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Segluromet Prescribing Information
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio, and metformin plasma levels generally >5 mcg/mL
[see Warnings and Precautions (5.1)]
.Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), 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
[see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1), Drug Interactions (7), and Use in Specific Populations (8.6, 8.7)]
.If metformin-associated lactic acidosis is suspected, immediately discontinue SEGLUROMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended
[see Warnings and Precautions (5.1)]
.| Dosage and Administration | 12/2024 |
| Warnings and Precautions | 12/2024 |
SEGLUROMET® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- Assess renal function prior to initiation and as clinically indicated.
- Correct volume depletion before initiation.
- Individualize the starting dosage based on the patient's current regimen.
- Maximum recommended dosage is 7.5 mg ertugliflozin/1,000 mg metformin orally twice daily.
- Take orally twice daily with meals, with gradual dose escalation.
- Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2.
- Use is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2.
- Use is contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), end stage-renal disease (ESRD), or on dialysis.
- SEGLUROMET may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures.
- Withhold SEGLUROMET for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting.
- Tablets: ertugliflozin 2.5 mg and metformin HCl 500 mg, pink, oval, debossed with "2.5/500" on one side and plain on the other side.
- Tablets: ertugliflozin 2.5 mg and metformin HCl 1,000 mg, pink, oval, debossed with "2.5/1000" on one side and plain on the other side.
- Tablets: ertugliflozin 7.5 mg and metformin HCl 500 mg, red, oval, debossed with "7.5/500" on one side and plain on the other side.
- Tablets: ertugliflozin 7.5 mg and metformin HCl 1,000 mg, red, oval, debossed with "7.5/1000" on one side and plain on the other side.
- Pregnancy:Advise females of the potential risk to a fetus, especially during the second and third trimesters.
- Lactation:Breastfeeding not recommended.
- Females and Males of Reproductive Potential:Advise premenopausal females of the potential for an unintended pregnancy.
- Geriatrics:Higher incidence of adverse reactions related to reduced intravascular volume.
- Renal impairment:Higher incidence of adverse reactions related to reduced intravascular volume and renal function.
- Hepatic impairment:Avoid use in patients with hepatic impairment.
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