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

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>STEGLATRO (ertugliflozin) tablets for oral use contain ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor.The 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="steglatro-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.STEGLATRO is supplied as film-coated tablets, containing 6.48 or 19.43 mg of ertugliflozin L-pyroglutamic acid, which is equivalent to 5 and 15 mg of ertugliflozin.Inactive ingredients are microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, and magnesium stearate.The film coating contains: hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide and iron oxide red.</section>

STEGLATRO

Steglatro

ertugliflozin

ertugliflozin 15 MG Oral Tablet

ertugliflozin 15 MG Oral Tablet [Steglatro]

ertugliflozin 5 MG Oral Tablet

ertugliflozin 5 MG Oral Tablet [Steglatro]

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

Steglatro is an oral medication designed to regulate blood sugar levels. Its active component, ertugliflozin, functions by facilitating the removal of glucose from the bloodstream through the kidneys.

It is prescribed in conjunction with dietary and exercise measures to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus. It's essential to note that Steglatro is not intended for the treatment of type 1 diabetes.

Invokamet ®(canagliflozin / metformin)	Steglatro®(ertugliflozin)

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 Steglatro is an oral medication designed to regulate blood sugar levels. Its active component, ertugliflozin, functions by facilitating the removal of glucose from the bloodstream...
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.	Recommended starting dose is 5 mg once daily, taken in the morning, with or without food. Increase dose to 15 mg once daily in those tolerating STEGLATRO and needing additional glycemic control.. Learn more.
Latin Shorthand
1 tab BID with meals. Starting dose: canagliflozin 50 mg BID, metformin HCl 500 mg BID.. Learn more.	Starting dose: 5mg qd (morning, with or without food). Increase to 15mg daily if tolerated and requiring more glycemic control.. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$0. Learn more.
Annual Cap
$3,000 and $200 per month. Learn more.	$583 per fill . Learn more.
Assistance Expiration
Calendar year. 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 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 (incidence ≥ 5%) were female genital mycotic infections. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Invokamet ® Alternatives