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Inpefa is used to lower the risk of dying from heart problems and reduce the need for urgent treatment or hospitalization for heart failure in certain people. It is thought to work by helping your body get rid of extra sugar, salt, and water. Common side effects include kidney or bladder infection, dehydration, diarrhea, and low blood sugar. 

Uses

What is Inpefa used for?

Inpefa (sotagliflozin) is commonly used to lower the risk of dying from heart problems and reduce the need for urgent treatment or hospitalization for heart failure in people with the following conditions.

Inpefa may also be used for other conditions as determined by your health care provider.

How does Inpefa work (mechanism of action)?

Inpefa is thought to lower the risk of complications from heart failure and heart disease by helping your body get rid of extra sugar, salt, and water.

How is Inpefa supplied (dosage forms)?

Brands and other names

  • Inpefa

Dosage forms and strengths

  • 200 mg oral tablets
  • 400 mg oral tablets

How should I store Inpefa?

Inpefa should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Inpefa?

The most common side effects of Inpefa are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Kidney or bladder infection (see below)
  • Dehydration (see below)
  • Diarrhea
  • Low blood sugar (see below)

There may be other side effects of Inpefa that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Inpefa?

While less common, the most serious side effects of Inpefa are described below, along with what to do if they happen.

Ketoacidosis. Inpefa may increase the risk of ketoacidosis, including diabetic ketoacidosis (DKA). Ketoacidosis is a serious condition and can be life-threatening. It can happen even if your blood sugar is not high. It may also happen if you are sick or need surgery while you are taking Inpefa. Follow your health care provider’s advice about whether to check for ketones (acids made in your liver) in your blood or pee. Stop taking Inpefa and get help right away if you have any of the following symptoms.

  • Nausea or vomiting
  • Stomach pain
  • Feeling very tired, woozy, or confused
  • Trouble breathing
  • Fruity- or sweet-smelling breath

Dehydration. Inpefa may cause dehydration, which may lead to low blood pressure, especially when you stand up (orthostatic hypotension), or kidney damage. Some factors may raise your risk of dehydration, such as diarrhea, vomiting, or being in the sun for too long. Ask your health care provider how much fluid you should drink every day. Call your health care provider right away if you have any of the following symptoms of dehydration, low blood pressure, or kidney damage.

  • Dizziness or lightheadedness
  • Weakness or unusual tiredness
  • Confusion
  • Unsteadiness
  • Peeing less than normal
  • Swelling in your legs, ankles, and feet
  • Loss of appetite or nausea
  • Extreme thirst

Kidney Infection. Inpefa may raise your chances of getting a kidney infection (pyelonephritis), including one that can cause a dangerous condition called sepsis (urosepsis). These are serious infections and may need to be treated in the hospital. Get help right away if you have any of the following symptoms.

  • Dark, cloudy, or bloody pee or pee that smells bad
  • Fever and chills
  • Loss of appetite
  • Needing to pee a lot, urgently, or feeling pain or burning when you pee
  • Pain in your lower back, side, or groin
  • Upset stomach, nausea, and vomiting

Fournier’s Gangrene. Inpefa may increase the risk of Fournier’s gangrene, which is an aggressive skin and tissue infection in your genital or anal area. Although rare, it is very serious, can lead to death, and may require surgery to treat it. Get help right away if you have any of the following symptoms of this serious infection.

  • Pain, redness, tenderness, or swelling of the genitals or perineum (area between the anus and genitals)
  • Fever
  • General feeling of being unwell, tired, or not having your usual energy

Genital Yeast Infections. Inpefa can cause yeast infections of the vagina or penis. People who have had genital yeast infections in the past may be at higher risk. Tell your health care provider right away if you have any symptoms of a genital yeast infection, such as the following.

  • Thick, white vaginal discharge
  • Bad-smelling discharge from the penis
  • Itching, swelling, rash, or redness of the vagina or penis
  • Pain or burning when you pee

Low Blood Sugar (Hypoglycemia). Inpefa can cause low blood sugar, especially if it is used with insulin or other medicines that increase your insulin levels. Low blood sugar can be serious and may lead to death. If you take diabetes medicines, ask your health care provider if you need a lower dose to reduce your risk of hypoglycemia. Do not take Inpefa and call your health care provider right away if you have any of the following symptoms of hypoglycemia.

  • Headache
  • Crankiness or anxiety
  • Hunger
  • Dizziness or confusion
  • Blurry vision
  • Slurred speech
  • Sweating
  • Feeling jittery or shaky
  • Fast heartbeat
  • Seizures

Severe Allergic Reactions. Inpefa may cause allergic reactions, which can be serious. Stop taking Inpefa and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Inpefa?

Allergies to Ingredients. People who are allergic to any of the following should not take Inpefa.

  • Inpefa
  • Sotagliflozin
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Inpefa.

What should I know about Inpefa before using it?

Do not take Inpefa unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Inpefa with other people, even if they have the same condition as you. It may harm them.

Keep Inpefa out of the reach of children.

Inpefa should be swallowed whole. Do not chew, cut, or crush the tablets.

Keep all appointments with your health care provider for lab work before starting and while taking this medicine. This can help check how well your kidneys are working and make sure you are not dehydrated.

People who are 65 years or older may be at greater risk of some side effects from Inpefa. Talk to your health care provider about your risks if you are in this age group.

Inpefa will cause your pee to test positive for glucose (sugar). Tell all of your health care providers about all medicines you take before any lab work.

What should I tell my health care provider before using Inpefa?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Inpefa is right for you.

In particular, make sure that you discuss any of the following.

Risk Factors for Ketoacidosis. Tell your health care provider if you have or have had any of the following risk factors for ketoacidosis or diabetic ketoacidosis. Your health care provider may monitor you more closely or choose a different medicine for you.

  • Type 1 diabetes, type 2 diabetes, or a history of diabetic ketoacidosis
  • Decrease in your insulin dose
  • Serious infection or illness with a fever
  • Drink alcohol often or in large amounts
  • Pancreas problems, including inflammation of the pancreas (pancreatitis) or surgery on your pancreas
  • Dehydration
  • Eating or drinking less than normal or following a ketogenic diet
  • Vomiting or diarrhea

Planned Surgery or Procedures. Tell your health care provider if you have any procedures or surgeries planned, especially if you need to fast before these procedures. You may need to stop Inpefa at least three days before certain surgeries. Talk with your health care provider about whether you need to temporarily stop Inpefa before your procedure.

History of Genital Yeast Infections. Tell your health care provider if you have a history of genital (penis or vagina) yeast infections. This may make it more likely that you will have yeast infections of the vagina or penis while taking Inpefa. Your health care provider may choose a different medicine for you. See the Side Effects section for more details.

Other Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

  • Kidney problems
  • Liver problems
  • Kidney or bladder infections or trouble peeing

Other Medicines and Supplements. Inpefa may interact with other medicines and supplements. Before taking Inpefa, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Inpefa may cause harm to a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant, contact your health care provider right away.

Breastfeeding. It is not known if Inpefa passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should stop breastfeeding or stop Inpefa.

How can I get more information about Inpefa?

For more information about Inpefa, you can visit the drugmaker’s website at www.lexpharma.com/products/inpefa or call them at 855-330-2573.

Interactions

Does Inpefa interact with foods or drinks?

Take each dose of Inpefa no more than one hour before the first meal of the day. 

Being on a low-salt diet while taking Inpefa may increase your risk of dehydration. See the Side Effects section for more details. 

Drinking too much alcohol while taking Inpefa may increase your risk of diabetic ketoacidosis. See the Side Effects section for more details. Alcohol may also affect blood sugar levels in people with diabetes. It is best to limit the amount of alcohol you drink while taking Inpefa.

Does Inpefa interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are taking any of the following before taking Inpefa.

  • Lithium, which is a medicine for certain mental health conditions
  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
  • Any medicine for diabetes

This may not be a complete list of medicines that can interact with Inpefa. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Inpefa?

If you or someone else has used too much Inpefa, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Inpefa?

If you miss a dose by six hours or less, take it as soon as you remember. If it has been more than six hours, skip the missed dose and only take the next dose. Do not take double or extra doses.