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 hydrochloride 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 sodium-glucose co-transporter 2 (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 hydrochloride 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 XR<ul class="Disc"><li>INVOKAMET/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). </li><li>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).</li></ul>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

Invokamet

canagliflozin

canagliflozin / metformin

canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral Tablet

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

metformin

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>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

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

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]

Trijardy

empagliflozin

empagliflozin / linagliptin / metformin

linagliptin

metformin hydrochloride

Invokamet is a medication that combines two active ingredients, canagliflozin and metformin. These components are both oral medications designed to help manage and regulate blood sugar levels.

Invokamet is prescribed to adults with type 2 diabetes mellitus, and it is typically used in conjunction with dietary adjustments and physical activity to enhance blood sugar management. Additionally, Invokamet is employed to decrease the likelihood of heart attack, stroke, or heart failure-related mortality in individuals with type 2 diabetes who also have heart disease.

Furthermore, Invokamet is utilized to lower the risk of end-stage kidney disease and the occurrence of hospitalization or death due to heart issues in adults who have kidney problems attributed to type 2 diabetes.

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

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Instructions For Use: Diabetes

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.

Invokamet ®(canagliflozin / metformin)	Trijardy XR®(metformin hydrochloride)

Prescription Only Invokamet is a medication that combines two active ingredients, canagliflozin and metformin. These components are both oral medications designed to help manage and regulate blood...	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
Oral. Learn more.	Oral . Learn more.
Dosing
One tablet, twice daily with meals, recommended starting dose of canagliflozin is 50 mg twice daily and metformin HCl 500 mg twice daily. Learn more.	The maximum recommended dose of TRIJARDY XR is 25 mg empagliflozin, 5 mg linagliptin and 2000 mg metformin HCl. Take once daily with a meal in the morning. Swallow whole; do not split, crush, dissolve, or chew.. Learn more.
Latin Shorthand
1 tab BID with meals. Starting dose: canagliflozin 50 mg BID, metformin HCl 500 mg BID.. Learn more.	Max dose TRIJARDY XR: 25 mg empagliflozin, 5 mg linagliptin, 2000 mg metformin HCl. Take 1x daily with AM meal. Swallow whole; no splitting, crushing, dissolving, or chewing.. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$10. Learn more.
Annual Cap
$3,000 and $200 per month. Learn more.	$175 per month. Learn more.
Assistance Expiration
Calendar year. 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 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 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

Invokamet ® Alternatives