cated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
STEGLATRO is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
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.
In patients with volume depletion, correct this condition prior to initiation of STEGLATRO [see Warnings and Precautions (5.1)].
2.2 Patients with Renal Impairment
Assess renal function prior to initiation of STEGLATRO and periodically thereafter [see Warnings and Precautions (5.3)].
Use of STEGLATRO is contraindicated in patients with an eGFR less than 30 mL/minute/1.73 m2 [see Contraindications (4)].
Initiation of STEGLATRO is not recommended in patients with an eGFR of 30 mL/minute/1.73 m2 to less than 60 mL/minute/1.73 m2 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)].
Continued use of STEGLATRO is not recommended when eGFR is persistently between 30 and less than 60 mL/minute/1.73 m2.
No dose adjustment is needed in patients with mild renal impairment.
3 DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, pink, triangular-shaped debossed with "701" on one side and plain on the other side.
Tablets: 15 mg, red, triangular-shaped debossed with "702" on one side and plain on the other side.
4 CONTRAINDICATIONS
Severe renal impairment, end-stage renal disease (ESRD), or dialysis [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)].
History of a serious hypersensitivity reaction to STEGLATRO.
5 WARNINGS AND PRECAUTIONS
5.1 Hypotension
STEGLATRO causes intravascular volume contraction. Therefore, symptomatic hypotension may occur after initiating STEGLATRO [see Adverse Reactions (6.1)] particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2) [see Use in Specific Populations (8.6)], elderly patients (≥65 years), in patients with low systolic blood pressure, and in patients on diuretics. Before initiating STEGLATRO, volume status should be assessed and corrected if indicated. Monitor for signs and symptoms of hypotension after initiating therapy.
5.2 Ketoacidosis
Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, have been identified in clinical trials and postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co-transporter-2 (SGLT2) inhibitors and cases have been reported in STEGLATRO-treated patients in clinical trials. Across the clinical program, ketoacidosis was identified in 3 of 3,409 (0.1%) of STEGLATRO-treated patients and 0% of comparator-treated patients. Fatal cases of ketoacidosis have been reported in patients taking SGLT2 inhibitors. STEGLATRO is not indicated for the treatment of patients with type 1 diabetes mellitus [see Indications and U
