For patients treated with ertugliflozin who are being switched to STEGLUJAN, the dose of ertugliflozin can be maintained.

In patients with volume depletion, correct this condition prior to initiation of STEGLUJAN [see Warnings and Precautions (5.2)].

2.2 Patients with Renal Impairment

 Assess renal function prior to initiation of STEGLUJAN and periodically thereafter [see Warnings and Precautions (5.4)].

Use of STEGLUJAN is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 [see Contraindications (4)].

Initiation of STEGLUJAN is not recommended in patients with an eGFR of 30 mL/min/1.73 m2 to less than 60 mL/min/1.73 m2 [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6)].

Continued use of STEGLUJAN is not recommended when eGFR is persistently between 30 and less than 60 mL/min/1.73 m2.

No dose adjustment is needed in patients with mild renal impairment. 

3 DOSAGE FORMS AND STRENGTHS

STEGLUJAN 5 mg/100 mg: ertugliflozin 5 mg and sitagliptin 100 mg tablets are beige, almond-shaped debossed with "554" on one side and plain on the other side. 

STEGLUJAN 15 mg/100 mg: ertugliflozin 15 mg and sitagliptin 100 mg tablets are brown, almond-shaped debossed with "555" on one side and plain on the other side.

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4 CONTRAINDICATIONS

Severe renal impairment, end-stage renal disease (ESRD), or dialysis [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6)].

History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema [see Warnings and Precautions (5.10) and Adverse Reactions (6.2)]. 

History of a serious hypersensitivity reaction to ertugliflozin.

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5 WARNINGS AND PRECAUTIONS

5.1 Pancreatitis

There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking sitagliptin, a component of STEGLUJAN. After initiation of STEGLUJAN, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, STEGLUJAN should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN.

5.2 Hypotension

Ertugliflozin, a component of STEGLUJAN, causes intravascular volume contraction. Therefore, symptomatic hypotension may occur after initiating STEGLUJAN [see Adverse Reactions (6.1)] particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2) [see Use in Specific Populations (8.6)], elderly patients (≥65 years), in patients with low systolic blood pressure, and in patients on diuretics. Before initiating STEGLUJAN, volume status should be assessed and corrected if indicated. Monitor for signs and symptoms of hypotension after initiating therapy.

5.3 Ketoacidosis