Class: SGLT2 Inhibitor

Manufacturer: Manufactured by: Getz Pharma (Pvt) Ltd 29-30/27, K.I.A, Karachi – 74900, Pakistan

Dosage Form: Tablet

Similar Brands:

Uses:

Empiget (Empagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus as:

Monotherapy – when diet and exercise alone do not provide adequate glycemic control in patients for whom use of metformin is considered inappropriate due to intolerance.

Add-on combination therapy – in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycemic control

Dosage:

Monotherapy and add-on combination therapy

The recommended starting dose is 10mg empagliflozin once daily with or without food for monotherapy and add-on combination therapy with other glucose lowering medicinal products including insulin. In patients tolerating empagliflozin 10mg once daily who have eGFR ≥60 ml/min/1.73 m2 and need tighter glycemic control, the dose can be increased to 25mg once daily. The maximum daily dose is 25mg. 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 risk of hypoglycemia.

Special populations

Renal impairment – No dose adjustment is required for patients with an eGFR ≥60 ml/min/1.73 m2 or CrCl ≥60ml/min. Empagliflozin should not be initiated in patients with an eGFR <60 ml/min/1.73 m2 or CrCl <60ml/min. in patients tolerating empagliflozin whose eGFR falls persistently below 60ml/min/1.73 m2 or CrCl <60ml/min, the dose of empagliflozin should be adjusted to or maintained at 10mg once daily. Empagliflozin should be discontinued when eGFR is persistently below 45/min/1.73m2 or CrCl persistently below 45ml/min. empagliflozin should not be used in patients with end stage renal disease (ESRD) or in patients on dialysis as it is not expected to be effective in these patients.

Hepatic impairment – no dose adjustment is required for patients eith hepatic impairment. Empagliflozin exposure is increase in patients with severe hepatic impairment. Therapeutic experience in patients with severe hepatic impairment is limited and therefore not recommended for use in this population.

Elderly – no dose adjustment is recommended based on age. In patients 75 years and older, an increased risk for volume depletion should be taken into account. In patients aged 85 years and older, initiation of empagliflozin therapy is not recommended due to the limited therapeutic experience.

Pediatric population – the safety and efficacy of empagliflozin in children and adolescents has not yet been established.

Side Effects:

Very common: hypoglycemia (when used with sulphonylurea or insulin).

Common: Vaginal monillasis, vulvovaginitis, balanitis and other genital infection, urinary tract infection, pruritus (generalized) and increased urination.

Uncommon: Volume depletion, dysuria and blood creatinine increased/glomerular filtration rate increased.

Rare: Diabetic ketoacidosis.

Warnings & Precautions:

• 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.
• 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.
• 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 sulphonylurea) or insulin. Therefore, a lower dose of insulin secretagogues or insulin may be required to reduce the risk of hypoglycemia when used in combination with empagliflozin.
• Empagliflozin increased the risk for genital mycotic infections. Patients with a history of chronic or recurrent genital mycotic infections were more likely to develop mycotic genital infections. Monitor and treat as appropriate.
• Empagliflozin increases the risk for urinary tract infections including urosepsis and pyelonephritis requiring hospitalization in patients receiving SGLT2 inhibitors, including empagliflozin. Monitor and treat as appropriate. Discontinuation of empagliflozin may be considered in cases of recurrent urinary tract infections.
• Empagliflozin should not be used in patients with type 1 diabetes or for treatment of diabetic ketoacidosis(DKA). In patients where DKA is suspected or diagnosed, treatment with empagliflozin should be discontinued immediately. Treatment should be interrupted in patients who are hospitalized for major surgical procedures or acute serious medical illness. In both cases, treatment with empagliflozin may be restarted once the patient’s condition has stabilized.
• Based on the mode of action of SGLT2 inhibitors, osmotic dieresis accompanying therapeutic glucosuria may lead to a modest decrease in blood pressure. Therefore, caution should be exercised in patients for whom an empagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on antihypertensive therapy with a history of hypotension or patients aged 75 years and older.
• Empagliflozin has minor influence on the ability to drive and use machines. Patients should be advised to take precautions to avoid hypoglycemia while driving and using machines, in particular when empagliflozin is used in combination with sulphonylrea and/or insulin.

Pregnancy & Lactation:

There are no adequate and well-controlled studies of empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers

It is not known if empagliflozin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from empagliflozin, a decision should be made whether to discontinue nursing or to discontinue empagliflozin, takin into account the importance of the drug to the mother

Drug Interactions:

• Co-administration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Empagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase a risk of dehydration and hypotension.
• Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as it increases 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.

Contraindications:

Empagliflozin is contraindicated in;

• Patients with known hypersensitivity to empagliflozin or to any excipient of the product.
• Severe renal impairment, end stage renal disease, or dialysis

Price: Ksh 900

Notes:

Pack Size: 14s

Price for Empiget 10mg is Ksh 900/-

Price for Empiget 25mg is Ksh 1390/-

Compositition

Empiget (Empagliflozin) is available for oral combination as:

Empiget Tablets 10mg, Each film coated tablet contains: Empagliflozin 10mg.

Empiget Tablets 25mg, Each film coated tablet contains: Empagliflozin 25mg

Mechanism of action

Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibition SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion.

Getz Pharma (Pvt) Ltd is a member of The Getz Group, USA.