(BPT) - For decades, physicians have been working to help patients with type 2 diabetes manage their A1C, or blood sugar, levels. But for some patients, lowering A1C alone may not be enough.
Approximately 30 million people in the United States have type 2 diabetes,1[*] but did you know that many of these people also have other serious health conditions associated with this disease?2-4 For example, one in three people with type 2 diabetes also has diabetic kidney disease,5,6 a condition in which the kidneys are damaged and do not function properly. Worse, many are unaware they have this condition.4
When your kidneys are damaged, they can't filter blood like they should, which can cause wastes to build up in your body and can increase the risk of reaching end-stage kidney disease. If that happens, dialysis or a kidney transplant are often a person’s only options for survival.3,6,7 In addition, diabetic kidney disease can increase the risk of certain cardiovascular complications including heart failure and death.2-4
Dr. Eden Miller, DO, Executive Director and Co-Founder of Diabetes Nation, is on the front lines of type 2 diabetes care. As a primary care physician, she is typically the first doctor to diagnose the disease in her patients. This means it is her responsibility to explain the severity of the disease and develop an effective long-term treatment plan.
“Type 2 diabetes is a marathon,” says Dr. Miller. “It’s our role as physicians to develop a treatment plan that not only addresses our patient’s immediate needs, but also looks toward future threats, like cardiovascular and kidney complications.”
For nearly 20 years, there have been no new treatment options to treat DKD in patients with type 2 diabetes8-10 — until now. INVOKANA® (canagliflozin) is the only type 2 diabetes medicine approved by the U.S. Food and Drug Administration to reduce the risk of end-stage kidney disease, doubling of serum creatinine, CV death, and hospitalization for heart failure in adults with T2D and diabetic nephropathy with albuminuria >300 mg/day. INVOKANA® is the only type 2 diabetes medicine proven to slow the progression of diabetic kidney disease in patients with type 2 diabetes and diabetic kidney disease.
INVOKANA® is a once-daily pill used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® is also used 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 and 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 mellitus and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine. INVOKANA® may increase your risk of lower-limb amputations. The most common side effects of INVOKANA® include genital yeast infections, urinary tract infection, and changes in urination. 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® is safe and effective in children under 18 years of age.
“We’ve been searching for tools to help manage some of the serious health conditions associated with type 2 diabetes,” says Dr. Miller. “INVOKANA® allows me to intervene and potentially improve outcomes for my patients with type 2 diabetes and diabetic kidney disease.”
“Patients with type 2 diabetes and diabetic kidney disease should work closely with their health care providers,” says Dr. Miller. “They need to make sure they're doing all they can to help their kidneys.”
WHAT IS INVOKANA®?
INVOKANA® is a prescription medicine used:
- along with diet and exercise to lower blood sugar (glucose) in adults with type 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 mellitus 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® is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
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 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 (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your INVOKANA® for a while 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), 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 blood pressure, take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older
- Vaginal yeast infection. Women who take INVOKANA® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or 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. Symptoms include: redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or 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.
Do not take INVOKANA® if you:
- are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, mouth, tongue, and throat that may cause difficulty in breathing or swallowing
- have severe kidney problems and are taking INVOKANA® to lower your blood sugar
- are on kidney dialysis
Before you take INVOKANA®, tell your doctor if you have a history of amputation; heart disease or are at risk for heart disease; blocked or narrowed blood vessels (usually in leg); damage to the nerves (neuropathy) of your leg; diabetic foot ulcers or sores; kidney problems; liver problems; history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; are going to have surgery; are eating less due to illness, surgery, or change in diet; pancreas problems; drink alcohol very often (or drink a lot of alcohol in short-term); ever had an allergic reaction to INVOKANA®; 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 unborn baby. If you become pregnant while taking INVOKANA®, tell your doctor right away. INVOKANA® may pass into your breast milk and may harm your baby. Do not breastfeed while taking INVOKANA®.
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 diuretics (water pills), 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 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, 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® 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. Sudden kidney injury has happened to people taking INVOKANA®. Talk to your doctor right away if you: 1) reduce the amount of food or liquid you drink, if you are sick, or cannot eat or 2) you start to lose liquids from your body from vomiting, diarrhea, or being in the sun too 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 a urinary tract 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). 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, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery
- A rare but serious bacterial infection that destroys the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the 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 of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, or redness of the skin (erythema)
- 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 emergency room
- Broken Bones (fractures): Bone fractures have been seen in patients taking 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 of the penis; changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
Trademarks are those of their respective owners.
For more information on treatment with INVOKANA®, visit www.INVOKANA.com.
- CDC National Diabetes Statistics Report 2017 https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. Accessed October 29, 2019.
- Tonelli M, Muntner P, Lloyd A, et al. Risk of coronary events in people with chronic kidney disease compared with those with diabetes: a population-level cohort study. Lancet. 2012; 380: 807–814.
- Afkarian M, Sachs MC, Kestenbaum B, et al. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013;24(2):302-308.
- National chronic kidney disease fact sheet, 2017. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/kidneydisease/pdf/kidney_factsheet.pdf. Accessed October 21, 2019.
- Bailey, Robert A, et al. Chronic Kidney Disease in US Adults with Type 2 Diabetes: An Updated National Estimate of Prevalence Based on Kidney Disease: Improving Global Outcomes (KDIGO) Staging. BMC Research Notes. 2014;7:415.
- National Institute of Diabetes and Digestive and Kidney Diseases. (2019). Diabetic Kidney Disease | NIDDK. [online] Available at: https://www.niddk.nih.gov/health-information/diabetes/overview/preventing-problems/diabetic-kidney-disease#what. Accessed October 22, 2019.
- Kidney Disease: Improving Global Outcomes (KDIGO) Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl. 2013;3(1):1-140.
- Mogensen CE. Long-term antihypertensive treatment inhibiting progression of diabetic nephropathy. BMJ. 1982; 285:685-688.
- Cozaar® [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; 2018.
- Avapro® [prescribing information]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; 2018.
[*] 2015, adults aged >18 years. Type 2 diabetes accounts for 90-95% of all diabetes cases.
|JanssenPharmaceuticals, Inc. 2019||November 2019||cp-121501v1|