P-Glycoprotein Inhibitors

Sodium-Glucose Cotransporter 2 Inhibitor

Sodium-Glucose Transporter 2 Inhibitors

<section class="Section" data-sectioncode="34089-3"><a name="s41"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">INPEFA tablets for oral administration contain sotagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor.</p><p>The chemical name of sotagliflozin is (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol.</p><p>Its molecular formula is C<span class="Sub">21</span>H<span class="Sub">25</span>ClO<span class="Sub">5</span>S and the molecular weight is 424.94. The structural formula is:</p><p><a name="f01"></a><img alt="Structural Formula
" src="sot00-0008-01.jpg"/></p><p>Sotagliflozin is a white to off-white solid. It is practically insoluble in water.</p><p>Each film-coated tablet of INPEFA contains 200 mg or 400 mg of sotagliflozin and the following inactive ingredients. The core of the tablet contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc. The film coating for the 200 mg tablet contains: indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol (partly hydrolyzed), talc, and titanium dioxide. The film coating for the 400 mg tablet contains: hypromellose, lactose monohydrate, titanium dioxide, triacetin, and yellow iron oxide. The 200 mg printed tablet also includes black ink which contains: ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac.</p></section>

INPEFA

Inpefa

sotagliflozin

sotagliflozin 200 MG Oral Tablet

sotagliflozin 200 MG Oral Tablet [Inpefa]

sotagliflozin 400 MG Oral Tablet

sotagliflozin 400 MG Oral Tablet [Inpefa]

Type 2 Diabetes Mellitus

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">INVOKANA <span class="Sup">®</span>(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 <span class="Italics">S</span>)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C <span class="Sub">24</span>H <span class="Sub">25</span>FO <span class="Sub">5</span>S∙1/2 H <span class="Sub">2</span>O and 453.53, respectively. The structural formula for canagliflozin is: </p><div class="Figure"><img alt="Chemical Structure" src="invokana-01.jpg"/></div><p>Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9.</p><p>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.</p><p>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).</p></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]

Inpefa is an oral tablet taken once daily, and it contains sotagliflozin. It can be used to lower the chances of cardiovascular death, hospitalization due to heart failure, and urgent heart failure-related visits in adults dealing with heart failure, type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

Inpefa received approval on May 26, 2023.

Report Adverse Event

Prescribing Information

Medication Guide 

Pharmacy List 

Coverage Authorization Request 

Coverage Authorization Appeals 

Enroll in Patient Savings Program 

Infepa Free Trial Vocuher 

Instructions For Use: Risk Reduction in CV death & hospitalization

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.

Inpefa®(sotagliflozin)	Invokana®(canagliflozin)

Prescription Only Inpefa is an oral tablet taken once daily, and it contains sotagliflozin. It can be used to lower the chances of cardiovascular death, hospitalization due to heart failure, and...	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
200 mg daily and titrate to 400 mg as tolerated.. 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
Take 200 mg qd, increase to 400 mg qd if tolerated.. 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
$2,600. Learn more.	$3000 and $200 per month. Learn more.
Assistance Expiration
12/31/25. 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 (incidence ≥ 5%) are urinary tract infection, volume depletion, diarrhea, and hypoglycemia. . 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

Inpefa® Alternatives