Important Safety Information for QTERN® (dapagliflozin and saxagliptin) and FARXIGA® (dapagliflozin)

 

Contraindications

  • Prior serious hypersensitivity reaction to dapagliflozin or saxagliptin

  • QTERN is contraindicated in moderate...Read More

  • Prior serious hypersensitivity reaction to dapagliflozin or saxagliptin

  • QTERN is contraindicated in moderate to severe renal impairment (eGFR <45 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis

  • FARXIGA is contraindicated in severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis

Warning and Precautions
  • 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

  • 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

Adverse Reactions

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%).

Drug Interactions

Strong CYP3A4/5 inhibitors (eg, ketoconazole): Co-administration with QTERN significantly increases saxagliptin concentrations. Do not co-administer QTERN.

Use in Specific Populations

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

Indication and Limitations of Use for QTERN and FARXIGA

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.

 

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Reimbursement Specialists are available by phone, Monday through Friday, from 8 AM to 7 PM ET at 1-800-777-5702 to answer your questions about your patients’ coverage.

Important Safety Information for QTERN® (dapagliflozin and saxagliptin) and FARXIGA® (dapagliflozin)

Contraindications

  • Prior serious hypersensitivity reaction to dapagliflozin or saxagliptin

  • QTERN is contraindicated in moderate to severe renal impairment (eGFR <45 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis

  • FARXIGA is contraindicated in severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis

Warning and Precautions
  • 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

  • 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

Adverse Reactions

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%).

Drug Interactions

Strong CYP3A4/5 inhibitors (eg, ketoconazole): Co-administration with QTERN significantly increases saxagliptin concentrations. Do not co-administer QTERN.

Use in Specific Populations

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.

Indication and Limitations of Use for QTERN and FARXIGA

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.

Please see US Full Prescribing Informationpdf icon and Medication Guidepdf icon for QTERN.

Please see US Full Prescribing Informationpdf icon and Medication Guidepdf icon for FARXIGA.