Dipeptidyl Peptidase 4 Inhibitors

Dipeptidyl Peptidase 4 Inhibitor

Diabetes Mellitus, Type 2

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>STEGLUJAN (ertugliflozin and sitagliptin) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and sitagliptin phosphate, a DPP-4 inhibitor.ErtugliflozinThe 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="steglujan-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.SitagliptinSitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate.The empirical formula is C16H15F6N5O∙H3PO4∙H2O and the molecular weight is 523.32. The structural formula is:<div class="Figure"><img alt="Chemical Structure" src="steglujan-02.jpg"/></div>Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate.STEGLUJAN is available for oral use as film-coated tablets containing:<ul class="Disc"><li>6.48 mg ertugliflozin L-pyroglutamic acid equivalent to 5 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (STEGLUJAN 5/100)</li><li>19.43 mg ertugliflozin L-pyroglutamic acid equivalent to 15 mg of ertugliflozin and 128.5 mg sitagliptin phosphate monohydrate equivalent to 100 mg sitagliptin (STEGLUJAN 15/100)</li></ul>Inactive ingredients are microcrystalline cellulose, dibasic calcium phosphate anhydrous, croscarmellose sodium, sodium stearyl fumarate, magnesium stearate, and propyl gallate.The film coating contains: hypromellose, hydroxypropyl cellulose, titanium dioxide, iron oxide red, iron oxide yellow, ferrosoferric oxide/black iron oxide, and carnauba wax.</section>

STEGLUJAN

ertugliflozin

ertugliflozin / sitagliptin

ertugliflozin 15 MG / sitagliptin 100 MG Oral Tablet

Steglujan

ertugliflozin 15 MG / sitagliptin 100 MG Oral Tablet [Steglujan]

ertugliflozin 5 MG / sitagliptin 100 MG Oral Tablet

ertugliflozin 5 MG / sitagliptin 100 MG Oral Tablet [Steglujan]

sitagliptin

P-Glycoprotein Inhibitors

Sodium-Glucose Transporter 2 Inhibitors

Sodium-Glucose Cotransporter 2 Inhibitor

<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

sotagliflozin

sotagliflozin 200 MG Oral Tablet

Inpefa

sotagliflozin 200 MG Oral Tablet [Inpefa]

sotagliflozin 400 MG Oral Tablet

sotagliflozin 400 MG Oral Tablet [Inpefa]

Steglujan is a medication that combines ertugliflozin and sitagliptin. These two components work together to manage blood sugar levels. Ertugliflozin helps the kidneys remove glucose from the bloodstream, while sitagliptin regulates insulin production in response to meals.

Steglujan is prescribed alongside diet and exercise to enhance blood sugar control in adults diagnosed with type 2 diabetes mellitus. It is important to note that Steglujan is not intended for the treatment of type 1 diabetes.

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About Steglujan

Side Effects 

FAQs: Type 2 Diabetes 

Instructions For Use: Type 2 Diabetes 

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.

Steglujan®(ertugliflozin / sitagliptin)	Inpefa®(sotagliflozin)

Prescription Only Steglujan is a medication that combines ertugliflozin and sitagliptin. These two components work together to manage blood sugar levels. Ertugliflozin helps the kidneys remove...	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...
Dosage & Administration
Administration
Oral . Learn more.	Oral . Learn more.
Dosing
Recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin once daily, taken in the morning, with or without food. Increase dose to 15 mg ertugliflozin/100 mg sitagliptin once daily in those tolerating STEGLUJAN for additional glycemic control. . Learn more.	200 mg daily and titrate to 400 mg as tolerated.. Learn more.
Latin Shorthand
5 mg ertugliflozin/100 mg sitagliptin qd in AM, with or without food. Increase to 15 mg ertugliflozin/100 mg sitagliptin qd for those tolerating STEGLUJAN and needing additional glycemic control.. Learn more.	Take 200 mg qd, increase to 400 mg qd if tolerated.. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$10. Learn more.
Annual Cap
$583 per fill . Learn more.	$2,600. Learn more.
Assistance Expiration
12 uses. Learn more.	12/31/25. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory
Adverse Reactions
Most common adverse reactions associated with ertugliflozin (incidence ≥5%): female genital mycotic infections. Most common adverse reactions associated with sitagliptin (incidence ≥5%): upper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin studies, hypoglycemia was also more commonly reported in patients treated with sitagliptin compared to placebo.. Learn more.	Most common adverse reactions (incidence ≥ 5%) are urinary tract infection, volume depletion, diarrhea, and hypoglycemia. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Steglujan® Alternatives