Linagliptin/​Metformin

DEA Class; Rx

Common Brand Names; Jentadueto, Jentadueto XR

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate

Renal impairment (eg, eGFR <30 ml/min/1.73 m²) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia

Acute or chronic metabolic acidosis, including diabetic ketoacidosis

History of hypersensitivity reaction to linagliptin (eg, urticaria, angioedema, bronchial hyperreactivity) or metformin

Hypoglycemia (with sulfonylurea) (22.9%)

Nasopharyngitis (6.3%)

Diarrhea (6.3%)

Hypoglycemia (without sulfonylurea) (1.4%)

Linagliptin

• Acute pancreatitis, including fatal pancreatitis
• Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions
• Severe and disabling arthralgia
• Bullous pemphigoid
• Rash
• Mouth ulceration, stomatitis
• Rhabdomyolysis

Metformin

• Cholestatic, hepatocellular, and mixed hepatocellular liver injury

Diabetic ketoacidosis should be treated with insulin

Monitor hepatic and renal function; risk of metformin accumulation and lactic acidosis increases with renal impairment; hepatic impairment limits ability to clear lactate

Avoid excessive alcohol intake; alcohol is known to potentiate effect of metformin on lactate metabolism

Use of concomitant medications that may affect renal function or metformin disposition

Use in combination with an insulin secretagogue (eg, sulfonylurea) was associated with a higher rate of hypoglycemia compared with placebo in a clinical trial; therefore, a lower dose of insulin secretagogue or insulin may be required to reduce risk of hypoglycemia when used in combination with this drug

Cardiovascular collapse (shock) from whatever cause (eg, acute congestive heart failure, acute myocardial infarction, and other conditions characterized by hypoxemia) has been associated with lactic acidosis and may also cause prerenal azotemia; discontinue drug promptly

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

No conclusive evidence of macrovascular risk reduction reported with antidiabetic drugs

Serious hypersensitivity reactions reported including anaphylaxis, angioedema, and exfoliative skin conditions; discontinue therapy promptly, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes

Heart failure has been observed with two other members of the DPP-4 inhibitor class; consider risks and benefits of empagliflozin 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; advise patients of the characteristic symptoms of heart failure and to immediately report such symptoms

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; patients should report development blisters/erosions; discontinue DPP-4 therapy and consult a dermatologist if bullous pemphigoid suspected

Limited data in pregnant women not sufficient to inform associated risk for major birth defects and miscarriage with product; published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy

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

Linagliptin/metformin

tablet (Jentadueto)

• 2.5mg/500mg
• 2.5mg/850mg
• 2.5mg/1000mg

extended-release tablet (Jentadueto XR)

• 2.5mg/1000mg
• 5mg/1000mg