HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. 

 

SEGLUROMET™ (ertugliflozin and metformin hydrochloride)tablets, for oral use 

Initial U.S. Approval: 2017 

 

WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning.  Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio, and metformin plasma levels generally >5 mcg/mL. (5.1) 

Risk factors include renal impairment, concomitant use of certain drugs, age ≥65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. (5.1) 

If lactic acidosis is suspected, discontinue SEGLUROMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. (5.1) 

INDICATIONS AND USAGE 

 

SEGLUROMET is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin. (1) 

 

Limitations of Use: 

Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. (1)

 

DOSAGE AND ADMINISTRATION 

 

Individualize the starting dose based on the patient's current regimen. (2.1)

Maximum recommended dose is 7.5 mg ertugliflozin/1,000 mg metformin twice daily. (2.1)

Take twice daily with meals, with gradual dose escalation. (2.1)

Assess renal function before initiating SEGLUROMET (2.2): Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2.

Initiation is not recommended in patients with an eGFR of 30 to less than 60 mL/minute/1.73 m2.

Continued use is not recommended in patients with an eGFR persistently between 30 and less than 60 mL/min/1.73 m2. 

 

SEGLUROMET may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. (2.3)

 

DOSAGE FORMS AND STRENGTHS 

 

Tablets: 

Ertugliflozin 2.5 mg and metformin hydrochloride 500 mg (3)

Ertugliflozin 2.5 mg and metformin hydrochloride 1,000 mg (3)

Ertugliflozin 7.5 mg and metformin hydrochloride 500 mg (3)

Ertugliflozin 7.5 mg and metformin hydrochloride 1,000 mg (3)

 

CONTRAINDICATIONS 

 

Severe renal impairment, end stage renal disease, or dialysis. (4, 5.1, 5.4)

Metabolic acidosis, including diabetic ketoacidosis. (4, 5.1)