance to Work For You If you already have nerve damage, it may take some time before you feel the difference. Evidence has shown patients receiving nutritional management with Metanx have experienced improvement within an average of 3 weeks. 17 Every person will respond differently to Metanx. Where Can I Get Metanx? Metanx is dispensed by prescription and is available at your local pharmacy. Even if Metanx is not covered by your insurance plan, Metanx may be less expensive than most insurance co-payments. See page 15 for a guaranteed low price through Brand Direct Health. How Do I Take Metanx? The usual adult dosage is one tablet twice daily. Is Metanx Safe? The active dietary ingredients in Metanx are well tolerated in short-term and chronic therapy. The side effects are similar to a sugar pill. 16 For complete prescribing information, visit 10 Metanx is an orally administered medical food for use only under medical supervision for the dietary management of endothelial dysfunction in patients with diabetic peripheral neuropathy. 11

7 What Else Can I Do To Help Myself? Take Care of YOU First The most important thing you can do for yourself is to keep your blood sugars as closely controlled as possible, get regular exercise and keep your weight under control. Get To Know Your Feet Remember, it s the numbness in your feet and toes, NOT the pain that increases your risk for further complications. Loss of sensation in the feet means that sores or injuries may not be noticed and may become ulcerated or infected. More than half of all lower limb amputations occur in people with diabetes. Doctors estimate that nearly half of the amputations caused by neuropathy and poor circulation could have been prevented by careful foot care. 4 Here are the steps to follow: Inspect your feet and toes everyday for cuts, blisters, redness, swelling, calluses, or other problems. Use a mirror; laying a mirror on the floor works well. Notify your health care provider of any problems. You may not recognize the numbness or tingling in your feet because it can be a slow process. Web Resources American Diabetes Association The American Diabetes Association (ADA) is an association working to fight the consequences of diabetes and to help those affected by diabetes offering information for both patients and healthcare professionals. The Neuropathy Association The Neuropathy Association is the leading national nonprofit organization serving the peripheral neuropathy community. dlife. For Your Diabetes Life complications/foot/diabetes-feet.html dlife is the largest diabetes consumer destination offering practical daily lifestyle resources. Diabetic Connect A free online community for diabetes patients offering support, education and a place to share what you want with complete privacy controls. Make sure to remove your socks and shoes in the exam room and have your feet checked at every doctor s visit. 12 Metanx is an orally administered medical food for use only under medical supervision for the dietary management of endothelial dysfunction in patients with diabetic peripheral neuropathy. 13

8 Important Points to Remember The most important thing you can do for yourself is to keep your blood sugar as closely controlled as possible, get regular exercise and keep your weight under control. Diabetic neuropathy is associated with reduced blood flow to your nerves. Metanx is designed to nutritionally manage the metabolic processes that regulate blood vessel and nerve health in patients with diabetic neuropathy. It s the numbness in your feet and toes that increases your risk for ulceration and amputation, NOT pain. 3 Most diabetic neuropathy treatments only cover up the painful symptoms while your nerve damage continues to get worse. Give Metanx a chance to work for you. If you already have nerve damage, it may take some time before you feel the difference. Evidence has shown patients receiving nutritional management with Metanx have experienced improvement within an average of 3 weeks. 17 Do not stop taking Metanx without talking to your healthcare provider. references: 1 Mayo Clinic Website. Diabetic Neuropathy. Available at com/health/diabetic-neuropathy/ds Zang K and Hayes D. Podiatry Today 2009; November: Abbott CA, et al. Diabet Med 2002;19: Adler AI, et al. Diabetes Care 1999;22(7): Adapted from Boulton A et al. Diabetes Care 2004;27(6): Lauria G and Devigili G. Nat Clin Pract Neurol 2007;3(10): Vinik, Aaron. The Am Journ of Med 1999;107(2B):17S-26S. 8 Abstracts of the 7th Annual Conference on Arteriosclerosis, Thrombosis, and Vascular Biology. Oral Presentations. Arterioscler Thromb Vasc Biol.2006;26:e43-e52* 9 Jacobs AM and Cheng D. Rev Neurol Dis 2011;8(1/2): Watanabe T, et al. J Neurol Sci 1994;122: De Sousa EA, et al. JNeurol Neurosurg Psychiatry 2006;77: Home-Delivery Pharmacy Personalized Customer Service Guaranteed Lowest Cash Price Flexible Payment Options 3 Month Supply 1 Payment (One-time) Metanx (1 tablet, twice daily) * One time, $5.00 processing fee with monthly payment option. Applied to first month s payment. Ordering 1. Ask your Healthcare Provider to send your prescription directly to Brand Direct Health on your behalf 2. A Brand Direct Health representative will contact you, with payment and shipping options. 3. Your prescription will be home delivered within 7 business days. support 3 Month Supply 3 Payments (Monthly) $ $48.00* On-site pharmacists and nurses experienced and knowledgeable in medical foods Highly trained customer service representatives Personal reminder prior to refill date 90 day Customer Satisfaction Promise 12 Obrosova IG, et al. Diabetes 2011;60(Suppl 1):A Klerk M, et al. A Meta Analysis. JAMA 2002;288: Section 5(b) of the Orphan Drug Amendments (21 U.S.C. 360ee (b) (3)). 15 Fonseca V, et al. Diabetes July 2011;60(suppl 1):A Vascular Disease Management 2005;2(supple 6):1S-9S. 17 Walker M, et al. Rev Neurol Dis 2010;7(4): contact Phone: Fax: CustomerService@BDHRx.com 14 Item #

9 Diabetic Neuropathy: Symptoms Survey If you are experiencing symptoms such as numbness, tingling and/or burning pain from diabetic neuropathy, use the following checklist as a resource when discussing the problem with your healthcare provider: I am experiencing one or more of the following symptoms: NUMBNESS OR WEAKNESS My feet are numb and feel dead I don t feel pain in my feet, even when I have blisters or injuries I can t feel my feet when I m walking I have trouble feeling heat or cold in my feet or hands Sometimes it feels like I have socks or gloves on when I don t TINGLING I feel pins and needles in my feet My feet or hands get very cold or very hot PAIN OR INCREASED SENSITIVITY I have burning, stabbing and/or shooting pains in my feet My feet are very sensitive to touch. For example, sometimes it hurts when the bed covers touch my feet My feet hurt worse at night If you check one or more of these symptoms, please speak with your healthcare provider. Sponsored by: