Duport^®

Duport is a preparation of sotagliflozin which is an inhibitor of SGLT2 and SGLT1. Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium which results in lowering both preload and afterload of the heart and downregulating sympathetic activity. Inhibiting SGLT1 reduces intestinal absorption of glucose and sodium.

No Data

Duport is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure treatment in adults with:
• Heart failure or
• Type 2 diabetes mellitus, chronic kidney disease and other cardiovascular risk factors.

Route of administration: Duport should be taken in oral route not more than one hour before the
first meal of the day.

The recommended starting dose is one Duport 200 tablet once daily. Up-titrate after at least 2
weeks to 400 mg orally once daily as tolerated. Down-titrate to 200 mg as necessary. If a dose is
missed by more than 6 hours, take the next dose as prescribed the next day. Withhold Duport® at
least 3 days prior to major surgery or procedures associated with prolonged fasting. Resume when
the patient is clinically stable and has resumed oral intake.

For patients with decompensated heart failure, dosing may begin as soon as the patient is
hemodynamically stable, including during hospitalization or urgent outpatient treatment or
immediately upon discharge.

Pregnancy: There are no adequate and well-controlled studies in pregnant women with sotagliflozin.

Lactation: There is no information regarding the presence of sotagliflozin in human milk, the effects on the breastfed infant or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended while taking sotagliflozin.

Use in children and adolescents
Safety and effectiveness in children and adolescents below 18 years of age have not been
established.

Consider ketone monitoring in patients with type 1 diabetes mellitus and at risk for ketoacidosis.
Monitor patients for resolution of ketoacidosis before restarting. Before initiating, assess and correct
volume status with renal function. Monitor for signs and symptoms of hypotension, urosepsis and
pyelonephritis during therapy and treat promptly. There’s a risk of hypoglycemia with concomitant
use with insulin and insulin secretagogues. Monitor for signs and symptoms of necrotizing fasciitis of
the perineum (Fournier’s Gangrene) and genital mycotic infections. Discontinue administration and
treat accordingly if necessary.

The most common side effects are urinary tract infection, volume depletion, diarrhea and hypoglycemia.

It is contraindicated in patients with history of known hypersensitivity to sotagliflozin or any other
components of this product.

Drug interaction with medication: Patients taking sotagliflozin with concomitant digoxin should be
monitored appropriately. The coadministration of rifampicin, an inducer of UGTs, with a single dose
of 400 mg sotagliflozin resulted in a decrease in the exposure to sotagliflozin. Concomitant use of an
SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Proper monitoring should
be ensured.

Drug interaction with food and others: Not applicable.

In case of overdose, proper monitoring and general supportive measures should be initiated.

No Data

No Data

Duport 200 Tablet: Each coated tablet contains Sotagliflozin INN 200 mg

Storage
Store below 30⁰ C in a dry place, protected from light. Keep away from the reach of children.

Packing
Duport 200 Tablet: Carton of 10 tablets in blister pack.