Biguanide

Type 2 Diabetes Mellitus

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>INVOKAMET ®(canagliflozin and metformin HCl) and INVOKAMET ®XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. <div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>CanagliflozinCanagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin 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="invokamet-01.jpg"/></div>Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>Metformin HClMetformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C 4H 11N 5∙ HCl and 165.62, respectively. The structural formula for metformin HCl is: <div class="Figure"><img alt="Chemical Structure" src="invokamet-02.jpg"/></div></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.3"></a>INVOKAMET and INVOKAMET XRINVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively).Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively).INVOKAMET contains the following inactive ingredients: croscarmellose sodium, hypromellose, 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 inactive ingredients: macrogol/PEG3350, polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, iron oxide yellow (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (150 mg/1,000 mg tablets only).INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate (vegetable-sourced), microcrystalline cellulose, polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350, polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, iron oxide red, iron oxide yellow, and iron oxide black (50 mg/1,000 mg and 150 mg/1,000 mg tablets only).INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion.</div></section>

INVOKAMET

24 HR canagliflozin 150 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR canagliflozin 150 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Invokamet]

24 HR canagliflozin 150 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet

24 HR canagliflozin 150 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Invokamet]

24 HR canagliflozin 50 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR canagliflozin 50 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Invokamet]

24 HR canagliflozin 50 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet

24 HR canagliflozin 50 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Invokamet]

Invokamet

canagliflozin

canagliflozin / metformin

canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral Tablet

canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral Tablet [Invokamet]

canagliflozin 150 MG / metformin hydrochloride 500 MG Oral Tablet

canagliflozin 150 MG / metformin hydrochloride 500 MG Oral Tablet [Invokamet]

canagliflozin 50 MG / metformin hydrochloride 1000 MG Oral Tablet

canagliflozin 50 MG / metformin hydrochloride 1000 MG Oral Tablet [Invokamet]

canagliflozin 50 MG / metformin hydrochloride 500 MG Oral Tablet

canagliflozin 50 MG / metformin hydrochloride 500 MG Oral Tablet [Invokamet]

metformin

metformin hydrochloride

Dipeptidyl Peptidase 4 Inhibitor

Dipeptidyl Peptidase 4 Inhibitors

Sodium-Glucose Cotransporter 2 Inhibitor

Sodium-Glucose Transporter 2 Inhibitors

<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 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 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: copovidone, corn starch, crospovidone, magnesium stearate, mannitol, pregelatinized starch, and talc. Coating: ferric oxide yellow (10 mg/5 mg) or ferric oxide red (25 mg/5 mg), hypromellose, mannitol, polyethylene glycol, talc, and titanium dioxide.</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

Invokamet XR is a medication that, when combined with dietary and exercise measures, is prescribed to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus.

Additionally, Invokamet XR serves as a preventive measure to reduce the risk of fatality due to heart attack, stroke, or heart failure in adults who have type 2 diabetes and coexisting heart disease. It is also employed to diminish the likelihood of end-stage kidney disease and hospitalization or fatality stemming from heart issues in individuals with kidney problems linked to type 2 diabetes.

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

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Instructions For Use: Diabetes

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.

Invokamet XR ®(metformin hydrochloride)	Glyxambi®(empagliflozin / linagliptin)

Prescription Only Invokamet XR is a medication that, when combined with dietary and exercise measures, is prescribed to enhance blood sugar management in adults diagnosed with type 2 diabetes...	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...
Dosage & Administration
Administration
Oral . Learn more.	Oral . Learn more.
Dosing
INVOKAMET XR: two tablets, once daily with the morning meal. Swallow whole. Never crush, cut, or chew. . Learn more.	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.
Latin Shorthand
2 tabs, 1x daily with AM meal. Swallow whole, do not crush, cut, or chew.. Learn more.	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.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$10. Learn more.
Annual Cap
$3000 and $200 per month. Learn more.	$175 per month. Learn more.
Assistance Expiration
Calendar year. Learn more.	Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory
Adverse Reactions
Most common adverse reactions associated with canagliflozin (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination. Most common adverse reactions associated with metformin HCl (5% or greater incidence) are diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache.. Learn more.	Most common adverse reactions (5% or greater incidence) were urinary tract infections, nasopharyngitis, and upper respiratory tract infections.. Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Invokamet XR ® Alternatives