Biguanide

Diabetes Mellitus, Type 2

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>SEGLUROMET (ertugliflozin and metformin hydrochloride) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and metformin HCl, a member of the biguanide class.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>ErtugliflozinThe 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="segluromet-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.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>Metformin HClMetformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:<img alt="Chemical Structure" src="segluromet-02.jpg"/>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 hydrochloride 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.SEGLUROMET is available as film-coated tablets containing:<ul class="Disc"><li>3.24 mg ertugliflozin L-pyroglutamic acid equivalent to 2.5 mg of ertugliflozin and 500 mg metformin HCl (SEGLUROMET 2.5/500)</li><li>3.24 mg ertugliflozin L-pyroglutamic acid equivalent to 2.5 mg of ertugliflozin and 1,000 mg metformin HCl (SEGLUROMET 2.5/1000)</li><li>9.71 mg ertugliflozin L-pyroglutamic acid equivalent to 7.5 mg of ertugliflozin and 500 mg metformin HCl (SEGLUROMET 7.5/500)</li><li>9.71 mg ertugliflozin L-pyroglutamic acid equivalent to 7.5 mg of ertugliflozin and 1,000 mg metformin HCl (SEGLUROMET 7.5/1000)</li></ul>Inactive ingredients are povidone, microcrystalline cellulose, crospovidone, sodium lauryl sulfate, and magnesium stearate.The film coating contains: hypromellose, hydroxypropyl cellulose, titanium dioxide, iron oxide red, and carnauba wax.</div></section>

SEGLUROMET

ertugliflozin

ertugliflozin / metformin

ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet

Segluromet

ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Segluromet]

ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet

ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet [Segluromet]

ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral Tablet

ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Segluromet]

ertugliflozin 7.5 MG / metformin hydrochloride 500 MG Oral Tablet

ertugliflozin 7.5 MG / metformin hydrochloride 500 MG Oral Tablet [Segluromet]

metformin hydrochloride

metformin

<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

canagliflozin

canagliflozin 100 MG Oral Tablet

Invokana

canagliflozin 100 MG Oral Tablet [Invokana]

canagliflozin 300 MG Oral Tablet

canagliflozin 300 MG Oral Tablet [Invokana]

Segluromet is a medication that combines ertugliflozin and metformin to regulate blood sugar levels. Ertugliflozin aids the kidneys in removing glucose from the bloodstream, while metformin reduces the amount of sugar released by the liver into the blood.

This medication is prescribed alongside diet and exercise to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus. It's important to note that Segluromet is not intended for the treatment of type 1 diabetes.

Report Adverse Event 

Prescribing Information

Medication Guide 

Pharmacy List 

Online Sample Form 

Coverage Authorization Request 

Coverage Authorization Appeals 

Enroll in Patient Savings Program 

Instructions For Use: Type 2 Diabetes 

Submit MSL Request 

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.

Formulary Information

Benefits Investigation Form 

Business Associate Agreement [Mandatory For HCP Office]

Janssen Patient Support Program Patient Authorization Form

Letter of Medical Necessity 

Appeals Considerations Checklist

Appeals Considerations Checklist - Spanish

Formulary Exception Request Letter 

Formulary Exception Request Letter - Spanish

Janssen Care Path - HCP Office Portal

PA Checklist 

PA Checklist - Spanish

J & J Patient Assistance Foundation Eligibility Check 

Other HCP Resources 

About Invokana 

FAQs: Diabetes

Patient Support 

Instructions For Use: Diabetes 

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Segluromet®(metformin hydrochloride)	Invokana®(canagliflozin)

Prescription Only Segluromet is a medication that combines ertugliflozin and metformin to regulate blood sugar levels. Ertugliflozin aids the kidneys in removing glucose from the bloodstream, while...	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
Maximum recommended dose is 7.5 mg ertugliflozin/1,000 mg metformin twice daily. Take twice daily with meals, with gradual dose escalation. Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2 . . 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
Max dose: 7.5 mg ertugliflozin / 1000 mg metformin BID. Take with meals, gradual dose increase. Avoid if eGFR < 30 mL/min/1.73 m².. 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
$0. Learn more.	$0. Learn more.
Annual Cap
$583 per fill . Learn more.	$3000 and $200 per month. Learn more.
Assistance Expiration
12 uses. 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 associated with ertugliflozin (incidence ≥5%) were female genital mycotic infections. Most common adverse reactions associated with metformin (incidence ≥5%) were diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. . 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

Segluromet® Alternatives