Dipeptidyl Peptidase 4 Inhibitor

Dipeptidyl Peptidase 4 Inhibitors

Type 2 Diabetes Mellitus

<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

Steglujan

ertugliflozin

ertugliflozin / sitagliptin

ertugliflozin 15 MG / sitagliptin 100 MG Oral Tablet

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

Biguanide

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>SEGLUROMET (ertugliflozin and metformin hydrochloride) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and metformin HCl, a member of the biguanide class.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>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="segluromet-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.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>Metformin HClMetformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:<img alt="Chemical Structure" src="segluromet-02.jpg"/>Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.SEGLUROMET is available as film-coated tablets containing:<ul class="Disc"><li>3.24 mg ertugliflozin L-pyroglutamic acid equivalent to 2.5 mg of ertugliflozin and 500 mg metformin HCl (SEGLUROMET 2.5/500)</li><li>3.24 mg ertugliflozin L-pyroglutamic acid equivalent to 2.5 mg of ertugliflozin and 1,000 mg metformin HCl (SEGLUROMET 2.5/1000)</li><li>9.71 mg ertugliflozin L-pyroglutamic acid equivalent to 7.5 mg of ertugliflozin and 500 mg metformin HCl (SEGLUROMET 7.5/500)</li><li>9.71 mg ertugliflozin L-pyroglutamic acid equivalent to 7.5 mg of ertugliflozin and 1,000 mg metformin HCl (SEGLUROMET 7.5/1000)</li></ul>Inactive ingredients are povidone, microcrystalline cellulose, crospovidone, sodium lauryl sulfate, and magnesium stearate.The film coating contains: hypromellose, hydroxypropyl cellulose, titanium dioxide, iron oxide red, and carnauba wax.</div></section>

SEGLUROMET

Segluromet

ertugliflozin / metformin

ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet

ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Segluromet]

ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet

ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet [Segluromet]

ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral Tablet

ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Segluromet]

ertugliflozin 7.5 MG / metformin hydrochloride 500 MG Oral Tablet

ertugliflozin 7.5 MG / metformin hydrochloride 500 MG Oral Tablet [Segluromet]

metformin

metformin hydrochloride

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

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FAQs: Type 2 Diabetes 

Instructions For Use: Type 2 Diabetes 

Segluromet is a medication that combines ertugliflozin and metformin to regulate blood sugar levels. Ertugliflozin aids the kidneys in removing glucose from the bloodstream, while metformin reduces the amount of sugar released by the liver into the blood.

This medication is prescribed alongside diet and exercise to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus. It's important to note that Segluromet is not intended for the treatment of type 1 diabetes.

Steglujan®(ertugliflozin / sitagliptin)	Segluromet®(metformin hydrochloride)

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 Segluromet is a medication that combines ertugliflozin and metformin to regulate blood sugar levels. Ertugliflozin aids the kidneys in removing glucose from the bloodstream, while...
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.	Maximum recommended dose is 7.5 mg ertugliflozin/1,000 mg metformin twice daily. Take twice daily with meals, with gradual dose escalation. Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2 . . 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.	Max dose: 7.5 mg ertugliflozin / 1000 mg metformin BID. Take with meals, gradual dose increase. Avoid if eGFR < 30 mL/min/1.73 m².. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$0. Learn more.
Annual Cap
$583 per fill . Learn more.	$583 per fill . Learn more.
Assistance Expiration
12 uses. 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 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 associated with ertugliflozin (incidence ≥5%) were female genital mycotic infections. Most common adverse reactions associated with metformin (incidence ≥5%) were diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Steglujan® Alternatives