Dapagliflozin/Saxagliptin/Metformin

DEA Class; Rx

Common Brand Names; Qternmet XR

Indicated for the treatment of type 2 diabetes mellitus in combination with diet and exercise.

Hypersensitivity to dapagliflozin, saxagliptin, or metformin

Moderate-to-severe renal impairment (eGFR <45 mL/min/1.73 m²), ESRD, or patients on dialysis

Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma

Urinary tract infection (5.7%)

Dyslipidemia (5.1%)

Headache (4.3%)

Diarrhea (3.7%)

Back pain (3.3%)

Genital infection (3%)

Arthralgia (2.4%)

Dapagliflozin

• Ketoacidosis
• Acute kidney injury
• Renal impairment
• Urosepsis
• Pyelonephritis
• Necrotizing fasciitis of the perineum (Fournier gangrene)
• Rash

Saxagliptin

• Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions
• Pancreatitis
• Severe and disabling arthralgia
• Bullous pemphigoid
• Rhabdomyolysis

Metformin

• Cholestatic, hepatocellular, and mixed hepatocellular liver injury

In cardiovascular outcomes trial, cases of definite acute pancreatitis were confirmed with patients treated with saxagliptin; if pancreatitis suspected, promptly discontinue treatment and initiate appropriate management; unknown if patients with history of pancreatitis are at increased risk for the development of pancreatitis while using Qternmet XR

Increased risk of hospitalization for heart failure in patients treated with saxagliptin reported; those with previous history of heart failure or renally impaired were at high risk

Dapagliflozin causes intravascular volume contraction; symptomatic hypotension may occur after starting therapy; assess volume status and correct

Necrotizing fasciitis of the perineum (Fournier gangrene) reported in postmarketing surveillance with SGLT2 inhibitors; it is a rare life-threatening necrotizing infection requiring urgent surgical intervention

Hypersensitivity reactions reported with saxagliptin; onset of reactions occurred within the first 3 months after initiating saxagliptin; exercise caution with history of angioedema to another DPP-4 inhibitor

In controlled clinical trials of metformin, a decrease to subnormal levels of serum vitamin B12 levels, without clinical manifestations, was observed

Dapagliflozin increases the risks of genital mycotic infections; patients with a history of genital mycotic infections were more likely to develop genital mycotic infections; monitor and treat appropriately

Increased LDL–C may occur with dapagliflozin; monitor LDL-C and treat per standard of care

In clinical studies for dapagliflozin, newly diagnosed cases of bladder cancer were reported; there were too few cases to determine whether the emergence of these events is related to dapagliflozin

Severe and disabling arthralgia in patients taking DPP-4 inhibitors have been reported; consider discontinuing drug if DPP-4 inhibitor is a cause for severe joint pain

Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use

No clinical studies establishing conclusive evidence of macrovascular risk reduction with treatment SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests

Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors

Not recommended during the second and third trimesters

Limited available data with dapagliflozin and saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage

Published clinical lactation studies report that metformin is present in human milk

Saxagliptin and dapagliflozin are present in the milk of lactating rats; since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney

Dapagliflozin/saxagliptin/metformin HCl extended-release

Tablet

• 2.5mg/2.5mg/1000mg
• 5mg/2.5mg/1000mg
• 5mg/5mg/1000mg
• 10mg/5mg/1000mg