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FARXIGA is contraindicated in severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis
Pancreatitis: There have been postmarketing reports of acute pancreatitis in patients taking saxagliptin and in the SAVOR cardiovascular outcomes trial. Observe for pancreatitis. If pancreatitis is suspected, discontinue QTERN
Heart Failure: In the SAVOR cardiovascular outcomes trial, more patients treated with saxagliptin were hospitalized for heart failure compared to placebo. Patients with a prior history of heart failure or renal impairment had a higher risk for hospitalization for heart failure. Consider the risks and benefits of QTERN in patients who have known risk factors for heart failure. Monitor for signs and symptoms. If heart failure develops, consider discontinuation of QTERN
Hypotension: Dapagliflozin causes intravascular volume contraction and symptomatic hypotension can occur. Assess and correct volume status before initiating QTERN or FARXIGA in patients with impaired renal function, elderly patients, or patients on loop diuretics. Do not initiate in patients with an eGFR <60 mL/min/1.73 m2. Monitor for hypotension
Ketoacidosis has been reported in patients with type 1 and type 2 diabetes receiving dapagliflozin. Some cases were fatal. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis regardless of blood glucose level. If suspected, discontinue QTERN or FARXIGA, evaluate and treat promptly. Before initiating QTERN or FARXIGA, consider risk factors for ketoacidosis. Patients on QTERN or FARXIGA may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis
Acute Kidney Injury and Impairment in Renal Function: Dapagliflozin causes intravascular volume contraction and renal impairment, with reports of acute kidney injury requiring hospitalization and dialysis. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat
Dapagliflozin increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Before initiating QTERN or FARXIGA, evaluate renal function and monitor periodically. Discontinue QTERN in patients if eGFR falls persistently below 60 mL/min/1.73 m2.
FARXIGA is not recommended in patients with an eGFR persistently between 30 and <60 mL/min/1.73 m2.
Urosepsis and Pyelonephritis: SGLT2 inhibitors increase the risk for urinary tract infections (UTIs) and serious UTIs have been reported with dapagliflozin. Evaluate for signs and symptoms of UTIs and treat promptly
Hypoglycemia: Both saxagliptin and dapagliflozin can individually increase the risk of hypoglycemia when co-administered with insulin and insulin secretagogues. Consider lowering the dose of these agents when co-administered with QTERN or FARXIGA
Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Rare but serious, life-threatening cases have been reported in patients receiving SGLT2 inhibitors including dapagliflozin. Cases have been reported in females and males. Serious outcomes have included hospitalization, surgeries, and death. Assess patients presenting with pain or tenderness, erythema, swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment and discontinue QTERN or FARXIGA
Hypersensitivity Reactions: Serious reactions have been reported in patients treated with saxagliptin, including anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment with saxagliptin, with some reports occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue QTERN. Use caution in patients with a history of angioedema to another DPP-4 inhibitor
Genital Mycotic Infections: Dapagliflozin increases the risk of genital mycotic infections, particularly in patients with prior genital mycotic infections. Monitor and treat appropriately
Increases in Low-Density Lipoprotein Cholesterol (LDL-C) occur with dapagliflozin. Monitor LDL-C and treat per standard of care
Bladder cancer: An imbalance in bladder cancers was observed in clinical trials. There were too few cases to determine whether the emergence of these events is related to dapagliflozin, and insufficient data to determine whether dapagliflozin has an effect on pre-existing bladder tumors. QTERN or FARXIGA should not be used in patients with active bladder cancer. Use with caution in patients with a history of bladder cancer
Severe and Disabling Arthralgia has been reported in patients taking DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation. A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor. Consider discontinuing drug if appropriate
Bullous Pemphigoid: There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If suspected, discontinue QTERN
Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with QTERN or FARXIGA
Most common adverse reactions reported in ≥5% of patients treated with QTERN were upper respiratory tract infection (13.6%), urinary tract infection (5.7%), and dyslipidemia (5.1%).
In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).
Strong CYP3A4/5 inhibitors (eg, ketoconazole): Co-administration with QTERN significantly increases saxagliptin concentrations. Do not co-administer QTERN.
Pregnancy: Advise females of the potential risk of QTERN or FARXIGA to a fetus especially during the second and third trimesters.
Lactation: QTERN or FARXIGA is not recommended when breastfeeding.
QTERN is 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. QTERN should only be used in patients who tolerate 10 mg dapagliflozin.
FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM.
QTERN or FARXIGA is not indicated for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.