P-Glycoprotein Inhibitors

Sodium-Glucose Cotransporter 2 Inhibitor

Sodium-Glucose Transporter 2 Inhibitors

<section class="Section" data-sectioncode="34089-3"><a name="s41"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>INPEFA tablets for oral administration contain sotagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor.The chemical name of sotagliflozin is (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol.Its molecular formula is C21H25ClO5S and the molecular weight is 424.94. The structural formula is:<a name="f01"></a><img alt="Structural Formula
" src="sot00-0008-01.jpg"/>Sotagliflozin is a white to off-white solid. It is practically insoluble in water.Each film-coated tablet of INPEFA contains 200 mg or 400 mg of sotagliflozin and the following inactive ingredients. The core of the tablet contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc. The film coating for the 200 mg tablet contains: indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol (partly hydrolyzed), talc, and titanium dioxide. The film coating for the 400 mg tablet contains: hypromellose, lactose monohydrate, titanium dioxide, triacetin, and yellow iron oxide. The 200 mg printed tablet also includes black ink which contains: ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac.</section>

INPEFA

Inpefa

sotagliflozin

sotagliflozin 200 MG Oral Tablet

sotagliflozin 200 MG Oral Tablet [Inpefa]

sotagliflozin 400 MG Oral Tablet

sotagliflozin 400 MG Oral Tablet [Inpefa]

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>STEGLATRO (ertugliflozin) tablets for oral use contain ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor.The chemical name of ertugliflozin L-pyroglutamic acid is (1S,2S,3S,4R,5S)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, compound with (2S)-5-oxopyrrolidine-2-carboxylic acid. The molecular formula is C27H32ClNO10 and the molecular weight is 566.00.The chemical structure is:<img alt="Chemical Structure" src="steglatro-01.jpg"/>Ertugliflozin L-pyroglutamic acid is a white to off-white powder that is soluble in ethyl alcohol and acetone, slightly soluble in ethyl acetate and acetonitrile and very slightly soluble in water.STEGLATRO is supplied as film-coated tablets, containing 6.48 or 19.43 mg of ertugliflozin L-pyroglutamic acid, which is equivalent to 5 and 15 mg of ertugliflozin.Inactive ingredients are microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, and magnesium stearate.The film coating contains: hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide and iron oxide red.</section>

STEGLATRO

Steglatro

ertugliflozin

ertugliflozin 15 MG Oral Tablet

ertugliflozin 15 MG Oral Tablet [Steglatro]

ertugliflozin 5 MG Oral Tablet

ertugliflozin 5 MG Oral Tablet [Steglatro]

Inpefa is an oral tablet taken once daily, and it contains sotagliflozin. It can be used to lower the chances of cardiovascular death, hospitalization due to heart failure, and urgent heart failure-related visits in adults dealing with heart failure, type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

Inpefa received approval on May 26, 2023.

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Instructions For Use: Risk Reduction in CV death & hospitalization

Steglatro is an oral medication designed to regulate blood sugar levels. Its active component, ertugliflozin, functions by facilitating the removal of glucose from the bloodstream through the kidneys.

It is prescribed in conjunction with dietary and exercise measures to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus. It's essential to note that Steglatro is not intended for the treatment of type 1 diabetes.

Inpefa®(sotagliflozin)	Steglatro®(ertugliflozin)

Prescription Only Inpefa is an oral tablet taken once daily, and it contains sotagliflozin. It can be used to lower the chances of cardiovascular death, hospitalization due to heart failure, and...	Prescription Only Steglatro is an oral medication designed to regulate blood sugar levels. Its active component, ertugliflozin, functions by facilitating the removal of glucose from the bloodstream...
Dosage & Administration
Administration
Oral . Learn more.	Oral. Learn more.
Dosing
200 mg daily and titrate to 400 mg as tolerated.. Learn more.	Recommended starting dose is 5 mg once daily, taken in the morning, with or without food. Increase dose to 15 mg once daily in those tolerating STEGLATRO and needing additional glycemic control.. Learn more.
Latin Shorthand
Take 200 mg qd, increase to 400 mg qd if tolerated.. Learn more.	Starting dose: 5mg qd (morning, with or without food). Increase to 15mg daily if tolerated and requiring more glycemic control.. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$10. Learn more.	$0. Learn more.
Annual Cap
$2,600. Learn more.	$583 per fill . Learn more.
Assistance Expiration
12/31/25. Learn more.	12 uses. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory
Adverse Reactions
Most common adverse reactions (incidence ≥ 5%) are urinary tract infection, volume depletion, diarrhea, and hypoglycemia. . Learn more.	Most common adverse reactions (incidence ≥ 5%) were female genital mycotic infections. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Inpefa® Alternatives