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This document outlines important safety information and warnings for individuals using Invokamet (canagliflozin/metformin). It is crucial to understand the potential risks and precautions associated with this medication to ensure safe and effective use. Please review the information below carefully and consult your healthcare provider if you have any questions or concerns.

• Lactic Acidosis: Metformin, a component of Invokamet, may rarely cause lactic acidosis, a serious condition characterized by the buildup of lactic acid in the blood. This is more likely to occur in individuals over 65, with kidney or liver issues, dehydration, heart problems, or heavy alcohol use. It can also be triggered by certain medications and procedures involving contrast dye. If you experience symptoms such as unusual tiredness, dizziness, severe drowsiness, chills, blue or cold skin, muscle pain, difficulty breathing, irregular heartbeat, or stomach pain with nausea, vomiting, or diarrhea, seek medical attention immediately.

• Leg and Foot Amputations: There is a rare risk of leg or foot amputations associated with Invokamet use, particularly in those with a history of amputations, heart or blood vessel issues, or nerve problems. Watch for new pain, tenderness, sores, ulcers, or infections on your legs or feet and consult your healthcare provider promptly. Regular foot examinations by your provider are recommended.

• Ketoacidosis: Some patients may develop ketoacidosis, a condition where the blood becomes too acidic due to excessive ketones. Risk factors include illness, reduced calorie intake, high doses of canagliflozin, alcohol consumption, recent surgery, or insulin dose reduction. Symptoms such as dry mouth, fruity breath, tiredness, nausea, vomiting, stomach pain, or trouble breathing require immediate medical attention.

• Dehydration and Low Blood Pressure: Invokamet can cause dehydration and low blood pressure, especially in individuals over 65 or those with kidney issues, on low-sodium diets, or taking diuretics. Ensure adequate hydration and seek advice if you experience dizziness or reduced urination. Inform your provider if you have vomiting or diarrhea.

• Genital and Urinary Tract Infections: There is an increased risk of developing genital infections and urinary tract infections. Symptoms like burning during urination, frequent urination, lower stomach pain, blood in urine, or unusual genital odor need medical attention.

• Low Blood Sugar (Hypoglycemia): When used with other diabetes medications, Invokamet can cause low blood sugar, which can be life-threatening. Symptoms include anxiety, shakiness, sleepiness, weakness, confusion, fast heartbeat, sweating, and excessive hunger. Monitor your blood sugar levels and know when to seek emergency help.

• Severe Allergic Reactions: Rare but serious allergic reactions can occur, characterized by rash, hives, breathing difficulties, or swelling of the face, lips, tongue, or throat. Immediate medical assistance is necessary in such cases.

• Bone Fractures: The risk of bone fractures may increase with the use of Invokamet, particularly after three months of starting the medication. Discuss bone health strategies with your provider.

• Low Vitamin B12 Levels: Long-term use of metformin may lead to low vitamin B12 levels, causing anemia. Symptoms like persistent fatigue, muscle weakness, low appetite, and tingling or numbness in extremities should be reported to your provider. Regular blood tests are advised to monitor vitamin B12 levels.

Contraindications: Invokamet should not be used by individuals with severe kidney problems, those on dialysis, those with too much acid in the blood (e.g., ketoacidosis), or those allergic to canagliflozin and/or metformin. Consult your healthcare provider if you have any of these conditions before starting the medication.

When taking this medication, you may experience some common side effects such as nausea, vomiting, stomach upset, diarrhea, bloating, gas, increased urination, or unusual dryness of the mouth. These effects are generally mild, but if they persist or worsen, it is advisable to consult your healthcare provider. Some individuals might also experience yeast infections, either vaginal or penile, which are generally treatable but should be discussed with a doctor if they occur.

More serious side effects, though rare, require immediate medical attention. These include signs of a urinary tract infection, such as burning or painful urination and blood in the urine, as well as kidney problems, marked by changes in urination and swelling in the legs or feet. High potassium levels in the blood can lead to muscle weakness and irregular heartbeat. A rare but serious bacterial infection, known as Fournier's gangrene, may also occur, characterized by pain, redness, or swelling in the genital or anal area, accompanied by fever.

Additionally, this medication may cause dehydration, which could lead to serious kidney damage. Ensure adequate fluid intake and be aware of symptoms like decreased urination and dry mouth. Bone loss or fractures are possible, so maintaining a healthy lifestyle with adequate calcium and vitamin D intake is beneficial. In rare cases, severe allergic reactions might occur, signaled by rash, swelling, or difficulty breathing, necessitating immediate medical help.

Finally, be aware that high blood sugar symptoms such as increased thirst and urination may indicate a need for adjustments to your diabetes management plan. Consult your healthcare provider for any concerns or unusual symptoms.