Sotagliflozin

Sotagliflozin is a prescription medication used to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure (HF), and urgent visits for HF in adults with HF or type 2 diabetes, chronic kidney disease, or other CV risk factors.

• Sotagliflozin is available under the following different brand names: Inpefa

Common side effects of Sotagliflozin include:

• diarrhea and GI disturbance
• thrush and genital fungal infections
• urinary tract infections
• dehydration
• low blood pressure, particularly in the elderly
• diabetic ketoacidosis

Serious side effects of Sotagliflozin include:

• not available

Rare side effects of Sotagliflozin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 200 mg
• 400 mg

Heart failure risk reduction

Adult dosage

• 200 mg orally once a day initially
• Increase after at least 2 weeks to 400 mg orally if tolerated; decrease to 200 mg as necessary

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Sotagliflozin has severe interactions with no other drugs
• Sotagliflozin has serious interactions with the following drugs:
  • carbamazepine
  • phenobarbital
  • phenytoin
  • rifampin
  • ritonavir
• Sotagliflozin has moderate interactions with at least 23 other drugs
• Sotagliflozin has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of serious hypersensitivity reaction to sotagliflozin (eg, angioedema)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sotagliflozin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sotagliflozin?”

Cautions

• Increases risk of urinary tract infections (UTIs), including life-threatening urosepsis and pyelonephritis; evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated
• Genital mycotic infections may occur; patients with a history of genital mycotic infections and uncircumcised men are more susceptible
• Volume depletion
  • Intravascular volume depletion, which may manifest as symptomatic hypotension or acute changes in creatinine, occurred
  • Acute kidney injury, some requiring hospitalization and dialysis, in patients with T2DM receiving SGLT2 inhibitors reported
  • Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension
  • Before initiating therapy in patients with one or more of these characteristics, assess volume status and renal function; in patients with volume depletion, correct this condition before initiating treatment; monitor for signs and symptoms of volume depletion, and renal function after initiating therapy
• Ketoacidosis
  • Ketoacidosis, including fatal cases, was reported
  • Sotagliflozin is not indicated for glycemic control
  • Before initiating therapy, consider factors in the patient’s history that may predispose to ketoacidosis, including type 1 or 2 diabetes mellitus, pancreatic insulin deficiency from any cause, alcohol abuse, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, insulin dose reduction, and volume depletion
  • Consider temporarily discontinuing therapy for at least 3 days for patients who undergo scheduled surgery
  • Signs and symptoms are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath
  • Blood glucose levels at presentation may be below those typically expected for diabetic ketoacidosis (e.g., below 250 mg/dL)
  • Ketoacidosis and glucosuria may persist longer than typically expected; urinary glucose excretion persists for 3 days after discontinuing; however, there have been postmarketing reports of ketoacidosis and glucosuria lasting greater than 6 days and some up to 2 weeks after discontinuation of SGLT2 inhibitors
  • Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis if indicated by the clinical situation; assess for ketoacidosis regardless of presenting blood glucose levels in patients who present with signs and symptoms consistent with severe metabolic acidosis; if ketoacidosis suspected, discontinue therapy, promptly evaluate, and treat ketoacidosis, if confirmed; monitor patients for resolution of ketoacidosis before restarting therapy
  • Withhold, if possible, in temporary clinical situations that could predispose patients to ketoacidosis; resume when the patient is clinically stable and has resumed oral intake.
  • Educate all patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue therapy and seek medical attention immediately if signs and symptoms occur
• Necrotizing fasciitis
  • Necrotizing fasciitis of the perineum (Fournier gangrene) was reported with SGLT2 inhibitors
  • Assess for necrotizing fasciitis if a patient presents with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise; discontinue therapy, closely monitor blood glucose levels, and provide an appropriate alternative therapy for heart failure
  • If suspected, discontinue the SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary
• Drug interaction overview
  • Sotagliflozin is a uridine 5'-diphospho-glucuronosyltransferase (UGT) 1A9 substrate.
  • UGT inducers
  • Caution, monitor
  • Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin
  • Coadministration of rifampicin, a UGT inducer, with a single 400-mg dose of sotagliflozin, resulted in decreased exposure to sotagliflozin, which may decrease the efficacy
• Digoxin
  • Dosage modification of digoxin may be necessary; monitor digoxin levels
  • Increased exposure to digoxin when coadministered with sotagliflozin 400 mg
• Lithium
  • Dosage modification of lithium may be necessary; monitor lithium levels
  • Coadministration of SGLT2 inhibitors with lithium may decrease serum lithium concentrations
  • Insulin and insulin secretagogues
• Dosage modification
  • Hypoglycemia risk increased with insulin and insulin secretagogues (eg, sulfonylureas).
  • Lower dose of insulin or insulin secretagogue may be required
• Laboratory testing
  • Urine glucose tests are not recommended in patients taking SGLT2 inhibitors, as SGLT2 inhibitors increase urinary glucose excretion and lead to positive urine glucose tests; use alternative methods to monitor glycemic control
  • 1,5-AG assay is not recommended, as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors; use alternative methods to monitor glycemic control

Pregnancy and Lactation

• Based on animal data showing renal effects, sotagliflozin is not recommended during the second and third trimesters of pregnancy
• Clinical considerations
• There are risks to the mother and fetus associated with untreated heart failure in pregnancy
• Pregnant women with congestive heart failure are at increased risk for preterm birth
• Clinical classification of heart disease may worsen with pregnancy and lead to maternal death
• Lactation
  • Data are not available regarding the presence of sotagliflozin in human milk, its effects on breastfed infants, or milk production
  • Present in rat milk; when a drug is present in animal milk, it is likely to be present in human milk.
  • Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be a risk to the developing human kidney
  • Advise women to avoid breastfeeding while taking sotagliflozin