Dipeptidyl Peptidase 4 Inhibitor

Dipeptidyl Peptidase 4 Inhibitors

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>GLYXAMBI tablets for oral use contain: empagliflozin and linagliptin.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>EmpagliflozinEmpagliflozin is an inhibitor of the sodium-glucose co-transporter 2 (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="glyxambi-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 dipeptidyl peptidase-4 (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="glyxambi-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>GLYXAMBIGLYXAMBI tablets are available in two dosage strengths containing 10 mg or 25 mg empagliflozin in combination with 5 mg linagliptin. The inactive ingredients of GLYXAMBI are the following: Tablet Core: mannitol, pregelatinized starch, corn starch, copovidone, crospovidone, talc and magnesium stearate. Coating: hypromellose, mannitol, talc, titanium dioxide, polyethylene glycol and ferric oxide, yellow (10 mg/5 mg) or ferric oxide, red (25 mg/5 mg).</div></section>

Glyxambi

empagliflozin

empagliflozin / linagliptin

empagliflozin 10 MG / linagliptin 5 MG Oral Tablet

empagliflozin 10 MG / linagliptin 5 MG Oral Tablet [Glyxambi]

empagliflozin 25 MG / linagliptin 5 MG Oral Tablet

empagliflozin 25 MG / linagliptin 5 MG Oral Tablet [Glyxambi]

linagliptin

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>INVOKANA ®(canagliflozin) contains canagliflozin, an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin, the active ingredient of INVOKANA, is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is: <div class="Figure"><img alt="Chemical Structure" src="invokana-01.jpg"/></div>Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9.INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively.Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only).</section>

INVOKANA

Invokana

canagliflozin

canagliflozin 100 MG Oral Tablet

canagliflozin 100 MG Oral Tablet [Invokana]

canagliflozin 300 MG Oral Tablet

canagliflozin 300 MG Oral Tablet [Invokana]

Glyxambi is a medication that combines empagliflozin and linagliptin, both of which are oral drugs designed to manage blood sugar levels. Empagliflozin operates by aiding the kidneys in removing excess glucose from the bloodstream, while linagliptin works to regulate insulin production in response to meals.

Glyxambi is prescribed alongside a balanced diet and regular exercise to enhance blood sugar management in adults dealing with type 2 diabetes mellitus. Additionally, it is employed to reduce the risk of mortality due to heart attack, stroke, or heart failure in adults who have both type 2 diabetes and heart disease.

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

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About Glyxambi

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Instructions For Use: Diabetes 

Invokana, an oral medication for diabetes, plays a crucial role in regulating blood sugar levels. Canagliflozin, its active component, functions by facilitating the elimination of glucose from the bloodstream through the kidneys.

Invokana is prescribed in conjunction with dietary adjustments and physical activity to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus.

Moreover, Invokana serves as a preventative measure, reducing the risk of fatality resulting from heart attack, stroke, or heart failure in adults who have both type 2 diabetes and heart disease. It is also employed to mitigate the risk of end-stage kidney disease and the likelihood of hospitalization or mortality due to heart-related issues in adults with kidney complications linked to type 2 diabetes.

Please note that Invokana is not suitable for the treatment of type 1 diabetes.

Glyxambi®(empagliflozin / linagliptin)	Invokana®(canagliflozin)

Prescription Only Glyxambi is a medication that combines empagliflozin and linagliptin, both of which are oral drugs designed to manage blood sugar levels. Empagliflozin operates by aiding the...	Prescription Only Invokana, an oral medication for diabetes, plays a crucial role in regulating blood sugar levels. Canagliflozin, its active component, functions by facilitating the elimination of...
Dosage & Administration
Administration
Oral . Learn more.	Oral. Learn more.
Dosing
The recommended dose of GLYXAMBI is 10 mg empagliflozin and 5 mg linagliptin once daily, taken in the morning, with or without food. Dose may be increased to 25 mg empagliflozin and 5 mg linagliptin once daily.. Learn more.	The recommended starting dose is 100 mg once daily, taken before the first meal of the day. Dose can be increased to 300 mg once daily in patients tolerating 100 mg once daily who have an eGFR of 60 mL/min/1.73 m2 or greater.. Learn more.
Latin Shorthand
Recommended GLYXAMBI dose: 10mg empagliflozin + 5mg linagliptin qd in the AM, with or without food. May increase to 25mg empagliflozin + 5mg linagliptin qd.. Learn more.	Starting dose: 100 mg daily before 1st meal. Increase to 300 mg daily if tolerating 100 mg daily with eGFR ≥ 60 mL/min/1.73 m².. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$10. Learn more.	$0. Learn more.
Annual Cap
$175 per month. Learn more.	$3000 and $200 per month. Learn more.
Assistance Expiration
Learn more.	Calendar year. 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, nasopharyngitis, and upper respiratory tract infections.. Learn more.	Most common adverse reactions (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Glyxambi® Alternatives