Dapagliflozin/​Saxagliptin

DEA Class; Rx

Common Brand Names; Qtern

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin

History of hypersensitivity to dapagliflozin or saxagliptin, including anaphylaxis, angioedema, or exfoliative skin conditions

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

Upper respiratory tract infection (13.6%)

Urinary tract infection (5.7%)

Dyslipidemia (5.1%)

Headache (4.3%)

Diarrhea (3.7%)

Back pain (3.3%)

Genital infection (3%)

Arthralgia (2.4%)

Renal impairment (2%)

Increased serum inorganic phosphorus (1.7%)

Hypoglycemia (1.6%)

Increased hematocrit (1.3%)

Elevated creatine kinase (1%)

Volume depletion (hypotension, dehydration, hypovolemia)

Acute pancreatitis

Decreased lymphocyte count

Newly diagnosed bladder cancer

Saxagliptin

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

Dapagliflozin

• Ketoacidosis
• Acute kidney injury and impaired renal function
• Urosepsis and pyelonephritis
• Rash

Acute pancreatitis reported; after initiating drug, monitor for signs and symptoms of pancreatitis; if suspected, promptly discontinue dapagliflozin/saxagliptin and initiate appropriate management

Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors; signs and symptoms include tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell; if suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary

May increase risk for developing heart failure (HF) or exacerbation of existing HR; observe patients for signs and symptoms of HF

Patients with diabetes and renal impairment using dapagliflozin for glycemic control may be more likely to experience hypotension and may be at higher risk for acute kidney injury secondary to volume depletion; evaluate renal function prior to initiation of therapy and monitor periodically thereafter; contraindicated in patients with an eGFR <45 mL/min/1.73 m²

Hypoglycemia risk increased with insulin and insulin secretagogues; adjust dose

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

Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization reported in patients receiving SGLT2 inhibitors, including dapagliflozin; treatment with SGLT2 inhibitors increases risk for urinary tract infections; evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated

Dose-related increases in LDL-C reported with dapagliflozin

Across 22 clinical studies, newly diagnosed cases of bladder cancer were reported in 10 (0.17%)/6045 patients treated with dapagliflozin and 1 (0.03%)/3512 patient treated with placebo/comparator; bladder cancer risk factors and hematuria (a potential indicator of preexisting tumors) were balanced between treatment arms at baseline and there were too few cases to determine whether the emergence of these events is related to dapagliflozin

Do not administer to patients with active bladder cancer and should be administered with caution in patients with a prior history of bladder cancer

Not recommended during the second and third trimesters

Adverse renal affects shown in animal studies

Unknown if distributed in human breast 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

tablet

• 10mg/5mg