Empagliflozin/Linagliptin

DEA Class; Rx

Common Brand Names; Glyxambi

Indicated for the treatment of type 2 diabetes mellitus in combination with diet and exercise to improve glycemic control when treatment with both empagliflozin and linagliptin is appropriate.

Severe renal impairment, end-stage renal disease, or dialysis

Hypersensitivity to empagliflozin, linagliptin, or excipients (eg, anaphylaxis, angioedema, exfoliative skin conditions, urticaria, bronchial hyperreactivity)

Also see individual drugs

Urinary tract infection (11.4-12.5%)

Upper respiratory tract infection (7%)

Nasopharyngitis (5.9-6.6%)

Increased LDL-C (4.6-6.5%)

Hypoglycemia (2.2-3.6%)

Increased hematocrit (2.8%)

Acute pancreatitis, including fatal pancreatitis

Ketoacidosis

Urosepsis and pyelonephritis

Necrotizing fasciitis of the perineum (Fournier gangrene)

Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions

Severe and disabling arthralgia

Bullous pemphigoid

Skin reactions (eg, rash, urticaria)

Mouth ulceration, stomatitis

Rhabdomyolysis

Acute kidney injury

Constipation

Acute pancreatitis, including fatal pancreatitis, reported; if pancreatitis is suspected, promptly discontinue and initiate appropriate management; unknown whether patients with history of pancreatitis are at risk for development of the disease while receiving therapy

Serious hypersensitivity reactions, (eg, angioedema) in patients treated with empagliflozin reported postmarketing; onset of these reactions occurred predominantly within first 3 months after initiation of treatment with this drug, with some reports occurring after first dose; angioedema reported with other dipeptidyl peptidase-4 (DPP-4) inhibitors; use caution in patient with history of angioedema to another DPP-4 inhibitor; unknown whether such patients will be predisposed to angioedema with this drug; discontinue therapy and treat promptly if it occurs per standard of care

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, advise patients of characteristic symptoms of heart failure and to immediately report such symptoms; 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; patients should report development blisters/erosions; discontinue DPP-4 therapy and consult a dermatologist if bullous pemphigoid suspected

Hypoglycemia risk increased with insulin and insulin secretagogues (eg, sulfonylureas); a lower dose of insulin or the insulin secretagogue may be required

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

Based on animal data showing adverse renal effects from empagliflozin, it is not recommended during the second and third trimesters of pregnancy

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

Empagliflozin/linagliptin

Tablet

• 10mg/5mg
• 25mg/5mg