Empagliflozin

DEA Class; Rx

Common Brand Names; Jardiance

  • Antidiabetics, SGLT2 Inhibitors

Oral sodium-glucose co-transporter 2 (SGLT2) inhibitor
Used in adults with type 2 diabetes mellitus (DM); to reduce the risk of cardiovascular (CV) death in adults with type 2 DM and established CV disease; to reduce risk of CV death and heart failure (HF) hospitalization in adults with HF
Not recommended for glycemic control in patients with severe renal impairment due to reduced efficacy

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease

Indicated to reduce the risk of cardiovascular death plus hospitalization in adults with heart failure (HF)

Serious hypersensitivity to empagliflozin (eg, anaphylaxis, angioedema)

Patients on dialysis

  • Urinary tract infection (7.6-9.3%)
  • Female genital mycotic infections (5.4-6.4%)
  • Upper respiratory tract infection (3.1-4%)
  • Increased urination (3.2-3.4%)
  • Dyslipidemia (2.9-3.9%)
  • Male genital mycotic infections (1.6-3.1%)
  • Arthralgia (2.3-2.4%)
  • Nausea (1.1-2.3%)
  • Polydipsia (1.5-1.7%)
  • Adverse reactions related to volume depletion (eg, blood pressure [ambulatory] decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope)
  • Increased urination (eg, nocturia)
  • Ketoacidosis
  • Urosepsis and pyelonephritis
  • Necrotizing fasciitis of the perineum (Fournier’s gangrene)
  • Angioedema
  • Skin reactions
  • Acute kidney injury
  • Constipation

Increases serum creatinine and decreases eGFR; risk increased in elderly or those with moderate renal impairment

Increased incidence of bone fractures reported; American Diabetes Association recommends avoiding sodium glucose cotransporter-2 inhibitors in patients with fracture risk factors

Genital mycotic infections may occur; patients with history of genital mycotic infections and uncircumcised males are more susceptible

Increases risk of urinary tract infections (UTIs), including life-threatening urosepsis and pyelonephritis that started as UTIs

Dose-related increases in LDL-C reported

No conclusive evidence of macrovascular risk reduction with antidiabetic agent

Serious hypersensitivity reactions (eg, angioedema) reported; if a hypersensitivity reaction occurs, discontinue treatment; treat promptly per standard of care, and monitor until signs and symptoms resolve

Based on animal data showing adverse renal effects, use not recommended during the second and third trimesters of pregnancy

Limited data available in pregnant women are insufficient to determine a drug-associated risk for major birth defects and miscarriage

There is no information regarding presence in human milk, the effects on breastfed infant or on milk production

Adults

25 mg/day PO.

Geriatric

25 mg/day PO.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Empagliflozin

tablet

  • 10mg
  • 25mg

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