Sodium-Glucose Cotransporter 2 Inhibitor

Sodium-Glucose Transporter 2 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>JARDIANCE tablets for oral use contain empagliflozin, an inhibitor of the SGLT2.The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S).Its molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is:<img alt="Chemical Structure" src="jardiance-01.jpg"/>Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile, soluble in 50% acetonitrile/water, and practically insoluble in toluene.Each film-coated tablet of JARDIANCE contains 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: hypromellose, polyethylene glycol, talc, titanium dioxide, and yellow ferric oxide.</section>

Jardiance

empagliflozin

empagliflozin 10 MG Oral Tablet

empagliflozin 10 MG Oral Tablet [Jardiance]

empagliflozin 25 MG Oral Tablet

empagliflozin 25 MG Oral Tablet [Jardiance]

Dipeptidyl Peptidase 4 Inhibitor

Dipeptidyl Peptidase 4 Inhibitors

<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, and magnesium stearate.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

Jardiance (empagliflozin) is an FDA-approved tablet used to manage blood sugar levels in individuals aged 10 and above with type 2 diabetes. It is also employed to lower the risk of cardiovascular issues in adults with heart failure or cardiovascular disease and type 2 diabetes. Jardiance operates by reducing blood glucose levels (HbA1c) through increased glucose elimination in the urine. When prescribed for type 2 diabetes, it should be used alongside diet and exercise. Jardiance belongs to the SGLT-2 inhibitor class (sodium-glucose cotransporter-2 inhibitors). It functions by inhibiting SGLT-2 proteins found in the renal tubules of the kidneys, responsible for reabsorbing glucose into the bloodstream.

Jardiance is available in 10mg and 25mg tablet forms.

The mechanism through which Jardiance reduces the risk of cardiovascular problems or heart failure is believed to involve altering heart muscle metabolism. This shift favors a balanced combination of fatty acids, ketone bodies (ketones), branched-chain amino acids (BCAA), and glucose over relying solely on glucose. Jardiance also enhances the heart's diastolic stiffness and function.

Type 2 diabetes is a chronic condition where elevated blood sugar levels (HbA1c) result from the body's inability to produce or utilize insulin properly. Prolonged high blood sugar levels can lead to severe health issues, including heart disease, vision impairment, and kidney disease. Maintaining better control of blood sugar levels helps mitigate the risk of diabetes-related complications.

Report Adverse Event 

Prescribing Information

Medication Guide 

Submit MSL Request 

Pharmacy List 

Formulary Information

Formulary Flash Card 

Coverage Authorization Request 

Coverage Authorization Appeals 

Enroll in Patient Savings Program 

BI Cares Foundation Patient Assistance Program

Other HCP Resources: Type 2 Diabetes 

Instructions For Use: Type 2 Diabetes 

Other HCP Resources: CVD

Instructions For Use: CVD

Other HCP Resources: Heart Failure 

Instructions For Use: Heart Failure 

About Jardience: Type 2 Diabetes 

Taking Jardience: Type 2 Diabetes 

Doctor Discussion Guide: Type 2 Diabetes

FAQs: Type 2 Diabetes 

My Jardience Support: Type 2 Diabetes 

Patient Resources: Type 2 Diabetes

About Jardience: Heart Failure 

Doctor Discussion Guide: Heart Failure 

Your Care Team: Heart Failure 

Caregiver Tips: Heart Failure 

Patient Support: Heart Failure 

FAQs: Heart Failure 

Managing Multiple Medications

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.

Jardiance®(empagliflozin)	Steglujan®(ertugliflozin / sitagliptin)

Prescription Only Jardiance (empagliflozin) is an FDA-approved tablet used to manage blood sugar levels in individuals aged 10 and above with type 2 diabetes. It is also employed to lower the risk...	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...
Dosage & Administration
Administration
Oral . Learn more.	Oral . Learn more.
Dosing
Recommended dosage is 10 mg once daily in the morning, taken with or without food. For additional glycemic control, dosage may be increased to 25 mg.. Learn more.	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.
Latin Shorthand
Recommended: 10mg qd in AM, with or without food. May increase to 25mg for better glycemic control.. Learn more.	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.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$10. Learn more.	$0. Learn more.
Annual Cap
$175 per month. Learn more.	$583 per fill . Learn more.
Assistance Expiration
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 (5% or greater incidence) were urinary tract infections and female genital mycotic infections. . Learn more.	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.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Jardiance® Alternatives