Ertugliflozin

What is Ertugliflozin?

• Ertugliflozin (STEGLATRO) is a sodium glucose co-transporter 2 (SGLT2) inhibitor used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

What are the uses of this medicine?

• This medicine is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

How does this medicine work?

SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Ertugliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Who Should Not Use this medicine ?

This medcine cannot be used in patients who:

• have severe kidney problems or are on dialysis.
• are allergic to ertugliflozin or any of the ingredients in STEGLATRO.

What drug interactions can this medicine cause?

• STEGLATRO may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue.
• STEGLATRO 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 when using STEGLATRO. Use alternative methods to monitor glycemic control.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosage ː

• The recommended starting dose of STEGLATRO is 5 mg once daily, taken in the morning, with or without food.
• In patients tolerating STEGLATRO 5 mg once daily, the dose may be increased to a maximum recommended dose of 15 mg once daily if additional glycemic control is needed.

Administration

• Take STEGLATRO exactly as your doctor tells you to take it.
• Take STEGLATRO by mouth 1 time in the morning each day, with or without food.
• Your doctor may change your dose if needed.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 2 doses of STEGLATRO at the same time.
• Your doctor may tell you to take STEGLATRO along with other diabetes medicines. Low blood sugar can happen more often when STEGLATRO is taken with certain other diabetes medicines.
• Stay on your prescribed diet and exercise program while taking STEGLATRO.
• Check your blood sugar as your doctor tells you to.
• Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.
• Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), complications of diabetes.
• Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with STEGLATRO.
• When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor's instructions.
• When taking STEGLATRO, you may have sugar in your urine, which will show up on a urine test.
• If you take too much STEGLATRO, call your doctor or go to the nearest hospital emergency room right away.

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

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg and 15 mg

This medicine is available in fallowing brand namesː

• STEGLATRO

What side effects can this medication cause?

The most common side effects of this medicine include:

• vaginal yeast infections and yeast infections of the penis
• changes in urination, including urgent need to urinate more often, in larger amounts, or at night

STEGLATRO may cause serious side effects, including:

• ketoacidosis
• kidney problems
• serious urinary tract infections
• amputations
• 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)
• increased fats in your blood (bad cholesterol or LDL)

What special precautions should I follow?

• Hypotension may occur particularly in patients with renal impairment, the elderly, or patients on diuretics. Before initiating, assess and correct volume status. Monitor for signs and symptoms during therapy.
• Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue, evaluate, and treat promptly. Before initiating, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
• STEGLATRO causes intravascular volume contraction and can cause renal impairment. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat. Monitor renal function.
• Serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization in patients receiving STEGLATRO. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
• Before initiating, consider factors that may increase risk of amputation. Monitor patients for infections or ulcers of lower limbs, and discontinue if these occur.
• Insulin and insulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia. STEGLATRO may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination.
• Patients treated with STEGLATRO 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. Serious, life-threatening cases have occurred in both females and males. 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
• STEGLATRO increases the risk of genital mycotic infections. Monitor and treat if indicated.
• Dose-related increases in LDL-C can occur with STEGLATRO. Monitor and treat as appropriate.

What to do in case of emergency/overdose?

• In the event of an overdose with STEGLATRO, contact the Poison Control Center.
• Take the usual supportive measures based on signs and symptoms.
• Removal of ertugliflozin by hemodialysis has not been studied.

Can this medicine be used in pregnancy?

• The limited available data with STEGLATRO in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• Safety and effectiveness of STEGLATRO in pediatric patients under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ertugliflozin.
• Inactive ingredients: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, and magnesium stearate. The tablet film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide, and iron oxide red.

Who manufactures and distributes this medicine?

• Manufactured for: ppMerck Sharp & Dohme Corp]]., a subsidiary of

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

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

• Store STEGLATRO at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep STEGLATRO dry.
• Store blister packs of STEGLATRO in the original package.
• Keep STEGLATRO and all medicines out of the reach of children.

• Dailymed label info on Ertugliflozin
• FDA Ertugliflozin

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