What is Farxiga (dapagliflozin)?
Farxiga (dapagliflozin), a sodium-glucose cotransporter (SGLT2) inhibitor, is a diabetes medication used to improve glycemia (blood glucose) control in patients with type 2 diabetes.
SGLT2 is found in the kidney tubules and is responsible for reabsorbing the majority of glucose filtered out of the blood by the kidneys. By inhibiting SGLT2, Farxiga reduces the reabsorption of filtered glucose and consequently increases excretion of glucose in the urine.
Farxiga is not recommended for use in patients with moderate to severe kidney disease.
No significant drug interactions have been reported with Farxiga use.
Farxiga is not recommended during the second and third trimesters of pregnancy; it may harm a fetus.
It is unknown if Farxiga is excreted in breast milk. Currently, the manufacturer does not recommend use of Farxiga while breastfeeding.
What are the side effects of Farxiga?
What are the common side effects of Farxiga?
Common side effects of Farxiga include
- vaginal yeast infections,
- yeast infections of the penis,
- nasopharyngitis (upper respiratory tract infections usually with associated sore throat, runny nose, nasal congestion, and sneezing), and
- changes in urination (urinary urgency, urinating more often and in larger amounts).
What are the serious side effects of Farxiga?
Serious side effects of Farxiga include
- low blood pressure (hypotension),
- kidney dysfunction,
- low blood sugar (hypoglycemia) when co-administered with insulin or insulin secretagogues,
- increase in low-density lipoprotein cholesterol (LDL-C),
- bladder cancer, and
- hypersensitivity reactions.
What drugs interact with Farxiga?
Positive Urine Glucose Test
- Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests.
- Use alternative methods to monitor glycemic control.
Interference With 1,5-Anhydroglucitol (1,5-AG) Assay
- Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors.
- Use alternative methods to monitor glycemic control.
Farxiga side effects list for healthcare professionals
The following important adverse reactions are described below and elsewhere in the labeling:
- Volume Depletion
- Ketoacidosis in Patients with Diabetes Mellitus
- Urosepsis and Pyelonephritis
- Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
- Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
- Genital Mycotic Infections
Clinical Trials Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
- Farxiga has been evaluated in clinical trials in patients with type 2 diabetes mellitus and in patients with heart failure.
- The overall safety profile of Farxiga was consistent across the studied indications.
- Severe hypoglycemia and diabetic ketoacidosis (DKA) were observed only in patients with diabetes mellitus.
Clinical Trials In Patients With Type 2 Diabetes Mellitus
Pool of 12 Placebo-Controlled Studies for Farxiga 5 and 10 mg for Glycemic Control
- The data in Table 1 is derived from 12 glycemic control placebo-controlled studies in patients with type 2 diabetes mellitus ranging from 12 to 24 weeks.
- In 4 studies Farxiga was used as monotherapy, and in 8 studies Farxiga was used as add-on to background antidiabetic therapy or as combination therapy with metformin.
- These data reflect exposure of 2338 patients to Farxiga with a mean exposure duration of 21 weeks.
- Patients received placebo (N=1393), Farxiga 5 mg (N=1145), or Farxiga 10 mg (N=1193) once daily.
- The mean age of the population was 55 years and 2% were older than 75 years of age.
- Fifty percent (50%) of the population were male; 81% were White, 14% were Asian, and 3% were Black or African American.
- At baseline, the population had diabetes for an average of 6 years, had a mean hemoglobin A1c (HbA1c) of 8.3%, and 21% had established microvascular complications of diabetes.
- Baseline renal function was normal or mildly impaired in 92% of patients and moderately impaired in 8% of patients (mean eGFR 86 mL/min/1.73 m2).
Table 2 shows common adverse reactions associated with the use of Farxiga. These adverse reactions were not present at baseline, occurred more commonly on Farxiga than on placebo, and occurred in at least 2% of patients treated with either Farxiga 5 mg or Farxiga 10 mg.
Table 2: Adverse Reactions in Placebo-Controlled Studies of Glycemic Control Reported in =2% of Patients Treated with Farxiga
|Adverse Reaction||% of Patients|
|Pool of 12 Placebo-Controlled Studies|
|Farxiga 5 mg
|Farxiga 10 mg
|Female genital mycotic infections*||1.5||8.4||6.9|
|Urinary tract infections†||3.7||5.7||4.3|
|Male genital mycotic infections§||0.3||2.8||2.7|
|Discomfort with urination||0.7||1.6||2.1|
|Pain in extremity||1.4||2.0||1.7|
|* Genital 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: Placebo=677, Farxiga 5 mg=581, Farxiga 10 mg=598).
† Urinary 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.
‡ Increased urination includes the following adverse reactions, listed in order of frequency reported: pollakiuria, polyuria, and urine output increased.
§ Genital 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, and posthitis. (N for males: Placebo=716, Farxiga 5 mg=564, Farxiga 10 mg=595).
Pool of 13 Placebo-Controlled Studies for Farxiga 10 mg for Glycemic Control
- Farxiga 10 mg was also evaluated in a larger glycemic control placebo-controlled study pool in patients with type 2 diabetes mellitus.
- This pool combined 13 placebo-controlled studies, including 3 monotherapy studies, 9 add-on to background antidiabetic therapy studies, and an initial combination with metformin study.
- Across these 13 studies, 2360 patients were treated once daily with Farxiga 10 mg for a mean duration of exposure of 22 weeks.
- The mean age of the population was 59 years and 4% were older than 75 years.
- Fifty-eight percent (58%) of the population were male; 84% were White, 9% were Asian, and 3% were Black or African American.
- At baseline, the population had diabetes for an average of 9 years, had a mean HbA1c of 8.2%, and 30% had established microvascular disease.
- Baseline renal function was normal or mildly impaired in 88% of patients and moderately impaired in 11% of patients (mean eGFR 82 mL/min/1.73 m2).
- Farxiga causes an osmotic diuresis, which may lead to a reduction in intravascular volume.
- Adverse reactions related to volume depletion (including reports of dehydration, hypovolemia, orthostatic hypotension, or hypotension) in patients with type 2 diabetes mellitus for the 12-study and 13-study, short-term, placebo-controlled pools and for the DECLARE study are shown in Table 3.
Table 3: Adverse Reactions Related to Volume Depletion* in Clinical Studies in Patients with Type 2 Diabetes Mellitus with Farxiga
|Pool of 12 Placebo-Controlled Studies||Pool of 13 Placebo-Controlled Studies||DECLARE Study|
|Placebo||Farxiga 5 mg||Farxiga 10 mg||Placebo||Farxiga 10 mg||Placebo||Farxiga 10 mg|
|Overall population N (%)||N=1393
|Patient Subgroup n (%)|
|Patients on loop diuretics||n=55
|Patients with moderate renal impairment with eGFR ≥30 and <60 mL/min/1.73 m2||n=107
|Patients ≥65 years of age||n=276
|* Volume depletion includes reports of dehydration, hypovolemia, orthostatic hypotension, or hypotension.|
- The frequency of hypoglycemia by study in patients with type 2 diabetes mellitus is shown in Table 4. Hypoglycemia was more frequent when Farxiga was added to sulfonylurea or insulin.
Table 4: Incidence of Severe Hypoglycemia* and Hypoglycemia with Glucose < 54 mg/dL† in Controlled Glycemic Control Clinical Studies in Patients with Type 2 Diabetes Mellitus
|Placebo/Active Control||Farxiga 5 mg||Farxiga 10 mg|
|Monotherapy (24 weeks)||N=75||N=64||N=70|
|Severe [n (%)]||0||0||0|
|Glucose <54 mg/dL [n (%)]||0||0||0|
|Add-on to Metformin (24 weeks)||N=137||N=137||N=135|
|Severe [n (%)]||0||0||0|
|Glucose <54 mg/dL [n (%)]||0||0||0|
|Add-on to Glimepiride (24 weeks)||N=146||N=145||N=151|
|Severe [n (%)]||0||0||0|
|Glucose <54 mg/dL [n (%)]||1 (0.7)||3 (2.1)||5 (3.3)|
|Add-on to Metformin and a Sulfonylurea (24 Weeks)||N=109||-||N=109|
|Severe [n (%)]||0||-||0|
|Glucose <54 mg/dL [n (%)]||3 (2.8)||-||7 (6.4)|
|Add-on to Pioglitazone (24 weeks)||N=139||N=141||N=140|
|Severe [n (%)]||0||0||0|
|Glucose <54 mg/dL [n (%)]||0||1 (0.7)||0|
|Add-on to DPP4 inhibitor (24 weeks)||N=226||–||N=225|
|Severe [n (%)]||0||–||1 (0.4)|
|Glucose <54 mg/dL [n (%)]||1 (0.4)||–||1 (0.4)|
|Add-on to Insulin with or without other OADs‡ (24 weeks)||N=197||N=212||N=196|
|Severe [n (%)]||1 (0.5)||2 (0.9)||2 (1.0)|
|Glucose <54 mg/dL [n (%)]||43 (21.8)||55 (25.9)||45 (23.0)|
|* Severe episodes of hypoglycemia were defined as episodes of severe impairment in consciousness or behavior, requiring external (third party) assistance, and with prompt recovery after intervention regardless of glucose level.
† Episodes of hypoglycemia with glucose <54 mg/dL (3 mmol/L) were defined as reported episodes of hypoglycemia meeting the glucose criteria that did not also qualify as a severe episode.
‡ OAD = oral antidiabetic therapy.
- In the DECLARE study, severe events of hypoglycemia were reported in 58 (0.7%) out of 8574 patients treated with Farxiga and 83 (1.0%) out of 8569 patients treated with placebo.
Genital Mycotic Infections
- In the glycemic control trials, genital mycotic infections were more frequent with Farxiga treatment.
- Genital mycotic infections were reported in 0.9% of patients on placebo, 5.7% on Farxiga 5 mg, and 4.8% on Farxiga 10 mg, in the 12-study placebo-controlled pool.
- Discontinuation from study due to genital infection occurred in 0% of placebo-treated patients and 0.2% of patients treated with Farxiga 10 mg.
- Infections were more frequently reported in females than in males (see Table 1).
- The most frequently reported genital mycotic infections were vulvovaginal mycotic infections in females and balanitis in males.
- Patients with a history of genital mycotic infections were more likely to have a genital mycotic infection during the study than those with no prior history (10.0%, 23.1%, and 25.0% versus 0.8%, 5.9%, and 5.0% on placebo, Farxiga 5 mg, and Farxiga 10 mg, respectively).
- In the DECLARE study, serious genital mycotic infections were reported in <0.1% of patients treated with Farxiga and <0.1% of patients treated with placebo.
- Genital mycotic infections that caused study drug discontinuation were reported in 0.9% of patients treated with Farxiga and <0.1% of patients treated with placebo.
- Hypersensitivity reactions (e.g., angioedema, urticaria, hypersensitivity) were reported with Farxiga treatment.
- In glycemic control studies, 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.
- If hypersensitivity reactions occur, discontinue use of Farxiga; treat per standard of care and monitor until signs and symptoms resolve.
Ketoacidosis in Patients with Diabetes Mellitus
- In the DECLARE study, events of diabetic ketoacidosis (DKA) were reported in 27 out of 8574 patients in the Farxiga-treated group and 12 out of 8569
patients in the placebo group. The events were evenly distributed over the study period.
Increases in Serum Creatinine and Decreases in eGFR
- Initiation of SGLT2 inhibitors, including Farxiga causes a small increase in serum creatinine and decrease in eGFR.
- In patients with normal or mildly impaired renal function at baseline, these changes in serum creatinine and eGFR generally occur within weeks of starting therapy and then stabilize.
- Increases that do not fit this pattern should prompt further evaluation to exclude the possibility of acute kidney injury.
- The acute effect on eGFR reverses after treatment discontinuation, suggesting acute hemodynamic changes may play a role in the renal function changes observed with Farxiga.
Increase in Hematocrit
- In the pool of 13 placebo-controlled studies of glycemic control, increases from baseline in mean hematocrit values were observed in Farxiga-treated patients starting at Week 1 and continuing up to Week 16, when the maximum mean difference from baseline was observed.
- At Week 24, the mean changes from baseline in hematocrit were −0.33% in the placebo group and 2.30% in the Farxiga 10 mg group.
- By Week 24, hematocrit values >55% were reported in 0.4% of placebo-treated patients and 1.3% of Farxiga 10 mg-treated patients.
Increase in Low-Density Lipoprotein Cholesterol
- In the pool of 13 placebo-controlled studies of glycemic control, changes from baseline in mean lipid values were reported in Farxiga-treated patients compared to placebo-treated patients.
- Mean percent changes from baseline at Week 24 were 0.0% versus 2.5% for total cholesterol, and -1.0% versus 2.9% for LDL cholesterol in the placebo and Farxiga 10 mg groups, respectively.
- In the DECLARE study, mean changes from baseline after 4 years were 0.4 mg/dL versus -4.1 mg/dL for total cholesterol, and -2.5 mg/dL versus -4.4 mg/dL for LDL cholesterol, in Farxiga-treated and the placebo groups, respectively.
Decrease in Serum Bicarbonate
- In a study of concomitant therapy of Farxiga 10 mg with exenatide extended-release (on a background of metformin), four patients (1.7%) on concomitant therapy had a serum bicarbonate value of less than or equal to 13 mEq/L compared to one each (0.4%) in the Farxiga and exenatide-extended release treatment groups.
DAPA-HF Heart Failure Study
- No new adverse reactions were identified in the DAPA-HF heart failure study.
- Additional adverse reactions have been identified during postapproval use of Farxiga in patients with diabetes mellitus. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Acute Kidney Injury
- Urosepsis and Pyelonephritis
- Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
Farxiga (dapagliflozin) is a sodium-glucose cotransporter (SGLT2) inhibitor used to improve glycemia (blood glucose) control in patients with type 2 diabetes. Common side effects of Farxiga include vaginal yeast infections, yeast infections of the penis, nasopharyngitis, and changes in urination (urinary urgency, urinating more often and in larger amounts). No significant drug interactions have been reported with Farxiga use. Farxiga is not recommended during the second and third trimesters of pregnancy; it may harm a fetus. It is unknown if Farxiga is excreted in breast milk.
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What Are the 3 Most Common Symptoms of Undiagnosed Diabetes?
Diabetes mellitus has become a worldwide epidemic, thanks to changing lifestyles and increasing obesity. Type 2 diabetes affects approximately 13% of the population of the United States. Worldwide prevalence of diabetes is estimated to be around 463 million people. Type 2 diabetes accounts for over 90% of patients with diabetes.
How and Why Does Ethnicity Affect Diabetes?
Diabetes is a condition that causes elevated blood sugar levels. Acquired risk factors are associated with diabetes although ethnicity plays a role in increasing the incidence of the condition.
Can Type 2 Diabetes be Cured?
Type 2 diabetes is a long-term medical condition in which the body is not able to regulate blood sugar (glucose) level because of the inability of the body to properly use insulin. An individual can get type 2 diabetes because of a number of factors that reduce insulin action or quantity in the body. The goals of diabetes management are to eliminate symptoms and prevent the development of complications. Many drugs, both oral and injectable, are available for diabetes management.
Tips for Managing Type 1 and 2 Diabetes at Home
Managing your diabetes is a full time commitment. The goal of diabetic therapy is to control blood glucose levels and prevent the complications of diabetes. Information about exercise, diet, and medication will help you manage your diabetes better. Blood glucose reagent strips, blood glucose meters, urine glucose tests, tests for urinary ketones, continuous glucose sensors, and Hemoglobin A1C testing information will enable you to mange your diabetes at home successfully.
Do Certain Ethnic Groups Have a Higher Risk of Diabetes?
One out of every 10 people in the United States has diabetes. Pacific Islanders, Alaskan natives and American Indians have the highest prevalence rates of diabetes among groups studied in the United States Census.
Is Quinoa Good for Diabetes?
Quinoa (pronounced as keen-wah) or Chenopodium quinoa is an annual herb of the goosefoot family. The herb is known for its edible starchy seeds. It is native to the Andean highlands and is popular over the world for its health benefits. Quinoa seeds may be used as cooked grains or grounded into flour.
What Are the Early Signs of Type 2 Diabetes?
Type 2 Diabetes is a chronic disease characterized by increased blood sugar (glucose) level. Type 2 Diabetes is caused by either insufficient insulin secretion or resistance to that hormone’s action. Insulin is produced by the pancreas and helps process the glucose in the blood. Thus, with inadequate insulin, the bodies can’t burn all the blood sugar for energy in an efficient way. This means the glucose level in the blood rises, causing a variety of symptoms and when severe may even lead to death.
Treatment & Diagnosis
- Diabetes: Dealing with the Complications
- Diabetes: Monitoring Your Sugar Levels
- Diabetes: Meeting the Diabetes Challenge
- Diabetes: Your Guide to Life With Diabetes
- Diabetes- Keeping Watch: Daily Diabetes Monitoring
- Diabetes: Maintaining Control
- Diabetes and Your Heart
- Diabetes and Diet: What Do I Eat?
- Diabetes: Maintaining Control with Nutrition
- Diabetes & Fitness: Get Moving!
- Diabetes Alert Day
- Diabetes: Dealing with Your New Diagnosis
- Diabetes: Your Treatment Options
- Diabetes: Psychological Challenges
- Diabetes FAQs
- Type 2 Diabetes FAQs
- Type 1 Diabetes FAQs
- What if I get COVID-19 with Diabetes?
- Diabetes Mellitus - The Work Pays Off
- Diabetes - Foot Care: A Walking Matter
- Heart Disease Stroke and Diabetes
- Diabetes - An Aspirin A Day
- Diabetes and Eye Disease...See No Evil
- Exercise Therapy in Type 2 Diabetes - Part 1
- Hypoglycemia (Low Blood Sugar) Symptoms and Diabetes
- Rheumatoid Arthritis & Diabetes Gene (PTPN22)
- What Foods to Eat to Reverse Diabetes
- Can You Get Diabetes from Stress?
- How Do You Know if You Have Diabetes?
- Can oral diabetes medications cause impotence?
- What Is the Treatment for Diabetes Eye Damage?
- Does Celiac Disease Cause Diabetes?
- 6 Frequently Asked Diabetes Question
- What Kind of Candy Can You Eat With Diabetes?
- Is Weight Loss Caused by Diabetes Dangerous?
- Can Diabetes Cause Muscle Pain?
- 11 Diabetes Diet Tips for the Holidays
- Diabetes Diet
- Top 10 Questions to Ask Your Doctor About Diabetes
- Diabetes: Eating Well with Type 2 Diabetes
- Diabetes: What Can I Eat?
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.