TIME!...you are on your way to taking an active role in your diabetes management. Controlling blood...

LET’S DO MEALTIME!

RESOURCE KIT

(insulin human) Inhalation Powder

Indications and Usage for Afrezza®

(insulin human) Inhalation PowderPrescription Afrezza® is a man-made rapid acting inhaled insulin breathed through your lungs and is used to control high blood sugar in adults with type 1 and type 2 diabetes.

Limitations of Use:

• Do not use Afrezza® in place of long-acting insulin; Afrezza® must be used with a long-acting insulin in patients with type 1 diabetes.

• Do not use Afrezza® to treat diabetic ketoacidosis.

• It is not known if Afrezza® is safe and effective for use in people who smoke. Afrezza® is not for use in patients who smoke or who have recently stopped smoking (less than 6 months).

• It is not known if Afrezza® is safe and effective in children under 18 years of age.

Important Safety Information for Afrezza®


WARNING: RISK OF SUDDEN LUNG PROBLEMS (BRONCHOSPASM) IN PATIENTS WITH

LONG-TERM (CHRONIC) LUNG DISEASE

• Sudden lung problems (acute bronchospasm) have been seen in patients with asthma and COPD (chronic obstructive pulmonary disease) using Afrezza®.

• Afrezza® is not to be used in patients with long-term lung disease such as asthma or COPD.

• Before initiating Afrezza®, your doctor will perform a detailed medical history, physical examination, and a breathing test (called spirometry) to identify potential lung problems.

Please see full Important Safety Information for Afrezza® on pages 24-25, and full Prescribing Information, including Boxed WARNING, available at Afrezza.com from where you downloaded this PDF.

https://www.afrezza.com/

http://products.sanofi.us/afrezza/afrezza.pdf



2 (insulin human) Inhalation Powder

WELCOME

Thank you for downloading the Let’s Do Mealtime! Resource Kit. With this kit, you are on your way to taking an active role in your diabetes management. Controlling blood sugar at mealtime can be an important part of overall diabetes management including diet and exercise. Afrezza® (insulin human) Inhalation Powder, the only inhaled insulin, is a mealtime insulin option for adults with diabetes.

Afrezza® works to lower blood sugar levels and is taken at the beginning of a meal. In this kit, you’ll find facts about Afrezza®, along with a Doctor Discussion Guide to use at your next appointment to see if Afrezza® could be right for you.

The Let’s Do Mealtime! Resource Kit is a valuable resource to help manage your mealtime diabetes needs.

Important Safety Information for Afrezza® (insulin human) Inhalation PowderDo not use Afrezza® if you have problems with your lungs, such as asthma or COPD (chronic obstructive pulmonary disease). Do not use Afrezza® during a low blood sugar reaction (hypoglycemia). If you are allergic to regular human insulin or to any of the ingredients in Afrezza®, do not use Afrezza® as this may cause a significant and severe allergic reaction.





CONTENTS

Insulin and MealtimeManaging Blood Sugar LevelsLearn about mealtime blood sugar control and how Afrezza® (insulin human) Inhalation Powder, the only inhaled insulin, may help

Mealtime PlanningMeal GuideCreate healthy dishes with these steps

Grocery Shopping TipsCreate diabetes-friendly meals by finding the right ingredients for healthy meals

GoMeals® AppDiscover the app that helps you make healthy lifestyle choices

Talking With Your DoctorAfrezza® Doctor Discussion GuideQuestions to guide your conversation about your diabetes treatment plan

Full Prescribing Information for Afrezza®, including Boxed WARNING

05

07

20

21

23

24

Important Safety Information for Afrezza® (insulin human) Inhalation PowderBefore using Afrezza®, it is important to tell your doctor about all your medical conditions, including if you have a history of lung problems, if you smoke or have recently quit smoking, if you are pregnant or plan to become pregnant, or if you are breast feeding or planning to breast-feed. Tell your doctor about all other medicines and supplements you take.





Insulin and Mealtime

Important Safety Information for Afrezza® (insulin human) Inhalation PowderYour doctor will take a medical history, and do a physical exam and a breathing test (called spirometry) to determine if you have lung problems. Patients with lung problems should not use Afrezza®. If your doctor finds you have lung problems, use of Afrezza® may cause a severe asthma-like breathing problem. Afrezza® can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza®, and then each year after that, even if you have no lung symptoms. More frequent testing should be done if you have symptoms such as wheezing or coughing.







MANAGING BLOOD SUGAR LEVELS

Afrezza® (insulin human) Inhalation Powder, the only mealtime insulin you inhale If diet, exercise, and your current diabetes medications are no longer giving you the blood sugar control you need, or you are looking for a mealtime insulin option, it may be time to ask your healthcare professional if Afrezza® inhaled insulin could be right for you.

Afrezza® at a glance:

• Provides the mealtime insulin you may need to help improve your blood sugar control

• Delivers insulin through a specially designed inhaler

• Includes access to the Afrezza® COACH patient support program

What happens at mealtime? Between meals, your pancreas produces low amounts of insulin. At mealtime, larger amounts of insulin are produced to absorb the blood sugar spikes you get from food.

As your diabetes changes, you may

need mealtime insulin to help control blood sugar spikes.

Important Safety Information for Afrezza® You must test your blood sugar levels while using insulin, such as Afrezza®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made carefully and only under your doctor’s care.

You may take oral medications as part of your overall diabetes treatment plan and still find you’re not achieving your blood sugar goal. This can be the case even if you already take a long-acting insulin. In spite of your best efforts, you may need to add a mealtime insulin such as Afrezza® to help manage the blood sugar spikes you get after you eat.

Even if you’re already on a mealtime insulin, Afrezza®—the only inhaled insulin—may be an option to discuss with your healthcare professional to help you manage your blood sugar.

Ask your healthcare professional if Afrezza® inhaled insulin may be right for you.




Mealtime Planning

Important Safety Information for Afrezza® (insulin human) Inhalation Powder There are certain serious side effects that are associated with the use of Afrezza®

Severe allergic reaction (including whole body reaction) is one of the serious side effects. Get medical help right away if you have any signs or symptoms of a severe allergic reaction, including a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.






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MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder Low blood sugar (hypoglycemia) is one of the most common side effects of insulin, including Afrezza®, which can be serious and life-threatening. Common symptoms of hypoglycemia are dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, or hunger. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza®, and to understand how to lessen the risk of hypoglycemia events.


10 HELPFUL THINGS TO KNOW ABOUT MEAL PLANNING





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The Plate Method features a very simple setup when mealtime rolls around. It suggests that half of your meal be non-starchy vegetables, one quarter be grains, and the other quarter be lean proteins – for breakfast, lunch, and dinner. It’s a great place to start if you’re looking to live a healthier lifestyle by balancing your nutrients throughout the day!

1. SERVE IT UP RIGHT. Your health care team can show you how many calories and carbs you should eat at each meal based on your age, weight, activity, and glucose level.

One carb serving is equal to 15 grams of carbohydrates. Most men can set a goal of 4-5 carb servings per meal, and most women can aim for 3-4 carb servings per meal, but ask your health care team what your goal should be.

By watching your serving sizes, it may be easier to lose weight. Shedding any necessary weight, following a healthy diet, and exercising can help manage your blood sugar levels.

NON-STARCHY VEGETABLES

MEAT,PROTEIN

GRAINS,STARCHES

9" PLATE

THE PLATE METHOD

FRUITMILK

8 OZ GLASS 1/2 CUP

MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder Lung cancer occurred in more people who were taking Afrezza® compared to other diabetes medications. There were too few cases to know if lung cancer was related to Afrezza®. Tell your doctor if you currently have lung cancer, have had it in the past, or if you have an increased risk of developing lung cancer.






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2. DECODING THE FOOD LABEL. It’s very useful to learn how to read food labels and understand the numbers on them.

So let’s look at a sample label. The % Daily Value represents the percentage of nutrients in one serving of food that the FDA believes you should consume on a daily basis (based on a

2000 calorie per day diet). Here are some additional tips on how to read the food label.

3. SERVING SIZES. The portion you’re planning to eat may not be the same as the serving size on

the label. So if the label serving size is 1/4 cup and you

eat 1/2 cup, you are getting twice the calories, fat, and carbohydrates listed on the label.

Nutrition FactsServing Size 1/4 Cup (30g)Servings Per Container about 38

Amount Per Serving

% Daily Value*

Calories 200 Calories from Fat 150

Total Fat 17g 26%

Protein 5g

Total Carbohydrate 7g 2%

Cholesterol 0mg 0%

Sodium 120mg 5%

Saturated Fat 2.5g 13%

Dietary Fiber 2g 8%

Trans Fat 0g

Sugars 1g


Amount Per Serving

% Daily Value*


Total Fat 17g 26%

Protein 5g


Cholesterol 0mg 0%

Sodium 120mg 5%


Dietary Fiber 2g 8%

Trans Fat 0g

Sugars 1g

MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder Heart failure can occur if you are taking insulin together with certain medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you already have heart failure it may get worse while you take TZDs with Afrezza®. Tell your doctor if you have any new or worsening symptoms of heart failure including shortness of breath, swelling of your ankles or feet or sudden weight gain. Your treatment with Afrezza® and TZDs may need to be changed or stopped if you have new or worsening heart failure.






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4. CARB COUNTING. Many people with diabetes count carbs because total

carb intake has the strongest impact on post-meal blood sugar levels. The total carbohydrates listed on the food label includes sugar, fiber, and complex carbohydrates.

Foods high in carbohydrates are rice, pasta, starchy vegetables, and beans.Fruits, milk, yogurt, and sweets are also high in carbs. Again, it’s okay to eat these foods, but moderation is key.

It’s a good idea to spread your carb intake out across your meals for the day. Skipping carbs completely in the morning and then overloading for dinner can cause a huge spike in your blood sugar levels.

Also, different carbs affect your blood sugar in different ways – some can have a rapid effect on your levels, and others a slower impact.

5. MAKE FRIENDS WITH FIBER. A meal plan high in dietary fiber may

help balance blood sugar

levels by slowing the breakdown of carbs into sugar. Fruits, vegetables, whole grains, and beans (such as pinto or kidney) are all good sources of fiber, which is an important part of any meal plan. It’s a good idea to eat about 25-30 grams of fiber each day.

6. GOOD FAT VS. SATURATED FAT. Although fat is helpful in slowing the

breakdown of carbs into sugar, it’s important to limit saturated

fat, trans fat, and cholesterol. Eating less of these foods may help lower your risk of heart disease. Some fat is okay in your diet, so it’s a good idea to consider unsaturated fat sources like avocados and healthy nuts like almonds. And be sure to eat reasonable servings of these foods.


Amount Per Serving

% Daily Value*


Total Fat 17g 26%

Protein 5g


Cholesterol 0mg 0%

Sodium 120mg 5%


Dietary Fiber 2g 8%

Trans Fat 0g

Sugars 1g


Amount Per Serving

% Daily Value*


Total Fat 17g 26%

Protein 5g


Cholesterol 0mg 0%

Sodium 120mg 5%


Dietary Fiber 2g 8%

Trans Fat 0g

Sugars 1g


Amount Per Serving

% Daily Value*


Total Fat 17g 26%

Protein 5g


Cholesterol 0mg 0%

Sodium 120mg 5%


Dietary Fiber 2g 8%

Trans Fat 0g

Sugars 1g

MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder Get emergency help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.






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Nonstarchy Vegetables Calories Carbs Serving Size

Broccoli (cooked)

33 7g 1/2 Cup

Carrots (raw)

50 12g2 Medium

Carrots

Cauliflower (cooked) 17 4g 1/2 Cup

Cauliflower (raw)

25 5g 1 Cup

Collard Greens (cooked)

26 6g 1/2 Cup

Cucumber (raw)

16 4g 1 Cup

Green Beans (cooked)

22 5g 1/2 Cup

Iceberg Lettuce 7 2g 1 Cup

Onions (raw)

67 16g 1 Cup

Summer Squash (cooked)

18 4g 1/2 Cup

Tomato 32 7g 1 Tomato

Zucchini(cooked)

14 4g 1/2 Cup

7. MORE THAN JUST SERVING SIZES. Here’s a list of common foods you might eat each day. It gives you an idea of the number of calories and carbs in each food. Figuring out how much a serving size is can be a bit confusing. Below is a helpful trick to help make sense of how much a cup and ounce is.

1 cup = about the size of a closed fist3 oz of meat/fish = about the size of your palm

1 oz of nuts = about a handful

Starchy Vegetables Calories Carbs Serving Size

Corn (cooked)

66 16g 1/2 Ear

McDonald’s™ French Fries 231 30g 1 Small Fries

Potato (baked)

79 18g 3 Oz

Potato (mashed with milk)

85 19g 1/2 Cup

Wendy’s™ Baked Potato 440 70g 1 Potato

Yam (cooked)

79 19g 1/2 Cup

HELPFUL TIP: Restaurant portion sizes can sometimes be double or triple a normal serving size. When you first learn serving sizes, use a measuring cup and spoon at home so when you eat out you know how much to enjoy and how much to doggy bag.

MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder While using Afrezza® do not drive or operate heavy machinery until you know how Afrezza® affects you. You should not drink alcohol or use other medicines that contain alcohol and you should not smoke.






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Fruits Calories Carbs Serving Size

Apple 54 15g 1 Small Apple

Applesauce (unsweetened)

52 14g 1/2 Cup

Banana 72 19g 1 Extra Small Banana

Blueberries 62 16g 3/4 Cup

Cantaloupe 56 14g 1 Cup

Dates 69 19g 3 Dates

Grapefruit 53 13g 1/2 Grapefruit

Grapes 60 15g 17 Grapes

Orange 62 16g1 Medium Orange

Peach 57 14g 1 Medium Peach

Pineapple 56 15g 3/4 Cup

Raisins 54 14g 2 Tbsps

Strawberries 57 13g 1 1/4 Cup

Watermelon 57 14g 1 1/4 Cup

HELPFUL TIP: It may not be so obvious at first but

fruits contain carbs, so keep that in mind.

MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder The most common side effects of Afrezza® include low blood sugar (hypoglycemia), cough, sore throat, headache, diarrhea, tiredness, and nausea.






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Dairy Calories Carbs Serving Size

Buttermilk (low-fat)

98 12g 1 Cup

Milk (fat-free)

90 13g 1 Cup

Milk 1% 110 13g 1 Cup

Milk 2% 130 12g 1 Cup

Milk (whole)

150 12g 1 Cup

Sour Cream (regular)

62 1g 2 Tbsps

Sour Cream (light)

61 3g 3 Tbsps

Yogurt (low-carb, plain)

70 28g 1 Container

Yogurt Fruited (non-fat)

150 28g 1 Container

Beans and Peas Calories Carbs Serving Size

Baked Beans 78 17g 1/3 Cup

Black Beans 114 20g 1/2 Cup

Lima Beans 99 18g 1/2 Cup

Peas (frozen)

62 16g 1/2 Cup

Pinto Beans 122 22g 1/2 Cup

Refried Beans 100 17g 1/2 Cup

Breads, Grains and Cereals Calories Carbs Serving Size

Bagel (white)

78 15g 1/4 Large Bagel

Bread (wheat)

69 13g 1 Slice

Bread (white)

67 12g 1 Slice

Cereal (all bran)

81 23g 1/2 Cup

Cereal (corn flakes)

76 18g 3/4 Cup

Crackers (graham)

99 18g 3 Small Rectangles

Grits 71 16g 1/2 Cup

Pasta 62 13g 1/3 Cup

Popcorn (butter, popped)

97 11g 3 Cups

Rice (cooked, brown)

71 15g 1/3 Cup

Rice (cooked, white)

69 15g 1/3 Cup

Rice (fried)

150 22g 1/3 Cup

Tortilla (corn)

52 11g 1 Medium Tortilla

Tortilla (flour)

112 19g 1 Medium Tortilla

HELPFUL TIP: Milk contains carbs so don’t forget

to take that into account.

MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder If you are taking prescription medicine, you are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.






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Fats Calories Carbs Serving Size

Almonds (dry roasted)

48 2g 6 Almonds

Bacon 85 0g 2 Slices

Butter(salted)

34 0g 1 Tsp

Canola Oil 40 0g 1 Tsp

Cashews (salted)

52 3g 6 Cashews

Cream Cheese (low-fat 2%)

54 1g 1 1/2 Tbsps

Cream Cheese (regular)

51 1g 1 Tbsp

Margarine 24 0g 1 Tsp

Mayonnaise 33 0g 1 Tsp

Olive Oil 40 0g 1 Tsp

Olives (black)

40 2g 8 Olives

Peanut Butter 48 2g 1 1/2 Tbsps

Pistachios(roasted, salted)

64 3g 16 Kernels

Salad Dressing 69 2g 1 Tbsp

Walnuts(halves)

52 1g 4 Halves

Protein Calories Carbs Serving Size

AmericanCheese

(processed)68 2g 1 Oz

Cheddar Cheese (fat-free)

45 2g 1 Oz

Chicken Wings 441 0g 6 Wings

Chicken (roasted)

58 0g 1 Oz

Cod(cooked)

30 0g 1 Oz

Cottage Cheese 1% 41 2g 1/4 Cup

Egg 74 1g 1 Egg

Ground Beef(extra-lean, cooked)

57 0g 1 Oz

Hot Dog (beef/pork)

70 6g 1 Hot Dog

Pork (baked or broiled)

57 0g 1 Oz

Prime Rib(roasted)

83 0g 1 Oz

Salmon(baked or broiled)

61 0g 1 Oz

Sausage(smoked)

40 3g 1 Oz

Taco Bell™ Soft Shell Beef Taco 210 21g 3 1/2 Oz

Tofu 80 2g 1/2 Cup

Turkey Breast 38 0g 1 Oz

Veal 64 0g 1 Oz

MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder Do not use Afrezza® if you have problems with your lungs, such as asthma or COPD (chronic obstructive pulmonary disease). Do not use Afrezza® during a low blood sugar reaction (hypoglycemia). If you are allergic to regular human insulin or to any of the ingredients in Afrezza®, do not use Afrezza® as this may cause a significant and severe allergic reaction.






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8. MINDFUL EATING. Many foods you cook or order every day can be made healthier without losing taste and without much effort. Try replacing unhealthy food with something that’s better for you. But as always, be mindful about your portion sizes.

When you go out to eat, look for key healthy words on the menu such as “grilled,” “broiled,” and “roasted,” instead of items that may be fried in saturated fats, or include unnecessary breading.

Also, be aware that many foods listed as “sugar free” can still be loaded with carbs. In other words, having some sugar free gelatin as a snack can have a much different effect on your body than sugar free cake. Make sure to read your labels!

MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder Before using Afrezza®, it is important to tell your doctor about all your medical conditions, including if you have a history of lung problems, if you smoke or have recently quit smoking, if you are pregnant or plan to become pregnant, or if you are breast feeding or planning to breast-feed. Tell your doctor about all other medicines and supplements you take.






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MINDFUL EATING (CONT.).

Here are some healthy substitutions.

Instead of… Try…

Candy Bar10 Strawberries with 2 Tbsps

Low-Fat Chocolate Whipped Topping

French Fries 1 Baked Potato with 1 Tbsp Reduced-Fat Sour Cream

Fried Chicken 3 Oz Roasted Chicken

Fried Fish Sticks 3 Oz Broiled Salmon

Fried Rice1/2 Cup Brown Rice

with 1/4 Cup Black Beans

Pretzels 10 Whole Wheat Pretzels

Sugary Cereal1 Cup Whole Grain Cereal

with Fresh Fruit

9. DRINKS WITH FRIENDS. Drinking alcohol lowers your blood sugar levels – sometimes with very little warning, and that can be dangerous. Ask your healthcare provider if it’s okay to drink alcohol at all, and if it is, find out how to manage your blood sugar levels when drinking. If you decide to have a drink, be sure to eat something, too. Never drink on an empty stomach.

MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder Your doctor will take a medical history, and do a physical exam and a breathing test (called spirometry) to determine if you have lung problems. Patients with lung problems should not use Afrezza®. If your doctor finds you have lung problems, use of Afrezza® may cause a severe asthma-like breathing problem. Afrezza® can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza®, and then each year after that, even if you have no lung symptoms. More frequent testing should be done if you have symptoms such as wheezing or coughing.






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BREAKFAST — Eggs, toast and fruit • 2 Scrambled Eggs

• 1 Slice Whole Wheat Toast (w/ 1 Tbsp Low-Fat

Cream Cheese)

• 1/2 Grapefruit

LUNCH — Turkey sandwich and snack • 2 Slices Turkey

• 2 Slices Whole Wheat

Bread

• 2 Slices Tomato

• 1/2 Cup Shredded

Iceberg Lettuce

• 1 Slice American Cheese

• 1 Apple

• 1 Small Bag of Pretzels

DINNER — Broiled salmon, rice and vegetable

• 5 Oz Salmon Fillet

• 1 Tbsp Chopped Onions

• 2 Tbsps Canola Oil

• 1 Cup Brown Rice

• 1 Cup Steamed Broccoli

• 1 Cup Fat-Free Milk

SNACKS

• 1 Oz Pistachios or

• 1 Cup Low-Fat Fruited Yogurt or

• 1 Watermelon Slice

10. MEALTIME IDEAS. If you’re looking to lose some weight, reducing your serving sizes can sometimes help. And if you lose weight, this can also help lower your blood sugar levels, as well as allow insulin to work more efficiently in your body. A true win-win. Here are some suggestions for a day’s worth of tasty meals and snacks for people who are counting carbs:

HELPFUL TIP: Consulting a registered dietitian is a great

way to help you with meal planning.

MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder You must test your blood sugar levels while using insulin, such as Afrezza®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made carefully and only under your doctor’s care.






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YOU

TALK TO & VISIT YOUR HEALTH CARE

TEAM REGULARLY.

BE PHYSICALLY

ACTIVE.

MONITOR & RECORD YOUR BLOOD SUGAR

LEVELS.

TAKE YOUR MEDICINE AS PRESCRIBED.

PLAN YOUR MEALS.

THE CIRCLE OF BETTER BLOOD SUGAR CONTROL.You are at the center of a successful plan to improve your blood sugar control. Reach out and embrace all of these steps, and start to live the healthy lifestyle you are capable of!

QUICK RECAP ● Remember to keep your portions under

control at mealtime.

● Try to avoid eating too many carbs, as they affect your levels the most.

● Stay away from saturated fat, cholesterol, trans fat, and sodium whenever possible.

● Alcohol can significantly lower your blood sugar levels, so be aware and never drink on an empty stomach.

● It sounds like a lot of work, but if you keep making healthy changes to your diet, you can do this!

MEAL GUIDE

HELPFUL TIP: Before you change your exercise routine

or diet, speak to your healthcare professional.

Important Safety Information for Afrezza® (insulin human) Inhalation Powder There are certain serious side effects that are associated with the use of Afrezza®







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TO LEARN MORE ABOUT EATING HEALTHY WITH DIABETESThere are plenty of online resources for people with diabetes. Some of them also contain advice on recipes, carb counting and making smart meal plans.

● www.diabetes.org (American Diabetes Association)

● www.diabeteseducator.org (American Association

of Diabetes Educators)

● www.eatright.org (American Dietetic Association)

● www.dlife.com (dLife)

● www.ndep.nih.gov (National Diabetes

Education Program)

● www.tcoyd.com (Taking Control of Your Diabetes)

MEAL GUIDE

Important Safety Information for Afrezza® (insulin human) Inhalation Powder Low blood sugar (hypoglycemia) is one of the most common side effects of insulin, including Afrezza®, which can be serious and life-threatening. Common symptoms of hypoglycemia are dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, or hunger. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza®, and to understand how to lessen the risk of hypoglycemia events.







GROCERY SHOPPING TIPS

Important Safety Information for Afrezza® (insulin human) Inhalation Powder Lung cancer occurred in more people who were taking Afrezza® compared to other diabetes medications. There were too few cases to know if lung cancer was related to Afrezza®. Tell your doctor if you currently have lung cancer, have had it in the past, or if you have an increased risk of developing lung cancer.






GoMeals® was developed to help you get the information you need to make healthy choices at home or on the go. We’ve upgraded GoMeals® to include features for eating healthy, staying active and tracking your blood glucose levels.

With GoMeals®, you can:

• Find facts about the foods you favor• Watch the calories burn• Keep your BG numbers handy• Eat healthy when you eat out

DOWNLOAD GOMEALS® FOR IPHONE®, IPOD TOUCH®, AND IPAD: 1. Go to the Apple App Store 2. Search for GoMeals® 3. Download the GoMeals® app

DOWNLOAD GOMEALS® FOR ANDROID® 1. Go to the Google Play store 2. Search for GoMeals® 3. Download the GoMeals® app

GO MEALS® APP

Important Safety Information for Afrezza® (insulin human) Inhalation Powder Heart failure can occur if you are taking insulin together with certain medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you already have heart failure it may get worse while you take TZDs with Afrezza®. Tell your doctor if you have any new or worsening symptoms of heart failure including shortness of breath, swelling of your ankles or feet or sudden weight gain. Your treatment with Afrezza® and TZDs may need to be changed or stopped if you have new or worsening heart failure.




Talking With Your Doctor

Important Safety Information for Afrezza® (insulin human) Inhalation PowderGet emergency help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.







DOCTOR DISCUSSION GUIDE

Start a conversation about Afrezza® (insulin human)

Inhalation Powder

Important Safety Information for Afrezza® (insulin human) Inhalation PowderWhile using Afrezza® do not drive or operate heavy machinery until you know how Afrezza® affects you. You should not drink alcohol or use other medicines that contain alcohol and you should not smoke.

Here are some questions to help you have a discussion about Afrezza® with your healthcare professional. This conversation will help you and your doctor decide whether Afrezza® may be an option for you.

“I have type 2 diabetes, and I’m thinking of adding insulin.”

Have I done everything I can to reach my blood sugar goals?

Would adding insulin help me achieve better blood sugar control?

Why can’t I control my blood sugar with my current treatment plan?

“I take a long-acting insulin.”

Why am I still experiencing high blood sugar levels with my current long-acting insulin?

Will Afrezza® replace my long-acting insulin?

Would adding Afrezza® insulin to my diabetes treatment plan be the right choice?

Will I need to adjust my long-acting insulin dose if I add Afrezza®?

“I already take a mealtime insulin.”

What are my options for taking mealtime insulin?

Is inhaled insulin the right option for me?

Will I need to adjust my current medications if I start using Afrezza®?

How often will I have to check my blood sugar with Afrezza®?

People portrayed are not actual patients.





Important Safety Information for Afrezza® (insulin human) Inhalation Powder

WARNING: RISK OF SUDDEN LUNG PROBLEMS (BRONCHOSPASM) IN PATIENTS WITH LONG-TERM (CHRONIC) LUNG DISEASE

• Sudden lung problems (acute bronchospasm) have been seen in patients with asthma and COPD (chronic obstructive pulmonary disease) using Afrezza®.

• Afrezza® is not to be used in patients with long-term lung disease such as asthma or COPD.

• Before initiating Afrezza®, your doctor will perform a detailed medical history, physical examination, and a breathing test (called spirometry) to identify potential lung problems

Do not use Afrezza® if you have problems with your lungs, such as asthma or COPD (chronic obstructive pulmonary disease). Do not use Afrezza® during a low blood sugar reaction (hypoglycemia). If you are allergic to regular human insulin or to any of the ingredients in Afrezza®, do not use Afrezza® as this may cause a significant and severe allergic reaction.

Before using Afrezza®, it is important to tell your doctor about all your medical conditions, including if you have a history of lung problems, if you smoke or have recently quit smoking, if you are pregnant or plan to become pregnant, or if you are breast feeding or planning to breast-feed. Tell your doctor about all other medicines and supplements you take.

Your doctor will take a medical history, and do a physical exam and a breathing test (called spirometry) to determine if you have lung problems. Patients with lung problems should not use Afrezza®. If your doctor finds you have lung problems, use of Afrezza® may cause a severe asthma-like breathing problem. Afrezza® can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza®, and then each year after that, even if you have no lung symptoms. More frequent testing should be done if you have symptoms such as wheezing or coughing.

You must test your blood sugar levels while using insulin, such as Afrezza®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made carefully and only under your doctor’s care.

There are certain serious side effects that are associated with the use of Afrezza®



Low blood sugar (hypoglycemia) is one of the most common side effects of insulin, including Afrezza®, which can be serious and life-threatening. Common symptoms of hypoglycemia are dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, or hunger. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza®, and to understand how to lessen the risk of hypoglycemia events.

Lung cancer occurred in more people who were taking Afrezza® compared to other diabetes medications. There were too few cases to know if lung cancer was related to Afrezza®. Tell your doctor if you currently have lung cancer, have had it in the past, or if you have an increased risk of developing lung cancer.

Heart failure can occur if you are taking insulin together with certain medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you already have heart failure it may get worse while you take TZDs with Afrezza®. Tell your doctor if you have any new or worsening symptoms of heart failure including shortness of breath, swelling of your ankles or feet or sudden weight gain. Your treatment with Afrezza® and TZDs may need to be changed or stopped if you have new or worsening heart failure.

Get emergency help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

While using Afrezza® do not drive or operate heavy machinery until you know how Afrezza® affects you. You should not drink alcohol or use other medicines that contain alcohol and you should not smoke.

The most common side effects of Afrezza® include low blood sugar (hypoglycemia), cough, sore throat, headache, diarrhea, tiredness, and nausea.

If you are taking prescription medicine, you are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.

Please see full Prescribing Information for Afrezza®, including Boxed WARNING , available at Afrezza.com from where you downloaded this PDF. Afrezza is a registered trademark owned by MannKind Corporation. Manufactured by: MannKind Corporation, Danbury, CT 06810 Distributed by: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807 A SANOFI COMPANY ©2005-2015 sanofi-aventis U.S. LLC. All rights reserved. US.HUM.15.05.048




©Sanofi

GoMeals is a registered trademark of sanofi-aventis U.S. LLC, iPhone, iPod, iPod touch, iPad and iTunes are trademarks of Apple Inc., registered in the U.S. and other countries. Android is a trademark of Google Inc. Use of this trademark is subject to Google Permissions. All other trademarks are the property of their respective owners.

Afrezza is a registered trademark owned by MannKind Corporation. Manufactured by: MannKind Corporation, Danbury, CT 06810Distributed by: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807 A SANOFI COMPANY©2005-2015 sanofi-aventis U.S. LLC. All rights reserved. US.HUM.15.05.048

Please see full Prescribing Information, including Boxed WARNING available at Afrezza.com from where you downloaded this PDF.



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