Inpefa (sotagliflozin) dosing, indications, interactions, adverse effects, and more

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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

200mg
400mg

Heart Failure Risk Reduction

Indicated to reduce 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

200 mg PO qDay initially

Increase after at least 2 weeks to 400 mg PO if tolerated; decrease to 200 mg as necessary

Dosage Modifications

Renal impairment

Safety profile across eGFR subgroups in clinical trials was consistent with the known safety profile
eGFR <30 mL/min/1.73 m²: Increased volume-related adverse events (eg, hypotension, dizziness)
eGFR <25 mL/min/1.73 m2 or on dialysis
- Not studied
- Sotagliflozin was discontinued after starting therapy if eGFR fell to <15 mL/min/1.73 m² or if patients were initiated on chronic dialysis

Hepatic impairment

Mild (Child-Pugh A): No dosage adjustment necessary
Moderate-to-severe (Child-Pugh B or C): Not recommended; safety and efficacy not established

Dosing Considerations

Before initiating

Assess volume status and, if necessary, correct volume depletion
Assess renal function before initiating and then as clinically indicated
For patients with decompensated heart failure, dosing may begin as soon as patient is hemodynamically stable, including during hospitalization or urgent outpatient treatment or immediately upon discharge

Safety and efficacy not established

No dosage change recommended based on age

≥65 years: May increase risk of volume depletion adverse reactions, including hypotension

Interaction Checker

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Serious - Use Alternative (5)

carbamazepine
carbamazepine will decrease the level or effect of sotagliflozin by Other (see comment). Avoid or Use Alternate Drug. Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin. Coadministration of UGT1A9 inducers may decrease exposure to sotagliflozin, which may decrease efficacy.
phenobarbital
phenobarbital will decrease the level or effect of sotagliflozin by Other (see comment). Avoid or Use Alternate Drug. Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin. Coadministration of UGT1A9 inducers may decrease exposure to sotagliflozin, which may decrease efficacy.
phenytoin
phenytoin will decrease the level or effect of sotagliflozin by Other (see comment). Avoid or Use Alternate Drug. Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin. Coadministration of UGT1A9 inducers may decrease exposure to sotagliflozin, which may decrease efficacy.
rifampin
rifampin will decrease the level or effect of sotagliflozin by Other (see comment). Avoid or Use Alternate Drug. Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin. Coadministration of UGT1A9 inducers may decrease exposure to sotagliflozin, which may decrease efficacy.
ritonavir
ritonavir will decrease the level or effect of sotagliflozin by Other (see comment). Avoid or Use Alternate Drug. Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin. Coadministration of UGT1A9 inducers may decrease exposure to sotagliflozin, which may decrease efficacy.

Monitor Closely (23)

chlorpropamide
sotagliflozin increases effects of chlorpropamide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.
digoxin
sotagliflozin will increase the level or effect of digoxin by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Increased exposure of digoxin when coadministered with sotagliflozin 400 mg
glimepiride
sotagliflozin increases effects of glimepiride by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.
glipizide
sotagliflozin increases effects of glipizide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.
glyburide
sotagliflozin increases effects of glyburide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.
insulin aspart
sotagliflozin increases effects of insulin aspart by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin aspart protamine/insulin aspart
sotagliflozin increases effects of insulin aspart protamine/insulin aspart by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin degludec
sotagliflozin increases effects of insulin degludec by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin degludec/insulin aspart
sotagliflozin increases effects of insulin degludec/insulin aspart by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin detemir
sotagliflozin increases effects of insulin detemir by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin glargine
sotagliflozin increases effects of insulin glargine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin glulisine
sotagliflozin increases effects of insulin glulisine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin inhaled
sotagliflozin increases effects of insulin inhaled by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin isophane human/insulin regular human
sotagliflozin increases effects of insulin isophane human/insulin regular human by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin lispro
sotagliflozin increases effects of insulin lispro by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin lispro protamine/insulin lispro
sotagliflozin increases effects of insulin lispro protamine/insulin lispro by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin NPH
sotagliflozin increases effects of insulin NPH by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin regular human
sotagliflozin increases effects of insulin regular human by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
lithium
sotagliflozin will decrease the level or effect of lithium by Other (see comment). Modify Therapy/Monitor Closely. Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations; monitor serum lithium concentration more frequently during therapy initiation and dosage changes
nateglinide
sotagliflozin increases effects of nateglinide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of nateglinide may be required.
repaglinide
sotagliflozin increases effects of repaglinide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of repaglinide may be required.
tolazamide
sotagliflozin increases effects of tolazamide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.
tolbutamide
sotagliflozin increases effects of tolbutamide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.

Minor (0)

carbamazepine
Serious - Use Alternative (1)carbamazepine will decrease the level or effect of sotagliflozin by Other (see comment). Avoid or Use Alternate Drug. Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin. Coadministration of UGT1A9 inducers may decrease exposure to sotagliflozin, which may decrease efficacy.
chlorpropamide
Monitor Closely (1)sotagliflozin increases effects of chlorpropamide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.
digoxin
Monitor Closely (1)sotagliflozin will increase the level or effect of digoxin by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Increased exposure of digoxin when coadministered with sotagliflozin 400 mg
glimepiride
Monitor Closely (1)sotagliflozin increases effects of glimepiride by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.
glipizide
Monitor Closely (1)sotagliflozin increases effects of glipizide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.
glyburide
Monitor Closely (1)sotagliflozin increases effects of glyburide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.
insulin aspart
Monitor Closely (1)sotagliflozin increases effects of insulin aspart by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin aspart protamine/insulin aspart
Monitor Closely (1)sotagliflozin increases effects of insulin aspart protamine/insulin aspart by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin degludec
Monitor Closely (1)sotagliflozin increases effects of insulin degludec by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin degludec/insulin aspart
Monitor Closely (1)sotagliflozin increases effects of insulin degludec/insulin aspart by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin detemir
Monitor Closely (1)sotagliflozin increases effects of insulin detemir by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin glargine
Monitor Closely (1)sotagliflozin increases effects of insulin glargine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin glulisine
Monitor Closely (1)sotagliflozin increases effects of insulin glulisine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin inhaled
Monitor Closely (1)sotagliflozin increases effects of insulin inhaled by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin isophane human/insulin regular human
Monitor Closely (1)sotagliflozin increases effects of insulin isophane human/insulin regular human by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin lispro
Monitor Closely (1)sotagliflozin increases effects of insulin lispro by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin lispro protamine/insulin lispro
Monitor Closely (1)sotagliflozin increases effects of insulin lispro protamine/insulin lispro by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin NPH
Monitor Closely (1)sotagliflozin increases effects of insulin NPH by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
insulin regular human
Monitor Closely (1)sotagliflozin increases effects of insulin regular human by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
lithium
Monitor Closely (1)sotagliflozin will decrease the level or effect of lithium by Other (see comment). Modify Therapy/Monitor Closely. Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations; monitor serum lithium concentration more frequently during therapy initiation and dosage changes
nateglinide
Monitor Closely (1)sotagliflozin increases effects of nateglinide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of nateglinide may be required.
phenobarbital
Serious - Use Alternative (1)phenobarbital will decrease the level or effect of sotagliflozin by Other (see comment). Avoid or Use Alternate Drug. Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin. Coadministration of UGT1A9 inducers may decrease exposure to sotagliflozin, which may decrease efficacy.
phenytoin
Serious - Use Alternative (1)phenytoin will decrease the level or effect of sotagliflozin by Other (see comment). Avoid or Use Alternate Drug. Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin. Coadministration of UGT1A9 inducers may decrease exposure to sotagliflozin, which may decrease efficacy.
repaglinide
Monitor Closely (1)sotagliflozin increases effects of repaglinide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of repaglinide may be required.
rifampin
Serious - Use Alternative (1)rifampin will decrease the level or effect of sotagliflozin by Other (see comment). Avoid or Use Alternate Drug. Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin. Coadministration of UGT1A9 inducers may decrease exposure to sotagliflozin, which may decrease efficacy.
ritonavir
Serious - Use Alternative (1)ritonavir will decrease the level or effect of sotagliflozin by Other (see comment). Avoid or Use Alternate Drug. Glucuronidation by UGT1A9, to form the 3-O-glucuronide, was identified as a major metabolic pathway for sotagliflozin. Coadministration of UGT1A9 inducers may decrease exposure to sotagliflozin, which may decrease efficacy.
tolazamide
Monitor Closely (1)sotagliflozin increases effects of tolazamide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.
tolbutamide
Monitor Closely (1)sotagliflozin increases effects of tolbutamide by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of sulfonylurea may be required.

>10%

Urinary tract infection (8.6-11.5%)

1-10%

Volume depletion (5.2-9.3%)

Diarrhea (6.9-8.4%)

Hypoglycemia (4.3-7.7%)

Dizziness (2.6-3.3%)

Genital mycotic infection (0.8-2.4%)

Frequency Not Defined

Initiation of SGLT2 inhibitors causes a small increase in serum creatinine and decrease in eGFR; these changes in serum creatinine and eGFR generally occur within 4 weeks of starting therapy and then stabilize regardless of baseline kidney function

Contraindications

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

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 history of genital mycotic infections and uncircumcised males 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 <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, reported
Sotagliflozin is not indicated for glycemic control
Before initiating therapy, consider factors in patient 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 (eg, <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 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 patient is clinically stable and has resumed oral intake
Educate all patients on 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) reported with SGLT2 inhibitors
Assess for necrotizing fasciitis if patient presents with pain or tenderness, erythema, or swelling in genital or perineal area, along with fever or malaise; discontinue therapy, closely monitor blood glucose levels, and provide appropriate alternative therapy for heart failure
If suspected, discontinue 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 efficacy
Digoxin
- Dosage modification of digoxin may be necessary; monitor digoxin levels
- Increased exposure of 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

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

Animal studies

In rats, renal changes were observed when administered during period of renal development corresponding to late second and third trimesters of human pregnancy
Exposure ~5 times the clinical exposure at maximum recommended human dose (MRHD) of 400 mg/day caused increased kidney weights and renal pelvis and tubule dilatations that were partially reversible

Clinical considerations

There are risks to 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 presence of sotagliflozin in human milk, effects on breastfed infants, or effects on milk production

Present in rat milk; when a drug is present in animal milk, it is likely 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 risk to the developing human kidney

Advise females that breastfeeding is not recommended when taking sotagliflozin

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Dual inhibitor of selective sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2)

Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium which may influence several physiological functions, such as lowering both pre-and afterload of the heart and downregulating sympathetic activity

Inhibiting SGLT1 reduces intestinal absorption of glucose and sodium which likely contributes to diarrhea

Absorption

Bioavailability: 25%

Peak plasma time: 1.25-3 hr (single-dose); 2.5-4 hr (multiple doses)

Steady-state achieved: ~5 days

Effect of food

Administration with a high-caloric breakfast compared to fasting conditions: Cmax and AUC_0-inf increased by 149% and 50%, respectively
Multiple doses of 400 mg given immediately before breakfast, 30 minutes before breakfast, and 1-hr before breakfast in healthy subjects showed a consistent effect of sotagliflozin on urine glucose excretion (UGE), insulin, and postprandial glucose (PPG) across all dose schedules
Administer ≤1 hr before first meal of the day

Distribution

Protein bound: >93% (parent drug and major metabolite)

Vd: 9000 L

Metabolism

Extensively metabolized predominantly to sotagliflozin 3-O-glucuronide and it represents 94.3% of the radioactivity in plasma

Metabolized by UGT1A9 (major), and to lesser extent by CYP3A4

Elimination

Half-life, terminal: 21-35 hr (sotagliflozin); 19-26 hr (major metabolite)

Half-life, effective: 5-10 hr

Clearance: 260-370 L/hr (healthy volunteers); ~300 L/hr (diabetics)

Excretion: Urine 57% (33% as metabolite); feces 37% (23% unchanged)

Oral Administration

Swallow tablets whole; do not cut, crush, or chew

Administer within 1 hr before first meal of the day

Missed dose: If dose missed by >6 hr, wait to take dose the next day

Temporary interruption for surgery

Withhold dosing at least 3 days, if possible, before major surgery or procedures associated with prolonged fasting
Resume when patient is clinically stable and has resumed oral intake

Storage

Store at 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Images

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Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

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View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Sections sotagliflozin
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Adverse Effects
Warnings
Pregnancy
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Images
Patient Handout
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sotagliflozin (Rx)