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  • Jardiance
    / Boehringer Ingelheim


    Active Ingredient
    Empagliflozin 10 mg, 25 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    30 X 10 mg

    partial basket chart 18588 10068

    Film Coated Tablets

    30 X 25 mg

    partial basket chart 18589 10069

    Related information


    Dosage

    Monotherapy and add-on combination: The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin. In patients tolerating empagliflozin 10 mg once daily, the dose can be increased to 25 mg once daily. The maximum daily dose is 25 mg. When empagliflozin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia. In patients with volume depletion, correcting this condition prior to initiation of empagliflozin is recommended.
    Patients with Renal Impairment: Assessment of renal function is recommended prior to initiation of empagliflozin and periodically thereafter.
    Empagliflozin should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m². Empagliflozin should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m².


    Indications

    Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusReduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular.
    Limitation of use: Empagliflozin is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.


    Contra-Indications

    History of serious hypersensitivity reaction to empagliflozin or any of the excipients. Severe renal impairment, end-stage renal disease, or dialysis.


    Special Precautions

    Hypotension: Empagliflozin causes intravascular volume contraction. Symptomatic hypotension may occur after initiating Empagliflozin particularly in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Before initiating Empagliflozin, assess for volume contraction and correct volume status if indicated. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected.
    Ketoacidosis: 
    Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co-transporter-2 (SGLT2) inhibitors, including empagliflozin. Fatal cases of ketoacidosis have been reported in patients taking this product. This product is not indicated for the treatment of patients with type 1 diabetes mellitus.
    Impairment in Renal Function: Empagliflozin increases serum creatinine and decreases eGFR . The risk of impaired renal function with Empagliflozin is increased in elderly patients and patients with moderate renal impairment. More frequent monitoring of renal function is recommended in these patients.Renal function should be evaluated prior to initiating Empagliflozin and periodically thereafter.
    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 Empagliflozin 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 Empagliflozin.
    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 postmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors, including JARDIANCE. Cases have been reported in both females and males.
    Serious outcomes have included hospitalization, multiple surgeries, and death.
    Patients treated with JARDIANCE 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 JARDIANCE, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.
    Genital Mycotic Infections: Empagliflozin 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) in patients treated with empagliflozin. If a hypersensitivity reaction occurs, discontinue empagliflozin; treat promptly per standard of care, and monitor until signs and symptoms resolve. Empagliflozin is contraindicated in patients with a previous serious hypersensitivity reaction to empagliflozin or any of the excipients in this formula.
    Urinary Tract Infections: Empagliflozin increases the risk for urinary tract infections.  Monitor and treat as appropriate.
    Increased Low-Density Lipoprotein Cholesterol (LDL-C): Increases in LDL-C can occur with Empagliflozin. Monitor and treat as appropriate.
    Lower limb amputations: An increase in cases of lower limb amputation (primarily of the toe) has been observed in ongoing 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.


    Side Effects

    Hypotension, KetoacidosisAcute 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.


    Drug interactions

    Diuretics: Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
    Insulin or Insulin Secretagogues: Coadministration of empagliflozin with insulin or insulin secretagogues increases the risk for 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 and Lactation

    Pregnancy: Based on animal data showing adverse renal effects, this product is not recommended during the second and third trimesters of pregnancy. Limited data available with this product 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 no information regarding the presence of empagliflozin in human milk, the effects of empagliflozin on the breastfed infant or the effects on milk production.
    See prescribing information for full details.           


    Overdose

    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.


    Important notes

    Storage: Store below 30°C.


    Manufacturer
    Boehringer Ingelheim Pharma KG, Germany
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