Inpefa

Pronunciation: in-peh'-fah
Generic name: sotagliflozin
Dosage form: oral tablet
Drug class: SGLT-2 inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 25, 2024.

What is Inpefa?

Inpefa (sotagliflozin) is a once-daily tablet that may be used to reduce the risk of death due to heart problems (cardiovascular death), hospitalization for heart failure, and urgent visits to the doctor for heart failure in adults with:

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

Inpefa (sotagliflozin) works by blocking the effects of 2 proteins responsible for regulating glucose levels in the blood, sodium-glucose co-transporters type 2 (SGLT2) and type 1 (SGLT1). SGLT-2 is located in the kidneys and is responsible for reabsorbing glucose back into the blood. By blocking SGLT-2, Inpefa lowers hemoglobin A1c levels, lowers blood pressure, and encourages weight loss. SGLT-1 is responsible for the absorption of glucose in the small intestine and the reabsorption of glucose in the kidneys, particularly in people with uncontrolled diabetes or those receiving an SGLT-2 inhibitor. By blocking SGLT-1, Inpefa SGLT-1 significantly improves blood sugar levels following a meal and acts independently of beta-cell function in the pancreas.

Inpefa was approved on May 26, 2023.

Inpefa side effects

The most common side effects of Inpefa include:

• urinary tract infection
• loss of fluid
• dehydration
• diarrhea
• low blood sugar levels.

Serious side effects and warnings

Inpefa can cause the following serious side effects.

Ketoacidosis (acidic blood with increased ketones in your blood or urine). Ketoacidosis has happened in people with type 1 or type 2 diabetes during treatment with Inpefa and can happen even when blood sugar levels are 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. It is a serious, sometimes fatal, condition that needs to be treated in a hospital.

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
• stomach-area (abdominal) pain
• vomiting
• trouble breathing
• 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 daily. 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. You should not start Inpefa if you are already dehydrated.

Serious urinary tract infections (UTIs). Serious UTIs 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
• weakness
• dizziness
• shaking or feeling jittery
• drowsiness
• hunger
• irritability
• sweating
• fast heartbeat
• confusion.

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)

Yeast infections

Inpefa can increase a female's risk of developing a vaginal yeast infection. Symptoms include:

• vaginal odor
• white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
• vaginal itching.

Inpefa may also increase a male's risk of developing a yeast infection of the penis (also called balanitis or balanoposthitis). Symptoms may include:

• swelling of the penis (in an uncircumcised penis this may make it difficult to pull back the skin around the tip of the penis)
• redness or itching of the penis
• rash of the penis
• foul-smelling discharge from the penis
• pain in the skin around the penis.

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

It is not known if Inpefa is safe and effective in children under 18 years of age.

This is not a complete list of side effects and others may occur. Call your doctor for more advice about side effects. You may report side effects to the FDA at 1 800 FDA 1088.

Related/similar drugs

Before taking

You should not use Inpefa if you are allergic to sotagliflozin, Inpefa, or any of the inactive ingredients contained in the tablet.

Tell your doctor if you:

• are dehydrated
• currently have an infection
• don’t drink much fluid during the day
• drink alcohol
• follow a ketogenic diet
• have had ketoacidosis before
• have a history of pancreatic disorders
• have surgery scheduled or are undergoing a procedure that requires prolonged fasting
• have a restricted food intake
• are pregnant or planning to become pregnant
• are breastfeeding.

Pregnancy

Inpefa may harm an unborn baby. You may have to undergo a pregnancy test before taking this medication if you are a female of childbearing potential and use adequate contraception during treatment. Yell your healthcare provider right away if you become pregnant.

Breastfeeding

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.

How should I take Inpefa?

Take Inpefa exactly as your healthcare provider tells you to take it. Do not change your dose of Inpefa without talking to your healthcare provider.

• Take Inpefa by mouth 1 time each day no more than 1 hour before your first meal of the day.
• Swallow Inpefa tablets whole. Do not cut, crush, or chew.

Inpefa will cause your urine to test positive for glucose.

Your healthcare provider may do certain blood tests before you start Inpefa and during your treatment as needed.

Inpefa dosage

Recommended Inpefa dosage for adults

Initial dose: 200mg orally once daily.

• This may be increased to 400mg once daily after at least 2 weeks if tolerated.
• Reduce the dosage back to 200mg once daily if not tolerated or side effects occur.

What happens if I miss a dose?

If you miss a dose of Inpefa by more than 6 hours, take your next dose at your next scheduled time the next day.

What happens if I overdose?

If you take too much Inpefa, call your healthcare provider or the Poison Help line at 1-800-222-1222, or go to the nearest emergency room right away.

What should I avoid while taking Inpefa?

Avoid becoming dehydrated, drinking alcohol to excess, or eating a reduced or ketogenic diet as these may increase your risk of developing ketoacidosis.

What other drugs will affect Inpefa?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Inpefa may affect the way other medicines work, and other medicines may affect how Inpefa works. Especially tell your healthcare provider if you take:

• Digoxin – there may be an increase in the absorption of digoxin with Inpefa and monitoring is necessary
• Rifampicin and other uridine 5'-diphospho-glucuronosyltransferase (UGT) inducers – may reduce the effectiveness of sotagliflozin
• Lithium – may cause a decrease in lithium concentrations.

Do not use urinary glucose tests in patients taking SGLT2 inhibitors because SGLT2 inhibitors increase the excretion of glucose in the urine. Use alternative testing methods to monitor glucose levels. Other glucose assays may also be unreliable.

This list is not complete. Other drugs may affect Inpefa, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. See the Inpefa Prescribing Information for a full list of interactions.

Storage

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

Inpefa ingredients

Active ingredient: sotagliflozin.
Inactive ingredients (tablet core): colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc.

Film coating (200 mg tablet): indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol (partly hydrolyzed), talc, and titanium dioxide.

Film coating (400 mg tablet): hypromellose, lactose monohydrate, titanium dioxide, triacetin, and yellow iron oxide.

For tablets that are printed and not debossed, the ink contains ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac.

Who makes Inpefa?

Lexicon Pharmaceuticals, Inc. makes Inpefa.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer