Invokamet contains a combination of canagliflozin and metformin. Canagliflozin and metformin are oral diabetes medicines that help control blood sugar levels.

Invokamet is used with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Invokamet is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.

Invokamet is also used to reduce the risk of end-stage kidney disease and hospitalization or death from heart problems in adults who also have kidney problems caused by type 2 diabetes.

This medicine is not for treating type 1 diabetes.

You should not use Invokamet if you have severe kidney disease or diabetic ketoacidosis.

Canagliflozin may increase your risk of lower leg amputation, especially if you have had a prior amputation, a foot ulcer, heart disease, circulation problems, or nerve damage.

Canagliflozin can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.

Invokamet may cause a serious condition called lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Take Invokamet exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

If you had been taking an evening dose of metformin extended-release tablets, skip your last dose the evening before you start taking Invokamet.

Take this medicine with food.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Your doctor may have you take extra vitamin B12. Take only the amount of vitamin B12 that your doctor has prescribed.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Invokamet, which can lead to severely low blood pressure or a serious electrolyte imbalance.

If you need surgery or medical tests, tell any doctor who treats you that you are using Invokamet. You may need to stop using this medicine at least 3 days before a surgery. Ask your doctor about how to control your blood sugar during this time.

Invokamet is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store tablets in their original container at room temperature, away from moisture and heat. Do not keep Invokamet tablets in a daily pill box for longer than 30 days.

Usual Adult Dose for Diabetes Type 2:

Initial dose: 100 mg orally once a day
-May increase to 300 mg orally once a day for additional glycemic control in patients who have tolerated therapy and who have an eGFR of 60 mL/min/1.73 m2 or greater
Maximum dose: 300 mg/day

Comments:
-Assess renal function before initiating therapy; consult renal dose adjustments for patients with an eGFR less than 60 mL/min/1.73 m2.
-Normalize volume status before initiating therapy.
-If used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue should be considered to reduce the risk of hypoglycemia.

Uses:
-As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
-To reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
-To reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.

Usual Adult Dose for Cardiovascular Risk Reduction:

Initial dose: 100 mg orally once a day
-May increase to 300 mg orally once a day for additional glycemic control in patients who have tolerated therapy and who have an eGFR of 60 mL/min/1.73 m2 or greater
Maximum dose: 300 mg/day

Comments:
-Assess renal function before initiating therapy; consult renal dose adjustments for patients with an eGFR less than 60 mL/min/1.73 m2.
-Normalize volume status before initiating therapy.
-If used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue should be considered to reduce the risk of hypoglycemia.

Uses:
-As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
-To reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
-To reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.

You should not use Invokamet if you are allergic to canagliflozin or metformin, or if you have:

• severe kidney disease; or

• ketoacidosis (call your doctor for treatment).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Invokamet.

To make sure Invokamet is safe for you, tell your doctor if you have:

• heart problems;

• a diabetic foot ulcer or amputation;

• circulation problems or nerve problems in your legs or feet;

• liver or kidney disease;

• low levels of vitamin B12 or calcium in your blood;

• bladder infections or other urination problems;

• a pancreas disorder or surgery;

• a change in your diet; or

• if you are on a low salt diet.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

Tell your doctor right away if you become pregnant. Canagliflozin may harm the unborn baby if you take Invokamet during your second or third trimester.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while using this medicine.

Invokamet is not approved for use by anyone younger than 18 years old.

Take the medicine (with food) as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Get emergency medical help if you have signs of an allergic reaction to Invokamet: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Stop taking Invokamet and call your doctor right away if you have unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

• new pain, tenderness, sores, ulcers, or infections in your legs or feet;

• little or no urination;

• a light-headed feeling, like you might pass out;

• high potassium level - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, muscle weakness;

• ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or

• signs of a bladder infection - pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back.

Older adults may be more likely to get dehydrated or have kidney problems while taking this medicine.

You may be more likely to have a broken bone while using this medicine. Talk with your doctor about how to avoid the risk of fractures.

Common Invokamet side effects may include:

• urinating more than usual;

• headache, weakness;

• gas, stomach pain, indigestion;

• nausea, vomiting; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• digoxin (digitalis, Lanoxin);

• a diuretic or "water pill";

• insulin or other oral diabetes medications;

• rifampin;

• ritonavir; or

• seizure medicine - phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with canagliflozin and metformin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.