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Jardiance

Generic Name: Empagliflozin
Drug Category: (SGLT2) Inhibitor
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 2 years.

Approved Uses

Indicated for:

  • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure
  • 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 the risk of diabetic ketoacidosis in these patients.

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.

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.

Data are insufficient to provide a dosing recommendation in patients:

  • who have type 2 diabetes and established cardiovascular disease with an eGFR less than 30mL/min/1.73 m2 or
  • who have heart failure with reduced ejection fraction with an eGFR less than 20 mL/min/1.73 m2

JARDIANCE is contraindicated in patients with severe renal impairment, end-stage renal disease, or on dialysis.

JARDIANCE should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2.

For patients who undergo scheduled surgery, consider temporarily discontinuing JARDIANCE for at least 3 days prior to surgery.

Fatal cases of ketoacidosis have been reported in patients taking JARDIANCE. Before initiating JARDIANCE, consider factors in the patient history that may predispose to ketoacidosis including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse. 

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 if blood glucose levels are less than 250 mg/dL.

JARDIANCE causes intravascular volume contraction. Symptomatic hypotension may occur after initiating JARDIANCE particularly in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Before initiating JARDIANCE, assess for volume contraction and correct volume status if indicated.

There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving SGLT2 inhibitors, including JARDIANCE; some reports involved patients younger than 65 years of age.

There have been postmarketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization in patients receiving SGLT2 inhibitors, including JARDIANCE.

JARDIANCE increases the risk for genital mycotic infections.

Reports of necrotizing fasciitis of the perineum (Fournier’s gangrene), a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in patients with diabetes mellitus receiving SGLT2 inhibitors, including JARDIANCE.

There have been postmarketing reports of serious hypersensitivity reactions, (e.g., angioedema) in patients treated with JARDIANCE.

Increases in LDL-C can occur with JARDIANCE.

JARDIANCE increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes.

JARDIANCE causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion.

Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Insulin and insulin secretagogues are known to cause hypoglycemia. The risk of hypoglycemia is increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin.

Co-administration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.

JARDIANCE is not recommended during the second and third trimesters of pregnancy.

Because of the potential for serious adverse reactions in a breastfed infant, advise women that use of JARDIANCE is not recommended while breastfeeding.

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Off-label Uses

• Type 1 diabetes mellitus and diabetic ketoacidosis. GoToSource 

• Use in patients under the age of 18. GoToSource 

• Dosage greater than 25 mg once daily. GoToSource 

• Antihypertensive and weight reduction. GoToSource

Adverse Events

Dehydration, leading to a drop in blood pressure (hypotension), urinary tract infections and genital infections. GoToSource

Hypoglycemia (low blood sugar). GoToSource

Necrotizing fasciitis of the perineum (fournier’s gangrene). GoToSource

Decreased kidney function, hyperbilirubinemia (excess bilirubin in the blood), elevated liver enzymes and liver injury. GoToSource 

Ketoacidosis (excess blood acids). GoToSource

Urosepsis (life-threatening blood infection) and pyelonephritis (kidney infection). GoToSource

Litigation

Lawsuits filed for pancreatic cancer and fournier’s gangrene.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024