Invokana

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 and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine.
• Invokana is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in blood or urine).
• Invokana is not used to lower blood sugar (glucose) in adults with type 2 diabetes with severe kidney problems.
• It is not known if Invokana is safe and effective in children under 18 years of age.

What is the most important information I should know about Invokana?

Invokana can cause serious 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 your leg
  • have damage to the nerves (neuropathy) in your leg
  • 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). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people with type 2 diabetes who are taking Invokana.
  You may be at higher risk of dehydration if you:
  • take medicines to lower your blood pressure, including diuretics (water pill)
  • are on a low sodium (salt) diet
  • have kidney problems
  • are 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. Call your doctor right away if you reduce the amount of food or liquid you drink, for example, if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long.

• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with Invokana. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery 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 (abdominal) pain
  • tiredness
  • trouble breathing
    
    If you get any of these symptoms during treatment with Invokana, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
• Vaginal yeast infection. 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 skin around the penis (balanitis or balanoposthitis). Swelling of an uncircumcised penis may develop which 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 of the penis
  • foul smelling discharge from the penis
  • rash of the penis
  • pain in the skin around the 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.

Who should not take Invokana?

Do not take Invokana if you:

• are allergic to canagliflozin or any of the ingredients in Invokana. See the end of this Medication Guide for a list of 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
• are on kidney dialysis

What should I tell my healthcare provider before taking Invokana?

Before taking Invokana, tell your doctor about all of your medical conditions, including 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 your leg.
• have damage to the nerves (neuropathy) in your leg.
• have had diabetic foot ulcers or sores.
• have kidney problems.
• have liver problems.
• have a history of urinary tract infections or problems with urination.
• are on a low sodium (salt) diet. Your doctor may change your diet or your dose of Invokana.
• are going to have surgery. Your doctor may stop your Invokana before you have surgery. Talk to your doctor if you are having surgery about when to stop taking Invokana and when to start it again.
• are eating less or there is a 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. If you 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 doctor about the best way to feed your baby if you are taking Invokana. 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.

Invokana may affect the way other medicines work, and other medicines may affect how Invokana works. Especially tell your doctor if you take:

• diuretics (water pills)
• phenytoin or phenobarbital (used to control seizures)
• digoxin (used to treat heart problems)
• rifampin (used to treat or prevent tuberculosis)
• ritonavir (used to treat HIV infection)

Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is listed above.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take Invokana?

• Take Invokana by mouth 1 time each day exactly as your doctor tells you to take it.
• Your doctor will tell you how much Invokana to take and when to take it. Your doctor may change your dose if needed.
• It is best to take Invokana before the first meal of the day.
• Your doctor may tell you to take Invokana along with other diabetes medicines. Low blood sugar can happen more often when Invokana is taken with certain other diabetes medicines. See "What are the possible side effects of Invokana?"
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses of Invokana at the same time. Talk to your doctor if you have questions about a missed dose.
• If you take too much Invokana, call your doctor or go to the nearest hospital emergency room right away.
• When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor's instructions.
• Stay on your prescribed diet and exercise program while taking Invokana.
• Check your blood sugar as your doctor tells you to.
• Invokana will cause your urine to test positive for glucose.
• Your doctor may do certain blood tests before you start Invokana and during treatment as needed. Your doctor may change your dose of Invokana based on the results of your blood tests.
• Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A_1C.

What are the possible side effects of Invokana?

Invokana may cause serious side effects including:

See "What is the most important information I should know about Invokana?".

• serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking Invokana. Tell your doctor if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need 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
  • confusion
  • hunger
  • shaking or feeling jittery
  • drowsiness
  • dizziness
  • fast heartbeat
  • weakness
  • irritability
  • sweating
• a rare but serious bacterial infection that causes damage to 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 people 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
  • 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. See "Who should not take Invokana?". Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
• 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 (See "What is the most important information I should know about Invokana?")
• changes in urination, including urgent need to urinate more often, in larger amounts, or at night

These are not all the possible side effects of Invokana.

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 Pharmaceuticals, Inc. at 1-800-526-7736.

General information about the safe and effective use of Invokana

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use Invokana for a condition for which it was not prescribed. Do not give Invokana to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about Invokana that is written for healthcare professionals.

How should I store Invokana?

• Store Invokana at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Invokana and all medicines out of the reach of children.

What are the ingredients in Invokana?

Active ingredient: canagliflozin

Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose.

Tablet coating contains: iron oxide yellow E172 (100 mg tablet only), macrogol/PEG, polyvinyl alcohol, talc, and titanium dioxide.

For more information about Invokana, call 1-800-526-7736 or visit our website at www.invokana.com.