JARDIANCE provides patients the convenience of a once-daily oral dose

10 MG

The recommended dose for JARDIANCE is 10 mg once daily

The 10 mg starting dose of JARDIANCE provides glycemic control and CV death risk reduction in adult T2D patients who also have established CVD¹
In patients who tolerate JARDIANCE 10 mg, the dose can be increased to 25 mg once daily

JARDIANCE is taken orally with or without food in the morning

No fasting requirements before or after taking JARDIANCE

No dose adjustment of JARDIANCE is recommended when coadministered with commonly prescribed medications

NO DOSE ADJUSTMENT NEEDED IN PATIENTS WITH eGFR ≥45 mL/min/1.73 m²

Dosing Considerations:

In patients with volume depletion, correcting this condition prior to initiation of JARDIANCE is recommended
A lower dose of insulin or insulin secretagogues (eg, sulfonylureas) may be required to reduce the risk of hypoglycemia when JARDIANCE is used in combination with these agents
JARDIANCE is contraindicated in patients with a history of serious hypersensitivity to empagliflozin or any of the excipients in JARDIANCE; severe renal impairment, end-stage renal disease, or dialysis
Dosing in patients with renal impairment:
- Glycemic efficacy of JARDIANCE is dependent on renal function, which should be assessed prior to initiation of JARDIANCE and periodically thereafter
- Should not be initiated if eGFR is <45 mL/min/1.73 m²
- Should be discontinued if eGFR is persistently <45 mL/min/1.73 m²
- Reduction in risk of CV death was consistently observed among patients, including those with eGFR <60 mL/min/1.73 m²

References

More patients have access to JARDIANCE than all DPP-4 inhibitors or SGLT2 inhibitors across Commercial and Medicare Part D*

More coverage may mean fewer callbacks

Search for coverage in your area:

^*Source: Fingertip Formulary, health plan or state listed above, and/or data on file, Boehringer lngelheim Pharmaceuticals, Inc. as of 11/01/19.

Placement on formulary does not establish clinical comparability of products, including safety and efficacy, and is not a guarantee of full or partial coverage and/or payment. Contact health plan, state, or www.medicare.gov for most current information, as it may change without notice. This is not intended to be an exhaustive list of all plans in your area. Boehringer lngelheim Pharmaceuticals, Inc. and Lilly USA, LLC does not sponsor or endorse any particular plan, and the company/plan names listed do not imply their endorsement of Boehringer lngelheim Pharmaceuticals, Inc., Lilly USA, LLC, or the product(s) referenced. Boehringer lngelheim Pharmaceuticals, Inc. either owns or uses the trademark JARDIANCE® under license. Other referenced trademarks are owned by third parties.

Help your patients save with the JARDIANCE Family co-pay card

Eligible patients can pay as little as $0^† per prescription for an entire year—and then re-enroll for another 12 months of savings after that, as long as they still qualify.

^† See Terms and Conditions. Medicare/Medicaid/cash-paying patients excluded from Savings Card enrollment.

Your patients can enroll here

CV=cardiovascular; CVD=cardiovascular disease; DPP-4=dipeptidyl peptidase-4; eGFR=estimated glomerular filtration rate; SGLT2=sodium glucose co-transporter-2; T2D=type 2 diabetes.

INDICATIONS AND LIMITATIONS OF USE

JARDIANCE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

JARDIANCE is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease.

JARDIANCE is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: History of serious hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, severe renal impairment, end-stage renal disease, or dialysis.

WARNINGS AND PRECAUTIONS

Hypotension: Empagliflozin causes intravascular volume contraction and symptomatic hypotension may occur. Before initiating JARDIANCE, assess and correct volume status in the elderly, and in patients with renal impairment, low systolic blood pressure, or on diuretics. Monitor for hypotension.

Ketoacidosis: Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been identified in patients with type 1 and type 2 diabetes mellitus receiving SGLT2 inhibitors, including empagliflozin. Fatal cases of ketoacidosis have been reported in patients taking empagliflozin. Patients who present with signs and symptoms of metabolic acidosis should be assessed for ketoacidosis, even if blood glucose levels are less than 250 mg/dL. If suspected, discontinue JARDIANCE, evaluate, and treat promptly. Before initiating JARDIANCE, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis. For patients who undergo scheduled surgery, consider temporarily discontinuing JARDIANCE for at least 3 days prior to surgery.

Acute Kidney Injury and Impairment in Renal Function: Empagliflozin causes intravascular volume contraction and can cause renal impairment. Acute kidney injury requiring hospitalization and dialysis has been identified in patients taking SGLT2 inhibitors, including empagliflozin; some reports involved patients younger than 65 years of age. Before initiating JARDIANCE, consider factors that may predispose patients to acute kidney injury. Consider temporary discontinuation in settings of reduced oral intake or fluid losses. Monitor patients for signs and symptoms of acute kidney injury. If it occurs, discontinue JARDIANCE and treat promptly.

Empagliflozin increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Before initiating JARDIANCE, evaluate renal function and monitor thereafter. More frequent monitoring is recommended in patients with eGFR <60 mL/min/1.73 m². Discontinue JARDIANCE in patients with a persistent eGFR <45 mL/min/1.73 m².

Urosepsis and Pyelonephritis: Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been identified in patients receiving SGLT2 inhibitors, including empagliflozin. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate for signs and symptoms of urinary tract infections and treat promptly.

Hypoglycemia: The use of JARDIANCE in combination with insulin or insulin secretagogues can increase the risk of hypoglycemia. A lower dose of insulin or the insulin secretagogue may be required.

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases requiring urgent surgical intervention have occurred in both females and males. Serious outcomes have included hospitalization, multiple surgeries, and death. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment and discontinue JARDIANCE.

Genital Mycotic Infections: Empagliflozin increases the risk for genital mycotic infections, especially in patients with prior infections. Monitor and treat as appropriate.

Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with JARDIANCE (angioedema). If hypersensitivity reactions occur, discontinue JARDIANCE, treat promptly, and monitor until signs and symptoms resolve.

Increased Low-Density Lipoprotein Cholesterol (LDL-C): Monitor and treat as appropriate.

MOST COMMON ADVERSE REACTIONS (≥5%): Urinary tract infections and female genital mycotic infections.

DRUG INTERACTIONS: Coadministration with diuretics may enhance the potential for volume depletion.

USE IN SPECIAL POPULATIONS

Pregnancy: JARDIANCE is not recommended, especially during the second and third trimesters.

Lactation: JARDIANCE is not recommended while breastfeeding.

Geriatric Use: JARDIANCE is expected to have diminished efficacy in elderly patients with renal impairment. Renal function should be assessed more frequently in elderly patients. The incidence of volume depletion-related adverse reactions and urinary tract infections increased in patients ≥75 years treated with empagliflozin.

CL-JAR-100056 01.27.2020

Please see JARDIANCE Prescribing Information, including Medication Guide.