Frequently Asked Questions about STEGLATRO® (ertugliflozin)
For answers to questions you may have, select any of the topics below to see a complete list of Q&As or scroll down.
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STEGLATRO® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
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Contraindications: STEGLATRO is contraindicated in patients with hypersensitivity to ertugliflozin or any excipient in STEGLATRO, reactions such as angioedema have occurred, and in patients on dialysis.
Ketoacidosis: Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been identified in patients with type 1 and type 2 diabetes receiving sodium glucose co-transporter 2 (SGLT2) inhibitors, including STEGLATRO. Some cases were fatal. In placebo-controlled trials of patients with type 1 diabetes, the risk of ketoacidosis was increased in patients who received SGLT2 inhibitors compared to patients who received placebo. The risk of ketoacidosis may be greater with higher doses. Assess patients with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If ketoacidosis is suspected, discontinue STEGLATRO, evaluate, treat promptly, and ensure risks for ketoacidosis are resolved prior to restarting. Before initiating, consider risk factors. Consider temporarily discontinuing STEGLATRO for at least 4 days prior to scheduled surgery. Monitor patients and temporarily discontinue STEGLATRO in clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or post-surgery). Educate patients on the signs and symptoms of ketoacidosis. Instruct patients to discontinue STEGLATRO and seek medical attention immediately if signs and symptoms occur.
Lower Limb Amputations: In a long-term cardiovascular outcomes study, in patients with type 2 diabetes and established cardiovascular disease, the occurrence of non-traumatic lower limb amputations was higher with ertugliflozin compared to placebo. Amputation of the toe and foot were most frequent (81 out of 109 patients with lower limb amputations). Some patients had multiple amputations, some involving both lower limbs. Lower limb infections, gangrene, and diabetic foot ulcers were the most common precipitating medical events leading to the need for an amputation. Patients with amputations were more likely to be male, have higher A1C (%) at baseline, have a history of peripheral arterial disease, amputation or peripheral revascularization procedure, diabetic foot, and to have been taking diuretics or insulin. Across seven Phase 3 clinical trials with STEGLATRO, non-traumatic lower limb amputations were reported in 1 (0.1%) patient in the comparator group, 3 (0.2%) patients in the STEGLATRO 5 mg group, and 8 (0.5%) patients in the STEGLATRO 15 mg group. Before initiating STEGLATRO, consider factors that may predispose patients to the need for amputations. Monitor patients and discontinue STEGLATRO if complications occur. Counsel patients about the importance of routine preventative foot care.
Volume Depletion: STEGLATRO can cause intravascular volume contraction which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors, including STEGLATRO. Patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients with low systolic blood pressure, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating STEGLATRO in these patients, assess volume status and renal function. Correct volume depletion before initiating STEGLATRO. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy.
Urosepsis and Pyelonephritis: There have been postmarketing reports of serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization in patients receiving SGLT2 inhibitors. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: 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. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with STEGLATRO.
Necrotizing Fasciitis of the Perineum (Fournier's Gangrene): A rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention has been identified in postmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors, including STEGLATRO. Serious outcomes have included hospitalization, multiple surgeries, and death. 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. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue STEGLATRO, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.
Genital Mycotic Infections: STEGLATRO increases the risk of genital mycotic infections. Patients who have a history of genital mycotic infections or who are uncircumcised are more likely to develop these infections. Monitor and treat appropriately.
The most common adverse reactions associated with STEGLATRO (≥5%) were female genital mycotic infections. -
Prior to Initiation of STEGLATRO
Assess renal function prior to initiation of STEGLATRO and as clinically indicated.
In patients with volume depletion, correct this condition before initiating STEGLATRO.
Recommended Dosage
The recommended starting dose of STEGLATRO is 5 mg once daily, taken in the morning, with or without food.
For additional glycemic control, the dose may be increased to 15 mg once daily in patients tolerating STEGLATRO.
Use of STEGLATRO is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2.
STEGLATRO is contraindicated in patients on dialysis.
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Concomitant Use with Insulin and Insulin Secretagogues
Clinical Impact
- The risk of hypoglycemia when STEGLATRO is used in combination with insulin and/or an insulin secretagogue.
Intervention
- A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with STEGLATRO.
Positive Urine Glucose Test
Clinical Impact
- SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests.
Intervention
- Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay
Clinical Impact
- Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors.
Intervention
- Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control.
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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.
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Yes. a clinical trial was conducted with STEGLATRO in initial combination with sitagliptin.
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There is clinical trial data that contains data regarding weight. STEGLATRO is not indicated for weight loss. To view the study data details, click the link below.
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There is clinical trial data that contains data regarding blood pressure. STEGLATRO is not indicated for the treatment of hypertension. To view the study data details, click the link below.
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STEGLATRO belongs to a class of drugs called sodium glucose co-transporter 2 (SGLT2) inhibitors.
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Yes. Your eligible, privately insured patients may save on their out-of-pocket prescription costs for STEGLATRO, paying as little as $0 per prescription on each of up to 12 qualifying prescriptions. Maximum savings is $583 per prescription.a
Your patients can visit Steglatro.com to request a coupon, and if eligible, activate and bring to their pharmacy along with their prescription.
Your Spanish-speaking patients can visit Steglatro.com/es-us/ to access information about a co-pay coupon.
aNot valid for patients who are uninsured or patients with Medicare or other Government Program insurance. Not all patients are eligible. Certain restrictions apply. Tell your eligible, privately insured patients to visit Steglatro.com to review the Terms and Conditions.
Also, eligible health care professionals may request coupons for STEGLATRO for use with their eligible patients.
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STEGLATRO received FDA approval in December 2017.
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Your patients can visit Steglatro.com to find product information and resources.
Your Spanish-speaking patients can visit Steglatro.com/es-us/ to find product information and resources.