WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL., Risk factors include renal impairment, concomitant use of certain drugs, age greater than 65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information., If lactic acidosis is suspected, discontinue INVOKAMET/INVOKAMET XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. Before you start treatment with Invokamet, be sure to discuss the following with your doctor:, All the medications you take, including prescription and over-counter-medications as well as vitamins and herbal supplements., Your allergies, Your medical history and current health problems, If you are pregnant or have plans to become pregnant, If you are breastfeeding or have plans to breastfeed, If you have any upcoming imaging procedures, Risk of lower limb amputations has been associated with canagliflozin. Talk to your doctor about your risk factors for lower limb amputations before you start taking Invokamet. Call your doctor right away if you have pain, tenderness, sores, or ulcers on your feet., Volume depletion can occur during treatment with Invokamet. Your risk may be greater if you have kidney problems, are elderly, or if you take certain fluid pills., Ketoacidosis, a severe condition that can be fatal, can occur with the use of Invokamet. Seek emergency care right away if you have nausea, vomiting, stomach pain, general discomfort, and trouble breathing., Urinary tract infections and kidney infections that may require hospitalization can occur with the use of Invokamet. Contact your doctor right away if you have burning upon urination, frequent urination, urination that looks cloudy, bright pink, or red, urine with a strong odor, pelvic pain, fever, nausea, or back pain., Low blood sugar can occur with the use of Invokamet, especially if taken with insulin or other medications that can lower blood sugar. Monitor your blood sugar and treat low blood sugar as your doctor has instructed., Although rare, necrotizing fasciitis of the perineum (Fournier's gangrene), a severe and potentially fatal necrotizing infection that warrants surgery, can occur during treatment with Invokamet. Seek emergency care right away if you have fever or discomfort and pain, tenderness, redness, or swelling in the general or perineal area., Genital fungal infections can occur during treatment with Invokamet., Serious allergic reactions can occur with the use of Invokamet. Seek emergency care right away if you have a rash, rapid heart rate, trouble breathing, or swelling of your face, lips, tongue, or throat., Treatment with Invokamet can increase your risk of bone fractures., Treatment with Invokamet can decrease your vitamin B12 levels. All the medications you take, including prescription and over-counter-medications as well as vitamins and herbal supplements., Your allergies, Your medical history and current health problems, If you are pregnant or have plans to become pregnant, If you are breastfeeding or have plans to breastfeed, If you have any upcoming imaging procedures
