Classes
DEA Class; Rx
Common Brand Names; Glyxambi
- Antidiabetics, Dipeptyl Peptidase-IV Inhibitors;
- Antidiabetics, SGLT2 Inhibitors
Description
Oral combination of a sodium-glucose co-transporter 2 (SGLT2) inhibitor combined with a dipeptidyl peptidase-4 (DPP-4) inhibitor
Used for adults with type 2 diabetes mellitus not adequately controlled on either drug alone; when used with metformin, many patients achieve target A1C goals
Not recommended for glycemic control in patients with severe renal impairment due to reduced efficacy of empagliflozin
Indications
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.
Contraindications
Severe renal impairment, end-stage renal disease, or dialysis
Hypersensitivity to empagliflozin, linagliptin, or excipients (eg, anaphylaxis, angioedema, exfoliative skin conditions, urticaria, bronchial hyperreactivity)
Adverse Effects
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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
Empagliflozin 25 mg/day PO and linagliptin 5 mg/day PO.
Empagliflozin 25 mg/day PO and linagliptin 5 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Empagliflozin/linagliptin
Tablet
- 10mg/5mg
- 25mg/5mg