Important Safety Information For Farxiga

Contraindications

  • Prior serious hypersensitivity reaction to FARXIGA...Read More
  • Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis

Warnings and Precautions

  • Hypotension: FARXIGA causes intravascular volume contraction, and symptomatic hypotension can occur. Assess and correct volume status before initiating FARXIGA 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 FARXIGA. 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 FARXIGA, evaluate and treat promptly. Before initiating FARXIGA, consider risk factors for ketoacidosis. Patients on FARXIGA may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis
  • Acute Kidney Injury and Impairment in Renal Function: FARXIGA 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.
  • FARXIGA increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Before initiating FARXIGA, evaluate renal function and monitor periodically. 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 FARXIGA. Evaluate for signs and symptoms of UTIs and treat promptly
  • Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with FARXIGA
  • Genital Mycotic Infections: FARXIGA 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 FARXIGA. 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 FARXIGA, and insufficient data to determine whether FARXIGA has an effect on pre-existing bladder tumors. FARXIGA should not be used in patients with active bladder cancer. Use with caution in patients with a history of bladder cancer
  • Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with FARXIGA

Adverse Reactions

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%).

Use in Specific Populations

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

  • Lactation: FARXIGA is not recommended when breastfeeding.

INDICATION AND LIMITATIONS OF USE

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

FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Please read US Full Prescribing Information and Medication Guide for FARXIGA.

You may report side effects related to AstraZeneca products by clicking here.

Explore the FARXIGA Mechanism of Action

Select a category to learn more or scroll  to begin the story.

Learn more about the role of the kidney in glucose homeostasis and the mechanism by which FARXIGA, a glucuretic, removes glucose through SGLT2* inhibition and renal excretion.

*Sodium-Glucose Cotransporter 2


The Role of the Kidney IN GLUCOSE HOMEOSTASIS

The Role of the Kidney

IN GLUCOSE HOMEOSTASIS

EXPLORE MORE

The Function of SGLT2

IN GLUCOSE REABSORPTION

EXPLORE MORE

How FARXIGA® Works:

Mechanism of Action

EXPLORE MORE

The Role of the Kidney in Glucose Homeostasis

  • The human kidney contributes significantly to the body’s regulation of glucose through: production, utilization, filtration, reabsorption1
  • In normal glucose-tolerant subjects, virtually all filtered glucose is reabsorbed2
  • Because the average plasma glucose concentration throughout a 24-hour period is 100 mg/dL, approximately 180 g of glucose are filtered out of the bloodstream per day1

Explore how the kidney plays a key role in glucose HOMEOSTASIS

The Function of SGLT2 in Glucose Reabsorption

  • SGLT2 is the cotransporter responsible for the majority of glucose reabsorption in the kidney1,2
  • SGLT2 is responsible for reabsorbing up to approximately 90% of the glucose filtered in
    the glomerulus3,†
  • Limited data suggest that subjects with type 2 diabetes mellitus (T2DM)
    experience increased reabsorption of glucose4

Take a closer look at SGLT2 in action

For adults with type 2 diabetes, in addition to diet and exercise

How FARXIGA Works: Mechanism of Action

  • By inhibiting SGLT2, FARXIGA, a glucuretic, removes glucose and associated calories5,6
  • FARXIGA reduces reabsorption of filtered glucose and lowers the renal threshold for glucose,
    and thereby increases urinary glucose excretion5
  • FARXIGA 10 mg is associated with the removal of approximately 70 g of glucose,
    or about 280 associated calories, into the urine, per day at 12 weeks of therapy7
  • FARXIGA is not indicated for weight loss

See how farxiga inhibits SGLT2

Loading the FARXIGA® (dapagliflozin) Mechanism of Action

The human kidney contributes significantly to the body’s regulation of glucose through1:

  • Production
  • Utilization
  • Filtration
  • Reabsorption

 

Because the average plasma glucose concentration throughout a 24-hour period is 100 mg/dL, approximately 180 g of glucose is filtered through the kidneys per day.1

 

In a pharmacodynamic study, FARXIGA 10 mg resulted in excretion of approximately 70 grams of glucose in the urine per day at Week 12. Results may vary. The recommended starting dose is 5 mg.

In subjects who are normally glucose-tolerant, virtually all filtered glucose is reabsorbed.2


The Function of SGLT2 IN GLUCOSE REABSORPTION

SGLT2 is the cotransporter responsible for the majority of glucose reabsorption in the kidney.2,5

 

SGLT2 is responsible for reabsorbing approximately 90% of the glucose filtered in the glomerulus in the S1 and S2 segments of the proximal tubule. The remaining 10% is reabsorbed by SGLT1 in the S3 segment of the proximal tubule.3,*

 

*Animal model

Limited data suggest that subjects with type 2 diabetes mellitus (T2DM) experience increased reabsorption of glucose.4


How FARXIGA Works: MECHANISM OF ACTION

By inhibiting SGLT2, FARXIGA, a glucuretic, removes glucose and associated calories.5,6

FARXIGA reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.5

FARXIGA 10 mg is associated with the removal of approximately 70 g of glucose, or about 280 associated calories into the urine, per day at 12 weeks of therapy.7

FARXIGA is not indicated for weight loss.


Prescribing FARXIGA FOR YOUR PATIENTS

Consider FARXIGA for patients who:

  • Need improvement in A1C
  • Could also benefit from weight and blood pressure reductions
  • Have sufficient renal function5,8,†

FARXIGA is not indicated for weight loss or the treatment of hypertension.

FARXIGA should not be initiated in patients with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2.

 

Important Safety Information For Farxiga

Contraindications

  • Prior serious hypersensitivity reaction to FARXIGA
  • Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis

Warnings and Precautions

  • Hypotension: FARXIGA causes intravascular volume contraction, and symptomatic hypotension can occur. Assess and correct volume status before initiating FARXIGA 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 FARXIGA. 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 FARXIGA, evaluate and treat promptly. Before initiating FARXIGA, consider risk factors for ketoacidosis. Patients on FARXIGA may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis
  • Acute Kidney Injury and Impairment in Renal Function: FARXIGA 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.
  • FARXIGA increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Before initiating FARXIGA, evaluate renal function and monitor periodically. 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 FARXIGA. Evaluate for signs and symptoms of UTIs and treat promptly
  • Hypoglycemia: FARXIGA can increase the risk of hypoglycemia when coadministered with insulin and insulin secretagogues. Consider lowering the dose of these agents when coadministered with FARXIGA
  • Genital Mycotic Infections: FARXIGA 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 FARXIGA. 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 FARXIGA, and insufficient data to determine whether FARXIGA has an effect on pre-existing bladder tumors. FARXIGA should not be used in patients with active bladder cancer. Use with caution in patients with a history of bladder cancer
  • Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with FARXIGA

Adverse Reactions

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%).

Use in Specific Populations

  • Pregnancy: Advise females of potential risk to a fetus especially during the second and third trimesters
  • Lactation: FARXIGA is not recommended when breastfeeding

INDICATION AND LIMITATIONS OF USE

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

FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Please read US Full Prescribing Information and Medication Guide for FARXIGA.

You may report side effects related to AstraZeneca products by clicking here.

References:

Reference:

  1. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  2. Data on File, REF-8609, AstraZeneca Pharmaceuticals LP.
  3. Nauck MA, Del Prato S, Meier JJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011;34(9):2015-2022.
  4. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  5. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  6. Wong ND, Patao C, Wong K, Malik S, Franklin SS, Iloeje U. Trends in control of cardiovascular risk factors among US adults with type 2 diabetes from 1999 to 2010: comparison by prevalent cardiovascular disease status. Diab Vasc Dis Res. 2013;10(6):505-513.
  7. Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of diabetes and its burden in the United States, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed September 28, 2015.
  8. Centers for Disease Control and Prevention. Age-adjusted percentage of adults aged 18 years or older with diagnosed diabetes who were overweight, United States, 1994–2010. http://www.cdc.gov/diabetes/statistics/comp/fig7_overweight.htm. Accessed September 18, 2015.
  9. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  10. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  11. Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska A, List JF. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012;66(5):446-456.
  12. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  13. Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska A, List JF. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012;66(5):446-456.
  14. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  15. Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise. Diabetes Care. 2010;33(10):2217-2224.
  16. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  17. Bailey CJ, Gross JL, Pieters A, Bastien A, List JF. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9733):2223-2233.
  18. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  19. Jabbour SA, Hardy E, Sugg J, Parikh S; Study 10 Group. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37(3):740-750.
  20. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  21. Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo controlled trial. Diabetes Obes Metab. 2011;13(10):928-938.
  22. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  23. Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012;35(7):1473-1478.
  24. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  25. Wilding JP, Woo V, Soler NG, et al. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012;156(6):405-415.
  26. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  27. Nauck MA, Del Prato S, Meier JJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011;34(9):2015-2022.
  28. Data on File, REF-4920, AstraZeneca Pharmaceuticals LP.
  29. Del Prato S, Nauck M, Duran-Garcia S, et al. Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. Diabetes Obes Metab. 2015;17(6):581-590.
  30. FARXIGA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017.
  31. Nauck MA, Del Prato S, Meier JJ, et al. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011;34(9):2015-2022.