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.

A TREATMENT FOR ADULTS WITH TYPE 2 DIABETES MELLITUS, IN ADDITION TO DIET AND EXERCISE

Safety Profile

Select a category or scroll to learn more.

5 Important Facts

 

5

IMPORTANT FACTS ABOUT FARXIGA

1

ADD-ON TO DIET AND EXERCISE

When your adult patient’s diet or exercise plan isn’t enough, FARXIGA is indicated as an adjunct to improve glycemic control in adult patients with type 2 diabetes mellitus.

 

2

NOT INDICATED FOR TYPE 1 DIABETES OR DIABETIC KETOACIDOSIS (DKA)

NOT INDICATED FOR TYPE 1 DIABETES OR DIABETIC KETOACIDOSIS (DKA)

NOT INDICATED FOR TYPE 1 DIABETES OR DKA

FARXIGA is not recommended to treat patients with type 1 diabetes or for the treatment of DKA.

 

3

RENAL ASSESSMENT RECOMMENDED

Assessment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter. FARXIGA is not recommended in patients with an eGFR persistently between 30 and <60 mL/min/1.73 m2. FARXIGA is contraindicated in patients with an eGFR <30 mL/min/1.73 m2

 

4

NOT APPROPRIATE FOR EVERY PATIENT

FARXIGA is contraindicated in patients with a history of a serious hypersensitivity to FARXIGA and patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis.

 

5

IT’S IMPORTANT TO MONITOR VOLUME STATUS

Your patient’s volume status should be assessed and corrected before starting FARXIGA. After initiating therapy, monitor for signs and symptoms of hypotension.

  1. ADD-ON TO DIET AND EXERCISE—When your adult patient’s diet or exercise plan isn’t enough, FARXIGA is indicated as an adjunct to improve glycemic control in adult patients with type 2 diabetes mellitus.
  2. NOT INDICATED FOR TYPE 1 DIABETES OR DIABETIC KETOACIDOSIS (DKA)—FARXIGA is not recommended to treat patients with type 1 diabetes or for the treatment of DKA.
  3. RENAL ASSESSMENT RECOMMENDEDAssessment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter. FARXIGA is not recommended in patients with an eGFR persistently between 30 and <60 mL/min/1.73 m2. FARXIGA is contraindicated in patients with an eGFR <30 mL/min/1.73 m2
  4. NOT APPROPRIATE FOR EVERY PATIENT—FARXIGA is contraindicated in patients with a history of a serious hypersensitivity to FARXIGA and patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis.
  5. IT’S IMPORTANT TO MONITOR VOLUME STATUS—Your patient’s volume status should be assessed and corrected before starting FARXIGA. After initiating therapy, monitor for signs and symptoms of hypotension.

FARXIGA Side Effects

Pooled Safety Analysis

ADVERSE REACTIONS IN 12 PLACEBO-CONTROLLED STUDIES

REPORTED IN ≥2% OF PATIENTS TREATED WITH FARXIGA1,a,b

  FARXIGA 5 mg FARXIGA 10 mg Placebo
Female genital mycotic infectionsc 8.4% 6.9% 1.5%
Nasopharyngitis 6.6% 6.3% 6.2%
Urinary tract infectionsd 5.7% 4.3% 3.7%
Back pain 3.1% 4.2% 3.2%
Increased urinatione 2.9% 3.8% 1.7%
Male genital mycotic infectionsf 2.8% 2.7% 0.3%
Nausea 2.8% 2.5% 2.4%
Influenza 2.7% 2.3% 2.3%
Dyslipidemia 2.1% 2.5% 1.5%
Constipation 2.2% 1.9% 1.5%
Discomfort with urination 1.6% 2.1% 0.7%
Pain in extremity 2.0% 1.7% 1.4%
  (N=1145) (N=1193) (N=1393)

aAdverse events were evaluated with FARXIGA 5 mg and 10 mg in 12 placebo-controlled studies ranging from 12 to 24 weeks.

bFARXIGA was studied as monotherapy in 4 studies, and in 8 studies as add-on to background antidiabetic therapy or as combination with metformin.

cGenital mycotic infections include the following adverse reactions, listed in order of frequency reported for females: vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis, vulvovaginitis, genital infection, genital candidiasis, fungal genital infection, vulvitis, genitourinary tract infection, vulval abscess, and vaginitis bacterial (N for females: FARXIGA 5 mg=581, FARXIGA 10 mg=598, placebo=677).

dUrinary tract infections include the following adverse reactions, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection, and prostatitis.

eIncreased urination includes the following adverse reactions, listed in order of frequency reported: pollakiuria, polyuria, and increased urine output.

fGenital mycotic infections include the following adverse reactions, listed in order of frequency reported for males: balanitis, fungal genital infection, balanitis candida, genital candidiasis, genital infection male, penile infection, balanoposthitis, balanoposthitis infective, genital infection, posthitis (N for males: FARXIGA 5 mg=564, FARXIGA 10 mg=595, placebo=716).

Volume depletion1

  • Volume depletion includes reports of dehydration, hypovolemia, orthostatic hypotension, or hypotension
  • In a pool of 12 short-term, placebo-controlled studies, these rates were 0.6% with FARXIGA 5 mg, 0.8% with FARXIGA 10 mg, and 0.4% with placebo
  • In a pool of 13 short-term, placebo-controlled studies, these rates were 1.1% with FARXIGA 10 mg vs 0.7% with placebo

Genital mycotic infections1

  • Genital mycotic infections (GMIs) were reported in 5.7% of patients with FARXIGA 5 mg, 4.8% with FARXIGA 10 mg, and 0.9% with placebo, in the 12-study placebo-controlled pool
  • Discontinuation from study due to GMI occurred in 0% of placebo-treated patients and 0.2% of patients treated with FARXIGA 10 mg
  • Rates of GMI were higher among patients with a history of GMI than in those without

Hypoglycemic Events

Rates of Hypoglycemia

INCIDENCE OF MAJORg AND MINORh HYPOGLYCEMIA

IN PLACEBO-CONTROLLED STUDIES1

 

FARXIGA 5 mg

FARXIGA 10 mg

Placebo/Active Control

Monotherapyg (24 weeks)

Major [n (%)]

Minor [n (%)]

N=64

0

0

N=70

0

0

N=75

0

0

Add-on to metforming (24 weeks)

Major [n (%)]

Minor [n (%)]

N=137

0

2 (1.5%)

N=135

0

1 (0.7%)

N=137

0

0

Active control add-on to metformin vs glipizide (52 weeks)

Major [n (%)]

Minor [n (%)]

-

-

-

N=406

0

7 (1.7%)

N=408

3 (0.7%)

147 (36.0%)

Add-on to glimepirideg (24 weeks)

Major [n (%)]

Minor [n (%)]

N=145

0

8 (5.5%)

N=151

0

9 (6.0%)

N=146

0

3 (2.1%)

Add-on to pioglitazoneg (24 weeks)

Major [n (%)]

Minor [n (%)]

N=141

0

3 (2.1%)

N=140

0

0

N=139

0

0

Add-on to DPP-4 inhibitor (24 weeks)

Major [n (%)]

Minor [n (%)]

-

-

-

N=225

1 (0.4%)

4 (1.8%)

N=226

0

3 (1.3%)

Add-on to insulin with or without other OADs (24 weeks)

Major [n (%)]

Minor [n (%)]

N=212

1 (0.5%)

92 (43.4%)

N=196

1 (0.5%)

79 (40.3%)

N=197

1 (0.5%)

67 (34.0%)

Monotherapyg (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg(N=64) 0 0
FARXIGA 10 mg (N=70) 0 0
Placebo/Active Control(N=75) 0 0
Add-on to metforming (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg(N=137) 0 2 (1.5%)
FARXIGA 10 mg (N=135) 0 1 (0.7%)
Placebo/Active Control(N=137) 0 0
Active control add-on to metformin vs glipizide (52 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg -
-
-
FARXIGA 10 mg (N=406) 0
7 (1.7%)
Placebo/Active Control(N=408) 3 (0.7%)
147 (36.0%)
Add-on to glimepirideg (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg (N=145)
0
8 (5.5%)
FARXIGA 10 mg (N=151) 0
9 (6.0%)
Placebo/Active Control(N=146) 0
3 (2.1%)
Add-on to pioglitazoneg (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg (N=141)
0
3 (2.1%)
FARXIGA 10 mg (N=140) 0
0
Placebo/Active Control(N=139) 0
0
Add-on to DPP-4 inhibitor (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg -
-
-
FARXIGA 10 mg (N=225) 1 (0.4%)
4 (1.8%)
Placebo/Active Control(N=226) 0
3 (1.3%)
Add-on to insulin with or without other OADs (24 weeks)
  Major [n (%)] Minor [n (%)]
FARXIGA 5 mg (N=212)
1 (0.5%)
92 (43.4%)
FARXIGA 10 mg (N=196) 1 (0.5%)
79 (40.3%)
Placebo/Active Control(N=197) 1 (0.5%)
67 (34.0%)

OAD=oral antidiabetic therapy.

gMajor episodes of hypoglycemia were defined as symptomatic episodes requiring external (third-party) assistance due to severe impairment in consciousness or behavior with a capillary or plasma glucose value <54 mg/dL and prompt recovery after glucose or glucagon administration.

hMinor episodes of hypoglycemia were defined as either a symptomatic episode with a capillary or plasma glucose measurement <63 mg/dL regardless of need for external assistance, or an asymptomatic capillary or plasma glucose measurement <63 mg/dL that does not qualify as a major episode.

Hypersensitivity reactions1

  • Hypersensitivity reactions (eg, angioedema, urticaria, hypersensitivity) were reported with FARXIGA treatment
  • Across the clinical program, serious anaphylactic reactions and severe cutaneous adverse reactions and angioedema were reported in 0.2% of comparator-treated patients and 0.3% of FARXIGA-treated patients

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.

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.