INVOKAMET® (canagliflozin/metformin HCl)

Important Safety Information

IMPORTANT SAFETY INFORMATION

INVOKAMET^®/INVOKAMET^® XR 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 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 INVOKAMET^®/INVOKAMET^® XR for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care.

Lactic Acidosis. Metformin, one of the medicines in INVOKAMET^®/INVOKAMET^® XR, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis: feel cold in your hands or feet; feel very weak or tired; have unusual (not normal) muscle pain; have trouble breathing; have unusual sleepiness or sleep longer than usual; have stomach pains, nausea, or vomiting; feel dizzy or lightheaded; or have a slow/irregular heartbeat

You have a higher chance of getting lactic acidosis with INVOKAMET^®/INVOKAMET^® XR if you have conditions such as: severe kidney problems, or your kidneys are affected by certain X-ray tests that use injectable dye; liver problems; drink alcohol very often (or drink a lot of alcohol in short-term); get dehydrated; have surgery; have a heart attack, severe infection, or stroke.

Do not take INVOKAMET^®/INVOKAMET^® XR if you:

Have moderate to severe kidney problems or are on dialysis, have conditions called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine). Are allergic to canagliflozin, metformin, or any of the ingredients in INVOKAMET^®/INVOKAMET^® XR. See the end of the Medication Guide for a list of ingredients in INVOKAMET^®/INVOKAMET^® XR. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing

Before you take INVOKAMET^®/INVOKAMET^® XR, tell your doctor 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 your leg; have had diabetic foot ulcers or sores; have moderate to severe kidney problems; have liver problems; have a history of urinary tract infections or problems with urination; are on a low sodium (salt) diet; have ever had an allergic reaction to INVOKAMET^®/INVOKAMET^® XR; are going to get an injection of dye or contrast agents for an X-ray procedure (INVOKAMET^®/INVOKAMET^® XR will need to be stopped for a short time); have heart problems (including congestive heart failure); are going to have surgery; are eating less due to illness, surgery, or a very low calorie diet; have or have had problems with your pancreas; drink alcohol very often (or drink a lot of alcohol in short-term); or have any other medical conditions.

Tell your doctor if you are or plan to become pregnant, are breastfeeding or plan to breastfeed. INVOKAMET^®/INVOKAMET^® XR may harm your unborn baby. If you become pregnant while taking INVOKAMET^®/INVOKAMET^® XR, tell your doctor as soon as possible. If you are a premenopausal woman (before the “change of life”), who does not have periods regularly or at all, INVOKAMET^®/INVOKAMET^® XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking INVOKAMET^®/INVOKAMET^® XR, if not planning to become pregnant. Tell your doctor right away if you become pregnant. INVOKAMET^®/INVOKAMET^® XR may pass into your breast milk and harm your baby. Do not breastfeed while taking INVOKAMET^®/INVOKAMET^® XR.

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 INVOKAMET^®/INVOKAMET^® XR

INVOKAMET^®/INVOKAMET^® XR may cause serious side effects, including:

Dehydration: INVOKAMET^®/INVOKAMET^® XR can cause some people to become dehydrated (the loss of too much body water). This may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk if you have low blood pressure, take medicines to lower blood pressure, are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older. Talk to your doctor about ways to prevent dehydration
Ketoacidosis (increased ketones in your blood or urine) has happened in people who have type 1 or type 2 diabetes, during treatment with canagliflozin. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with INVOKAMET^®/INVOKAMET^® XR, even if your blood sugar is less than 250 mg/dL. Stop taking INVOKAMET^®/INVOKAMET^® XR 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 INVOKAMET^®/INVOKAMET^® XR. 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.
A high amount of potassium in your blood (hyperkalemia)
Serious Urinary Tract Infections: may lead to hospitalization and have happened in people taking canagliflozin, one of the medicines in INVOKAMET^®/INVOKAMET^® XR. 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 INVOKAMET^®/INVOKAMET^® XR 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 taking INVOKAMET^®/INVOKAMET^® XR.

Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking or feeling jittery.

Vaginal yeast infection: Women taking INVOKAMET^®/INVOKAMET^® XR may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish discharge, or vaginal itching.

Yeast infection of the penis (balanitis or balanoposthitis): Men taking INVOKAMET^®/INVOKAMET^® XR may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling of the penis; rash; foul smelling discharge; or pain in the skin around penis.

Serious allergic reaction: If you have any symptoms of a serious allergic reaction, stop taking INVOKAMET^®/INVOKAMET^® XR 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 INVOKAMET^®/INVOKAMET^® XR. Talk to your doctor about factors that may increase your risk of bone fracture.

Low vitamin B₁₂ (vitamin B₁₂ deficiency): Using metformin for long periods of time may cause a decrease in the amount of vitamin B₁₂ in your blood. Your doctor may do blood tests to check your levels.

The most common side effects of INVOKAMET^®/INVOKAMET^® XR include: changes in urination, including urgent need to urinate more often, in larger amounts, or at night; diarrhea, nausea and vomiting, gas, weakness, indigestion, upset stomach, or headache.

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.

Please see full Product Information for INVOKAMET^® and INVOKAMET^® XR, including Boxed Warnings, and Medication Guides for INVOKAMET^® and INVOKAMET^® XR.

Please see full Product Information, including Boxed Warning, and Medication Guide for INVOKANA^®.

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Important Safety Information

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Important Safety Information

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