d 60 mL/min/1.73 m2 and 111 patients exposed to STEGLATRO (5 mg or 15 mg) had an eGFR between 30 and 45 mL/min/1.73 m2. The mean duration of diabetes for the study population was approximately 14 years, and the majority of patients were receiving background insulin (55.9%) and/or sulfonylurea (40.3%) therapy. Approximately 50% had a history of cardiovascular disease or heart failure.
STEGLATRO did not show efficacy in this study. The HbA1c reductions from baseline to Week 26 were not significantly different between placebo and STEGLATRO 5 mg or 15 mg [see Use in Specific Populations (8.6)].
16 HOW SUPPLIED/STORAGE AND HANDLING
STEGLATRO (ertugliflozin) tablets are available in the strengths listed below:
5 mg tablets, are pink, triangular-shaped, biconvex, with "701" debossed on one side and plain on the other side. They are supplied as follows:
NDC 0006-5363-03 unit-of-use bottles of 30
NDC 0006-5363-06 unit-of-use bottles of 90
NDC 0006-5363-07 bulk bottles of 500
15 mg tablets, are red, triangular-shaped, biconvex, with "702" debossed on one side and plain on the other side. They are supplied as follows:
NDC 0006-5364-03 unit-of-use bottles of 30
NDC 0006-5364-06 unit-of-use bottles of 90
NDC 0006-5364-07 bulk bottles of 500
Storage of Bottles
Store at 20°C -25°C (68°F -77°F), excursions permitted between 15°C -30°C (between 59°F -86°F) [see USP Controlled Room Temperature]. Protect from moisture. Store in a dry place.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Instructions
Instruct patients to read the Medication Guide before starting STEGLATRO (ertugliflozin) and to reread it each time the prescription is renewed.
Inform patients of the potential risks and benefits of STEGLATRO and of alternative modes of therapy. Also inform 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 for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change.
Instruct patients to take STEGLATRO only as prescribed. If a dose is missed, advise patients to take it as soon as it is remembered unless it is almost time for the next dose, in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time. Advise patients not to take two doses of STEGLATRO at the same time.
Hypoglycemia with Concomitant Use of Insulin and/or Insulin Secretagogue
Inform patients that the incidence of hypoglycemia may increase when STEGLATRO is added to insulin and/or an insulin secretagogue and that a lower dose of insulin or insulin secretagogue may be required to reduce the risk of hypoglycemia [see Warnings and Precautions (5.6)].
Hypotension
Inform patients that symptomatic hypotension may occur with STEGLATRO and advise them to contact their doctor if they experience suc
