5.8 Genital Mycotic Infections

 

Ertugliflozin, a component of SEGLUROMET, 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.

 

5.9 Vitamin B12 Levels

 

In controlled clinical trials of metformin, a component of SEGLUROMET, of 29 weeks duration, a decrease to subnormal levels of previously normal serum vitamin B12 levels, without clinical manifestations, was observed in approximately 7% of patients. Such decrease, possibly due to interference with B12 absorption from the B12-intrinsic factor complex, is, however, very rarely associated with anemia and appears to be rapidly reversible with discontinuation of metformin or vitamin B12 supplementation. Measurement of hematologic parameters on an annual basis is advised in patients on SEGLUROMET and any apparent abnormalities should be appropriately investigated and managed.

 

Certain individuals (those with inadequate vitamin B12 or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B12 levels. In these patients, routine serum vitamin B12 measurements at two- to three-year intervals may be useful.

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

 

Dose-related increases in LDL-C can occur with ertugliflozin, a component of SEGLUROMET [see Adverse Reactions (6.1)]. Monitor and treat as appropriate.

5.11 Macrovascular Outcomes

 

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

 

6 ADVERSE REACTIONS 

 

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

Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1)] 

Hypotension [see Warnings and Precautions (5.2)]  

Ketoacidosis [see Warnings and Precautions (5.3)] 

Acute Kidney Injury and Impairment in Renal Function [see Warnings and Precautions (5.4)] 

Urosepsis and Pyelonephritis [see Warnings and Precautions (5.5)] 

Lower Limb Amputation [see Warnings and Precautions (5.6)] 

Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.7)] 

Genital Mycotic Infections [see Warnings and Precautions (5.8)] 

Vitamin B12 Levels [see Warnings and Precautions (5.9)] 

Increases in Low-Density Lipoprotein Cholesterol (LDL-C) [see Warnings and Precautions (5.10)] 

6.1 Clinical Trials Experience

 

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.