Sotagliflozin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Overview
Sotagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that is FDA approved for the prophylaxis of heart failure in patients with history of heart failure, type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.. Common adverse reactions include urinary tract infection, volume depletion, diarrhea, and hypoglycemia..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Sotagliflozin is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure in patients with history of heart failure or with underlying comorbidities like diabetes mellitus, chronic kidney disease and other cardiovascular risk factors
The recommended starting dose is 200mg mg administered orally once daily not more than one hour before the meal. It can up titrated to 400mg once daily as tolerated only after 2 weeks.
Always assess the volume status and renal function prior to administering the drug. If the patient has decompensated heart failure, Sotagliflozin is administered as soon as the patient in hemodynamically stable.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Sotagliflozin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
Sotagliflozin is contraindicated in patients with hypersensitivity reaction to Sotagliflozin.
Warnings
1. Diabetic ketoacidosis
2. volume depleation'
3. Urosepsis
4. Hypoglycemia with concomitant usage of insulin and insulin secretagogues
5. Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)
6. Genital Mycotic Infections
7. Avoid monitoring Glucose level through urine glucose test while on Sotagliflozin as SGLT2 inhibition leads to glucosuria casing Urine Glucose test to be positive.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Sotagliflozin Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Sotagliflozin Postmarketing Experience in the drug label.
Drug Interactions
1. Digoxin there is increase in digoxin level when concomitantly administered with INPEFA. Always monitor the blood digoxin level while INPEFA.
2. Uridine 5'-diphospho-glucuronosyltransferase (UGT) Inducer INPEFA undergoes glucorindation by UGT forming 3-O-glucuronide, Therefore coadministration with a UGT inducer like Rifampin will lead to decreased exposure to sotagliflozin. Hence, decreased efficacy of Sotagliflozin.
3. Lithium Co-administration of Lithium with a SGLT2 inhibitor like Sotagliglozin will lead to decreased exposure to Lithium, hence decreased efficacy of Lithium. Alway monitor the serum level of Lithium while on Sotagliflozin.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): X
Based on the animal study,INPEFA is best avoided in the 2nd and 3rd trimester as renal anomalies were observed in the second and third trimester.
In rats, the exposure approximately 5 times the clinical exposure at the maximum recommended human dose (MRHD) of 400 mg once daily caused increased kidney weights and renal pelvis and tubule dilatations that were partially reversible
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sotagliflozin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Sotagliflozin during labor and delivery.
Nursing Mothers
There has been no data regarding the presence of INPEFA in human milk, the effects on the breastfed infant, or the effects on milk production.
However, studies has shown presence of INPEFA in the rat milk indicating the human milk to most likely have the drug and thus best avoided during the breastfeeding period.
Pediatric Use
There is no FDA guidance on the use of Sotagliflozin in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Sotagliflozin in geriatric settings.
Gender
There is no FDA guidance on the use of Sotagliflozin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Sotagliflozin with respect to specific racial populations.
Renal Impairment
Patients with eGFR < 30 mL/min/1.73 m2 relative to the overall safety population had volume related adverse affects like hypotention, and dizziness
Hepatic Impairment
INPEFA is not recommended in patients with moderate or severe hepatic impairment because there was 3-fold and 6-fold increase in blood INPEFA level in patients with moderate and severe hepatic failure respectively in comparison to normal hepatic functioning patient.
However, no dose adjustment of INPEFA was required for patients with mild hepatic failure.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sotagliflozin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Sotagliflozin in patients who are immunocompromised.
Administration and Monitoring
Administration
INPEFA tablets contain sotagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor which is administered orally.
INPEFA tablets are available in 200mg and 400mg. The patients are usually started at 200mg given not more than 1 hour before the first meal of the day. It can uptitarted to 400mg only after 2 weeks if the patients tolerate it well.
Monitoring
Always assess the volume status and correct the depletion if necessary prior to administering the INPEFA.
If the patients are hospitalized due to decompensated heart failure, INPEFA is administered as soon as the patient's vitals recovers to normal baseline.
If the patient is fasting due to surgery or any procedures, their INPEFA is kept on hold for atleast 3 days.
IV Compatibility
There is limited information regarding the compatibility of Sotagliflozin and IV administrations.
Overdosage
There is limited information regarding Sotagliflozin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Sotagliflozin Pharmacology in the drug label.
Mechanism of Action
Sotagliflozin is an inhibitor of SGLT2 and SGLT1. Inhibiting the Sodium-glucose cotransport inhibitor-2 decreases the reabsorption of sodium and glucose further lowering both pre-and afterload of the heart and downregulating sympathetic activity. However, the exact mechanism for sotagliflozin's cardiovascular benefits has not been established.
Inhibiting SGLT1 reduces the absorption of intestinal absorption of glucose further leading to diarrhea.
Structure
The molecular formula is C21H25ClO5S and the molecular weight is 424.94
Pharmacodynamics
Plasma Cmax and AUC of sotagliflozin increased in a dose-proportional manner in the therapeutic dose range of 200 mg to 400 mg once daily.
Pharmacokinetics
There is limited information regarding Sotagliflozin Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Sotagliflozin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Sotagliflozin Clinical Studies in the drug label.
How Supplied
INPEFA tablets are available in 200mg (blue color) and 400mg (yellow color) in a bottle of 30.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F)
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Sotagliflozin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Sotagliflozin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
INPEFA
Look-Alike Drug Names
There is limited information regarding Sotagliflozin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.