QTERN® (dapagliflozin and saxagliptin) may be an appropriate next step, in addition to diet and exercise, for adults with type 2 diabetes who require additional glycemic control.

QTERN is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

HELP KEEP THE MOMENTUM GOING WITH QTERN

Combines Dapagliflozin & Saxagliptin into a Single Pill Icon

Combines dapagliflozin and saxagliptin into a single pill

Once‐Daily Dosing Icon

Once-daily dosing

Take Qtern in the Morning Icon

Taken in the morning with or without food

APPROVED WITH TWO DOSING OPTIONS AVAILABLE1

QTERN

(dapagliflozin 5 mg/saxagliptin 5 mg)

Dapagliflozin 5 mg/Saxagliptin 5 mg Dosing

Dapagliflozin 10 mg/Saxagliptin 5 mg Dosing

QTERN

(dapagliflozin 10 mg/saxagliptin 5 mg)

Tablets are not actual size.
  • For patients not already taking dapagliflozin, the recommended starting dose of QTERN is 5 mg dapagliflozin/5 mg saxagliptin tablet once daily

  • In patients tolerating 5 mg dapagliflozin and 5 mg saxagliptin once daily who require additional glycemic control, the QTERN dose can be increased to 10 mg dapagliflozin/5 mg saxagliptin tablet once daily

  • Swallow tablet whole. Do not crush, cut or chew

  • Assess renal function before initiation of therapy and periodically thereafter

IMPORTANT SAFETY INFORMATION for QTERN® (dapagliflozin and saxagliptin)

Contraindications

  • Prior serious hypersensitivity reaction to QTERN or its components

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

Warnings 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 in patients with impaired renal function, elderly patients, or patients on loop diuretics. 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, evaluate and treat promptly. Before initiating QTERN, consider risk factors for ketoacidosis. Patients on QTERN may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis

  • Acute Kidney Injury: Dapagliflozin causes intravascular volume contraction and acute kidney injury, with some 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

    Increases in serum creatinine and decreases in eGFR may be observed with initiation of QTERN. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Before initiating QTERN, evaluate renal function and monitor periodically

  • 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: QTERN can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with QTERN

  • 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 both 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

  • Hypersensitivity Reactions: Serious reactions have been reported in patients treated with saxagliptin, including anaphylactic reactions, 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

  • 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

Adverse Reactions

Most common adverse reactions reported in ≥5% of patients treated with 10 mg dapagliflozin and 5 mg saxagliptin were upper respiratory tract infection (13.6%), urinary tract infection (5.7%), and dyslipidemia (5.1%).

Drug Interactions

Strong CYP3A4/5 inhibitors (eg, ketoconazole): Coadministration with QTERN significantly increases saxagliptin concentrations. Do not coadminister QTERN.

Use in Specific Populations

Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters

Lactation: QTERN is not recommended when breastfeeding

INDICATION AND LIMITATIONS OF USE for QTERN® (dapagliflozin and saxagliptin)

QTERN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

QTERN is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Please see US Full Prescribing Information pdf icon and Medication Guide pdf icon for QTERN.

References:

Reference:

  1. 1. QTERN [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  2. 2. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  3. 1. DeFronzo RA. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58(4):773-795.
  4. 2. QTERN [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  5. 3. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  6. 4. Merovci A, Mari A, Solis C, et al. Dapagliflozin lowers plasma glucose concentration and improves β-cell function. J Clin Endocrinol Metab. 2015;100(5):1927-1932.
  7. 5. Merovci A, Solis-Herrera C, Daniele G, et al. Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production. J Clin Invest. 2014;124(2):509-514.
  8. 6. Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2018 executive summary. Endocr Pract. 2018;24(1):91-120.
  9. 1. QTERN [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  10. 2. Merovci A, Mari A, Solis-Herrera C, et al. Dapagliflozin lowers plasma glucose concentration and improves ß-cell function. J Clin Endocrinol Metab. 2015;100(5):1927-1932.
  11. 3. Merovci A, Solis-Herrera C, Daniele G, et al. Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production. J Clin Invest. 2014;124(2):509-514.
  12. 1. QTERN [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  13. 2. Matthaei S, Catrinoiu D, Celiński A, et al. Randomized, double-blind trial of triple therapy with saxagliptin add-on to dapagliflozin plus metformin in patients with type 2 diabetes. Diabetes Care. 2015;38(11):2018-2024.
  14. 3. Matthaei S, Catrinoiu D, Celiński A, et al. Randomized, double-blind trial of triple therapy with saxagliptin add-on to dapagliflozin plus metformin in patients with type 2 diabetes. Diabetes Care. 2015;38(11)(suppl):2018-2024.
  15. 4. Mathieu C, Ranetti AE, Li D, et al. Randomized, double-blind, phase 3 trial of triple therapy with dapagliflozin add-on to saxagliptin plus metformin in type 2 diabetes. Diabetes Care. 2015;38(11):2009-2017.
  16. 1. QTERN [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  17. 2. Matthaei S, Catrinoiu D, Celiński A, et al. Randomized, double-blind trial of triple therapy with saxagliptin add-on to dapagliflozin plus metformin in patients with type 2 diabetes. Diabetes Care. 2015;38(11):2018-2024.
  18. 3. Mathieu C, Ranetti AE, Li D, et al. Randomized, double-blind, phase 3 trial of triple therapy with dapagliflozin add-on to saxagliptin plus metformin in type 2 diabetes. Diabetes Care. 2015;38(11):2009-2017.
  19. 1. QTERN [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  20. 2. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  21. 1. QTERN [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020.