and diabetic kidney disease: Anew treatment option. “| took m life back H. : 197 ole Mireya’s family history of diabetes Piel ee genet ni) Pe a ects e eect urn conch with goddaughter Judith.star speak! “Diabetes won't defeat us!” Celebrities share the insights that keep them vibrant, upbeat—and on top of their blood sugar levels. Live— actively! Respect your body “Before, my body was just a body. | was always worried about my hair, my makeup and my clothes. tridopeetas Today, my body means the worid to me—those other inoes Se things are secondary. The mast important thin room... in the kitchen] 's my body on the inside, not |1do pushups against # temple, not an ann the countertop. actress Sherri Shepherd on squeezin ocala OraoS FEEL YOUR® 3 AY PC soe ne tailored treatment plan @ Outsmart diabetes- elle Keovn oles ay . ; 1 Put tésted tips to work! . ba | “f took life back 15) ola Me MECa cI acumen cnc Soe ee cna) erences ara emcelneienee ac eo tak Preece i COMPLIMENTS OF YOUR HEALTHCAY WALGORZATA HARTA:Guide to living with Diabetes 8 “With Jennifers help | found a medication that helped get my diabetes under control,” says Mireya Martinez (left) with her nurse practitioner, Jennifer Kucera, 2 HEALTH MONITOR | Guide to Living with Diabetes The basics 4 Live to the max— despite diabetes! Take it one choice at a time & Why you must take charge Left unchecked, high blood sugar can wreak havoc throughout your body You & your healthcare team 7 How medications can help Review the options with your diabetes healthcare team 11 O&A Expert answers that help you live a happier, healthier life 16 Is your treatment all it can be? Fill out and review this worksheet with your care team True inspiration 8 “I took my life back from type 2” Mireya’s family history of diabetes and kidney disease was catching up to her. Then she got ahead of it! 22 “Diabetes can't stand in our way!" Sandra, Anna and Thomas share the tips that help them thrive COVER PHOTO BY LAURIE PEREZ :Anna 2 and Thomas aren't letting diabetes prevent them from fulfilling their dreams! See if their management strategies can work for you, Everyday strategies 18 4 ways to protect your kidneys You can fend off serious damage 20 Apple-icious! Satisfy your sweet tooth without sending your blood sugar soaring SPECIAL THANKS TO OUR MEDICAL REVIEWER: Rachel Pessah-Pollack, MD, FACE Clinical Associate Professor af Medicine at NYULangone Content AACE i not responsible for reviewed by | tatamantsandopinons | fauthors or the cams ‘made by advertiser. The appearance of advertising does not imply endorsement ‘for guarantse the las of the advertisers Healtmonitor Vice President, Editor-in-Chief Maria Lissandrello ‘Managing Editor Lindsay Bosslett Senior Editor Karen Kleimann, Senior Associate Editor Joana Mangune Vice President, Creative Director John Angelini Senior Art Director Jennifer Webber Gea Vice President, Production and Project Management Kimberly H. 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NAJ20the basics Live to the ee You have what it takes to rein in your diabetes and enjoy life! Lean on your diabetes care team, and take it one step—and one choice—at a time. n Wednesday evenings and O Saturday mornings, Nancy, 48, laces her sneakers and heads to the community recreation center for Zumba class. “I wouldn't miss it It picks me up and fills me with energy. When I look back, I realize that I'm more active now and in better shape than ever” ‘The irony? Nancy's life turned around three years ago when a routine exam revealed she had type 2 diabetes, “My doctor called me up a day after my checkup to tell me. He said my AIC was 8.2 and asked ‘me to come back the next day.” He explained that an A1C isa blood test that reflects the average blood glucose levels over the past three months. Her doctor then explained what diabetes is and prescribed an oral ‘medication and told her to take small steps in the right direction. “He made me feel calm but definitely stressed that I had to take action” says Nancy. “He referred me to a diabetes educator, and that was a lifesaver. Janiece helped me figure out various meal plans I knew I could follow” Nancy says it also helped that she’ a “blabbermouth” “I told my friends I had diabetes, and one of them practically dragged me to Zumba.” Within six months, her AIC had dropped a point, and her clothes fit better! 4 HEALTH MONITOR | Guide to Living with Inspired? No matter where you are on your diabetes journey, its never too late to follow Nancy's lead! Start With this refresher on diabetes: What is diabetes? “Diabetes is a metabolic disorder that causes your blood sugar levels to be too high,” says Rachel Pessah-Pollack, Clinical Associate Professor of Medicine at NYU Langone. “People are diagnosed with diabetes if they have a fasting ‘glucose level above or equal to 126 mg/dL, a random glucose level [taken during the day, when you have eaten normally] of 200 mg/dl. or above, along with symptoms such as frequent thirst and urination, or ifttheir AIC level is greater than or equal t0 65.” In people with type 1 diabetes, the pancreas produces little or no insulin, the hormone that helps blood sugar enter cells, where it is used for energy. In type 2 diabetes, the pancteas produces insulin, but itis either not enough or the body doesnt respond normally to the insulin, In either case, excess blood sugar builds up in the bloodstream. What can happen then? “Over time, exces blood sugar can damage the vessels in your eyes, ‘your fingers, your toes and your kidneys," says Dr, Pessah-Pollack, People with diabetes are also at higher risk for heart disease, What can | do? “See your endocrinologist and diabetes educator regularly. They'll ‘monitor your progress and watch for complications,” says Dr. Pessah-despite diabetes! THE TEAM ON YOUR SIDE + Primary care provider (PCP): Your physician (usually a general practitioner famity doctor orintemis), nurse practioner or physician assistant may be the person who diagnosed your diabetes. Pollack. Also: Make sure you understand how your medication ‘works—and how to take it. + Endocrinologist: This MD specializes in diseases of the endocrine glands and hormones, including diabetes. Finally: Tur to your care team, * Certified diabetes educator (CDE): A healthcare professional who i ‘your loved ones and this guide, too, ‘can counsel and educate people with diabetes. for help with eating smarter, moving + Neurologist: This doctor can treat nerve damage, known as ‘more and following your plan ettertyy tat resis horn tee Remember: You have the power to take on diabetes—tap it! ®the basics Why you must take charge of your diabetes! When you have diabetes, DENTAL your blood sugar levels PROBLEMS are higher than normal, _ Uncontrolled blood Over time, that can lead to sugars linked to ‘gum inflammation, periodontal disease and dry mouth complications that affect your whole body. During your checkups, ask your care ‘team to assess your risk for the problems shown here. And keep in mind: Doing everything you can to keep your blood sugar in check can also help protect you from potentially life-altering complications. NERVE DAMAGE Nerves throughout the body may become impaired Those of the feet are commonly affected, leading to numbness, ulcers and infections, FOOT PROBLEMS Nerve damage in the legs and feet (neuropathy) can make ithard to tell if your foot has been injured. This, can lead to foot ulcers, gangrene and, in severe cases, amputation. 6 HEALTH MONITOR | Guide to Living with Diabetes EYE DISEASE Blood vessels in the eyes can swell and leak, which can lead to diabetic retinopathy and potential blindness if Untreated. HEART AND BLOOD VESSELS Blood vessels become stif making it easier for blockages to form and setting the stage for increased risk of heart attacks and/or strokes. KIDNEY DISEASE Out-of-control blood sugar levels make it harder for kidneys to filter waste. In time kidneys may leak small amounts of protein. In severe cases, they may fail, requiring hemodialysis or a kidney transplant.you & your healthcare team eee. é How medications * can help rein in blood sugar Eating well and staying active are key ways to keep blood sugar levels steady »~ when you have type 2. But when lifestyle changes alone don't do the trick, medications ~*~ can lend a helping hand. In fact, in many cases, = taking medication as soon as you're diagnosed ~~) can significantly improve your health. Review these options with your diabetes team. IVs olor Nol} Diabetes pills * Oral meds help the body make more insulin orresponci better to it. * Metformin decreases blood sugar made by the liver and improves insulin sensitivity. ® Sodium-glucose co-transporter 2 (SGLT2) inhibitors promote the release of excess blood sugar through urine. * Dipeptidy| peptidase-4 (DPP-A) inhibitors prevent breakdown of a compound that lowers blood sugar levels. + Thiazolidinediones (TZDs or gltazones) help lower your body's resistance to insulin. Pea aMiieu4 + Sulfonylureas stimulate the pancreas to produce insulin. Non-insulin * Glucagon-like peptide-1 (GLP-1) agonist is a daly or weekly injection that injectable lowers blood sugar levels by working with your gut hormones to increase mediation! insulin secretion and make you feel fll + Pramlintde isa daily injection that slows emptying of the stomach to increase feelings of fullness. Insulin Insulin helps your body use blood sugar more efficiently and helps lower blood injections sugar after meals. + Basal, or long-acting, insulin is typically taken once a day and acts slowiy over 24hours. + Bolus, or rapic-acting, insulin is taken at mealtimes to prevent blood suger spikes after eating Combination injectable Long-acting insulin helps control blood sugar levels, while GLP-1 agonist medications {insulin medication helps the pancreas release more insulin. Comes in a fixed dose pen, + GLP-1 agonist which allows for ease of use. medication)true inspiration “I took my life back from type 2!” With diabetes-related kidney disease threatenin: Pastor, loving godmother and devoted daughter ig to steal her joy as an impassioned r, Mireya Martinez fought back with a “health makeover” that includes an effective treatment. —BY AMY CAPETTA hether shes speaking before her congregation or chasing after her three-year-old sgoddaughter, Judith, in the park, Mireya Martinez gives it her all “When Judith and I play together, we play hard!” says the 41-year-old pastor from Houston, adding that she’ filled with gratitude for such special moments, ‘Yet only a few years ago, Mireya could have barely kept up. Not only had she reached her highest ‘weight, but she was also batlling dangerously low blood sugars overnight and dramatic spikes after every meal. Even more alarming, blood tests showed early signs of Kidney disease, “Both my parents had been on dialysis, so this was a light bulb moment for me” says Mireya, who, at age 19, lost her father to diabetes-related kidney disease. “Plus, Judith had just bbeen born, and I take the job of godmother very seriously. I have to be alive to watch her grow up” “Diabetes was in my genes” “I come from the perfect gene pool for this disease ‘grandparents, both of my parents and most of my aunts and uncles had diabetes” says Mireya, who ce all four of my ‘Was just 13 when her pediatrician diagnosed her with prediabetes, Itdidntt help that high-carb foods were a staple of her Mexican- American culture. By the time she was 23, the prediabetes had blossomed into full-blown type 2. She took medication, but other than that, didat give her diabetes ‘muuch consideration, “A hectic schedule made everything worse!” But about 12 years ago, Mireyas world turned upside down: Her ‘mother was put on dialysis, and she began studying for a master’s degree at seminary school. “Between being in my car, a classroom and a library, was doing a lot of siting” she says. “And I was mostly eating fastfood” Post-gradluation, she spent even ‘more time behind the wheel, making Visits to peoples homes, where she was greeted with lots of food. To ‘make matters worse, the diabetes ‘medications she was taking were ‘causing her to put on weight. Before Jong, she weighed 220 pounds, and her blood sugar was out of control with an AIC of nearly 11 “I had to do something” ‘Mireya had never seen an endocrinologist, but she knew she 8 HEALTH MONITOR | Guide to Living with Diabetes needed one now! For the firs time, she learned about carb counting and the importance of building muscle, Her doctor also prescribed a new medication, which along with a few lifestyle changes, helped the weight fll off and stabilized her blood sugars. But a couple years later, her levels were all over the place—dangerously low at night and spiking during the day. She still hadnt made significant diet and exercise changes and the medication wasn't working as wel The pounds started piling back on, until the scale reached 240. And then came the lab report showing her kidneys were at risk. Desperate fora different approach, Mireya met with Jennifer Kucera, a family nurse practitioner, while waiting to switch to another endocrinologist. “My health makeover made all the difference! With Kucera’s guidance, Mireya underwent a complete health makeover, For one, she started taking an SGLT2 (sodium glucose o-transporter) inhibitor, an oral ‘medication that flushes excess blood sugar through the kidneys into the urine. Even better: The rug has been shown to reduce the PHOTOS 8Y LAURIE PEREZ“| take the job of — — godmother very :2”. seriously. | have to “~ be alive to watch Judith grow up!” says Mireya. 4 we strue inspiration risk of worsening kidney disease She brought protein shakes to "I'm proof it is possible!” and foster weight loss. “This was meetings and encouraged her A few months later, Mireya’s | big for me?” she says. congregation to bring healthier blood work showed her AIC Mireya also started recording _meals and snacks, like baked had dropped to 6.7. Today, she's “every single thing that went into chicken and veggie trays, to 60 pounds slimmer than her al: 1 ‘my mouth, every blood sugar gatherings, And her favorite time high (“Tm focusing on 10 j reading, how I felt ater each ‘Mexican restaurant was fine pounds ata time”), her kidneys are meal, the type of exercise I was _with her whipping out a bag of stronger and she meets with her 1 doing, you name it? she explains. Beanitos chips (made from fiber _ endocrinologist four times a year to j “It was the best thing I did and protein) from her purse. stay accountable, “On social media, because I got to understand my As for monitoring, it became a _ use the hashtag Si Se Puede, body and how it reacts to things. no-brainer because Mireya tossed which means ‘Yes, its possible! ” She tweaked her eating habits, _glucometers and glucose tabs into says Mireya. “When I feel stuck, 100. High-« rb dishes were hier purse, desk drawer and gym I believe I wil figure it out. I will replaced with fruits and veggies, bag so sheld have no excuses for _—keep doing this for me—and I'll keep doing it for Judith” @ Jean meats, salads and yogurt. not testing! What works for you? Here, Mireya offers more of the strategies that have been keeping her on track. Ask your diabetes care team if any make sense for you. Put together a solid team. Along with her nurse practitioner, Jennifer Kucera ("She's relentless in help- ing me find answers"), Mireya relies on her endocri- nologist, trainer, therapist and pharmacist. “They al have each other's phone numbers,” she adds. “Ihad to get to the point of being sick and tired of being sick and tired before | realized | needed to surround myself with good people.” Keep moving. Mireya exercises up to six days a week, sweating it out during cardio and/or weight- training sessions. While some of the workouts are done at the gym, she also follows routines posted on Pinterest and clocks thousands of steps by walking around her neighborhood, Change your mindset. Mireya found herself getting stressed each time the scale moved in the wrong direction. Kucera reminded her that most people deal with slight weight fluctuations, “She also reminded me of the 60 pounds | haven't regained. Its about taking @ shift in your thinking.” Tell your story. “As a pastor, my philosophy in life isto be transparent,” says Mireyo, who turned to Instagram (she can be found @HopeJunkie1978) to 10 HEALTH MONITOR | Guide to Living with Diabetes Nurse practitioner Jennifer Kucera helps Mireya mee! challenges of Ty ‘connect with others who have type 2 diabetes. Staying true to her word, Mireya also speaks about her health journey with her ministry and discusses the pivotal role her healthcare team plays in her life, “While some may say | overshare, | believe that sharing our experiences helps others—because it j makes usall stronger.”ie SNIFFLES SOS came down with the ‘worst cold ever—the first since I found out I have diabetes. What should I do? Ifyou are running a fever, be sure it isnt a sign of more significant infection (eg. flu); ask your provider if you need an evaluation. They ‘may recommend ibuprofen or acetaminophen. Also, drink plenty of calorie-free liquids and continue to take your diabetes ‘medications, Start monitoring your blood sugar every four hours and contact your provider if your readings are consistently elevated. Eat easy-to-digest foods like broths, sugar-free applesauce and plain toast. Check with your diabetes healthcare team before taking any cough syrups—some may contain sugar. —Alethtea Shepardson, ENP, CDE, Montefiore Medical Group, Bronx, NY you & your healthcare team Tips for living a happier, healthier life KEEPING KIDNEYS HEALTHY Thave type 2.as well as early stage kidney disease. ‘What I can do to keep my kidneys healthy? Early diabetic kidney disease is indicated by an increase in albumin level (microalbuminuria) in a urine sample. When your doctor notices microalbuminuria, they may recommend a blood pressure medication that can protect the kidneys. Also certain SGLT2-inhibitors are being studied with benefits protecting against kidney disease progression in people with type 2, You can also help by keeping your blood sugar and your blood pressure under control. Home monitoring of both can help kkeep you on track. Ask your healthcare professional if this is right for you. —Rachel Pessak-Pollack, MD, Clinical Associate Professor of Medicine at NYU Langone OVERCORRECTING BLOOD SUGAR LOWS Whenever I have a blood sugar low, [let myself indulge in anything—cupcakes, candy bars, pasta, As result, I gained 10 pounds last year! How can I tame this habit? First, ifyou are getting low blood sugars a few times a month, it could bea sign you are taking more diabetes medication than you need, Talk to your provider about adjusting your dose. If that’s not the case, then try the 15-15 rule: If your blood sugar is less than 70 mg/l, limit yourself to eating just 15 grams of carbohydrates, then recheck blood sugar in 15 minutes and ifit’s still below 70, eat 15 mote grams. Have preplanned 15-gram carb snacks easily available, such. as a small box of raisins, an apple or a 6-07. juice box. —Beverly Thomassian, RN, MPH, CDE, BC-ADM, president and founder of Diabetes Education Services, Chico, CA FLAKY SKIN? It looks like my skin is peeling from a sunburn but I haven't been in the sun. Is it related to my diabetes—and if so, what can I do about it? Dry skin may be a sign your blood sugar is high. When your blood sugar is high, your body tries to get rid of the excess glucose through urination, As a result, you also lose fluids—and that can dry out skin. First, make sure to get your blood sugar under control. ‘Then try using lotions or creams to help moisturize your skin, After a shower, gently pat skin dry and apply lotion while skin is still damp. © —Susan Weiner, MS, RDN, CDE, CDN, Susan Weiner Nutrition, PLLC, New York, NY "WHAT IS INVOKANA® (canagliflozin)? INVOKANA® is a prescription medicine used: + along with diet and exercise to lower blood sugar (glucose) in adults with type2 diabetes + to reduce the risk of major cardiovascular events such as heart attack, stroke, or death Inadults with type 2 diabetes who have known cardiovascular disease +10 reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart falluce in adults with type 2 diabetes meltus and diabetic kidney disease (nephropathy) witha certain amount of protein in the urine INVOKANAG is not for people with type diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). tis nat known if INVOKANA® is safe and effective in children under 18 years of age. IMPORTANT SAFETY INFORMATION INVOKANA® can cause important side effects, including: + Amputations. INVOKANA® may inerease your risk of lower-limb amputations. Amputations mainly involve removal ofthe toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, ‘some on both sides ofthe body. You may be at higher risk oflower-im amputation f you: havea history of amputation, have heart disease or are at ‘sk for heart disease, have had blocked or narrowed blood vessels (usually in eg), have damage to the nerves (neuropathy) n the leg, or have had siabetic foot ulcers or sores. Call your doctor right away if you have new pain ortenderness, any sores, ulcers, infections in your leg or foot ‘Your doctor may decideto stop your INVOKANIA® for awhile if youhave any these signs or symptoms. Talk to your doctor about proper foot care + Dehydration. INVOKANA® can cause some people to become dehydrated (the loss of too much body water), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you have low blocd pressure, take medicines to lower your blood pressure including diuretics [water pil), areon alow sodium (salt) diet, have kidney problems, orare65 years ofage or elder + Vaginal yeast infection. women who take NVOKANA® may get vaginal ‘yeast infections, Symptoms include: vaginal aor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), (or vaginal itching + Yeast infection ofthe penis (balanitis or balanoposthits). Men who take INVOKANA® may get a yeast infection of he skin around the penis Symptoms include: redness, itching, orsweling of the penis: rash ofthe penis foul-smelling discharge from the penis or painin the skin around penis Talk to our doctor about what to do if you get symptoms ofa yeast Infection ofthe vagina or pen Do not take INVOKANA® if you + are allergic to canaglflzin or any ofthe ingredients in INVOKANAY. ‘symptoms of allergic reaction may include: rash raised red patches on your skin (hives); orsweling ofthe face lips, mouth, langue, and throat that may cause dffcutyin breathing or swallowing ‘have severe kidney problems and are taking INVOKANA® to lower your blood sugar + aren kidney dialysis. Before you take INVOKANA®, tll your doctor if you have history ‘of amputation; heart disease or are at risk far heart disease; blocked ‘or narrowed blood vessels (usually in leg) damage to the nerves (neuropathy) of yourleg; dabeti foot ulcers or sores; kidney problems iver problems; history of urinary tract infections or problems with Lrination; are ona low sodium (salt) diet; are going to have surgery: are eating les due to illness, surgery, or change in diet; pancreas probleme; drink alcohol very often (or drink a lot of leahol in short-term); ever had anallergic reaction to INVOKANAF; or have other medical conditions Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. INVOKANA® may harm your Lnisorn baby. Ifyou become pregnant while taking INVOKANA®, tell your doctor right away. INVOKANA® may passinto your breast milkandmay harm ‘your baby. Donnot breastfeed while taking INVOKANA®, wo aySure, blood sugar and heart health are important, but our kidneys also do some very important things for us. Unfortunately, type 2 diabetes can cause diabetic kidney disease, a serious condition that often shows few to no early symptoms and can lead to dialysis, transplant, hospitalization for heart failure, and even death, Now—INVOKANA' is the only type 2 diabetes medicine to help lower the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine. Invokana (canagliflozin) tablets pe 2 diabetes, really need your attention. In people with type 2 diabetes, INVOKANA* is also proven to help: Lower the risk of heart attack, stroke, and cardiovascular death (in people with established cardiovascular disease) Lower AIC long with diet and exercise) The most common side effects of INVOKANA® include genital yeast infections, urinary tract infections, and changes in urination. Make an appointment to talk to your doctor about INVOKANA’ today. Tell your doctor about athe medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Espacialy tell your doctor if you take diuretics (water pls), rfarnpin (used to "weat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvire, Kaletra® ~ used to treat HIV infection), or digoxin (Lanoxin®— used to treat hear problems), Possible Side Effects of INVOKANA® INVOKANA® may cause serious side effects, including: + Ketoacidosis (increased ketones in your blood or urine), Ketoacidosis has happened in people who have type 1 or type 2 diabetes, curing treatment with INVOKANA®. Ketoacidosis isa serious condition, which may need to be treated in a hospital Ketoacidosis ‘may lend to death, Ketoacidosis can happen with INVOKANA® even if your blood sugars less than 250 mg/dL. Stop taking INVOKANA® and call your doctor right away if you get any of the following ‘symptoms: nausea, vomiting, stomach-area pain, tiredness, or trouble breathing + Kidney problems. Suciden kidney injury has happened to people taking INVOKANA®, Tak to your doctor right away iFyou: 1) reduce the amount ‘of fod or liquid you drink, you are sick. or cannot eat or 2} you start to lose liquids from your body from vomiting, darthea, or being inthe sun 100 long + Serious Urinary Tract Infections: may lead to hospitalization and have happened in people taking INVOKANA®, Tell your doctor if you have signs ‘or symptoms of urinary act infection su ning feeling while Urinating, need to urinate often or right away, pain in the lower part of ‘your stomach (pelvis) or blood in the urine. Some pecple may also have high fever, back pain, nausea, or vomiting + Low blood sugar (hypoglycemia). you take INVOKANA® with another medicine that can cause low blood sugar, such a 2 sulfonylurea or insulin, your rick of getting low blood suger ishioher. The dose of your sulfonylurea medicine or insulin mayneedto be lowered while you take INVOKANAS, Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion irritability, hunger, fast heartbeat, sweating, shaking, orfeeling jittery + Arare but serious bacterial infection that destroys the tissue tnder the skin (necrotizing fasciitis) in the area between and, around the anus and genitals (perineum). Necrotizing fascitis ofthe perineum has happened in women and men who take INVOKANA®, Necrotizing fasciis ofthe perineum may lead to hospitalization, may cequire mulkiple surgeries, and may lead to {desth, Seek medical attention immediately if you have fever or you are feeling very weak, tired, or uncomfortable (malaise) {and you develop any of the following symptoms in the area ‘between and around your anus and genitals: paino: tenderness, swelling, or redness ofthe skin (erythema) + Serious allergic reaction. if you have any symptoms of a serious allesic reaction, stop taking INVOKANA and call your doctor right away or goto the nearest hospital emergencyroom + Broken Bones (fractures): Bone fractures have been seen in patie talking INVOKANA®. Talk to your doctor about factors that may increase ‘your risk of bone fracture ‘The most common side effects of INVOKANA® include: vaginal yeast infections and yeast infections ofthe penis; changes in urination, including Urgent need to urinate more often, in larger amounts, or at night. Tell your doctorf you have any side effect that bothers you or that does rot go avay Call your doctor for medical advice about side effects. You ‘may report side effects to FDA at -800-FDA-1088. You may also report side effects to lanssen Scientific Afairs, LLC at -800-526-7736, Please read Important Brief Summary, including Boxed Warning, for INVOKANA® on pages 14-15, and discuss any questions you have with your dector. {© Janssen Pharmaceuticals Ine.2019 December 2019 cp-10254Wv1 cp-68573V2Consumer Brief Summary e Invokana INVOKANA® (in-vo-KAHN-uh) saci os (canagifiozin) Tablets What is the most important information | should know about INVOKANA®? INVOKANA® can cause important side effects, including: + Amputations. INVOKANA® may increase your risk of lower- limb amputations. Amputations mainly involve removal of ‘the toe or part of the foot, however, amputations involving the leg, below and above the knee, have also occurred. ‘Some people had more than one amputation, some on both sides ofthe bodly. You may be at a higher risk of lower-limb ‘amputation if you: have @ history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot Lee Call your doctor right away if you have new or tenderness, any sores, ulcers, or infections in your Teor foot. Your doctor may decide to stop your NVOKANA® for awhile if you have any of these signs or symptoms. Talk to your doctor about proper foot care. + Dehydration. INVOKANA® can cause some people to become dehydrated (the loss of too much body water). Dehydration may cause you to feel dizzy, faint, lightheaded, ‘or weak, especially when you stand up (orthost hypotension). You may be at higher risk of dehydration if you: have low blood pressure « take medicines to lower your blood pressure, including diuretics (water pill) ara on a low sodium (salt) diet have kidney problems aro 65 years of age or older Talk to your doctor about what you can do to prevent, dehydration including how much fluid you should drink on a daily basis, + Vaginal yeast infection. Women who take INVOKANA® may got vaginal yeast infections. Symptoms of a vaginal yeast infection include: + vaginal odor © white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese) vaginal itching + Yeast infection of the penis (balanitis or balanoposthitis) Men who take INVOKANA® may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include: + redness, itching, or swelling ofthe penis «rash of the penis + foul-smelling discharge from the penis «pain in the skin around penis Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may suggest you use an over-the-counter antifungal medicine Talk to your doctor right away if you use an over-the-counter antifungal medication and your symptoms do not go away. INVOKANA® is a prescription medicine used: + along with diet and exercise to lower blood sugar (glucose) in adults with typo 2 diabetes. “to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes Who have known cardiovascular disease. *to reduce the risk of end stage kidney disease (ESKD}, worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® s safe and effective in children under 18 years of age. Do nottake INVOKANAS if you: are allergic to canaglifiozin or any of the ingredients in INVOKANA® Symptoms of allergic reaction to INVOKANA® ‘may include: rash, raised red patches on your skin (hives), swelling of the face, lips, mouth, tongue, and throat that may cause difficulty in breathing or swallowing. Do not take INVOKANA® if you have severe kidney problems and are taking INVOKANA® to lower your blood sugar or are on kidney dialysis. Before you take INVOKANA®, tell your doctor if you: have a history of amputation ‘have heart disease or are atrisk for heart disease. ‘have blocked or narrowed vessels (usualy in leg) ‘shave damage to the nerves (neuropathy) of your leg ‘have had diabetic foot ulcers or sores have kidney problems + have liver problems ‘have a history of urinary tractinfections or problems with urination * re on a low sodium (salt) diet. Your doctor may change ‘your diet or your dose of INVOKANA® + are going to have surgery + are eating less due to illness, surgery, or change in your diet, * have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas * drink alcohol very often, or drink a lot of alcohol in the short-term ("binge” drinking) * have ever had an allergic reaction to INVOKANA® * are pregnant or plan to become pregnant. INVOKANA® may harm your unborn baby. Ifyou become pregnant while taking INVOKANA® tell your doctor as soon as possible. Talk with your doctor about the best way to control your blood sugar while you are pregnant. + are breastfeeding or plan to breastfeed. INVOKANA® ‘may pass into your breast milk and may harm your baby. Talk with your dactor about the best way to feed your baby if you are taking INVOKANA®, Do not breastieed while taking INVOKANA®.Consumer Brief Summary @!nvokana INVOKANA® (in-vo-KAHN-uh} (canagiifiozin) tablets (canagliflozin) Tablets + serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® and call your doctor right away or go to the nearest hospital Toll your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. | The most serious risks with INVOKANA® include: | +ketoas \creased ketones in your blood or urine). Ketoacidosis has happened in people who have type | 1 diahetes or type 2 diabetes, during treatment with INVOKANA®. Ketoacidosis is a serious condition, which ‘may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKANA® even if your blood sugar is less than 250 mg/dL Stop taking INVOKANA‘ of the following symptoms: nausea, tiredness, vomiting, trouble breathing, stomach area (abdominal) pain «If you get any of these symptoms during treatment with INVOKANAS, if possible, check for ketones in Your urine, even if your blood sugar is less than 250 mg/dL. idney problems. Sudden kidney injury has happened to people taking INVOKANA®. Talk to your doctor right away Ifyou: reduce the amount of food or liquid you drink, for example, ifyou are sick or cannot eat; or you start to lose liquids from your body, for example, from vomiting, diarrhea, ‘or being in the sun too long, + sorious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking INVOKANA®. Tel your doctor if you have any signs or symptoms ofa urinary tract infection such as: a burning feeling when passing urine, aneed to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people may also have a fever, back pain, nausea, or vomiting, + low blood sugar (hypoglycemia). if you take INVOKANA® with another medicine that can cause low blood sugar, such, as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA®, Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, confusion, dizziness, irritability, hunger, fastheartbeat, sweating, shaking, or feeling jittery. +a rare but serious bacterial infection that destroys the tissue under the skin (necrotizing fasciitis) in the area botweon and around the anus and genitals (perineum). Necrotizing fasciitis ofthe perineum has happened in women and men who take INVOKANA®. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired, or uncomfortable (malaise) and you develop any ofthe following symptoms in the area between and around your anus and genitals: pain or tenderness, ‘swelling, or redness of the skin (erythema). ‘emergency room. + broken bones (fractures). Bone fractures have been seen in patients teking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture. ‘Most common side effects with INVOKANA® include: | | | «vaginal yeast infections and yeast infections of the penis | + changes in urination, including urgent need to urinate more | often, in larger amounts, or a night Those are not all the possible side effects of INVOKANA®. Call your dactor for medical advice about side effects. Important facts + This information is not complete, How to gat more information: « talk to your healthcare provider or pharmacist. « visit www.INVOKANA.com to obtain the FDA-approved product labeling. « call to report side effects to FDA at 1-800-FDA-1088. Active Ingredient: canagliflozin [oe eo eee es yanssen JT ‘© Jenssen Pharmaceuticals, ne. 2018 Trademarks are property af their respective owners. cp 1025401To reach my blood sugar goals 1. Can any of these improve my blood sugar control? Ifo, which do you recommend? (check al that apply) C1 Diet and exercise i Starting medication D More frequent exams or diabetes education Gi Trying a new medication 1 A support program 2, What can | do to make my medication schedule easier? | have problems with it... (check all that apply) OI Atwor 1 When | socialize 1 Because of side effects {@.g, upset stomach, dizziness, water retention) Cl Because it costs toomuch 1 Other To lose weight/avoid weight gain 1. What lifestyle changes can help me control my weight? 2. Isweight gain a side effect of my current medications)? ‘Should | consider @ new medication? Do any of my ‘medications increase my sugar levels? 3. What isa sensible weight-loss plan for me? To avoid complications of diabetes 1. What signs and symptoms should | watch for? 2. What health screenings do I need, and how often? 3. What health checks should | perform at home, ‘and how often? 4, What can I do to prevent: Heart and blood vessel disease Kidney disease (nephropathy) Vision problems (retinopathy) Nerve damage (neuropathy) 16 HEALTH MONITOR | Guide to Living with DiabetesMake the most of your medication 1. Know how it works People who know how their medication works are more likely to take it as prescribed—and reap the benefits, including better blood sugar control and lower risk of complications. Ask these questions: T How does my medication help lower my blood sugar? D When will start to see the results? 1 How can we tell fits working? 2. Know how to take it Find out the following: 1 What dosage should | take? 1 When should | take it? 1D Are extended release forms of my medication available? LD Ifaround mealtimes, do | need to take it before eating or with food? 3. Make sure you take it on time ‘These strategies may help: 1 Set reminders, such as alerts and alarms on your computer and smartphone. I Create a routine, such as always taking meds when you brush your teeth. I Ask loved ones to remind you. 4, Find out if it's working Many people with diabetes must use various medications, as needs may change over time. These strategies can help reveal if your treatment is on track ‘or if you need an adjustment: 1D Get regular checkups as instructed by your care team and track your A1C numbers. 1D Monitor and track your blood sugar. 1D Track symptoms that indicate your blood sugar may be high or low. ® 7everyday strategies Diabetes can put your kidneys Fere’s how to protect them! The kidneys filter your blood of waste and water, but “when diabetes is not well controlled, high blood sugars can damage blood vessels in the organs, making it harder for them to do their job,” says Rachel Pessah-Pollack, MD, Clinical Associate Professor of Medicine at NYU Langone. (Follow her on Twitter @drpess.) "Over time, vessel damage can lead to diabetic nephropathy, a type of chronic kidney disease.” Luckily Dr. Pessah-Pollack says taking the steps below can help safeguard the kidneys. —BY KAREN KLEIMANN Get tested early “One in three people with diabetes develop diabetic nephropathy. However, there often arentt signs and symptoms until the disease has progressed” says Dr. Pessah-Pollack. So get screened for kidney disease as soon as youre diagnosed with diabetes and then your diabetes care team will. + Assess your kidney function: Blood and urine tests can measure your overall kidney fanction and identify if any proteins are present, “an early alert to your healthcare provider that your kidneys may not be working as they should is small amounts of protein in your urine,” says Dr. Pessah-Pollack. + Check your blood pressure: Hypertension (high blood pressure) puts even more stress on the kidneys filtration system, which can cause further damage. It often occurs with diabetes, making it a double whammy for the kidneys. Keep blood sugars in your target range “Research shows tight blood sugar control not only improves management of diabetes, but also reduces the risk of kidney damage’ says Dr. Pessah- Pollack. “And if you already have kidney damage, it can prevent it from getting worse” + Turn to a critical tool: Review your daily blood sugar goals with your diabetes care team, who will personalize your target numbers, and go over your treatment plan, too. Then make sure to use a tool to monitor and analyze your blood sugar. Look for patterns—what effect do specific foods or activities have? What about stress and emotions? Could certain choices keep you on track? Ask your healthcare provider about a . glucose monitoring system that’s best for you. Pn CRIT iere el If these sound familiar, tell your healthcare teeter Sree eee ee nee) eet 18 HEALTH MONITOR | Guide to Living with Diabetesat risk. ae Take medications as prescribed IF test results suggest you have early diabetic Ar nephropathy. to delay or halt that progression with treatment, says Dr. Pessah-Pollack. The good news is that the same treatments that can help you manage | diabetes and hypertension can also help protect your kidneys! Your healthcare provider may recommend drugs that Reduce blood pressure. Both angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) have been found to decrease protein in the urine and ‘may even improve kidney function. Benefit the kidneys. Recent research has shown that sodium glucose cotransporter-2 (SGLT-2) inhibitors—medications used to treat type 2 diabetes—may also help maintain healthy kidney function. “These drugs lower blood sugar levels by helping the kidneys get rid of excess blood glucose through the urine? says Dr. Pessah-Pollack. “Studies have found that in patients with type 2 diabetes who had small amounts of protein in the urine, these medications reduced the amount of protein in the urine as well as the risk of chronic kidney disease” ’s a window of opportunity A as Lower high blood pressure F “Hypertension is both a cause and a symptom of kidney disease, so getting blood Pressure to a normal level—below 140/90 Hg— can allow the organs to work more effectively” says Dr. Pessah-Pollack Stay the course: If your healthcare provider has prescribed an antihypertensive medication, such as an ACE inhibitor or ARB, be sure to take it as directed. Talk to a dietitian or your diabetes educator about ‘ways to reduce the salt in your diet and stick to your diabetes management plan, too. Fortunately, most ofthe lifestyle strategies that help keep your blood ssigar im check will also help lower your blood pressure. @ Presented as a public service by the American Association of Clinical Endocrinologists and the American College of Endocrinologyeveryday strategies Apple-icious! Craving a little something? Swap apple slices for bread and crackers! Smear or drizzle with something creamy, then sprinkle with nutrient-loaded fruits, nuts and more! You'll satisfy your yen without sending your blood sugar soaring! Mixed Fruit Apple Rings Core and thinly slice half of a medium apple crosswise into rings. Spread slices with 2 Tesp blueberry flavored fat-free Greek yogurt and top with 1/4 cup fresh raspberries, halved. Serves 1. Calories 100, carbs 22 g, fiber 4 g, sugars 159 Excerpted fom Diabetic Uivng Eat Smart LogdWeighe © 2018 ‘by Meret Corporation. Raproduced ty foisson of Houghton Miia Horcous. Al gts eserves 20 HEALTH MONITOR | Guide to Living with Diabetes Strawberry Cream Apple Rings Core and thinly slice half of a medium apple crosswise into rings. Stir together 1 oz, reduced- fat cream cheese, softened, and 1/4 tsp. vanilla Spread slices with cream cheese mixture and top with 1/4 cup chopped fresh strawberries. Serves 1. Calories 134, carbs 16 g, fiber 3 g, sugars 12 9 Peanut Butter-Chocolate Apple Core and thinly slice half of a medium apple eross- wise into rings. Drizzle slices with 2 tsp. peanut * butter, melted, and top with 1 tsp. miniature semisweet chocolate pieces. Serves 1. Calories 134, carbs 18 g fiber 3g, sugars 13gHerbed Ricotta Apple Rings Core and thinly slice half of 2 medium apple crosswise into rings. Spread slices with 2 Tbsp. part-skim ricotta cheese and top with 1/2 o2. prosciutto or ham, cut into thin strips, and 1 tsp. snipped fresh herbs (basil, parsley, thyme and/or rosemary). Serves 1. Calories 120, carbs 14 g, fiber2 9, sugars 10g Blackberry-Mascarpone Apple Rings Core and thinly slice half of a medium apple cross- wwise into fings. Stir together 1 Tbsp. each mascarpone cheese and plain fat-free Greek yogurt and 1/4 tsp. vanilla. Spread slices with mixture; top with 1/4 cup fresh blackberries and fresh mint and/or lemon zest. Serves 1. Calories 156, carbs 27 g, ber 4, sugars 21 g Cranberry-Cashew Apple Rings Core and thinly slice half of a medium apple crosswise into rings. Spread slices with 2 tsp. cashew butter and drizzle with 2 tsp. maple syrup. Top with 1 Tbsp. finely chopped dried cranberries. Serves 1. Calories 170, carbs 31 9, fiber 3 g, sugars 24 g ‘Honey-Almond Apple Rings Core and thinly slice half of a medium apple crosswise into rings. Drizzle slices with 2 ts... honey and top with 2768p! sliced almonds, toasted. Serves 1. Calories 156, carbs 27 g, fiber 4 g, sugars 21. @ 2“Diabetes wont 2 a) stand in our way! Sandra, Anna and Thomas are busy living and loving life— despite diabetes. Here they share the strategies that are a key part of their management plans. Ask your healthcare team if their tips can help you, too! —py KAREN KLEIMANN, [ Se 3 5 5 e 5 z “« '29 Prepare all your meals. Pal CLL eC hae See nae ay Sandra Ewers Tall it being ‘breakfast/lunch/ Buckinghamshire, UK dinner ready’ [ like to research 22. HEALTH MONITOR | Guide to Living with Diabetes delicious recipes ahead of time so Tm excited about what I will eat You're also less likely to wander Into the kitchen for snacks because you may be bored or peckish. If ‘you already have an idea of what sounds good to you and you have snacks on hand, it helps keep your ‘weight and impulses under your control—and asa result, a better handle on your blood sugars” Hydrate throughout the day. “A lot of the time you're actually thirsty not hungry. I drink water at all meals and throughout the day. Water can also help you feel full so even if you are hungry, you won't be so famished that you'll eat more than the right portion for your diabetes goals” Swap out “unfriendly” foods. “Lfood swap often, so Pll replace heavy carbs and rich dishes with more vegetables and nuts, Not only are those better for blood sugar control, but they help you feel fall for longer so you wont crave those sweets as much, But diabetes affects everyone differently, so work out ‘what works for you as an individual. ‘That may take some experimenting cof which food swaps are best, but always work with your diabetes care team to figure it out!”“Learn what works for you” Anna Hyvarinen, West Palm Beach, FL Schedule “me” time. ‘Whether it sitts enjoying a cup of cofite o: reading a book or journaling, I schedule ti relaxing. I also practice yoga to reset my mind and body. Monitor—your way. “There is no one x monitor, but moni negotiabl ee olay right way to monitor, ae non-negotiable.” sports, so I have to monitor my blood sugar a lot. Because Ido martial arts and physical contact is high, Tm not always able to wear a CGM so I still use a manual blood glucose meter and an app to help me track my blood sugar and my patterns during the day. But I have tried a CGM, and I recommend it. 1 found it really helps take the guesswork out” true inspiration Find a diet fit for you, 1 personally use a paleo-type diet that consists of whole, unprocessed foods including carbs since I'm an athlete and often train twice a day. But it depends on the day. If don't train at all or justin the morning, then have lower carbs. However, Ti all about finding a diet that works for you because we all have different bodies, lifestyles and goals that impact our diabetes and one diet doesn't it all” >true inspiration “Don't hide or be ; - ashamed Thomas Glass, Houston, TX Stay active. “Being healthy makes a big, difference. I used to weigh quite a bit more. and I found that when I was heavier, ‘medication wasn't as effective It was harder to manage. Now Tm physically and mentally ‘more fit. I run 12 miles a ‘week. I was super active in high school so I have that background to get back into that kind of discipline But once you make that commitment, it makes a world of difference” Be open. “The more up front with people you are about living with diabetes, the more I find people are understanding. No oone ever gave me grief over it It doesnt need to be a big deal everyone’ got something, 0 most people can relate in og some way?” ks ie em enielas Tame stress. este eerie with people you are and I can get frustrated lotta Cele mY ZLag sometimes with managing diabetes the more diabetes, To get back a sense : j of control, Igo fora run or | find people are take my mind off it by playing understanding. “— fantasy football or hanging with my girlfriend, friends and family? ® 24 HEALTH MONITOR | Guide to Living with Diabetes PHOTO BY NATHAN LINDSTROMISINVOKANA® (canaglifiozin)? KANAS is 2 prescription medicine used: ng With diet and exercise to lower blood sugar (glucose) in adults with [Bre Zciabetes fo reduce the risk of major cardiovaselarevents such as heart attack, stroke, or death in adults with typeaaiabetes who have known cardiovascular disease . to reduce the risk of end-stage kidney disease (ESKO), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults sith type 2 diabetes melitus and diabetic kidney disease (nephropathy) with a certain amount of protein in Rene INVOKANA® isnot for peoplewith type diabetes or with diabetic Ketoacidosis increased ketones inBleod ertifine). tis not known if INVOKANA® is safe and effectivelineligren ander 6 years of age. IMPORTANT SAFETY INFORMATION INVOKANA" can cause important side aac, including: + Amputations. INVOKANA® may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot: however, amputations involving the leg, below and above the knee, have also occurred. Some more than one amputation, some on both sider ofthe body ios may Seats one eso er mb smputation yous have histonpetamenaation ave hear disease or ae at fskfor heart disease, have hadllecied or ResToweblood vessels (usually inleg, have damage to the Beeps) intel or havehad Gabeticfoot ulcers orzores ight away ifyou have new pain or tenderness, any sores,’ Jin your leg or foot. ‘Your doctor may decide tos for awhile if youhave ‘any ofthese signs or symptoms ‘about proper foot care = Dehydration. INVOKANA® : to become dehydrated (the loss of which may cause you tofeal dizzy, faint, i jwihen you stand up (orthostatic hypotension). higher sk of dehydration if ‘you have low blood pressure. (including dluretis (water kidney problems, orare 6S yeast + Vaginal yeast infection. yeast infections. Symptoms vaginal discharge (dischanae fr vaginal itching + Yeast infection of the penis take INVOKANA® may deta Symptoms include: redness penis; foul-smeling dis penis Talk to your doctor about what ‘the vagina or penis. ‘Do not take INVOKANA® if your + are allergic to canagliflzin Symptoms of allergic reaction’ skin (hives); or sweling ofthefa may cause difficulty in bresthings ower your blood pressure (Galt) diet, have OKANA® may get vaginal oder, white or yellowish Hook like cottage cheese), posthitis). Mien who shin around the penis, ofthe penis; rash ofthe ferpainin the skin around ‘of a yeastinfection s2ised red patches on your and throat that "shave severe kidney problems tolower your blood sugar + are on kidney dialysis Before you take INVOKANA®, fReveshistory _ of amputation; heart disease oraret jdsease: blocked or narrowed blood vessels (usually snerves (neuropathy) cf your leg; dlabetic foot uicers or jstory of urinary tract infections’ sium (salt diet; are going to. gery, or change in diet; drink lat of alcohol in shore /OKANA®; or have other medical your doctor if you are or} are stfeeding, or planto| fmay harm your unborn Ifyou become pregnant while taRSINMEMANA®, tell your doctor away. INVOKANA® may pass into breast mic and may harm your Dont breastfeed while taking INVORARNAS bles: ver problems; sunation; are on alow Bagless due to illness, leohol very often fanalersic reaction to Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor iF you take duretics (water pill), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra® - used to treat HIV infection), or digoxin (Lanoxin® ~ used to treat heart problems). Possible Side Effects of INVOKANAY INVOKANA® may cause serious side effects, including: = Ketoacidosis (increased ketones in your bload or urine), Ketoacidosts thas happened in people who have type Tor type? diabetes, during treatment with INVOKANA®. Ketoacidosisisa serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. ‘ketoacidosis can happen with INVOKANA® aven if your blood sugar is less than 250 mg/dL. Stop taking INVOKANA® and call your doctor right away if you get any of the following symptoms: nausea, vomiting, stomach-area pai, tiredness, or trouble breathing + Kidney problems. Sudden kidney injury has happened to people taking INVOKANA®, Talk to your doctor right away ifyou: 1) educe the amount ‘of food ar liquid you drink, if you are sick, oF cannot eat or 2) you start to lose liquids from your body from voriting, diarrhea, or being inthe sun toolong + Serious Urinary Tract Infections: may lead to hospitalization and have happened in people taking INVOKANA®. Tell your dactor i you have signs ‘or symptoms of aurinary trac infection such as: burning feeling while urinating, need to urinate often or right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Some people may also have high fever, back pain, nausea, or vomiting + Low blood sugar (hypoglycemia). I you take INVOKAN2® with another medicine that can cause low blood sugar, such asa sulfonylurea or insulin, ‘your risk oF getting low blood sugar is higher. fhe dase of your sulfonylurea ‘medicine or insulin may need to be lowered while you take INVOKANAS, Signs and symptoms of low blood sugar may include: headache, drowsi ‘weakness, dizziness, confusion, iritabilty, hunger, fast heartbeat, sweating, shaking, or feeling tery + Arrare but serious bacterial infection that destroys the tissue under the skin (necrotizing fascittis) n the area between and around the anus and genitals (perineum). Necrotizing fscitis ‘of the perineum hashappened in women and men who take IINVOKANA®. Necrotizing fasciitis ofthe perineum may lead to hospitalization, may require multiple surgeries, and may lead to death, Seek medical attention immediately if you have fever or yyouare feeling very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, oF redness ofthe skin (erythema) cp-68573v2 « Serious allergic reaction. Ifyou have any symptoms ofa serious aleraic feaction, stop taking INVOKANse® and call your doctor right away or 90 to the nearest hospital emergency room + Broken Bones (fractures): Sone fractures have been seen in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture ‘The mast common side effects oF INVOKANA® include: vaginal yeast infections and yeast infections of the penis; changes in urination, including urgent need to urinate more often, in larger amounts, of at right Tell your doctor you have any side effect that bothers you or that does not {g0 avay. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-108B. You may aso report side effects to Janssen Scientific Affairs, LLC at 1-200-526-7736. Please read Important Brief Summary including Boxed Warning, for INVOKANA® on pages 14-15, and discuss any questions you have with ‘your doctor. canagiflozin i licensed from Mitsubishi Tanabe Pharma Corporation. ‘Trademarks are those of their respective owners ‘© Janssen Pharmaceuticals, Inc.2019 December 2019 cp-10254Wv1We're important, too! Type 2 diabetes impacts more than your heart! Now approved: the only type 2 diabetes medicine to help lower the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine. In people with type 2 diabetes, INVOKANA‘ has also been proven to help: + Lower the risk of heart attack, stroke, and cardiovascular death Cin people with established cardiovascular disease) + Lower AIC (along with diet and exercise) The most common side effects of INVOKANA* include genital yeast infections, urinary tract infections, and changes in urination. Diabetic kidney disease is a serious condition that may often show no early symptoms. Ask your doctor about INVOKANA® today. WHAT IS INVOKANA® (canagliflozin)? INVOKANA® isa prescription medicine used + along with diet and exercise to lower blood sugar (glucose) in adults with type2 diabetes + to reduce the risk of major cardiovascular events such as heart attack stroke, or death in adults with type2 diabetes who have known cardiovascular disease + to reduce the risk of end-stage kidney disease (ESKD), worsening ‘of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes melitus and diabetic kidney disease (nephropathy) with a certain amount of protein in theurine INVOKANA® is not for people with type | diabetes or with diabetic ketoacidosis (increased ketones in biood or urine). is not known if INVOKANA® is safe and effective in children under8 years of age. | e Invokana (canagliflozin) tablets SELECT IMPORTANT SAFETY INFORMATION INVOKANA® can cause important side effects, including: + Amputations. INVOKANA® may inerease your risk of lower-limb amputations. Amputations mainly involve rernoval of thetoe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usuallyin leg), have damage to the nerves (neuropathy) inthe le, or have had diabetic foot ulcers or sores. Call your doctor right away ifyou have new pain or tenderness, any sores, ulcers, oF infections in yourleg or foot. Your doctor may decide to 0p your INVOKANA® for awhile if you have any ofthese signs or symptoms, Talkto your doctor about proper foot care Please see inside back cover for the full Important Safety Information. Please read Important Brief Summary, including Boxed Warning, for INVOKANA® on pages 14.15, and discuss any questions you have with your doctor. Canagiiflozin i licensed from Mitsubishi Tanabe Pharma Corporation. Trademarks are those oftheir respective owners. © Janssen Pharmaceuticals, Inc. 2019 December 2019 cp-102541v1