5.4 Urosepsis and Pyelonephritis

 

There have been postmarketing reports of serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization in patients receiving SGLT2 inhibitors. Cases of pyelonephritis also have been reported in STEGLATRO-treated patients in clinical trials. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. eva luate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated [see Adverse Reactions (6.1)].

 

5.5 Lower Limb Amputation

 

An increased risk for lower limb amputation (primarily of the toe) has been observed in clinical studies with another SGLT2 inhibitor. Across seven Phase 3 clinical trials in the STEGLATRO development program, 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. A causal association between STEGLATRO and lower limb amputation has not been definitively established.

 

Before initiating STEGLATRO, consider factors in the patient history that may predispose them to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy and diabetic foot ulcers. Counsel patients about the importance of routine preventative foot care. Monitor patients receiving STEGLATRO for signs and symptoms of infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue STEGLATRO if these complications occur.

 

5.6 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 [see Adverse Reactions (6.1)]. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with STEGLATRO.

 

5.7 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 genital mycotic infections [see Adverse Reactions (6.1)]. Monitor and treat appropriately.

 

5.8 Increases in Low-Density Lipoprotein Cholesterol (LDL-C)

 

Dose-related increases in LDL-C can occur with STEGLATRO [see Adverse Reactions (6.1)]. Monitor and treat as appropriate.

 

5.9 Macrovascular Outcomes

 

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with STEGLATRO.

 

6 ADVERSE REACTIONS 

 

The following important adverse reactions are described elsewhere in the labeling:

Hypotension [see Warnings and Precautions (5.1)] 

Ketoacidosis [see Warnings and Precautions (5.2)] 

Acute Kidney Injury and Impairment in Renal Function [see Warnings and Precautions (5.3)] 

Urosepsis and Pyelonephritis [see Warnings and Precautions (5.4)] 

Lower Limb Amputation [see Warnings and Precautions (5.5)]