Metformin/​Sitagliptin

DEA Class; Rx

Common Brand Names; Janumet, Janumet XR

Serious hypersensitivity reaction (eg, anaphylaxis, angioedema) to sitagliptin/metformin, sitagliptin, or metformin

Severe renal impairment (eGFR <30 ml/min/1.73 m²)

Acute/chronic metabolic acidosis, including diabetic ketoacidosis

• Abdominal pain (2.2%)
• Diarrhea (2.4%)
• Hypoglycemia (2.1%)
• Nausea (1.3%)
• Vomiting (1.1%)
• Exfoliative disorder of skin of scalp
• Lactic acidosis (rare)
• Hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome
• Upper respiratory tract infection
• Hepatic enzyme elevations
• Acute pancreatitis including fatal and nonfatal hemorrhagic and necrotizing pancreatitis
• Gastrointestinal: Constipation, vomiting
• Neurologic: Headache
• Rhabdomyolysis
• Worsening renal function, including acute renal failure (sometimes requiring dialysis)
• Myalgia, pain in extremity, and back pain
• Severe disabling arthralgia
• Pruritus
• Bullous pemphigoid
• Mouth ulceration; stomatitis
• Tubulointerstitial nephritis

Metformin-associated lactic acidosis have been reported; cases primarily occurred in patients with significant renal impairment; assess renal function before initiating, at least annually during treatment, and more frequently in high-risk patients (eg, elderly)

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

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

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

Metformin may lower vitamin B12 levels; monitor hematologic parameters annually and 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

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, its effects on breastfed infants, or on milk production

Metformin/sitagliptin

tablet

• 500mg/50mg
• 1,000mg/50mg

tablet, extended-release

• 500mg/50mg
• 1,000mg/50mg
• 1,000mg/100mg