Ertugliflozin/Sitagliptin

DEA Class; Rx

Common Brand Names; Steglujan

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

Hypersensitivity to drugs or excipients; reactions such as angioedema or anaphylaxis have occurred

Severe renal impairment (<30 mL/min/1.73 m²), end-stage renal disease, or dialysis

 Ertugliflozin

• Female genital mycotic infections (9.1-12.2%)
• Volume depletion adverse effects (1.9-4.4%)
• Male genital mycotic infections (3.7-4.2%)
• Urinary tract infections (4-4.1%)
• Headache (2.9-3.5%)
• Vaginal pruritus (2.4-2.8%)
• Increased urination (2.4-2.7%)
• Nasopharyngitis (2-2.5%)
• Back pain (1.7-2.5%)
• Renal adverse effects (1.3-2.5%)
• Weight decreased (1.2-2.4%)
• Thirst (1.4-2.7%)

Sitagliptin

• Upper respiratory tract infection
• Nasopharyngitis
• Headache
• Abdominal pain
• Nausea
• Diarrhea
• Peripheral edema
• Hypersensitivity including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions
• Hepatic enzyme elevations
• Acute pancreatitis
• Worsening renal function and acute renal failure
• Bullous pemphigoid
• Constipation
• Vomiting
• Headache
• Myalgia
• Pain in extremity
• Back pain
• Pruritus
• Rhabdomyolysis
• Tubulointerstitial nephritis

Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking sitagliptin reported; promptly discontinue if pancreatitis suspected

Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors; signs and symptoms include tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell; if suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary

Causes intravascular volume contraction; symptomatic hypotension may occur after initiating, particularly in patients with renal impairment, with low systolic blood pressure, on diuretics, or who are elderly; before initiating treatment in patients with one or more of risk factors, assess volume status and renal function

Renal impairment may occur owing to intravascular volume contraction; before initiating, consider factors that may predispose patients to acute kidney injury, including hypovolemia, chronic renal insufficiency, CHF, and concomitant medications (eg, diuretics, ACE inhibitors, ARBs, NSAIDs); consider temporarily discontinuing ertugliflozin in any setting of reduced oral intake or fluid loss; monitor for signs and symptoms of acute kidney injury, and, if evident, discontinue drug promptly and institute treatment

Serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization reported in patients receiving SGLT2 inhibitors

Heart failure has been observed in cardiovascular outcomes trials for 2 other DPP-4 inhibitors; consider the risks and benefits prior to initiating treatment in patients at risk for heart failure (eg, those with a prior history of heart failure, a history of renal impairment), and observe these patients for signs and symptoms of heart failure during therapy

Genital mycotic infections may occur; patients with history of genital mycotic infections and uncircumcised males are more susceptible

Serious hypersensitivity reported with sitagliptin, including anaphylaxis, angioedema, and exfoliative skin conditions, including Stevens-Johnson syndrome (see Contraindications)

Dose-related increases in LDL-C reported

Severe and disabling arthralgia reported in patients taking DDP-4 inhibitors; may occur at any time; symptoms relieved upon discontinuation

Bullous pemphigoid requiring hospitalization reported with DPP-4 inhibitors; patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor

No conclusive evidence of macrovascular risk reduction with empagliflozin or any other antidiabetic agent

Ertugliflozin

• Based on animal data showing adverse renal effects, not recommended during the second and third trimesters of pregnancy

Sitagliptin

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to sitagliptin during pregnancy

Lactation

Not recommended while breastfeeding

Ertugliflozin/sitagliptin

tablet

• 5mg/100mg
• 15mg/100mg