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Farxiga (dapagliflozin) is an oral diabetes medicine that helps control blood sugar levels. Dapagliflozin works by helping the kidneys get rid of glucose from your bloodstream.
Farxiga is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Farxiga is also used to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes.
Farxiga is not for treating type 1 diabetes.
Farxiga is not for use in people with diabetic ketoacidosis (increased ketones in the blood or urine).
You should not use Farxiga if you have bladder cancer, diabetic ketoacidosis, severe kidney disease, or if you are on dialysis.
Taking Farxiga can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).
Farxiga can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.
Some people taking this medicine have had bladder cancer, but it is not clear if dapagliflozin was the actual cause.
You should not use Farxiga if you are allergic to dapagliflozin, or if you have:
active bladder cancer;
severe kidney disease (or if you are on dialysis); or
diabetic ketoacidosis (call your doctor for treatment).
To make sure Farxiga is safe for you, tell your doctor if you have ever had:
liver or kidney disease;
bladder cancer;
bladder infections or other urination problems;
low blood pressure;
problems with your pancreas, including surgery;
if you drink alcohol often; or
if you are on a low salt diet.
Follow your doctor's instructions about using Farxiga if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.
You should not use dapagliflozin during the second or third trimester of pregnancy.
You should not breast-feed while using this medicine.
Farxiga is not approved for use by anyone younger than 18 years old.
Farxiga is usually taken once per day in the morning. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
You may take Farxiga with or without food.
Call your doctor if you are sick with vomiting or diarrhea, if you consume less food or fluid than usual, or if you are sweating more than usual.
Your blood sugar may need to be checked often, and you may also need to test the level of ketones your urine. Dapagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have ketones in the urine.
Low blood sugar (hypoglycemia) can happen to anyyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.
Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.
Farxiga is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
Store at room temperature away from moisture and heat.
Usual Adult Dose for Diabetes Type 2:
To improve glycemic control:
Initial dose: 5 mg orally once a day
-May increase to 10 mg orally once a day for additional glycemic control if lower dose has been tolerated
Maximum dose: 10 mg/day
To reduce the risk of hospitalization for heart failure: 10 mg orally once a day
Comments:
-Correct volume depletion prior to initiating therapy.
-If used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue should be considered to reduce the risk of hypoglycemia.
Uses:
-As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
-To reduce the risk of hospitalization for heart failure in patients with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Get emergency medical help if you have signs of an allergic reaction to Farxiga: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.
Call your doctor at once if you have:
little or no urination;
dehydration symptoms - dizziness, weakness, feeling light-headed (like you might pass out);
ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
signs of a bladder infection - pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back.
Some people taking this medicine have had bladder cancer, but it is not clear if dapagliflozin was the actual cause.
Side effects may be more likely to occur in older adults.
Common Farxiga side effects may include:
genital yeast infection;
urinating more than usual; or
sore throat and runny or stuffy nose.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all your other medicines, especially:
insulin or other oral diabetes medicines; or
a diuretic or "water pill."
This list is not complete. Other drugs may interact with dapagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Farxiga only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Farxiga (www.drugs.com/farxiga.html).
Note: This document contains side effect information about dapagliflozin. Some of the dosage forms listed on this page may not apply to the brand name Farxiga.
More frequent side effects include: cystitis, pyelonephritis, urinary tract infection, vulvovaginal candidiasis, bacterial vaginosis, genital candidiasis, genitourinary infection, prostatitis, urethritis, vaginal infection, vulvitis, and vulvovaginitis. See below for a comprehensive list of adverse effects.
Applies to dapagliflozin: oral tablet
Along with its needed effects, dapagliflozin (the active ingredient contained in Farxiga) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking dapagliflozin:
More common
Less common
Rare
Incidence not known
Some side effects of dapagliflozin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to dapagliflozin: oral tablet
The most common adverse reactions included female genital mycotic infections, nasopharyngitis, and urinary tract infections.
Common (1% to 10%): Urinary tract infections increased urination, discomfort with urination, female genital mycotic infections (including vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis, vulvovaginitis, genital infection, genital candidiasis fungal genital infection, vulvitis, genitourinary tract infection, vulval abscess, and vaginitis bacterial), and male mycotic infections (including balanitis, fungal genital infection, balanitis candida, genital candidiasis, genital infection male, penile infection, balanoposthitis, balanoposthitis infective, genital infection, posthitis)
Postmarketing reports: Urosepsis, pyelonephritis, Fournier's gangrene
In the 5 years (2013 to 2018) since SGLT2 inhibitor approval, 12 cases of Fournier's gangrene have been reported. Reports were almost equal in men and women (men=7; women=5), ages ranged from 38 to 78 years, and the average time to onset after starting an SGLT2 inhibitor was 9.2 months (range 7 days to 25 months). All SGLT2 inhibitor drugs except ertugliflozin were included in the reports. Ertugliflozin being the most recently approved agent, is expected to have the same risk, but insufficient patient use to assess risk. All patients were hospitalized, all required surgery, all required surgical debridement, 5 required more than 1 surgery and 1 required skin grafting. Four cases were complicated by diabetic ketoacidosis, acute kidney injury, and septic shock, leading to prolonged hospitalization, and death in 1 case. In the general population, Fournier's gangrene occurs in about 1.6 out of 100,000 males annually, with the highest incidence in men 50 to 79 years. Since diabetes is a risk factor for Fournier's gangrene, a review of the FAERS database for the last 34 years was done and only 6 cases (all males, median age 57 years) were found with several other classes of antidiabetic drugs. Findings with SGLT2 inhibitors appear to show an association over a shorter time frame and involve both males and females.
Common (1% to 10%): Dyslipidemia
Uncommon (0.1% to 1%): adverse reactions related to reduced intravascular volume (postural hypotension, orthostatic hypotension, hypotension, dehydration, and syncope)
Very common (10% or more): Hypoglycemia (up to 43%)
Common (1% to 10%): Hyperphosphatemia, increases in low-density lipoprotein cholesterol (LDL-C)
Uncommon (0.1% to 1%): Decreased weight
Postmarketing reports: Acidosis including diabetic ketoacidosis, ketoacidosis, or ketosis
Hypoglycemia was reported more frequently when this drug was added to sulfonylurea or insulin (up to 43%). Hypoglycemia was not reported in monotherapy trials, and was reported infrequently in add-on trials with metformin, pioglitazone, and dipeptidyl peptidase-4 inhibitors (up to 1.5%,2.1%, and 1.8% respectively).
Twenty reports of acidosis have been identified in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database during the period March 2013 through 06 June 2014. All patients required emergency room treatment or hospitalization. These cases were not typical of ketoacidosis or diabetic ketoacidosis (DKA) in that they occurred in patients with type 2 diabetes and their blood sugar levels were only slightly increased. Some factors identified as potentially triggering the acidosis included major illness, reduced food and fluid intake, and reduced insulin dose.
Common (1% to 10%): Nausea, constipation
Uncommon (0.1% to 1%): Thirst, dry mouth
Rare (less than 0.1%): Serious anaphylactic reactions, severe cutaneous reactions, and angioedema
Bone fractured occurred in 13 patients receiving this drug compared with no placebo patients in a study of patients with an eGFR of 30 to less than 60 mL/min/1.73 m2.
Common (1% to 10%): Back pain, extremity pain
Frequency not reported: Bone fracture
Common (1% to 10%): Influenza
Uncommon (0.1% to 1%): Bladder cancer
Newly diagnosed bladder cancer was reported in 10 of 6045 (0.17%) patients receiving this drug in clinical trials compared with 1 of 3512 (0.03%) patients receiving placebo or comparator. Upon excluding patients in whom exposure to study drug was less than 1 year at time of diagnosis, there were no cases associated with placebo and 4 cases with this drug. Due to the low number of cases, further studies are needed.
From March 2013 to October 2015, the US FDA received 101 confirmable case reports of acute kidney injury (AKI) with use of canagliflozin (n=73) or dapagliflozin (the active ingredient contained in Farxiga) (n=28). Hospitalization was necessary for evaluation and management in 96 cases; admission to the intensive care unit occurred in 22 cases, and death occurred in 4 patients, of which 2 were cardiac-related. Dialysis was necessary in 15 patients, 3 of whom had a history of chronic kidney disease or previous AKI. In 58 cases, time to onset of AKI was within 1 month or less of initiating therapy. In 78 cases in which drug discontinuation was reported, 56 reported subsequent improvement; 3 patients recovered with sequelae, 11 patients did not recover (including the 4 deaths mentioned earlier). Median age was 57 years (range 28 to 78 years; based on 84 cases reporting age). Concomitant ACE inhibitor therapy was reported in 51 cases, diuretic use in 26 cases, and NSAID use in 6 cases. Almost half the patients reported a change in renal function at time of diagnosis (median elevation of serum creatinine from baseline 1.6 mg/dL [based on 32 cases reporting serum creatinine] and median decrease in eGFR 46 mL/min/1.73m2 [based on 13 cases reporting eGFR]).
Frequency not reported: Renal failure, serum creatinine increase
Postmarketing reports: Acute kidney injury, renal impairment
Frequency not reported: Small increases in serum parathyroid hormone levels
Common (1% to 10%): Dizziness, headache
Very rare (less than 0.01%): Hepatitis
Common (1% to 10%): Nasopharyngitis
Postmarketing reports: Rash
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Farxiga (www.drugs.com/farxiga.html).
August 9, 2016
March 28, 2020
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