Jardiance

/ Boehringer Ingelheim

Prior to Initiation
– Assess renal function before initiation and as clinically indicated
– In patients with volume depletion, correct this condition before initiation
 Recommended Dosage
– The recommended dose 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 10 mg daily.
– 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
who have type 2 diabetes and established cardiovascular disease with an eGFR less than 30 mL/min/1.73 m², or
– who have heart failure with reduced ejection fraction with an eGFR less than 30 mL/min/1.73 m².

Products 10 mg and 25mg are 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 adult patients with type 2 diabetes mellitus and established cardiovascular disease.
Product 10mg is indicated:
* To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
* To reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.
* As an adjunct to diet and exercise to improve glycemic control in pediatric patients aged 10 years and older with type 2 diabetes mellitus.
Limitations of Use
* The drug is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
* The drug 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.

Hypersensitivity, reactions such as angioedema have occurred.
Patients on dialysis.

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. Fatal cases of ketoacidosis have been reported in patients taking this drug. 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. Not indicated for the treatment of patients with type 1 diabetes mellitus.
Patients treated with this drug 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 this drug may be present even if blood glucose levels are less than 250 mg/dL. If ketoacidosis is suspected, treatment should be discontinued, patient should be evaluated, and prompt treatment should be instituted. Treatment of ketoacidosis may require insulin, fluid and carbohydrate replacement. See prescribing information for full details.
Volume Depletion
This drug can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension.
Before initiating treatment in patients with one or more of these characteristics, assess volume status and renal function. In patients with volume depletion, correct this condition before initiating treatment. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.
Urosepsis and Pyelonephritis
There have been reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization in patients receiving SGLT2 inhibitors. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
Insulin and insulin secretagogues are known to cause hypoglycemia. The risk of hypoglycemia is increased when this drug is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin. Therefore, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with this drug.
Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
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. Cases have been reported in both females and males. Serious outcomes have included hospitalization, multiple surgeries, and death.
Patients treated with this drug presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise, should be assessed for necrotizing fasciitis. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue treatment, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.
Genital Mycotic Infections
This drug increases the risk for genital mycotic infections. Patients with a history of chronic or recurrent genital mycotic infections were more likely to develop genital mycotic infections. Monitor and treat as appropriate.
Hypersensitivity Reactions
There have been postmarketing reports of serious hypersensitivity reactions, (e.g., angioedema). If a hypersensitivity reaction occurs, discontinue treatment; treat promptly per standard of care, and monitor until signs and symptoms resolve. This drug is contraindicated in patients with a previous hypersensitivity to empagliflozin or any of the excipients.
Lower limb amputations
An increase in cases of lower limb amputation (primarily of the toe) has been observed in long-term clinical studies with another SGLT2 inhibitor. It is unknown whether this constitutes a class effect. Like for all diabetic patients it is important to counsel patients on routine preventative footcare.
See prescribing information for full details.

most common: Urinary tract infections. Unknown frequency:  Hypotension, Ketoacidosis, Acute Kidney Injury and Impairment in Renal Function, Urosepsis and Pyelonephritis, Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), Genital Mycotic Infections, Hypersensitivity Reactions, Increased Low-Density Lipoprotein Cholesterol.
See prescribing information for full details.

Diuretics
Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
Before initiating treatment, assess volume status and renal function. In patients with volume depletion, correct this condition before initiation. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.
Insulin or Insulin Secretagogues
The risk of hypoglycemia is increased when is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin.
Coadministration with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
Positive Urine Glucose Test: 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.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay: 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.

Pregnancy: Based on animal data showing adverse renal effects, this drug is not recommended during the second and third trimesters of pregnancy. The limited available data in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.
Lactation: There is limited information regarding this.
Because of the potential for serious adverse reactions in a breastfed infant, including the potential for empagliflozin to affect postnatal renal development, advise patients that use of this drug is not recommended while breastfeeding.
See prescribing information for full details.           

In the event of an overdose with this product, contact the Poison Control Center. Employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment) as dictated by the patient’s clinical status. Removal of empagliflozin by hemodialysis has not been studied.

Storage: Store below 30°C.