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Ertugliflozin

Class: Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors
Chemical Name: (1S,2S,3S,4R,5S)-5-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol with (2S)-5-oxopyrrolidine-2-carboxylic acid
Molecular Formula: C27H32ClNO10
CAS Number: 1210344-57-2
Brands: Steglatro

Medically reviewed by Drugs.com on Jun 21, 2021. Written by ASHP.

Introduction

Antidiabetic agent; sodium-glucose cotransporter 2 (SGLT2) inhibitor.

Uses for Ertugliflozin

Type 2 Diabetes Mellitus

Used as monotherapy as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Used in combination with other antidiabetic agents as an adjunct to diet and exercise in patients with type 2 diabetes mellitus who have not achieved adequate glycemic control.

Used in fixed combination with metformin (Segluromet) as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus who are not adequately controlled with ertugliflozin or metformin monotherapy, or in patients who are already receiving therapy with both drugs.

Used in fixed combination with sitagliptin (Steglujan) as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with both drugs is appropriate.

Current guidelines for the treatment of type 2 diabetes mellitus generally recommend metformin as first-line therapy in addition to lifestyle modifications in patients with recent-onset type 2 diabetes mellitus or mild hyperglycemia because of its well-established safety and efficacy (i.e., beneficial effects on glycosylated hemoglobin [hemoglobin A1c; HbA1c], weight, and cardiovascular mortality).

In patients with metformin contraindications or intolerance (e.g., risk of lactic acidosis, GI intolerance) or in selected other patients, some experts suggest that initial therapy with a drug from another class of antidiabetic agents (e.g., a glucagon-like peptide-1 [GLP-1] receptor agonist, SGLT2 inhibitor, dipeptidyl peptidase-4 [DPP-4] inhibitor, sulfonylurea, thiazolidinedione, basal insulin) may be acceptable based on patient factors.

May need to initiate therapy with 2 agents (e.g., metformin plus another drug) in patients with high initial HbA1c (>7.5% or ≥1.5% above target). In such patients with metformin intolerance, some experts suggest initiation of therapy with 2 drugs from other antidiabetic drug classes with complementary mechanisms of action.

Consider early initiation of combination therapy for the treatment of type 2 diabetes mellitus to extend the time to treatment failure and more rapidly attain glycemic goals.

For patients with inadequate glycemic control on metformin monotherapy, consider patient comorbidities (e.g., atherosclerotic cardiovascular disease [ASCVD], established kidney disease, heart failure), hypoglycemia risk, impact on weight, cost, risk of adverse effects, and patient preferences when selecting additional antidiabetic agents for combination therapy.

Consider early introduction of insulin for severe hyperglycemia (e.g., blood glucose of ≥300 mg/dL or HbA1c >9–10%), especially if accompanied by catabolic manifestations (e.g., weight loss, hypertriglyceridemia, ketosis) or symptoms of hyperglycemia.

Experts recommend that patients with type 2 diabetes mellitus who have established (or are at a high risk for) ASCVD, established kidney disease, or heart failure receive a GLP-1 receptor agonist or SGLT2 inhibitor with demonstrated cardiovascular disease benefit. In patients with these comorbidities, consider GLP-1 receptor agonist or SGLT2 inhibitor therapy independently of patient's HbA1c.

In patients with type 2 diabetes mellitus and CKD, consider a GLP-1 receptor agonist or SGLT2 inhibitor shown to reduce the risk of CKD progression, cardiovascular events, or both, in addition to metformin therapy or in those in whom metformin cannot be used.

In patients on metformin monotherapy without established ASCVD or indicators of high ASCVD risk, heart failure, or CKD, base decision regarding addition of other antidiabetic agents on avoidance of adverse effects, cost, and individual patient factors.

Not indicated for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Beneficial Effects on Renal Function

Some experts suggest that SGLT2 inhibitor therapy be considered to reduce risk of CKD progression, cardiovascular events, or both in patients with type 2 diabetes mellitus and diabetic kidney disease with albuminuria (eGFR ≥30 mL/minute per 1.73 m2 and urinary albumin >30 mg/g [particularly >300 mg/g] creatinine).

Ertugliflozin Dosage and Administration

General

  • Correct volume depletion before initiating ertugliflozin therapy. Assess renal function prior to treatment and periodically thereafter.

Administration

Oral Administration

Administer ertugliflozin or ertugliflozin in fixed combination with sitagliptin orally once daily in the morning, with or without food.

Administer ertugliflozin in fixed combination with metformin hydrochloride orally twice daily with meals.

Dosage

Available as ertugliflozin L-pyroglutamic acid; dosage expressed in terms of ertugliflozin.

Adults

Type 2 Diabetes Mellitus
Ertugliflozin
Oral

Initially, 5 mg once daily.

If well tolerated, increase dosage to 15 mg once daily in patients who require additional glycemic control.

Ertugliflozin/Metformin Hydrochloride Fixed-combination Therapy
Oral

Initial dosage based on patient's current regimen with ertugliflozin and/or metformin hydrochloride. May increase dosage gradually based on effectiveness and tolerability.

Patients currently receiving metformin hydrochloride: Initially, total daily dosage of 5 mg of ertugliflozin (administered as fixed-combination tablets containing 2.5 mg of ertugliflozin) and a metformin hydrochloride dosage similar to patient's existing total daily dosage, given in 2 divided doses daily.

Patients currently receiving ertugliflozin: Initially, total daily dosage of 1 g of metformin hydrochloride and an ertugliflozin dosage similar to the patient's existing total daily dosage, given in 2 divided doses daily.

Patients currently receiving ertugliflozin and metformin hydrochloride (administered as separate tablets): Initially, give fixed combination containing same total daily dosage of ertugliflozin and a metformin hydrochloride dosage similar to patient's existing total daily dosage, in 2 divided doses daily.

Ertugliflozin/Sitagliptin Fixed-combination Therapy
Oral

Initially, 5 mg of ertugliflozin and 100 mg of sitagliptin once daily in the morning without regard to meals.

If well tolerated, increase dosage to 15 mg of ertugliflozin and 100 mg of sitagliptin once daily in patients who require additional glycemic control.

Patients currently receiving ertugliflozin: Maintain current ertugliflozin dosage with sitagliptin 100 mg once daily.

Prescribing Limits

Adults

Type 2 Diabetes Mellitus
Ertugliflozin
Oral

Maximum 15 mg daily.

Ertugliflozin/Metformin Hydrochloride Fixed-combination Therapy
Oral

Maximum 15 mg of ertugliflozin and 2 g of metformin hydrochloride daily (in divided doses).

Ertugliflozin/Sitagliptin Fixed-combination Therapy
Oral

Maximum 15 mg of ertugliflozin and 100 mg of sitagliptin daily.

Special Populations

Hepatic Impairment

Ertugliflozin Monotherapy
Oral

Mild or moderate hepatic impairment: No dosage adjustment necessary.

Severe hepatic impairment: Data lacking on use of ertugliflozin; use not recommended.

Ertugliflozin/Metformin Hydrochloride Fixed-combination Therapy
Oral

Use of the fixed combination of ertugliflozin and metformin hydrochloride not recommended.

Ertugliflozin/Sitagliptin Fixed-combination Therapy
Oral

Mild or moderate hepatic impairment: No dosage adjustment necessary.

Severe hepatic impairment: Data lacking on use of the fixed combination of ertugliflozin and sitagliptin; use not recommended.

Renal Impairment

Ertugliflozin Monotherapy
Oral

Mild renal impairment (eGFR 60–89 mL/minute per 1.73 m2): No dosage adjustment necessary.

Moderate renal impairment (eGFR 30 to <60 mL/minute per 1.73 m2): Do not initiate ertugliflozin. (See Renal Impairment under Cautions.) Continued use not recommended in patients with an eGFR persistently between 30 and <60 mL/minute per 1.73 m2.

Severe renal impairment (eGFR <30 mL/minute per 1.73 m2): Contraindicated.

Ertugliflozin/Metformin Hydrochloride Fixed-combination Therapy
Oral

Mild renal impairment (eGFR 60–89 mL/minute per 1.73 m2): No dosage adjustment necessary.

Moderate renal impairment (eGFR 30 to <60 mL/minute per 1.73 m2): Do not initiate the fixed combination of ertugliflozin and metformin hydrochloride. Continued use not recommended in patients with an eGFR persistently between 30 and <60 mL/minute per 1.73 m2.

Severe renal impairment (eGFR <30 mL/minute per 1.73 m2): Contraindicated.

Ertugliflozin/Sitagliptin Fixed-combination Therapy
Oral

Mild renal impairment (eGFR 60–89 mL/minute per 1.73 m2): No dosage adjustment necessary.

Moderate renal impairment (eGFR 30 to <60 mL/minute per 1.73 m2): Do not initiate the fixed combination of ertugliflozin and sitagliptin. Continued use not recommended in patients with an eGFR persistently between 30 and <60 mL/minute per 1.73 m2.

Severe renal impairment (eGFR <30 mL/minute per 1.73 m2): Contraindicated.

Cautions for Ertugliflozin

Contraindications

  • History of serious hypersensitivity reaction to ertugliflozin or any ingredient in the formulation.

  • Severe renal impairment (eGFR <30 mL/minute per 1.73 m2), end-stage renal disease (ESRD), or on dialysis.

Warnings/Precautions

Hypotension

May cause intravascular volume contraction. Symptomatic hypotension can occur, particularly in patients with impaired renal function (eGFR <60 mL/minute per 1.73 m2), geriatric patients, or patients receiving diuretics. Assess and correct intravascular volume status prior to initiating ertugliflozin in such patients.

Monitor patients for signs and symptoms of hypotension after initiating therapy.

Ketoacidosis

Ketoacidosis (e.g., diabetic ketoacidosis, ketoacidosis, ketosis) requiring hospitalization reported with SGLT2 inhibitors; may occur without markedly elevated blood glucose concentrations (e.g., <250 mg/dL).

Evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing signs or symptoms of acidosis regardless of the patient's blood glucose concentration; discontinue SGLT2 inhibitor and initiate appropriate treatment to correct acidosis if confirmed. (See Advice to Patients.)

Prior to initiating ertugliflozin therapy, consider factors that may predispose patients to ketoacidosis (e.g., pancreatic insulin deficiency, reduced caloric intake, alcohol abuse).

Consider discontinuing ertugliflozin for ≥4 days prior to surgery for patients with scheduled surgery.

Consider temporarily discontinuing SGLT2 inhibitor in patients with other clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or post-surgery). Risk factors for ketoacidosis should be resolved prior to restarting ertugliflozin.

Some clinicians suggest monitoring of urine and/or plasma ketone levels if patients feel unwell, regardless of ambient glucose concentrations.

Renal Effects

Causes intravascular volume contraction and can cause renal impairment.

May increase Scr concentration and decrease eGFR; geriatric patients and patients with impaired renal function may be more susceptible to these changes. Adverse effects related to renal function can occur following initiation of the drug.

Prior to initiating ertugliflozin therapy, consider factors that may predispose patients to acute kidney injury, such as hypovolemia, chronic renal insufficiency, heart failure, and concomitant medications (e.g., diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIAs).

Consider temporarily discontinuing ertugliflozin in any setting of reduced oral intake (e.g., acute illness, fasting) or fluid losses (e.g., GI illness, excessive heat exposure).

Evaluate renal function prior to initiation of ertugliflozin and monitor periodically thereafter. Discontinue ertugliflozin and initiate appropriate treatment if kidney injury occurs.

Urosepsis and Pyelonephritis

Treatment with an SGLT2 inhibitor increases the risk for urinary tract infections. Serious urinary tract infections (e.g., urosepsis, pyelonephritis requiring hospitalization) reported in patients receiving an SGLT2 inhibitor.

Prior to initiating ertugliflozin therapy, consider patient factors that may predispose to serious urinary tract infections (e.g., history of difficulty urinating; infection of the bladder, kidneys, or urinary tract).

Monitor patients for urinary tract infections and initiate treatment if indicated.

Lower Limb Amputation

Analysis of data from clinical studies evaluating another SGLT2 inhibitor (canagliflozin) revealed a twofold increase in leg and foot amputations, mostly affecting the toes and midfoot, in patients receiving the drug.

Lower limb amputations reported in 0.2 or 0.5% of patients receiving ertugliflozin 5 or 15 mg daily, respectively, compared with 0.1% of patients receiving a comparator drug during clinical trials.

Causal association between ertugliflozin and lower limb amputation not established.

Concomitant Therapy with Hypoglycemic Agents

When adding ertugliflozin to therapy with an insulin secretagogue (e.g., a sulfonylurea) or insulin, consider reducing dosage of the concomitant insulin secretagogue or insulin to reduce the risk of hypoglycemia. (See Specific Drugs and Laboratory Tests under Interactions.)

Fournier Gangrene

Fournier gangrene (necrotizing fasciitis of the perineum), a rare but serious life-threatening bacterial infection requiring urgent surgical intervention, reported during postmarketing surveillance of men and women with type 2 diabetes mellitus receiving an SGLT2 inhibitor.

Assess patient for necrotizing fasciitis if pain or tenderness, erythema, or swelling in the genital or perineal area occurs in addition to fever or malaise.

If Fournier gangrene suspected, discontinue ertugliflozin and initiate treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Closely monitor blood glucose concentrations and initiate alternative antidiabetic agent to maintain glycemic control.

Genital Mycotic Infections

Increases risk of genital mycotic infections in males (e.g., balanitis) and females (e.g., vulvovaginal mycotic infection). Patients with a history of genital mycotic infections and uncircumcised males are more likely to develop such infections.

Monitor patients for genital mycotic infections and institute appropriate treatment if these infections occur.

Risk of Bone Fracture

Increased risk of bone fractures and dose-related decreases in bone mineral density in older adults observed in patients receiving another SGLT2 inhibitor (canagliflozin).

Effects on Lipoproteins

Increases in LDL-cholesterol can occur. Monitor serum LDL-cholesterol concentrations and treat such lipid elevations according to the standard of care.

Use of Fixed Combinations

When ertugliflozin is used in fixed combination with metformin hydrochloride, sitagliptin, or other drugs, consider the cautions, precautions, contraindications, and interactions associated with the concomitant agent(s) in addition to those associated with ertugliflozin.

Specific Populations

Pregnancy

Studies in animals indicate that ertugliflozin use during pregnancy may affect renal development and maturation, especially during the second and third trimesters of pregnancy.

Limited data with ertugliflozin in pregnant women not sufficient to determine a drug-associated risk for major birth defects or miscarriage, and poorly controlled diabetes mellitus during pregnancy carries risks to the mother and fetus; however, ertugliflozin therapy is not recommended in pregnant women during the second and third trimesters of pregnancy.

Lactation

Distributed into milk in rats; not known whether distributed into human milk. Discontinue nursing or the drug.

Pediatric Use

Safety and efficacy not established in pediatric patients <18 years of age.

Geriatric Use

In clinical trials, geriatric patients receiving ertugliflozin more likely to experience certain adverse reactions related to volume depletion compared with younger patients.

Diminished efficacy expected in geriatric patients with renal impairment.

Hepatic Impairment

Data lacking on the use of ertugliflozin in patients with severe hepatic impairment; such use not recommended.

Renal Impairment

Assess renal function prior to initiation of ertugliflozin therapy and periodically thereafter.

Safety and efficacy of ertugliflozin not established in patients with moderate renal impairment (eGFR 30–59 mL/minute per 1.73 m2). In a clinical trial in patients with type 2 diabetes mellitus inadequately controlled on diet and exercise with or without other antidiabetic agents, the addition of ertugliflozin (5 or 15 mg once daily) to background antidiabetic agents did not improve glycemic control compared with placebo. Patients who received ertugliflozin had increased risk of renal impairment, renal-related adverse effects, and adverse effects related to volume depletion compared with placebo-treated patients.

Not expected to be effective in patients with severe renal impairment (including those with ESRD or undergoing dialysis); contraindicated in such patients. (See Contraindications.)

Common Adverse Effects

Female genital mycotic infection, male genital mycotic infections, urinary tract infections, headache, vaginal pruritus, increased urination, nasopharyngitis, back pain, decreased weight, thirst.

Interactions for Ertugliflozin

Major metabolic pathway is glucuronidation; principally glucuronidated by uridine diphosphate-glucuronosyltransferase (UGT) isoenzymes 1A9 and 2B7.

Did not inhibit UGT1A6, 1A9, or 2B7 in vitro; was a weak inhibitor of UGT1A1 and 1A4. Ertugliflozin glucuronides did not inhibit UGT1A1, 1A4, 1A6, 1A9, or 2B7 in vitro.

Minimally metabolized by CYP isoenzymes. Ertugliflozin and ertugliflozin glucuronides did not inhibit CYP isoenzymes 1A2, 2B6, 2C9, 2C19, 2C8, 2D6, or 3A4 in vitro; did not induce CYP isoenzymes 1A2, 2B6, or 3A4 in vitro. Not a time-dependent inhibitor of CYP3A in vitro.

Not a substrate of organic anion transporters (OAT) 1 or OAT3, organic cation transporters (OCT) 1 or OCT2, or organic anion transport polypeptides (OATP) 1B1 or 1B3. Ertugliflozin and ertugliflozin glucuronides did not meaningfully inhibit OAT1, OAT3, OCT2, OATP1B1, or OATP1B3.

Substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Ertugliflozin and ertugliflozin glucuronides did not meaningfully inhibit P-gp.

Drugs Metabolized by Hepatic Microsomal Enzymes

Drugs metabolized by CYP isoenzymes 1A2, 2B6, 2C9, 2C19, 2C8, 2D6, or 3A4: Pharmacokinetic interactions unlikely.

Drugs Affected by Organic Anion Transporters

Substrates of OAT1 or OAT3: Pharmacokinetic interactions unlikely.

Drugs Affected by Organic Cation Transporters

Substrates of OCT2: Pharmacokinetic interactions unlikely.

Drugs Affected by P-glycoprotein Transport

P-gp substrates: Pharmacokinetic interactions unlikely.

Drugs Affected by Uridine Diphosphate-glucuronosyltransferase

Substrates of UGT1A1, 1A4, 1A6, 1A9, or 2B7: Pharmacokinetic interactions unlikely.

Drugs Affected by Organic Anion Transport Polypeptides

Substrates of OATP1B1 or OATP1B3: Pharmacokinetic interactions unlikely.

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Diuretics

Possible increased incidence of symptomatic hypotension

Assess and correct intravascular volume prior to ertugliflozin initiation; monitor for signs and symptoms of hypotension after initiating therapy

Insulin or insulin secretagogue (e.g., sulfonylureas)

Increased risk of hypoglycemia

Glimepiride: No clinically important effect on pharmacokinetics of either drug

Reduced dosage of insulin or insulin secretagogue may be required to reduce the risk of hypoglycemia

Mefenamic acid

Increased ertugliflozin peak plasma concentration and AUC; increases not clinically relevant

Metformin

No clinically important effect on pharmacokinetics of either drug

No dosage adjustment necessary

Rifampin

Decreased ertugliflozin peak plasma concentration and AUC

No dosage adjustment necessary

Simvastatin

No clinically important effect on pharmacokinetics of either drug

No dosage adjustment necessary

Sitagliptin

No clinically important effect on pharmacokinetics of either drug

No dosage adjustment necessary

Urine glucose tests (e.g., 1,5-anhydroglucitol assay)

SGLT2 inhibitors increase urinary glucose excretion and will result in false-positive urine glucose tests

Use alternative methods to monitor glycemic control

Ertugliflozin Pharmacokinetics

Absorption

Bioavailability

Absolute oral bioavailability: 100%. Peak plasma concentration attained 1 hour after oral dosing in fasted state.

Food

Administration with a high-fat, high-calorie meal decreased peak plasma concentration by 29% and prolonged time to peak plasma concentration by approximately 1 hour, but did not alter AUC. These changes not considered clinically meaningful.

Special Populations

Moderate hepatic impairment (Child-Pugh class B): AUC and peak plasma concentrations decreased by 13 and 21%, respectively; these decreases not considered clinically meaningful.

Severe hepatic impairment: Data lacking.

Mild renal impairment: AUC increased 1.6-fold compared with individuals with normal renal function.

Moderate renal impairment: AUC increased 1.7-fold compared with individuals with normal renal function.

Severe renal impairment: AUC increased 1.6-fold compared with individuals with normal renal function.

Distribution

Plasma Protein Binding

93.6%.

Special Populations

Renal or moderate hepatic impairment does not alter plasma protein binding.

Elimination

Metabolism

Metabolized principally by UGT1A9 and UGT2B7 to inactive metabolites.

Elimination Route

41 and 50% of total radioactivity excreted in urine and feces, respectively, with 1.5 and 33.8% in urine and feces, respectively, as parent drug.

Half-life

Approximately 16.6 hours.

Stability

Storage

Oral

Tablets

20–25°C (may be exposed to 15–30°C). Protect from moisture; store in dry place.

Actions

  • Inhibits SGLT2, a transporter expressed in proximal renal tubules and responsible for majority of reabsorption of filtered glucose from the tubular lumen.

  • Reduces reabsorption of filtered glucose and lowers the renal threshold for glucose in a dose-dependent manner, leading to increased urinary glucose excretion.

  • Increases glucose excretion independent of insulin secretion.

Advice to Patients

  • Importance of patient reading medication guide before initiating therapy and each time the drug is dispensed.

  • Importance of informing patients of the potential risks and benefits of ertugliflozin and of alternative therapies.

  • Importance of informing patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications.

  • Importance of promptly seeking medical advice during periods of stress such as fever, trauma, infection, or surgery as medication requirements may change.

  • Importance of taking ertugliflozin exactly as directed by clinician. Importance of advising patients about what to do if a dose of ertugliflozin is missed. (See Administration under Dosage and Administration.)

  • Importance of informing patients that the incidence of hypoglycemia may be increased if ertugliflozin is used concomitantly with insulin and/or an insulin secretagogue. Importance of informing patients that a lower dosage of insulin or insulin secretagogue may be required to reduce the risk of hypoglycemia if used concomitantly with ertugliflozin.

  • Importance of informing patients that symptomatic hypotension may occur with ertugliflozin and to report such symptoms to their clinicians. Inform patients that ertugliflozin-induced dehydration may increase the risk of hypotension and that patients should maintain adequate fluid intake.

  • Importance of informing patients that ketoacidosis, which can be a life-threatening condition, has been reported with ertugliflozin therapy (sometimes associated with illness or surgery, among other risk factors). Importance of informing patients and their caregivers of the signs and symptoms of ketoacidosis (e.g., tachypnea or hyperventilation, anorexia, abdominal pain, nausea, vomiting, lethargy, mental status change) and of instructing patients to discontinue ertugliflozin and seek medical attention immediately should they experience any such signs or symptoms. Advise patients to use a ketone dipstick to check for ketones in their urine (when possible) if symptoms of ketoacidosis occur, even if blood glucose is not elevated (e.g., <250 mg/dL).

  • Importance of informing patients that acute kidney injury has been reported with ertugliflozin therapy. Advise patients to seek medical advice immediately if they have reduced oral intake (such as due to acute illness or fasting) or increased fluid losses (such as due to vomiting, diarrhea, or excessive heat exposure), as it may be appropriate to temporarily discontinue ertugliflozin in those settings. Importance of regular renal function testing while receiving ertugliflozin.

  • Importance of informing patients of the potential for urinary tract infections, which may be serious, with ertugliflozin therapy. Advise patients of the signs and symptoms of urinary tract infection and the need to contact a clinician if such signs and symptoms occur.

  • Importance of informing patients of the potential for an increased risk of amputations with ertugliflozin therapy. Advise patients of the importance of routine preventative foot care. Advise patients to monitor for new pain, tenderness, sores or ulcers, or infections involving the leg or foot and to seek prompt medical advice if such signs or symptoms develop.

  • Importance of informing patients that necrotizing infections of the perineum (Fournier gangrene) have occurred with SGLT2 inhibitor therapy. Advise patients to promptly seek medical attention if they develop pain or tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, in addition to fever (>38°C) or malaise.

  • Importance of informing patients that yeast infection may occur (e.g., vulvovaginitis, balanitis, balanoposthitis). Importance of informing female patients of the signs and symptoms of vaginal yeast infections (e.g., vaginal discharge, odor, itching) and male patients of the signs and symptoms of balanitis or balanoposthitis (e.g., rash or redness of the glans or foreskin of the penis). Advise patients of treatment options and when to seek medical advice.

  • Importance of informing patients that due to the mechanism of action of ertugliflozin, patients taking the drug will test positive for glucose in their urine. Importance of not using urine glucose tests to monitor glycemic status while taking ertugliflozin.

  • Importance of women informing their clinicians immediately if they are or plan to become pregnant or plan to breast-feed. Advise patients that ertugliflozin use is not recommended while breast-feeding. Importance of advising pregnant women about the potential risks to the fetus if ertugliflozin is used during pregnancy. All women of childbearing potential should be advised to report pregnancy to their clinician as soon as possible. (See Pregnancy and see Lactation under Cautions.)

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Ertugliflozin L-pyroglutamic Acid

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

5 mg (of ertugliflozin)

Steglatro

Merck

15 mg (of ertugliflozin)

Steglatro

Merck

Ertugliflozin L-pyroglutamic Acid Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

2.5 mg (of ertugliflozin) with Metformin Hydrochloride 500 mg

Segluromet

Merck

2.5 mg (of ertugliflozin) with Metformin Hydrochloride 1 g

Segluromet

Merck

5 mg (of ertugliflozin) with Sitagliptin Phosphate 100 mg (of sitagliptin)

Steglujan

Merck

7.5 mg (of ertugliflozin) with Metformin Hydrochloride 500 mg

Segluromet

Merck

7.5 mg (of ertugliflozin) with Metformin Hydrochloride 1 g

Segluromet

Merck

15 mg (of ertugliflozin) with Sitagliptin Phosphate 100 mg (of sitagliptin)

Steglujan

Merck

AHFS DI Essentials™. © Copyright 2022, Selected Revisions June 21, 2021. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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