Sitagliptin

DEA Class; Rx

Common Brand Names; Januvia

Serious hypersensitivity to sitagliptin (eg, anaphylaxis, angioedema)

Combination with insulin with or without metformin

• Hypoglycemia (15.5%)

Combination with glimepiride with or without metformin

• Hypoglycemia (12.2%)

Monotherapy

• Nasopharyngitis (5.2%)

• Upper respiratory tract infection (4.5%)

• Headache (1.1%)

Combination with pioglitazone

• Upper respiratory tract infection (6.3%)

• Headache (5.1%)

Combination with metformin

• Nasopharyngitis (6.2%)

• Upper respiratory tract infection (5.9%)

Combination with metformin and rosiglitazone

• Nasopharyngitis (6.1%)

• Upper respiratory tract infection (5.5%)

Combination with glimepiride with or without metformin

• Nasopharyngitis (6.3%)

• Upper respiratory tract infection (5.9%)

Hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome

Hepatic enzyme elevations; acute pancreatitis, including fatal and nonfatal hemorrhagic and necrotizing pancreatitis

Worsening renal function, including acute renal failure (sometimes requiring dialysis)

Severe and disabling arthralgia

Tubulointerstitial nephritis

Constipation, vomiting

Headache, myalgia, pain in extremity, back pain

Rhabdomyolysis

Pruritus

Bullous pemphigoid

Mouth ulceration; stomatitis

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

Acute renal failure reported, sometimes requiring dialysis; assess renal function before initiation and periodically thereafter

Serious allergic and hypersensitivity reactions (eg, anaphylaxis, angioedema, exfoliative skin conditions including Stevens-Johnson syndrome) reported; promptly stop treatment and assess for other potential causes; appropriately monitor and treat

Severe and disabling arthralgia reported in patients taking DPP-4 inhibitors; consider as a possible cause for severe joint pain and discontinue drug if appropriate

Heart failure observed with other DPP-4 inhibitors; consider risks and benefits in patients with risk factors for heart failure; monitor for signs and symptoms; if heart failure develops, manage accordingly to standard of care and consider interrupting treatment

Bullous pemphigoid reported with DPP-4 inhibitor use, which required hospitalization; in reported cases, patients recovered with topical or systemic immunosuppressive treatment and discontinuation of DPP-4 inhibitor; advise to report any developing blisters/erosions; discontinue DPP-4 therapy and consult a dermatologist if bullous pemphigoid suspected

Limited available data in pregnant females are not sufficient to inform a drug-associated risk for major birth defects and miscarriage

There is no information regarding presence of drug in human milk, effects on breastfed infants, or on milk production

Present in rat milk and therefore possibly present in human