What is the most important information I should know about INPEFA?
INPEFA can cause serious side effects, including:

• Ketoacidosis (acidic blood with increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 or type 2 diabetes during treatment with INPEFA. Ketoacidosis can happen with INPEFA even if your blood sugar is not high. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Ketoacidosis can also happen in people who are sick or who have surgery during treatment with INPEFA. Ketoacidosis is a serious condition which needs to be treated in a hospital. Ketoacidosis may lead to death.
  • Stop taking INPEFA and call your healthcare provider or get medical help right away if you get any of the following symptoms. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL:

    nausea vomiting trouble breathing

    stomach-area (abdominal) pain tiredness ketones in your urine or blood

• Dehydration. INPEFA can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury due to dehydration in people with type 2 diabetes who are taking a medicine that works like INPEFA.

  You may be at higher risk of dehydration if you:

  • take medicines to lower your blood pressure, including water pills (diuretics)
  • are 65 years of age or older
  • are on a low salt diet
  • have kidney problems

  Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider 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.

• heart failure (when the heart is weak and cannot pump enough blood to the rest of your body), or
• type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.

• have type 1 diabetes or have had diabetic ketoacidosis.
• are going to have surgery or a procedure that requires fasting. Your healthcare provider may stop your INPEFA for at least 3 days before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking INPEFA 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 over a short period (“binge” drinking).
• have a history of urinary tract infections or problems urinating.
• have a history of infection of the vagina or penis.
• have kidney or liver problems.
• are pregnant or plan to become pregnant. INPEFA may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with INPEFA. Your healthcare provider may switch you to a different medicine.
• are breastfeeding or plan to breastfeed. It is not known if INPEFA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with INPEFA. You should not breastfeed during treatment with INPEFA.

What are the possible side effects of INPEFA?
INPEFA can cause serious side effects, including:

• See “What is the most important information I should know about INPEFA?”
• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking INPEFA. Tell your healthcare provider 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 also may have a fever, back pain, nausea, or vomiting.
• Low blood sugar (hypoglycemia). If you take INPEFA 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 INPEFA. Signs and symptoms of low blood sugar may include:

  headache shaking or feeling jittery irritability fast heartbeat

  weakness drowsiness sweating confusion

  dizziness hunger

• 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 women and men with diabetes who take INPEFA. 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 a 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 the anus and genitals:

  pain or tenderness

  swelling

  redness of skin (erythema)

• 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 penis (balanitis or balanoposthitis). Swelling of an uncircumcised penis may develop that 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 rash of the penis

  foul smelling discharge from the penis pain in the skin around the penis

• Store INPEFA at room temperature between 68°F to 77°F (20°C to 25°C).