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PRESCRIBING INFORMATION ------WARNINGS and PRECAUTIONS------These Highlights Do Not Include All the Information Needed to Use JARDIANCE Safely and Effectively

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PRESCRIBING INFORMATION ------WARNINGS and PRECAUTIONS------These Highlights Do Not Include All the Information Needed to Use JARDIANCE Safely and Effectively HIGHLIGHTS OF PRESCRIBING INFORMATION -----------------------WARNINGS AND PRECAUTIONS------------------------ These highlights do not include all the information needed to use JARDIANCE safely and effectively. See full prescribing information for Ketoacidosis: Assess patients who present with signs and symptoms of JARDIANCE. metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue JARDIANCE, evaluate and treat promptly. JARDIANCE® (empagliflozin tablets), for oral use Before initiating JARDIANCE, consider risk factors for ketoacidosis. Initial U.S. Approval: 2014 Patients on JARDIANCE may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ---------------------------RECENT MAJOR CHANGES--------------------------- ketoacidosis. (5.1) Volume Depletion: Before initiating JARDIANCE, assess volume status Indications and Usage (1) 8/2021 and renal function in patients with impaired renal function, elderly Dosage and Administration (2.1) 6/2021 patients, or patients on loop diuretics. Monitor for signs and symptoms Dosage and Administration (2.2) 8/2021 during therapy. (5.2, 6.1) Dosage and Administration (2.3) – Removed 8/2021 Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms Contraindications (4) 6/2021 of urinary tract infections and treat promptly, if indicated (5.3) Warnings and Precautions (5.1, 5.2) 6/2021 Hypoglycemia: Consider lowering the dose of insulin secretagogue or Warnings and Precautions (5.3, 5.5) 8/2021 insulin to reduce the risk of hypoglycemia when initiating JARDIANCE Warnings and Precautions (5.9) – Removed 6/2021 (5.4) ----------------------------INDICATIONS AND USAGE--------------------------- Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor life-threatening cases have occurred in both females and males. Assess indicated: patients presenting with pain or tenderness, erythema, or swelling in the as an adjunct to diet and exercise to improve glycemic control in adults genital or perineal area, along with fever or malaise. If suspected, with type 2 diabetes mellitus. (1) institute prompt treatment. (5.5) to reduce the risk of cardiovascular death in adults with type 2 diabetes Genital Mycotic Infections: Monitor and treat as appropriate (5.6) mellitus and established cardiovascular disease. (1) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., to reduce the risk of cardiovascular death plus hospitalization for heart angioedema) have occurred with JARDIANCE. If hypersensitivity failure in adults with heart failure and reduced ejection fraction. (1) reactions occur, discontinue JARDIANCE, treat promptly, and monitor until signs and symptoms resolve. (5.7) Limitations of Use: ------------------------------ADVERSE REACTIONS------------------------------- Not recommended in patients with type 1 diabetes mellitus. It may The most common adverse reactions associated with JARDIANCE (5% increase the risk of diabetic ketoacidosis in these patients (1) or greater incidence) were urinary tract infections and female genital Not recommended for use to improve glycemic control in adults with mycotic infections (6.1) type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2 (1) ----------------------DOSAGE AND ADMINISTRATION----------------------- To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Assess volume status and correct volume depletion before initiating Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or FDA at 1-800-FDA- (2.1) 1088 or www.fda.gov/medwatch. The recommended dose of JARDIANCE is 10 mg once daily in the -----------------------USE IN SPECIFIC POPULATIONS------------------------ morning, taken with or without food (2.2) Pregnancy: Advise females of the potential risk to a fetus especially For additional glycemic control, dose may be increased to 25 mg in during the second and third trimesters (8.1) patients tolerating JARDIANCE (2.2) Lactation: JARDIANCE is not recommended when breastfeeding (8.2) ---------------------DOSAGE FORMS AND STRENGTHS---------------------- Geriatric Patients: Higher incidence of adverse reactions related to Tablets: 10 mg, 25 mg (3) volume depletion and reduced renal function (5.2, 8.5, 8.6) -------------------------------CONTRAINDICATIONS------------------------------ Renal Impairment: Higher incidence of adverse reactions related to reduced renal function (2.2, 5.2, 8.6) Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE (4) See 17 for PATIENT COUNSELING INFORMATION and Medication Patients on dialysis (4) Guide. Revised: 8/2021 _______________________________________________________________________________________________________________________________________ FULL PRESCRIBING INFORMATION: CONTENTS* 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 1 INDICATIONS AND USAGE 8.2 Lactation 2 DOSAGE AND ADMINISTRATION 8.4 Pediatric Use 2.1 Prior to Initiation of JARDIANCE 8.5 Geriatric Use 2.2 Recommended Dosage 8.6 Renal Impairment 3 DOSAGE FORMS AND STRENGTHS 8.7 Hepatic Impairment 4 CONTRAINDICATIONS 10 OVERDOSAGE 5 WARNINGS AND PRECAUTIONS 11 DESCRIPTION 5.1 Ketoacidosis 12 CLINICAL PHARMACOLOGY 5.2 Volume Depletion 12.1 Mechanism of Action 5.3 Urosepsis and Pyelonephritis 12.2 Pharmacodynamics 5.4 Hypoglycemia with Concomitant Use with Insulin and Insulin 12.3 Pharmacokinetics Secretagogues 13 NONCLINICAL TOXICOLOGY 5.5 Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.6 Genital Mycotic Infections 14 CLINICAL STUDIES 5.7 Hypersensitivity Reactions 16 HOW SUPPLIED/STORAGE AND HANDLING 6 ADVERSE REACTIONS 17 PATIENT COUNSELING INFORMATION 6.1 Clinical Trials Experience 6.2 Postmarketing Experience *Sections or subsections omitted from the full prescribing information are not 7 DRUG INTERACTIONS listed. 1 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE JARDIANCE is indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction. Limitations of Use JARDIANCE is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1)]. JARDIANCE is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2. JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action. 2 DOSAGE AND ADMINISTRATION 2.1 Prior to Initiation of JARDIANCE Assess renal function before initiating JARDIANCE and as clinically indicated [see Warnings and Precautions (5.2)]. In patients with volume depletion, correct this condition before initiating JARDIANCE [see Warnings and Precautions (5.2), Use in Specific Populations (8.5, 8.6)]. 2.2 Recommended Dosage The recommended dose of JARDIANCE is 10 mg once daily in the morning, taken with or without food. For additional glycemic control, the dose may be increased to 25 mg in patients tolerating JARDIANCE. Use for glycemic control is not recommended in patients with an eGFR less than 30 mL/min/1.73 m2. Data are insufficient to provide a dosing recommendation in patients; o who have type 2 diabetes and established cardiovascular disease with an eGFR less than 30 mL/min/1.73 m2, or o who have heart failure with reduced ejection fraction with an eGFR less than 20 mL/min/1.73 m2 [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)]. JARDIANCE is contraindicated in patients on dialysis [see Contraindications (4)]. 3 DOSAGE FORMS AND STRENGTHS JARDIANCE tablets available as: 10 mg pale yellow, round, biconvex and bevel-edged, film-coated tablets debossed with “S 10” on one side and the Boehringer Ingelheim company symbol on the other side. 25 mg pale yellow, oval, biconvex, film-coated tablets debossed with “S 25” on one side and the Boehringer Ingelheim company symbol on the other side. 4 CONTRAINDICATIONS Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions (5.7)]. Patients on dialysis [see Use in Specific Populations (8.6)]. 2 5 WARNINGS AND PRECAUTIONS 5.1 Ketoacidosis Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in clinical trials and postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co-transporter-2 (SGLT2) inhibitors, including JARDIANCE. Fatal cases of ketoacidosis have been reported in patients taking JARDIANCE. In placebo-controlled trials of patients with type 1 diabetes, the risk of ketoacidosis was increased in patients who received SGLT2 inhibitors compared to patients who received placebo. JARDIANCE is not indicated for the treatment of patients with type 1 diabetes mellitus [see Indications and Usage (1)]. Patients treated with JARDIANCE who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of presenting blood glucose levels, as ketoacidosis associated with JARDIANCE may be present even
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