Sotagliflozin

What is Sotagliflozin?

• Sotagliflozin (Inpefa),is an inhibitor of SGLT2 and SGLT1.

What are the uses of this medicine?

Sotagliflozin (Inpefa) is a prescription medicine 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), or
• type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.

How does this medicine work?

• An orally bioavailable inhibitor of the sodium-glucose co-transporter subtypes 1 (SGLT1) and 2 (SGLT2), with potential antihyperglycemic activity.
• Upon oral administration, sotagliflozin binds to and blocks both SGLT1 in the gastrointestinal (GI) tract and SGLT2 in the kidneys, thereby suppressing the absorption of glucose from the GI tract and the reabsorption of glucose by the proximal tubule into the bloodstream, respectively. T
• his decreases glucose uptake and enhances the urinary excretion of glucose, which lowers and/or normalizes blood glucose levels.
• SGLT1 is the primary transporter responsible for glucose absorption from the GI tract.
• SGLT2, a transport protein exclusively expressed in the proximal renal tubules, mediates approximately 90% of renal glucose reabsorption from tubular fluid.
• The mechanism for sotagliflozin's cardiovascular benefits has not been established.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to sotagliflozin or any of the ingredients in Inpefa.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Inpefa may affect the way other medicines work, and other medicines may affect how Inpefa works.

Be sure to mention any of the following:

• Digoxin
• Uridine 5'-diphospho-glucuronosyltransferase (UGT) Inducer
• Lithium

Is this medicine FDA approved?

• Sotagliflozin was approved for medical used in the United States in May 2023, to reduce the risk of death due to heart failure.

How should this medicine be used?

• Assess volume status and, if necessary, correct volume depletion prior to initiation of Inpefa.
• Assess renal function prior to initiation of Inpefa and then as clinically indicated.

Recommended dosage:

• The recommended starting dose of Inpefa is 200 mg orally once daily not more than one hour before the first meal of the day.
• Titrate to 400 mg as tolerated.

Administration:

• 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.
• If you miss a dose of Inpefa by more than 6 hours after taking Inpefa, take your next dose at your next scheduled time the next day.
• 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.
• If you take too much Inpefa, call your healthcare provider or local poison control center, or go to the nearest emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 200 mg and 400 mg

This medicine is available in fallowing brand namesː

• Inpefa

What side effects can this medication cause?

The most common side effects of this medicine include:

• urinary tract infection
• dehydration
• diarrhea
• low blood sugar levels

Less common, but serious side effects may include:

• Ketoacidosis
• Dehydration
• Serious urinary tract infections
• hypoglycemia
• necrotizing fasciitis
• Vaginal yeast infection
• balanitis or balanoposthitis

What special precautions should I follow?

• In patients with type 1 diabetes mellitus, Inpefa significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate.
• Inform patients that symptomatic hypotension may occur with Inpefa and advise them to contact their healthcare provider if they experience such symptoms. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.
• Treatment with SGLT2 inhibitors, including Inpefa, increases the risk for urinary tract infections. Monitor for signs and symptoms during therapy and treat promptly.
• Insulin and insulin secretagogues are known to cause hypoglycemia. Inpefa may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required.
• Inform patients that necrotizing infections of the perineum (Fournier's Gangrene) have occurred with Inpefa in patients with diabetes mellitus. Counsel patients to promptly seek medical attention if they develop pain, tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, along with a fever above 100.4°F or malaise.
• Inpefa increases the risk of genital mycotic infections. Inform female patients that vaginal yeast infections may occur and provide them with information on the signs and symptoms of vaginal yeast infections. Advise them of treatment options and when to seek medical advice.
• Inform male patients that yeast infections of the penis (e.g., balanitis or balanoposthitis) may occur, especially in patients with prior history. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice.
• Monitoring glucose levels with urine glucose tests is not recommended as SGLT2 inhibition increases urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glucose levels.
• Monitoring glucose levels with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glucose levels in patients taking SGLT2 inhibitors. Use alternative methods to monitor glucose levels.
• Inform patients that hypersensitivity reactions (e.g., urticaria, anaphylactic reactions, and angioedema) have been reported with other SGLT2 inhibitors. Advise patients to immediately report any signs or symptoms suggesting allergic reaction or angioedema and to discontinue the drug until they have consulted their prescribing physician.
• 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 to do in case of emergency/overdose?

Symptoms of overdose may include:

• There were no confirmed reports of symptomatic overdose with sotagliflozin.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Employ the usual supportive measures as dictated by the patient's clinical status.
• The removal of sotagliflozin by hemodialysis has not been studied.

Can this medicine be used in pregnancy?

• Based on animal data showing renal effects, Inpefa is not recommended during the second and third trimesters of pregnancy.
• 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.

Can this medicine be used in children?

• The safety and effectiveness of Inpefa in pediatric patients under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: sotagliflozin.
• Inactive ingredients: The core of the tablet contains: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc. The film coating for the 200 mg tablet contains: indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol (partly hydrolyzed), talc, and titanium dioxide. The film coating for the 400 mg tablet contains: hypromellose, lactose monohydrate, titanium dioxide, triacetin, and yellow iron oxide. The black printing ink contains: ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac.

Who manufactures and distributes this medicine?

• Manufactured for: Lexicon Pharmaceuticals, Inc. The Woodlands, TX.
• Inpefa is a registered trademark of Lexicon Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Sotagliflozin
• FDA Sotagliflozin

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