STEGLUJAN™

(ertugliflozin and sitagliptin) 5 mg/100 mg, 15 mg/100 mg tablets

Administration and Dosing

Administration

STEGLUJAN™ (ertugliflozin and sitagliptin) Taken Orally

Oral

STEGLUJAN™ (ertugliflozin and sitagliptin) Taken Once Daily in the Morning

Once daily, taken in the morning

STEGLUJAN™ (ertugliflozin and sitagliptin) May Be Taken With or Without Food

With or without food

Dosing

STEGLUJAN™ (ertugliflozin and sitagliptin): Convenient Dosing Schedule

STEGLUJAN™ (ertugliflozin and sitagliptin) 5 mg/100 mg Tablets

5 mg/100 mg; 1 tablet, once daily

STEGLUJAN™ (ertugliflozin and sitagliptin) 15 mg/100 mg Tablets

15 mg/100 mg; 1 tablet, once daily

Tablets not shown as actual size.

Recommended Dosage

  • The recommended starting dose of STEGLUJAN is 5 mg ertugliflozin/100 mg sitagliptin once daily, taken in the morning, with or without food. In patients tolerating STEGLUJAN, the dose may be increased to a maximum recommended dose of 15 mg ertugliflozin/100 mg sitagliptin, once daily, if additional glycemic control is needed.
  • 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

Patients With Renal Impairment

  • Assess renal function prior to initiation of STEGLUJAN and periodically thereafter
  • Use of STEGLUJAN is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2
  • 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
  • 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

eGFR = estimated glomerular filtration rate.

Indication

STEGLUJAN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. STEGLUJAN is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. STEGLUJAN has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN.

Selected Safety Information

Contraindications: STEGLUJAN is contraindicated in patients with severe renal impairment, end-stage renal disease, or on dialysis, and/or a history of a serious hypersensitivity reaction to sitagliptin (such as anaphylaxis or angioedema) and/or ertugliflozin.

Pancreatitis: Acute pancreatitis (including fatal and nonfatal hemorrhagic or necrotizing pancreatitis) has been reported in patients taking sitagliptin. Observe for signs and symptoms, and if suspected, discontinue STEGLUJAN and institute treatment. It is unknown whether patients with a history of pancreatitis are at increased risk for developing pancreatitis while using STEGLUJAN.

Hypotension: Ertugliflozin causes intravascular volume contraction. Symptomatic hypotension may occur, particularly in patients with impaired renal function such as elderly patients, in patients with low systolic blood pressure, and in patients on diuretics. Before initiating STEGLUJAN, assess and correct volume status as indicated. Monitor for hypotension.

Ketoacidosis: Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been reported in patients with type 1 and type 2 diabetes receiving sodium glucose co-transporter 2 inhibitors (SGLT2is), including ertugliflozin. Some cases were fatal. Assess patients with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If ketoacidosis is suspected, discontinue STEGLUJAN, evaluate, treat promptly, and ensure risks for ketoacidosis are resolved prior to restarting. Before initiating, consider risk factors. Consider temporarily discontinuing STEGLUJAN for at least 4 days prior to scheduled surgery. Monitor patients and temporarily discontinue STEGLUJAN in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or post-surgery). Educate patients on the signs and symptoms of ketoacidosis. Instruct patients to discontinue STEGLUJAN and seek medical attention immediately if signs and symptoms occur.

Acute Kidney Injury and Impairment in Renal Function: STEGLUJAN causes intravascular volume contraction and renal impairment, and there have been reports of acute kidney injury requiring hospitalization and dialysis. Consider risk factors before initiating and temporarily discontinue in settings of reduced oral intake or fluid losses. Monitor patients for signs and symptoms of acute kidney injury. If acute kidney injury occurs, discontinue and promptly treat. Ertugliflozin increases serum creatinine and decreases eGFR. Patients with moderate renal impairment may be more susceptible. Evaluate renal function prior to initiating and monitor periodically. Use is not recommended when eGFR is persistently 30 – < 60 mL/min/1.73 m2 and is contraindicated with eGFR < 30 mL/min/1.73 m2. There have been postmarketing reports of worsening renal function with sitagliptin, including acute renal failure, sometimes requiring dialysis.

Urosepsis and Pyelonephritis: Serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization have occurred in patients receiving SGLT2is. Cases of pyelonephritis also have been reported in ertugliflozin-treated patients in clinical trials. SGLT2is increase the risk for urinary tract infections. Monitor for urinary tract infections and treat promptly.

Lower Limb Amputations: An increased risk for lower limb amputation has been observed in clinical studies with another SGLT2i. Across seven Phase 3 clinical trials with ertugliflozin, nontraumatic lower limb amputations were reported in 1 (0.1%) patient in the comparator group, 3 (0.2%) patients in the ertugliflozin 5-mg group, and 8 (0.5%) patients in the ertugliflozin 15-mg group. A causal association between ertugliflozin and lower limb amputation has not been definitively established. Before initiating STEGLUJAN, consider risk factors. Monitor and discontinue STEGLUJAN if complications occur. Counsel about routine preventative foot care.

Heart Failure: Heart failure has been observed in cardiovascular outcomes trials for two other members of the dipeptidyl peptidase-4 inhibitor (DPP-4i) class. Consider risks and benefits of STEGLUJAN prior to initiating treatment in patients at risk for heart failure. Monitor for, and advise patients to immediately report, symptoms. If heart failure develops, consider discontinuation of STEGLUJAN.

Hypoglycemia With Concomitant Use With Insulin and Insulin Secretagogues: STEGLUJAN in combination with insulin or insulin secretagogues can increase the risk of hypoglycemia. A lower dose of insulin or insulin secretagogue may be required.

Necrotizing Fasciitis of the Perineum (Fournier's Gangrene): A rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention has been reported in men and women taking SGLT2is. Serious outcomes have included hospitalization, multiple surgeries, and death. Assess reports of pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, treat promptly and discontinue STEGLUJAN.

Genital Mycotic Infections: Ertugliflozin increases the risk of genital mycotic infections, particularly in patients with a history of these infections or who are uncircumcised. Monitor and treat appropriately.

Hypersensitivity Reactions: There have been reports of serious hypersensitivity reactions with sitagliptin, such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. If suspected, discontinue STEGLUJAN, assess for potential causes, and institute other treatment for diabetes. Angioedema also has been reported with DPP-4is. Use caution in patients with a history of angioedema with another DPP-4i.

Increases in Low-Density Lipoprotein Cholesterol (LDL-C): Monitor and treat as appropriate.

Severe and Disabling Arthralgia: There have been reports of severe and disabling arthralgia with DPP-4is. Consider DPP-4is as a possible cause and discontinue if appropriate.

Bullous Pemphigoid: Bullous pemphigoid requiring hospitalization has been reported with DPP-4is. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue STEGLUJAN and consider referral to a dermatologist.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with STEGLUJAN.

The most common adverse reactions associated with ertugliflozin (≥5%) were female genital mycotic infections.

The most common adverse reactions with sitagliptin (≥5%) were upper respiratory tract infection, nasopharyngitis, and headache.

Before prescribing STEGLUJANTM (ertugliflozin and sitagliptin), please read the accompanying Prescribing Information. The Medication Guide also is available.

US-LUJ-0033810/20