Sodium-Glucose Transporter 2 Inhibitors

Sodium-Glucose Cotransporter 2 Inhibitor

Diabetes Mellitus, Type 2

<section class="Section" data-sectioncode="34089-3"><a name="ID_fd36fb00-7c31-4b1a-ad48-5d227ed82c01"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>Dapagliflozin, an inhibitor of SGLT2, is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6•C3H8O2•H2O and the molecular weight is 502.98. The structural formula is:<div class="Figure"><a name="id6857421"></a><img alt="Dapagliflozin Chemical Structure" src="dapagliflozin_struct.jpg"/></div>FARXIGA is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol or the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol, and the following inactive ingredients: anhydrous lactose, crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.</section>

FARXIGA

Farxiga

dapagliflozin 10 MG Oral Tablet [Farxiga]

dapagliflozin 5 MG Oral Tablet [Farxiga]

dapagliflozin

dapagliflozin 10 MG Oral Tablet

dapagliflozin 5 MG Oral Tablet

Dipeptidyl Peptidase 4 Inhibitors

Dipeptidyl Peptidase 4 Inhibitor

Biguanide

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>TRIJARDY XR tablets for oral use contain: empagliflozin, linagliptin, and metformin HCl.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>EmpagliflozinEmpagliflozin is 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).The molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is:<img alt="Chemical Structure" src="trijardy-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.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>LinagliptinLinagliptin is an inhibitor of the DPP-4 enzyme.The chemical name of linagliptin is 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-The molecular formula is C25H28N8O2 and the molecular weight is 472.54. The structural formula is:<img alt="Chemical Structure" src="trijardy-02.jpg"/>Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water. Linagliptin is soluble in methanol, sparingly soluble in ethanol, very slightly soluble in isopropanol, and very slightly soluble in acetone.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.3"></a>Metformin HClMetformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a biguanide. 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 HCl 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. The structural formula is:<img alt="Chemical Structure" src="trijardy-03.jpg"/></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.4"></a>TRIJARDY XREach film-coated tablet of TRIJARDY XR consists of an extended-release metformin hydrochloride core tablet that is coated with the immediate-release drug substances: empagliflozin and linagliptin.TRIJARDY XR tablets for oral administration are available in four strengths containing:<ul class="Disc"><li>5 mg empagliflozin, 2.5 mg linagliptin, and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li><li>10 mg empagliflozin, 5 mg linagliptin, and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li><li>12.5 mg empagliflozin, 2.5 mg linagliptin, and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li><li>25 mg empagliflozin, 5 mg linagliptin, and 1,000 mg metformin HCl (equivalent to 779.86 mg of metformin)</li></ul>Each film-coated tablet of TRIJARDY XR contains the following inactive ingredients: Tablet Core: hypromellose, magnesium stearate, and polyethylene oxide. Film Coatings and Printing Ink: ammonium hydroxide, arginine, carnauba wax, ferric oxide yellow and ferric oxide red (10 mg/5 mg/1,000 mg), ferrosoferric oxide and ferric oxide red (12.5 mg/2.5 mg/1,000 mg), ferrosoferric oxide and ferric oxide yellow (5 mg/2.5 mg/1,000 mg and 25 mg/5 mg/1,000 mg), hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, propylene glycol, purified water, shellac glaze, talc, and titanium dioxide.</div></section>

Trijardy XR

linagliptin

empagliflozin

empagliflozin / linagliptin / metformin

metformin hydrochloride

24 HR empagliflozin 10 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

Trijardy

24 HR empagliflozin 10 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]

24 HR empagliflozin 12.5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR empagliflozin 12.5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]

24 HR empagliflozin 25 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR empagliflozin 25 MG / linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]

24 HR empagliflozin 5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR empagliflozin 5 MG / linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Trijardy]

metformin

Farxiga (dapagliflozin) is an oral medication prescribed for individuals with diabetes, heart disease, or kidney disease to enhance their health outcomes. Here's how Farxiga is utilized:

Farxiga is employed in adults with type 2 diabetes mellitus, complementing dietary and exercise measures to regulate blood sugar levels.

It helps lower the likelihood of hospitalization due to heart failure in adults with type 2 diabetes who have either cardiovascular disease or multiple cardiovascular risk factors.

Farxiga reduces the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults already dealing with heart failure.

It also diminishes the risk of further deterioration in kidney function, progression to end-stage kidney disease (ESKD), cardiovascular-related deaths, and hospitalization due to heart failure in adults with chronic kidney disease who are at risk. 

Farxiga operates by inhibiting the sodium-glucose cotransporter 2 (SGLT2) found in the kidneys' proximal renal tubules. This inhibition prevents the reabsorption of glucose, causing it to be excreted in the urine. Additionally, Farxiga reduces sodium reabsorption in the kidneys, affecting various physiological functions. These include reducing the heart's preload and afterload, regulating sympathetic activity, and decreasing renal pressure.

Farxiga received FDA approval on January 8, 2014, and belongs to the class of medications known as selective sodium-glucose cotransporter-2 inhibitors.

Report Adverse Event 

Submit MSL Request

Pharmacy List 

Online Sample Form 

Formulary Look Up Tool

Coverage Authorization Request 

Coverage Authorization Appeals 

Enroll in Patient Savings Program 

Farxiga Support 

Other HCP Resources: Video

Other HCP Resources 

Wallet Card 

Farxiga Newly Diagnosed CKD Patient Tear Sheet 

Doctor Discussion Guide

Doctor Discussion Guide (Spanish)

Side Effects 

FAQs: Diabete, CKD & Heart Failure 

Instructions For Use: Diabetes

Instructions For Use: CKD

Trijardy XR tablets combine empagliflozin, linagliptin, and metformin, which are all oral medications for managing blood sugar levels.

This prescription medication, Trijardy XR, is employed in conjunction with dietary and exercise measures to enhance blood sugar regulation in adults diagnosed with type 2 diabetes mellitus. Additionally, it is utilized to reduce the risk of mortality resulting from heart attack, stroke, or heart failure in adults who have both type 2 diabetes and heart disease.

It's important to note that Trijardy XR is not intended for the treatment of type 1 diabetes.

Farxiga®(dapagliflozin)	Trijardy XR®(metformin hydrochloride)

Prescription Only Farxiga (dapagliflozin) is an oral medication prescribed for individuals with diabetes, heart disease, or kidney disease to enhance their health outcomes. Here's how Farxiga is...	Prescription Only Trijardy XR tablets combine empagliflozin, linagliptin, and metformin, which are all oral medications for managing blood sugar levels. This prescription medication, Trijardy XR,...
Dosage & Administration
Administration
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Dosing
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Latin Shorthand
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Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$10. Learn more.
Annual Cap
$175 per month. Learn more.	$175 per month. Learn more.
Assistance Expiration
Learn more.	12/31/23. 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 female genital mycotic infections, nasopharyngitis, and urinary tract infections. . Learn more.	Most common adverse reactions (5% or greater incidence) were upper respiratory tract infection, urinary tract infection, nasopharyngitis, diarrhea, constipation, headache, and gastroenteritis. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Farxiga® Alternatives