Helping patients start, stay, and save with INPEFA®

INPEFA Together™ works with your office and patients to support with benefit verification and prior authorization, and find the lowest available out‑of‑pocket options*

INPEFA Together™ logo - your patient journey partner

*Please visit INPEFATogether.com for full Terms and Conditions.

Start

Patients can get started on INPEFA today

All patients receive a free 30‑day supply* of INPEFA as prescribed by their doctor via Blink Health.

Lexicon's digital pharmacy partner, Blink Health (1-844-265-6444), can automatically get patients started with their free 30‑day supply of INPEFA. INPEFA Together™ will reach out to coordinate delivery to their home.

Digital pharmacy

(1‑844‑265‑6444)

If the patient chooses to receive their prescription through Blink Health, Lexicon's digital pharmacy partner, they automatically get their free 30‑day supply of INPEFA.

Local pharmacy

Patients who choose to use a retail pharmacy should consult their plan design for information about their retail pharmacy benefit and formulary options.

Stay

While patients receive their free 30‑day supply of INPEFA, a dedicated INPEFA Together™ Support Specialist follows up with them and your office regarding next steps, including delivery of INPEFA. INPEFA Together™ also:

  • Supports your office with the benefit verification and coverage requirements such as prior authorization
  • Connects your patients to financial support options for INPEFA
  • Answers questions and provides relevant resources

Save

INPEFA Together™ Copay Program

Patients with commercial insurance may get INPEFA for as little as $10 per prescription*

INPEFA Together™ automatically enrolls eligible patients in the Copay Program and helps patients get their free 30‑day supply* of INPEFA.

More options for financial support

Other patients experiencing affordability concerns or who do not currently have insurance coverage for INPEFA may be eligible for additional financial support, including the INPEFA Together™ Cash Pay Program.

*Please visit INPEFATogether.com for full Terms and Conditions.

Resources for your practice

Office flashcardPatient flashcard

Important Safety Information

Dosing:

Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA. INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.

Contraindications:

INPEFA is contraindicated in patients with hypersensitivity to any component.

Warnings and Precautions

  • Ketoacidosis:

    INPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM). Type 2 diabetes mellitus (T2DM) and pancreatic disorders are also risk factors. The risk of ketoacidosis may be greater with higher doses. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors. Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis, and educate patients on the signs/symptoms of ketoacidosis. Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.

    Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level. If suspected, discontinue INPEFA, evaluate, and treat promptly. Monitor patients for resolution of ketoacidosis before restarting INPEFA.

  • Volume Depletion:

    INPEFA can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating INPEFA in patients with one or more of these characteristics, assess volume status and renal function, and monitor for signs and symptoms of hypotension during therapy.

  • Urosepsis and Pyelonephritis:

    Treatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections. Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly.

  • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues:

    Insulin and insulin secretagogues are known to cause hypoglycemia. INPEFA may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used with INPEFA.

  • Necrotizing Fasciitis of the Perineum (Fournier's Gangrene):

    Reports of Fournier's Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors. Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure.

  • Genital Mycotic Infections:

    INPEFA increases the risk of genital mycotic infections. Monitor and treat as appropriate.

  • Urinary Glucose Test and 1,5‑anhydroglucitol (1,5‑AG) Assay:

    These are not reliable for patients taking SGLT2 inhibitors. Use alternative testing methods to monitor glucose levels.

Common Adverse Reactions:

The most commonly reported adverse reactions (incidence ≥ 5%) were urinary tract infection, volume depletion, diarrhea, and hypoglycemia.

Drug Interactions:

  • Digoxin:

    Monitor patients appropriately as there is an increase in the exposure of digoxin when coadministered with INPEFA 400 mg.

  • Uridine 5'‑diphospho‑glucuronosyltransferase (UGT) Inducer:

    The coadministration of rifampicin, an inducer of UGTs, with sotagliflozin resulted in a decrease in the exposure of sotagliflozin.

  • Lithium:

    Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Monitor serum lithium concentration more frequently during INPEFA initiation and with dosage changes.

Use in Specific Populations:

  • Pregnancy and Lactation:

    INPEFA is not recommended during the second and third trimesters of pregnancy, nor while breastfeeding.

  • Geriatric Use:

    No INPEFA dosage change is recommended based on age. No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension.

  • Renal Impairment:

    INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m2) and in patients with heart failure with eGFR <60 mL/min/1.73 m2. The safety profile of INPEFA across eGFR subgroups in these studies was consistent with the known safety profile. There was an increase in volume-related adverse events (e.g., hypotension, dizziness) in patients with eGFR <30 mL/min/1.73 m2 relative to the overall safety population. Efficacy and safety studies with INPEFA did not enroll patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis. After starting therapy in the studies, patients were discontinued if eGFR fell below 15 mL/min/1.73 m2 or were initiated on chronic dialysis.

  • Hepatic Impairment:

    INPEFA is not recommended in patients with moderate or severe hepatic impairment.

Indication

INPEFA® is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:

  • heart failure or
  • type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors

Please see full Prescribing Information and Patient Medication Guide.