sotagliflozin

Contraindicated in:

Hypersensitivity;
Type 1 diabetes;
Moderate or severe hepatic impairment;
eGFR <15 mL/min/1.73 m² or hemodialysis;
Rep: SGLT2 inhibitors are not recommended for the treatment of HF in women of reproductive potential;
OB: 2nd and 3rd trimesters of pregnancy; SGLT2 inhibitors are not recommended for the treatment of HF during pregnancy;
Lactation: Lactation.

Use Cautiously in:

History of type 1 or 2 diabetes, pancreatitis, pancreatic surgery, acute febrile illness, reduced caloric intake due to illness or surgery, surgical procedures, volume depletion, or alcohol abuse (↑ risk of ketoacidosis);
Hypovolemia, chronic kidney disease (eGFR <60 mL/min/1.73 m²), or concurrent use of loop diuretics (↑ risk of volume depletion or hypotension);
History of genital mycotic infections;
OB: Safety not established during 1st trimester of pregnancy;
Pedi: Safety and effectiveness not established in children;
Geri: Older adults may have ↑ risk of hypovolemia and hypotension.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypotension

Endo: hypoglycemia (↑ with other medications)

F and E: dehydration, KETOACIDOSIS

GI: diarrhea

GU: urinary tract infection (including pyelonephritis), acute kidney injury, genital mycotic infection, NECROTIZING FASCIITIS OF PERINEUM (FOURNIER GANGRENE)

Neuro: dizziness

Interactions ⬆ ⬇

Drug-drug:

↑risk of hypoglycemia with insulin or insulin secretagogues; dose adjustments may be required.
May ↑ levels and risk of toxicity of digoxin; closely monitor levels.
UGT inducers, including rifampin, may ↓ levels and effectiveness.
May ↓ lithium levels and effectiveness.

Availability ⬆ ⬇

Tablets: 200 mg; 400 mg

Route/Dosage ⬆ ⬇

PO (Adults ): 200 mg once daily; then after 2 wk, ↑ to 400 mg once daily.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits both sodium-glucose co-transporter 1 (SGLT1) and SGLT2. Inhibition of SGLT1 reduces intestinal absorption of glucose and sodium. Inhibition of SGLT2 reduces renal reabsorption of glucose and sodium, which reduces cardiac preload and afterload and sympathetic activity. Exact mechanism of cardiovascular benefit unknown.

Therapeutic effects:

Reduction in the risk of cardiovascular death, hospitalization for HF and urgent HF visits.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: Sodium-glucose cotransporter 1 (SGLT1) inhibitors, sodium-glucose co-transporter 2 (SGLT2) inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: 25% absorbed following oral administration. High-caloric meals ↑ absorption.

Distribution: Extensively distributed to tissues.

Protein Binding: >93%.

Metabolism/Excretion: Primarily metabolized in the liver via UGT1A9 and to a lesser extent by the CYP3A4 isoenzyme. Primarily excreted in the urine (57%) with 37% excreted in the feces.

Half-Life: 21–35 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1.25–3 hr	24 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Instruct patient to take medication as directed. If a dose is missed by >6 hr, take the next dose as prescribed the next day. Advise patient to read Patient Information before starting therapy.
Teach the patient how and when to self-monitor blood glucose and how to treat hypoglycemia. Glucose tablets, glucose gel, cranberry juice, or hard candy should be kept at home for use in hypoglycemia emergency. Symptoms of hypoglycemia include nausea, rapid heartbeat, sweating, hunger, dizziness, light-headedness, confusion, and anxiety.
Tell patient to maintain adequate hydration to prevent hypotension and report symptoms of hypotension (faintness, light-headedness, dizziness, palpitations, heart racing).
Instruct patient to immediately seek treatment for and report symptoms of ketoacidosis (weakness, fatigue, flushed face, nausea, vomiting, thirst, fruity breath, frequent urination).
Tell patient to immediately seek treatment for and report symptoms of necrotizing fasciitis of the perineum (Fournier gangrene: tenderness, redness, or swelling of the genitals or perineum; fever; malaise; perineal skin discoloration; sores; blisters; drainage; foul odor).
Teach about the importance of and how to perform meticulous daily foot and lower leg care. Counsel patient to report new pain or tenderness, sores, ulcers, or infections involving the leg or foot.
Advise patient to report symptoms of UTI (fever, frequent and painful urination, bloody urine, flank pain, pelvic pain or pressure) or genital mycotic infections (genital itchiness, yeasty discharge).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Instruct women of reproductive potential to notify health care professional if pregnancy if planned or suspected and to avoid breastfeeding. Avoid use in 2nd and 3rd trimester of pregnancy and weigh risk vs. benefit of use during 1st trimester.

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Indications ⬇

Contraind./Precautions ⬆ ⬇