Female genital mycotic infections† 3.0% 9.1% 12.2% 

Male genital mycotic infections‡ 0.4% 3.7% 4.2% 

Urinary tract infections§ 3.9% 4.0% 4.1% 

Headache 2.3% 3.5% 2.9% 

Vaginal pruritus¶ 0.4% 2.8% 2.4% 

Increased urination# 1.0% 2.7% 2.4% 

Nasopharyngitis 2.3% 2.5% 2.0% 

Back pain 2.3% 1.7% 2.5% 

Weight decreased 1.0% 1.2% 2.4% 

ThirstÞ 0.6% 2.7% 1.4% 

Volume Depletion 

 

STEGLATRO causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion, particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2). In patients with moderate renal impairment, adverse reactions related to volume depletion (e.g., dehydration, dizziness postural, presyncope, syncope, hypotension, and orthostatic hypotension) were reported in 0%, 4.4%, and 1.9% of patients treated with placebo, STEGLATRO 5 mg, and STEGLATRO 15 mg, respectively. STEGLATRO may also increase the risk of hypotension in other patients at risk for volume contraction [see Use in Specific Populations (8.5, 8.6)].

 

Ketoacidosis 

 

Across the clinical program, ketoacidosis was identified in 3 of 3,409 (0.1%) ertugliflozin-treated patients and 0.0% of comparator-treated patients [see Warnings and Precautions (5.2)].

Impairment in Renal Function 

 

Treatment with STEGLATRO was associated with increases in serum creatinine and decreases in eGFR (see Table 2). Patients with moderate renal impairment at baseline had larger mean changes. In a study in patients with moderate renal impairment, these abnormal laboratory findings were observed to reverse after treatment discontinuation [see Use in Specific Populations (8.5, 8.6)].

 

Table 2: Changes from Baseline in Serum Creatinine and eGFR in the Pool of Three 26-Week Placebo-Controlled Studies, and a 26-Week Moderate Renal Impairment Study in Patients with Type 2 Diabetes Mellitus 

 

Pool of 26-Week Placebo-Controlled Studies 

 Placebo

N=515 STEGLATRO 5 mg

N=519 STEGLATRO 15 mg

N=510 

Baseline Mean Creatinine (mg/dL) 0.83 0.82 0.82 

eGFR (mL/min/1.73 m2) 89.5 88.2 89.0 

Week 6 Change Creatinine (mg/dL) 0.00 0.03 0.03 

eGFR (mL/min/1.73 m2) -0.3 -2.7 -3.1 

Week 26 Change Creatinine (mg/dL) -0.01 0.00 0.01 

eGFR (mL/min/1.73 m2) 0.7 0.5 -0.6 

 Moderate Renal Impairment Study  

 Placebo

N=154 STEGLATRO 5 mg

N=158 STEGLATRO 15 mg

N=155 

Baseline Creatinine (mg/dL) 1.39 1.38 1.37 

eGFR (mL/min/1.73 m2) 46.0 46.8 46.9 

Week 6 Change Creatinine (mg/dL) -0.02 0.11 0.12 

eGFR (mL/min/1.73 m2) 0.6 -3.2 -4.1 

Week 26 Change Creatinine (mg/dL) 0.02 0.08 0.10 

eGFR (mL/min/1.73 m2) 0.0 -2.7 -2.6