Empagliflozin

What is Empagliflozin?

• Empagliflozin (JARDIANCE) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor used together with diet and exercise to treat type 2 diabetes.

What are the uses of this medicine?

This medicine is used to:

• lower blood sugar along with diet and exercise in adults with type 2 diabetes.
• reduce the risk of cardiovascular death in adults with type 2 diabetes and who also have known cardiovascular disease.
• reduce the risk of cardiovascular death and hospitalization for heart failure (when the heart is weak and cannot pump enough blood to the rest of your body) in adults with heart failure.

Limitations of Use:

• JARDIANCE is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in blood or urine).
• JARDIANCE is not for use to lower blood sugar in adults with type 2 diabetes who have severe kidney problems, because it may not work.

How does this medicine work?

• Empagliflozin is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2), the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation.
• By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
• Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule.
• This may influence several physiological functions such as lowering both pre-and afterload of the heart and downregulating sympathetic activity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE
• Patients on dialysis

What drug interactions can this medicine cause?

• Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
• The risk of hypoglycemia is increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin.
• Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
• Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

• Assess renal function before initiating JARDIANCE and as clinically indicated.
• In patients with volume depletion, correct this condition before initiating JARDIANCE.

Recommended Dosage:

• 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.

Administration

• Take JARDIANCE exactly as your healthcare provider tells you to take it.
• Take JARDIANCE by mouth 1 time in the morning each day, with or without food.
• Your healthcare provider may change your dose if needed.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of JARDIANCE at the same time. Talk with your healthcare provider if you have questions about a missed dose.
• Your healthcare provider may tell you to take JARDIANCE along with other diabetes medicines. Low blood sugar can happen more often when JARDIANCE is taken with certain other diabetes medicines.
• If you take too much JARDIANCE, call your healthcare provider or go to the nearest hospital emergency room right away.
• When taking JARDIANCE, you may have sugar in your urine, which will show up on a urine test.
• Your healthcare provider may do blood tests to check how well your kidneys are working before and during your treatment with JARDIANCE.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 10 mg, 25 mg

This medicine is available in fallowing brand namesː

• JARDIANCE

What side effects can this medication cause?

The most common side effects of this medicine include:

• urinary tract infections
• yeast infections in females

JARDIANCE may cause serious side effects, including:

• Serious urinary tract infections
• Low blood sugar (hypoglycemia)
• A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum)
• Vaginal yeast infection
• Yeast infection of the penis (balanitis)
• Allergic (hypersensitivity) reactions

What special precautions should I follow?

• Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in clinical trials. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue JARDIANCE, evaluate and treat promptly. Before initiating JARDIANCE, consider risk factors for ketoacidosis. Patients on JARDIANCE may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
• Before initiating JARDIANCE, assess volume status and renal function in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for signs and symptoms during therapy.
• There have been reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization in patients receiving SGLT2 inhibitors, including JARDIANCE. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
• 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. Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating JARDIANCE.
• 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. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.
• JARDIANCE increases the risk for genital mycotic infections. Monitor and treat as appropriate.
• Serious hypersensitivity reactions (e.g., angioedema) have occurred with JARDIANCE. If hypersensitivity reactions occur, discontinue JARDIANCE, treat promptly, and monitor until signs and symptoms resolve.

What to do in case of emergency/overdose?

Management of overdosage:

• In the event of an overdose with JARDIANCE, contact the Poison Control Center. Removal of empagliflozin by hemodialysis has not been studied.

Can this medicine be used in pregnancy?

• Based on animal data showing adverse renal effects, JARDIANCE is not recommended during the second and third trimesters of pregnancy.
• The limited available data with JARDIANCE in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage.

Can this medicine be used in children?

• The safety and effectiveness of JARDIANCE have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: empagliflozin
• Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and yellow ferric oxide.

Who manufactures and distributes this medicine?

• Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA
• Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA and Eli Lilly and Company, Indianapolis, IN 46285 USA

What should I know about storage and disposal of this medication?

• Store JARDIANCE at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep JARDIANCE and all medicines out of the reach of children.

• Dailymed label info on Empagliflozin
• FDA Empagliflozin

Empagliflozin Resources
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