Sotagliflozin (soe-ta-gli-FLOE-zin)

Used to lower the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure when the heart is weak and cannot pump enough blood, type 2 diabetes, kidney disease, or other cardiovascular risk factor.

Brand Name(s):

Inpefa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not cut, crush, or chew it.
• Take this medicine not more than 1 hour before your first meal of the day.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you miss a dose and it is more than 6 hours, skip the missed dose and take your next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how sotagliflozin works. Tell your doctor if you are using digoxin, lithium, or rifampin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. Do not use this medicine during the second and third part of your pregnancy, unless your doctor tells you to.
• Tell your doctor if you have kidney disease, liver disease, heart failure, or a history of pancreas problems, or genital yeast or urinary tract infections. Tell your doctor if you are on a low-salt diet, if you drink alcohol, or if you are having a surgery or other procedures.
• Do not breastfeed during treatment with this medicine.
• This medicine may cause the following problems:
  • Ketoacidosis (high ketones and acid in the blood), which can be life-threatening
  • Low blood pressure
  • Kidney problems
  • Increased risk of genital yeast or urinary tract infections
  • Low blood sugar, when used with other diabetes medicines
  • Fournier's gangrene (skin or tissue damage of the area between the anus and genitals)
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, bloody urine, painful or difficult urination, lower back or side pain, chills
• Fast or trouble breathing, tiredness, stomach pain, nausea, vomiting
• Increased hunger, headache, confusion, shaking, trembling, sweating
• Lightheadedness, dizziness, fainting
• Pain, tenderness, redness, or swelling of the area between the anus and genitals, fever
• Unusual bleeding, bruising, or weakness
• White or yellow vaginal discharge, vaginal itching or odor

If you notice these less serious side effects, talk with your doctor:

• Diarrhea

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088