Medications have different
dosing and administration
instructions

For adults with type 2 diabetes,
along with diet and exercise

JARDIANCE offers convenient
once-daily oral dosing

For adults with type 2 diabetes,
along with diet and exercise

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

For adults with type 2 diabetes,
along with diet and exercise

JARDIANCE is taken with or without food in the morning

• No fasting requirements before or after taking JARDIANCE

For adults with type 2 diabetes,
along with diet and exercise

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

Important Dosing Considerations:

• Assess renal function before initiating JARDIANCE and as clinically indicated
• In patients with volume depletion, correct this condition before initiating JARDIANCE
• 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 hypersensitivity to empagliflozin or any
   of the excipients in JARDIANCE (reactions such as angioedema have occurred) and in patients on
   dialysis

Dosing in patients with renal impairment:

• JARDIANCE is not recommended for use in patients with an eGFR <30 mL/min/1.73 m2 and is
   contraindicated in patients on dialysis

See what JARDIANCE can do
for your patients

Not for type 1 diabetes, or type 2 diabetes with an eGFR <30 mL/min/1.73 m2

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Prescribing Information and Medication Guide

IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATIONS: Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred; patients on dialysis.

WARNINGS AND PRECAUTIONS

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.

Volume Depletion: Empagliflozin can cause intravascular volume depletion which may manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors, including empagliflozin. Before initiating, assess volume status and renal function in patients with impaired renal function (eGFR <60 mL /min/1.73 m2), elderly patients or patients on loop diuretics. In patients with volume depletion, correct this condition. After initiating, monitor for signs and symptoms of volume depletion and renal function.

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.

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. Monitor for signs and symptoms.

USE IN SPECIAL POPULATIONS

Pregnancy: JARDIANCE is not recommended 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‑100092 08.18.2021

INDICATIONS AND LIMITATIONS OF USE

JARDIANCE is indicated:

  • to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction.
  • to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
  • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

JARDIANCE is not recommended in patients with type 1 diabetes mellitus. It may increase their risk of diabetic ketoacidosis.

JARDIANCE is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR <30 mL/min/1.73 m2. JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.

Please see Prescribing Information and Medication Guide.

T2D=Type 2 Diabetes; CV=cardiovascular; CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate.

References: 1. Zinman B, Wanner C, Lachin JM, et al; EMPA‑REG OUTCOME Investigators. N Engl J Med. 2015;373(22):2117‑2128. 2. Das SR, Everett BM, Birtcher KK, et al. J Am Coll Cardiol. 2018;72(24):3200‑3223.

Copyright © 2021 Boehringer Ingelheim Pharmaceuticals, Inc.
All rights reserved. (08/21) PC-US-122694A