Inpefa (sotagliflozin) is a newer medication that's approved to lessen the risk of heart-related complications in people with heart failure and in people with Type 2 diabetes, chronic kidney disease (CKD), and other heart-related conditions. This medication comes as a tablet that you take by mouth once daily. Side effects can include urinary tract infections (UTIs) and diarrhea. Inpefa (sotagliflozin) is expected to be available in the U.S. in summer 2023.
Lessen the risk of heart-related death and complications in adults with:
Inpefa (sotagliflozin) is a sodium-glucose cotransporter 1 and 2 (SGLT1/SGLT2) inhibitor. It blocks a protein in the kidneys called SGLT2. This prevents sugar and sodium (salt) from getting absorbed back into your body. This can help lower stress on your heart.
Inpefa (sotagliflozin) has the added benefit of working in the intestines (gut), where SGLT1 proteins are located. By blocking SGLT1, the medication prevents sugar and sodium absorption from the gut.
Source: FDA
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Taken just once a day
Can lower the risk of heart-related death, heart failure (HF) hospitalizations, and urgent HF visits by up to [33%
First-of-its-kind medication that blocks both SGLT1 and SGLT2 proteins
Raises risk of UTIs and genital yeast infections
Newer medication, so there's no lower-cost generic version available yet
Unknown if safe or works well in people with severe kidney problems or are on dialysis
Take Inpefa (sotagliflozin) within an hour before breakfast or your first meal of the day. This will help make sure your body absorbs enough medication so it works well for you.
If you miss your Inpefa (sotagliflozin) dose by more than 6 hours, skip this missed dose. Then, take your next dose as prescribed on the next day. Don't double up to make up for a missed dose because this could lead to more side effects.
Practice good hygiene to prevent yeast and urinary tract infections since these are common side effects of Inpefa (sotagliflozin). Change clothes and shower as soon as possible after exercising or after a hot day. Also wear underwear and clothing made from breathable, natural materials like cotton.
Be sure to ask your provider how much fluid you should be drinking because Inpefa (sotagliflozin) can raise your risk for dehydration (low fluids in the body). If you feel dizzy, let your provider know.
Tell your provider if you're thinking of becoming pregnant, become pregnant, or are breastfeeding while taking Inpefa (sotagliflozin). This medication isn't recommended during the second and third trimesters of pregnancy or if you're breastfeeding because it can potentially harm your baby.
Inpefa (sotagliflozin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Diabetes | Illness | Lowered calorie intake | Insulin dose reduction | Pancreatic problems | Surgery | Alcohol abuse
Some people with diabetes taking Inpefa (sotagliflozin) have experienced a serious life-threatening condition called ketoacidosis. This can happen when your body makes too many ketones, which makes your blood acidic. Your risk might be higher if you're ill, eating less calories, drinking a lot of alcohol, or have recently had surgery or a reduction in your insulin dose. If possible, check your ketone levels if you experience dry mouth, fruity breath, tiredness, nausea, vomiting, stomach pain, or trouble breathing. If any of these symptoms happen, stop taking Inpefa (sotagliflozin) and get medical help right away.
Risk factors: Age 65 years or older | Kidney problems | Taking other medications that lower blood pressure, like loop diuretics (water pills) | Low-salt diet
Inpefa (sotagliflozin) can cause low levels of fluids in the body. This can lead to dehydration, low blood pressure, or kidney damage. You're more likely at risk if you already have kidney problems or take water pills known as loop diuretics. Your provider might regularly check your kidney health with blood tests. Make sure to stay hydrated while you're taking Inpefa (sotagliflozin), and ask your provider how much fluid you should be drinking. Talk to your provider if you experience dizziness, lightheadedness, or if you're urinating less than usual. Also let them know if you're vomiting or have diarrhea (you're also losing liquids from your body this way, which can lead to dehydration). Your provider can recommend ways to keep your body fluids up.
Risk factors: History of genital yeast infections or urinary tract infections (UTIs)
Inpefa (sotagliflozin) raises the risk of genital infections, like yeast infections and UTIs. Although rare, these infections can become serious and require hospitalization. Call your provider if you experience a burning feeling when urinating; a need to urinate often; lower stomach pain; blood in your urine; an odor from your genitals; or pain, itching, swelling, redness, or tenderness around your genitals.
Risk factors: Changes in diet and exercise | Drinking alcohol | Taking certain other medications for diabetes
When taken together with certain other diabetes medications, such as insulin and sulfonylureas like glimepiride, Inpefa (sotagliflozin) can raise your risk for low blood sugar (hypoglycemia). Very low blood sugar can be life-threatening. Symptoms of low blood sugar include feeling shaky, being nervous or anxious, having a fast heartbeat, sweating or body chills, confusion, feeling sleepy or weak, and excessive hunger. If you take other diabetes medications with Inpefa (sotagliflozin) and you experience any of these symptoms, be sure to check your blood sugar.
The typical starting dose is 200 mg by mouth daily within an hour before breakfast (or your first meal of the day). If you're able to handle taking that dose for a couple of weeks, your provider will probably raise your dose to 400 mg daily.
Lessen the risk of heart-related death and complications in adults with:
Type 2 diabetes (in addition to diet and exercise) in people age 10 years and older
Lowering the risk of death due to heart problems in adults with Type 2 diabetes and heart disease
Lowering the risk of hospitalization and death due to heart problems in adults with heart failure
Lowering the risk of worsening kidney problems, hospitalization, and death due to heart problems in adults with chronic kidney disease (CKD)
Type 2 diabetes (in addition to diet and exercise) in people age 10 and over
Lowering the risk of hospitalization for heart failure in adults with Type 2 diabetes and heart disease
Lowering the risk of hospitalization and death due to heart problems in people with heart failure
Lowering the risk of worsening kidney problems, hospitalization for heart failure, and death due to heart problems in adults with chronic kidney disease (CKD)
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American Diabetes Association. (n.d.). Diabetes & DKA (ketoacidosis).
Bhatt, D.L., et al. (2021). Sotagliflozin in patients with diabetes and recent worsening heart failure. The New England Journal of Medicine.
Lexicon Pharmaceuticals, Inc. (2023). Inpefa (sotagliflozin) tablets, for oral use [package insert].
Lexicon Pharmaceuticals, Inc. (2023). Lexicon announces FDA approval of Inpefa™ (sotagliflozin) for treatment of heart failure.
National Kidney Foundation. (n.d.). Dialysis.
Pitt, B., et al. (2021). Does SGLT1 inhibition add benefit to SGLT2 inhibition in Type 2 diabetes? Circulation.
Sanvictores, T., et al. (2023). Physiology, fasting. StatPearls.
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