Side effects of farxiga

Contents

Farxiga (dapagliflozin)

You may wonder how Farxiga compares to other medications that are prescribed for similar uses. Below are comparisons between Farxiga and several medications.

Farxiga vs. Jardiance

Farxiga and Jardiance (empagliflozin) are both in the same class of medications: sodium-glucose co-transporter 2 (SGLT2) inhibitors. This means they work in the same way to treat type 2 diabetes.

Uses

Both Farxiga and Jardiance are FDA-approved to improve blood sugar control in adults with type 2 diabetes.

Jardiance is also FDA-approved to reduce the risk of heart disease-related death in people with type 2 diabetes and heart disease.

Drug forms and administration

Both Farxiga and Jardiance come as tablets that are taken by mouth, once daily in the morning.

Side effects and risks

Farxiga and Jardiance have similar effects in the body and therefore cause very similar side effects. Below are examples of these side effects.

More common side effects

More common side effects that can occur with both Farxiga and Jardiance include:

  • vaginal yeast infection
  • respiratory infections such as the common cold or flu
  • urinary tract infection
  • increased urination
  • genital infection in men
  • back pain
  • nausea
  • increased cholesterol levels

Serious side effects

Serious side effects that can occur with both Farxiga and Jardiance include:

  • dehydration and low blood pressure
  • ketoacidosis (increased ketones in the blood or urine)
  • kidney damage*
  • serious urinary tract infections
  • low blood sugar (hypoglycemia)
  • severe allergic reaction

* Both Farxiga and Jardiance can cause kidney damage. However, an analysis of studies found that the risk of kidney damage may be higher in people who take Farxiga compared to those who take Jardiance.

Effectiveness

The only condition both Farxiga and Jardiance are used to treat is type 2 diabetes. The effectiveness of these drugs in treating this condition hasn’t been directly compared in clinical studies. However, they have been indirectly compared in several analyses of clinical studies.

The effects of Farxiga and Jardiance on hemoglobin A1c (HbA1c) are very similar. But a 2016 analysis of studies found that Jardiance may reduce HbA1c slightly more than Farxiga does. Another 2016 analysis also found that Jardiance may reduce HbA1c a little more than Farxiga does.

The two drugs have also been compared in other areas:

  • Reducing heart risks: A 2017 analysis found that Jardiance may reduce the risk of heart failure and dying from heart disease in people who have type 2 diabetes. This benefit wasn’t found for Farxiga.
  • Lowering blood pressure: Both Farxiga and Jardiance can reduce blood pressure in people with type 2 diabetes. One analysis found that Jardiance and Farxiga worked about equally well to reduce blood pressure.
  • Causing weight loss: Both Farxiga and Jardiance can also reduce weight in people with type 2 diabetes. In an analysis of studies, the two drugs worked about equally well for weight loss.

Costs

Both Farxiga and Jardiance are available as brand-name drugs. They’re not available in generic forms, which typically cost less than brand-name forms.

Farxiga may cost a little more than Jardiance. The exact price you pay for either drug will depend on your insurance plan.

Farxiga vs. Invokana

Farxiga and Invokana (canagliflozin) are both in the same class of medications: sodium-glucose co-transporter 2 (SGLT2) inhibitors. This means they work in the same way to treat type 2 diabetes.

Uses

Both Farxiga and Invokana are FDA-approved to improve blood sugar control in adults with type 2 diabetes.

Drug forms and administration

Both Farxiga and Invokana come as tablets that are taken by mouth, once daily in the morning.

Side effects and risks

Farxiga and Invokana have similar effects in the body, and therefore cause very similar side effects. Below are examples of these side effects.

Farxiga and Invokana Farxiga Invokana
More common side effects
  • urinary tract infection
  • increased urination
  • nausea
  • vaginal yeast infection
  • genital infection in men
  • increased cholesterol
  • constipation
  • respiratory infections such as the common cold or flu
  • back pain
  • thirst
Serious side effects
  • dehydration and low blood pressure
  • ketoacidosis (increased ketones in blood or urine)
  • kidney damage
  • serious urinary tract infections
  • low blood sugar (hypoglycemia)
  • severe allergic reaction
(few unique serious side effects)
  • high potassium levels
  • bone fracture
  • limb amputation*

* Invokana has a boxed warning from the FDA about limb amputation. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

The only condition both Farxiga and Invokana are used to treat is type 2 diabetes. The effectiveness of these drugs in treating type 2 diabetes hasn’t been directly compared in clinical studies. However, they have been indirectly compared in analyses of clinical studies.

The effects of Farxiga and Invokana on hemoglobin A1c (HbA1c) have been found to be similar. But a 2016 analysis of studies found that Invokana may reduce HbA1c more than Farxiga does. Another 2016 analysis also found that Invokana may reduce HbA1c more than Farxiga does.

The two drugs have also been compared in other areas:

  • Lowering blood pressure: Both Farxiga and Invokana can reduce blood pressure in people with type 2 diabetes. One analysis found that Invokana and Farxiga worked about equally well to reduce blood pressure.
  • Causing weight loss: Both Farxiga and Invokana can reduce weight in people with type 2 diabetes. In an analysis of studies, people taking Invokana had slightly more weight loss than people taking Farxiga.

Costs

Both Farxiga and Invokana are available as brand-name drugs. They’re not available in generic forms, which typically cost less than brand-name forms.

Farxiga and Invokana cost about the same amount. The exact price you pay for either drug will depend on your insurance plan.

Farxiga vs. Januvia

Farxiga and Januvia (sitagliptin) belong to different drug classes. Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. Januvia is a dipeptidyl peptidase-4 (DPP-4) inhibitor.

These drugs work in different ways to treat type 2 diabetes.

Uses

Both Farxiga and Januvia are FDA-approved to improve blood sugar control in adults with type 2 diabetes.

Drug forms and administration

Both Farxiga and Januvia come as tablets that are taken by mouth, once daily.

Side effects and risks

Farxiga and Januvia have some similar side effects and some that differ. Below are examples of these side effects.

Farxiga and Januvia Farxiga Januvia
More common side effects
  • nausea
  • respiratory infections such as the common cold or flu
  • vaginal yeast infection
  • urinary tract infection
  • increased urination
  • genital infection in men
  • back pain
  • increased cholesterol
  • constipation
  • headache
  • swelling of feet and legs (peripheral edema)
  • stomach pain
  • diarrhea
Serious side effects
  • severe allergic reaction
  • kidney damage
  • low blood sugar (hypoglycemia)
  • dehydration and low blood pressure
  • ketoacidosis (increased ketones in blood or urine)
  • serious urinary tract infections
  • pancreatitis
  • heart failure
  • severe joint pain
  • severe skin reaction (bullous pemphigoid)

Effectiveness

The only condition that both Farxiga and Januvia are used to treat is type 2 diabetes. The effectiveness of these drugs in treating this condition hasn’t been directly compared in clinical studies.

In an indirect comparison, Farxiga and Januvia worked about equally well for reducing hemoglobin A1c (HbA1c). However, Farxiga had the additional benefit of weight loss. Januvia didn’t reduce weight.

Costs

Both Farxiga and Januvia are available as brand-name drugs. They’re not available in generic forms, which typically cost less than brand-name forms.

Januvia may cost less than Farxiga. The exact price you pay for either drug will depend on your insurance plan.

Farxiga vs. Victoza

Farxiga and Victoza (liraglutide) belong to different drug classes. Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. Victoza is a glucagon-like peptide-1 (GLP-1) receptor agonist.

These drugs work in different ways to treat type 2 diabetes.

Uses

Both Farxiga and Victoza are FDA-approved to improve blood sugar control in adults with type 2 diabetes.

Victoza is also FDA-approved to reduce the risk of heart disease–related problems in people who have type 2 diabetes and heart disease. These problems include heart attack and stroke.

Drug forms and administration

Farxiga comes as a tablet that’s taken by mouth once daily in the morning.

Victoza comes as a solution that’s self-injected under the skin (subcutaneous) once daily.

Side effects and risks

Farxiga and Victoza have some similar side effects and some that differ. Below are examples of these side effects.

Farxiga and Victoza Farxiga Victoza
More common side effects
  • nausea
  • respiratory infections such as the common cold or flu
  • back pain
  • constipation
  • vaginal yeast infection
  • urinary tract infection
  • increased urination
  • genital infection in men
  • increased cholesterol
  • diarrhea
  • headache
  • vomiting
  • decreased appetite
  • stomach upset
  • injection site reactions
Serious side effects
  • kidney damage
  • severe allergic reaction
  • low blood sugar (hypoglycemia)
  • dehydration and low blood pressure
  • ketoacidosis (increased ketones in blood or urine)
  • serious urinary tract infections
  • pancreatitis
  • gallbladder disease
  • thyroid cancer*

* Victoza has a boxed warning from the FDA about thyroid cancer. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

The only condition both Farxiga and Victoza are used to treat is type 2 diabetes. The effectiveness of these drugs in treating this condition hasn’t been directly compared in clinical studies.

However, an indirect comparison found that Farxiga may reduce hemoglobin A1c (HbA1c) more than GLP-1 receptor agonists, such as Victoza, do.

Costs

Both Farxiga and Victoza are available as brand-name drugs. They’re not available in generic forms, which typically cost less than brand-name forms.

Farxiga typically costs less than Victoza. The exact price you pay for either drug will depend on your insurance plan.

Farxiga vs. glipizide

Farxiga and glipizide (Glucotrol, Glucotrol XL) belong to different drug classes. Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. Glipizide is a sulfonylurea.

These drugs work in different ways to treat type 2 diabetes.

Uses

Both Farxiga and glipizide are FDA-approved to improve blood sugar control in adults with type 2 diabetes.

Drug forms and administration

Farxiga comes as a tablet that’s taken by mouth once daily in the morning.

Glipizide comes as a regular-release tablet (Glucotrol) and an extended-release tablet (Glucotrol XL). Both are taken once daily by mouth. Regular-release glipizide is taken 30 minutes before breakfast or the first meal of the day. Extended-release glipizide is taken with breakfast or the first meal of the day.

Side effects and risks

Farxiga and glipizide have some similar side effects and some that differ. Below are examples of these side effects.

Farxiga and glipizide Farxiga Glipizide
More common side effects
  • nausea
  • vaginal yeast infection
  • respiratory infections such as the common cold or flu
  • urinary tract infection
  • increased urination
  • genital infection in men
  • back pain
  • increased cholesterol
  • dizziness
  • diarrhea
  • tremor
  • gas
  • nervousness
  • weight gain
  • headache
  • rash or red, itchy skin
Serious side effects
  • low blood sugar (hypoglycemia)*
  • severe allergic reaction
  • dehydration and low blood pressure
  • ketoacidosis (increased ketones in blood or urine)
  • kidney damage
  • serious urinary tract infections
  • liver damage
  • blood disorders such as leukopenia or anemia

* Although both Farxiga and glipizide can cause low blood sugar (hypoglycemia), this side effect is more common with glipizide than with Farxiga.

Effectiveness

The only condition both Farxiga drug and glipizide are used to treat is type 2 diabetes. The effectiveness of these drugs in treating this condition hasn’t been directly compared in clinical studies.

However, in an indirect comparison, Farxiga and glipizide worked about equally well for reducing hemoglobin A1c (HbA1c). But Farxiga has the additional benefit of weight loss, while glipizide is more likely to cause weight gain.

Costs

Both Farxiga and glipizide are available as brand-name drugs. The brand-name versions of glipizide are Glucotrol and Glucotrol XL. Glipizide is also available in generic form, but Farxiga isn’t. Generic drugs usually cost less than brand-name drugs.

Farxiga typically costs more than the brand-name and generic versions of glipizide. The exact price you pay for any of these drugs will depend on your insurance plan.

What are Invokana and Farxiga?

Invokana (canagliflozin) and Farxiga (dapagliflozin) belong to the drug class sodium-glucose co-transporter-2 (SGLT2) inhibitors. The FDA approved Invokana in March 2013 and Farxiga was approved in January 2014. They are both indicated for blood glucose (sugar) control in patients who have type 2 diabetes and should be combined with a healthy diet and exercise. These medications decrease blood glucose in people with diabetes by blocking the kidney from reabsorbing glucose and removing excess glucose through the urine. They do this by blocking the sodium-glucose co-transporter-2 (SGLT2), which is an enzyme (protein) in the kidney that is responsible for reabsorbing glucose back into the body. Lowering high blood glucose can help prevent nerve problems, blindness, and kidney damage in people with diabetes

Evidence from clinical studies has shown a reduction in body weight among diabetic patients. However, Invokana and Farxiga are not approved for the management of weight loss or obesity. It is important to understand the risks and benefits before considering their use in weight loss.

How Does Invokana and Farxiga Cause Weight Loss?

Invokana and Farxiga increase urinary glucose excretion (UGE) by inhibiting SGLT2. This results in the removal of excess glucose calories every day, ultimately leading to weight loss. Subjects in an Invokana trial showed a UGE of 80 to 100 grams per day which is equivalent to 400 kilocalories (kcal) per day.

Next: Farxiga, Invokana Weight Management Studies In Diabetics And Non-diabetics

Does Farxiga (Dapagliflozin) Cause Weight Loss?

What is Farxiga (Dapagliflozin)?

Farxiga also known as dapagliflozin is an oral drug that helps to lower blood sugar levels in diabetic patients. This is achieved by helping your body to filter excess sugar out of the blood. Dapagliflozin belongs to a class of drugs known as SGLT2 inhibitors. SGLT2 proteins are responsible for 90 percent of sugar that is reabsorbed into the bloodstream. The medication allows sugar in the bloodstream to be removed by the kidney and excreted via urine, by inhibiting SGLT2 proteins. Forxiga should not be used to treat type 1 diabetes, a medical condition where the body does not produce any insulin. Note that this medicine is part of a medication treatment program that includes exercise, diet, regular blood sugar testing and weight control.

Farxiga and weight loss

Many people want to use farxiga to reduce weight even if they don’t have diabetes. However, the drugis not yet approved for weight loss. Moreover, this medication will have less effect on weight in people with normal blood sugar, since less glucose will leak into the urine. However, a recent study showed that dapagliflozin helps type 2 diabetic patients lose a few pounds in addition to lowering blood glucose levels. The study showed that dapagliflozin leads to a loss of fat mass, with major reductions in both subcutaneous adipose tissue and abdominal visceral adipose tissue. Even though trials showed that dapagliflozin can lead to moderate weight loss, the exact figure of the pounds lost remains largely unknown.

Farxiga Side Effects

Generic Name: dapagliflozin

Medically reviewed by Drugs.com. Last updated on Jan 30, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

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.

In Summary

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.

For the Consumer

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

  • Anxiety
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • decreased frequency or amount of urine
  • depression
  • difficult, burning, or painful urination
  • dizziness
  • fast heartbeat
  • frequent urge to urinate
  • headache
  • increased hunger
  • increased thirst
  • itching of the vagina or genitals
  • loss of appetite
  • lower back or side pain
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • swelling of the face, fingers, or lower legs
  • thick, white vaginal discharge with mild or no odor
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • weight gain

Less common

  • Foul smelling discharge from the penis
  • pain in the skin around the penis
  • rash of the penis
  • redness, itching, or swelling of the penis

Rare

  • Cough
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fainting
  • increase in heart rate
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid breathing
  • skin rash, hives, or itching
  • sunken eyes
  • sweating
  • tightness in the chest
  • wrinkled skin

Incidence not known

  • Fever
  • flushed, dry skin
  • fruit-like breath odor
  • loss of consciousness
  • stomach pain
  • troubled breathing
  • unexplained weight loss

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

  • Fever
  • muscle aches
  • sore throat
  • stuffy or runny nose

Less common

  • Back pain
  • difficulty having a bowel movement (stool)
  • pain in the arms or legs

For Healthcare Professionals

Applies to dapagliflozin: oral tablet

General

The most common adverse reactions included female genital mycotic infections, nasopharyngitis, and urinary tract infections.

Genitourinary

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.

Cardiovascular

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)

Metabolic

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.

Gastrointestinal

Common (1% to 10%): Nausea, constipation

Uncommon (0.1% to 1%): Thirst, dry mouth

Hypersensitivity

Rare (less than 0.1%): Serious anaphylactic reactions, severe cutaneous reactions, and angioedema

Musculoskeletal

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

Immunologic

Common (1% to 10%): Influenza

Oncologic

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.

Renal

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 and median decrease in eGFR 46 mL/min/1.73m2 ).

Frequency not reported: Renal failure, serum creatinine increase

Postmarketing reports: Acute kidney injury, renal impairment

Endocrine

Frequency not reported: Small increases in serum parathyroid hormone levels

Nervous system

Common (1% to 10%): Dizziness, headache

Hepatic

Very rare (less than 0.01%): Hepatitis

Respiratory

Common (1% to 10%): Nasopharyngitis

Dermatologic

Postmarketing reports: Rash

1. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

2. Cerner Multum, Inc. “Australian Product Information.” O 0

3. “Product Information. Farxiga (dapagliflozin).” Bristol-Myers Squibb, Princeton, NJ.

5. FDA. U.S. Food and Drug Administration “FDA: SGLT2 inhibitors: Drug Safety Communication – FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood Available from: URL: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm44699” (2015 May 15):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Related questions

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Medical Disclaimer

More about Farxiga (dapagliflozin)

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Related treatment guides

  • Diabetes, Type 2

Farxiga

Farxiga is the brand-name form of the drug dapagliflozin, which is used along with diet and exercise to treat type 2 diabetes.

Type 2 diabetes is a condition where the body does not produce or use insulin properly, which results in high blood sugar. It’s the most common form of diabetes.

Farxiga works by helping the kidneys rid the body of glucose, which aids in controlling blood sugar levels. It’s in a class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.

People with type 2 diabetes can develop serious complications such as heart disease, stroke, kidney problems, eye problems, and nerve damage.

Taking Farxiga, along with implementing a healthy lifestyle, may reduce your chances of having these complications.

Farxiga is manufactured by Bristol-Myers Squibb and AstraZeneca and was approved by the U.S. Food and Drug Administration (FDA) in 2014. In 2019, the FDA approved Farxiga as an adjunct therapy to reduce heart failure hospitalization in people with type 2 diabetes. It’s the first SGLT2 inhibitor with this indication.

Nonetheless, the FDA has told the manufacturers that they must conduct post-market studies to bolster the drug’s safety profile.

The drug is approved in 40 countries, including countries in the European Union and Australia.

Farxiga and Bladder Cancer

One of the main safety concerns is the increased risk of bladder cancer in those taking Farxiga.

Studies conducted for the FDA have shown that people taking Farxiga were more than five times more likely to develop bladder cancer than those who took an older diabetes drug.

Scientists from the FDA say that the drug might stimulate bladder cancer in people who are already at risk.

Other Farxiga Warnings

Farxiga should not be used to treat type 1 diabetes, a condition in which the body does not produce any insulin.

It should also not be used to treat diabetic ketoacidosis, a condition that may develop when patients with diabetes have an increase in chemicals called ketones in their blood.

You may experience blurred vision, drowsiness, or dizziness due to low or high blood sugar levels on Farxiga, so check your blood sugar levels often while taking it.

In addition, your healthcare provider may check your glycosylated hemoglobin (HbA1c) levels.

Before taking Farxiga, you should tell your doctor if you:

  • Are on dialysis or if you have or have ever had kidney disease
  • Have liver disease
  • Have high cholesterol
  • Are on a low sodium diet or have or have ever had low blood pressure
  • Have ever had bladder cancer
  • Have ever had yeast infections
  • Have never been circumcised (males)
  • Use insulin or take any other oral diabetes drugs
  • Are having surgery, including dental surgery

You should alert your physician if you become ill, are injured, develop a fever or infection, or experience unusual stress while taking Farxiga.

These conditions can affect your blood sugar and may prompt your doctor to change your dose of the medicine.

Farxiga and Weight Loss

In a preliminary study presented at the European Association for the Study of Diabetes in September, 2014, researchers said SGLT2 inhibitors (such as Farxiga) offered diabetes patients the additional benefit of weight loss.

However, the patients also had an increased risk of hypoglycemia (low blood sugar).

Scientists say more research needs to be done to confirm these findings.

Pregnancy and Farxiga

It’s not known whether taking when pregnant Farxiga will harm an unborn baby.

You should tell your doctor if you are pregnant or might become pregnant while taking Farxiga.

It’s also not known whether the drug passes into breast milk or if it could harm a breastfeeding baby.

Farxiga Coupons

As with many prescription medications, there are several coupon and rebate programs offering discounts on Farxiga, both online and from various pharmacies.

Such programs can help make treatment more affordable.

However, a prescription from your doctor is still required to use Farxiga, and the drug may or may not be the best option for your symptoms.

The decision on which medication to use should be based on your specific symptoms and needs, and not on available financial incentives.

Talk to your doctor to see if Farxiga is right for you before exploring discount options.

Forxiga

How does this medication work? What will it do for me?

Dapagliflozin belongs to the class of medications known as oral antihyperglycemic agents. It is used alone and in combination with other medications for the control of blood glucose in people with type 2 diabetes. This medication should be used as part of an overall diabetes management plan that includes a diet and exercise program. Dapagliflozin works by increasing the amount of glucose being removed from the body by the kidneys, which decreases the amount of sugar in the blood.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

5 mg
Each yellow, biconvex, round, film-coated tablet, with “5” engraved on one side and “1427” engraved on the other side, contains 5 mg of dapagliflozin as dapagliflozin propanediol monohydrate. Nonmedicinal ingredients: anhydrous lactose, crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide; film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.

10 mg
Each yellow, biconvex, diamond, film-coated tablet with “10” engraved on one side and “1428” engraved on the other side, contains 10 mg of dapagliflozin as dapagliflozin propanediol monohydrate. Nonmedicinal ingredients: anhydrous lactose, crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide; film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.

How should I use this medication?

The recommended starting dose for dapagliflozin is 5 mg taken by mouth once a day. Your doctor may adjust the dose up to a maximum 10 mg daily, depending on how effective it is and how well it is tolerated.

Dapagliflozin should be taken at the same time every day. The tablets should be swallowed whole with some fluid and may be taken with food or on an empty stomach.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are administering the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. Do not stop using the medication because you feel better. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to dapagliflozin or any ingredients of this medication
  • are taking the medication pioglitazone
  • have moderate-to-severely reduced kidney function or end stage kidney disease
  • have type 1 diabetes

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • back pain
  • constipation
  • diarrhea
  • flu-like illness
  • headache
  • nausea
  • pain in the arms, legs, hands, or feet
  • sore throat

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • dizziness or lightheadedness when rising from a sitting or lying position
  • redness or rash of the penis or foreskin (yeast infection)
  • signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
  • signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
  • signs of vaginal yeast infection (e.g., vaginal odour, curd-like discharge, itching)
  • symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness, blurred vision)
  • symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain, strong odour)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • fainting or lightheadedness when standing
  • severe dehydration (e.g., confusion, sweating stops, heart palpitations)
  • severe hypoglycemia (low blood sugar; disorientation, loss of consciousness, seizure)
  • signs of ketoacidosis (e.g., confusion, extreme thirst, loss of appetite, stomach pain, trouble breathing, nausea, vomiting, or unusual tiredness)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • symptoms of a serious infection (e.g., fever, chills, rapid breathing or heartbeat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

Health Canada has issued new restrictions concerning the use of dapagliflozin (Forxiga). To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.

Bladder cancer: In clinical trials, a small number of people who took dapagliflozin developed bladder cancer. However, there is insufficient data to suggest that this medication increases the risk of bladder cancer. If you have a history of bladder cancer, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have concerns about the risk of bladder cancer, talk to your doctor.

Cholesterol: Dapagliflozin may cause increases in the levels of low-density lipoprotein (LDL) cholesterol in your blood. If you have elevated cholesterol, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dizziness: Some people taking dapagliflozin may experience decreases in blood pressure. This occurs because the medication causes an increased amount of fluid, along with the glucose, to be removed from the body through the kidneys. These blood pressure drops could lead to dizziness, lightheadedness, and falls. This may occur when you shift your body position, such as rising from a sitting or lying position. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor. Seniors and other individuals who are at risk of experiencing low blood pressure (e.g., dehydration, taking medications for high blood pressure) should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Glucose control: When dapagliflozin is taken along with other medications for diabetes, glucose levels may drop too far, causing confusion, cold sweats, cool and pale skin, headache, fast heartbeat, or weakness. Your doctor may suggest decreasing the dose of your other medications when you first start taking dapagliflozin. If you take other medications for diabetes or medications that can decrease blood glucose levels, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Ketoacidosis: There have been reports that diabetic ketoacidosis has been experienced by people taking dapagliflozin and other similar medications. Ketoacidosis is a serious condition that occurs when the body does not have enough insulin to use the glucose in the blood. As a result, the body starts to break down fat for energy. This can cause ketones to build up in the blood, making it more acidic. This is a warning sign that your diabetes is out of control.

If you experience high blood glucose levels, thirst, very dry mouth or frequent urination, you may be experiencing early signs of ketoacidosis. Contact your doctor as soon as possible for advice on how to manage this condition.

Kidney function: The effectiveness of dapagliflozin depends on kidney function because it increases the amount of glucose eliminated through the kidneys. Over time, this medication may cause kidney problems. If you experience signs of kidney problems, such as puffy hands, face or feet, high blood pressure, unusual muscle cramping, or darkened urine, this medication may be affecting how well your kidneys are working. If you notice any of these symptoms, contact your doctor as soon as possible.

Yeast infections: There is an increased risk of developing genital or vaginal yeast infections when taking dapagliflozin as a result of increased glucose in the urine. This is more likely to occur for uncircumcised males and for people who have a history of yeast infections.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if dapagliflozin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Breast-feeding is not recommended when you are taking this medication.

Children: The safety and effectiveness of this medication have not been established for children less than 18 years of age.

Seniors: Seniors are more likely to experience side effects with this medication and may require lower doses.

What other drugs could interact with this medication?

There may be an interaction between dapagliflozin and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Forxiga

Generic Name: dapagliflozin (DAP a gli FLOE zin)
Brand Names: Farxiga

Medically reviewed by Sanjai Sinha, MD Last updated on Dec 15, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is Farxiga?

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).

Important Information

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.

Before taking this medicine

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.

How should I take Farxiga?

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.

Farxiga dosing information

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

-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.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Farxiga?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Farxiga side effects

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.

What other drugs will affect Farxiga?

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.

Copyright 1996-2020 Cerner Multum, Inc. Version: 5.01.

  • What are the ingredient drugs contained in Qternmet XR?

Medical Disclaimer

SIDE EFFECTS

The following important adverse reactions are described below and elsewhere in the labeling:

  • Hypotension
  • Ketoacidosis
  • Acute Kidney Injury and Impairment in Renal Function
  • Urosepsis and Pyelonephritis
  • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
  • Genital Mycotic Infections
  • Increases in Low-Density Lipoprotein Cholesterol (LDL-C)
  • Bladder Cancer

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.

Pool Of 12 Placebo-Controlled Studies For FARXIGA 5 And 10 mg

The data in Table 1 is derived from 12 placebo-controlled studies 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 1 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 1: Adverse Reactions in Placebo-Controlled Studies Reported in ≥ 2% of Patients Treated with FARXIGA

Adverse Reaction % of Patients
Pool of 12 Placebo-Controlled Studies
Placebo
N=1393
FARXIGA 5 mg
N=1145
FARXIGA 10 mg
N=1193
Female genital mycotic infections* 1.5 8.4 6.9
Nasopharyngitis 6.2 6.6 6.3
Urinary tract infections† 3.7 5.7 4.3
Back pain 3.2 3.1 4.2
Increased urination‡ 1.7 2.9 3.8
Male genital mycotic infections§ 0.3 2.8 2.7
Nausea 2.4 2.8 2.5
Influenza 2.3 2.7 2.3
Dyslipidemia 1.5 2.1 2.5
Constipation 1.5 2.2 1.9
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, posthitis. (N for males: Placebo=716, FARXIGA 5 mg=564, FARXIGA 10 mg=595).

Pool Of 13 Placebo-Controlled Studies For FARXIGA 10 mg

The safety and tolerability of FARXIGA 10 mg was also evaluated in a larger placebo-controlled study pool. 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).

Volume Depletion

FARXIGA causes an osmotic diuresis, which may lead to reductions in intravascular volume. Adverse reactions related to volume depletion (including reports of dehydration, hypovolemia, orthostatic hypotension, or hypotension) are shown in Table 2 for the 12-study and 13-study, short-term, placebo-controlled pools .

Table 2: Adverse Reactions of Volume Depletion* in Clinical Studies with FARXIGA

Impairment Of Renal Function

Use of FARXIGA was associated with increases in serum creatinine and decreases in eGFR (see Table 3). In patients with normal or mildly impaired renal function at baseline, serum creatinine and eGFR returned to baseline values at Week 24. Renal-related adverse reactions, including renal failure and blood creatinine increase, were more frequent in patients treated with FARXIGA (see Table 4). Elderly patients and patients with impaired renal function were more susceptible to these adverse reactions (see Table 4). Sustained decreases in eGFR were seen in patients with moderate renal impairment (eGFR 30 to less than 60 mL/min/1.73 m²).

Table 3: Changes in Serum Creatinine and eGFR Associated with FARXIGA in the Pool of 12 Placebo-Controlled Studies and Moderate Renal Impairment Study

Table 4: Proportion of Patients with at Least One Renal Impairment-Related Adverse Reaction

The safety of FARXIGA was evaluated in a study of patients with moderate renal impairment (eGFR 30 to less than 60 mL/min/1.73 m²) . In this study 13 patients experienced bone fractures for treatment durations up to 104 weeks. No fractures occurred in the placebo group, 5 occurred in the FARXIGA 5 mg group, and 8 occurred in the FARXIGA 10 mg group. Eight of these 13 fractures were in patients who had a baseline eGFR of 30 to 45 mL/min/1.73 m². Eleven of the 13 fractures were reported within the first 52 weeks. There was no apparent pattern with respect to the anatomic site of fracture.

Hypoglycemia

The frequency of hypoglycemia by study is shown in Table 5. Hypoglycemia was more frequent when FARXIGA was added to sulfonylurea or insulin .

Table 5: Incidence of Major* and Minor† Hypoglycemia in Controlled Clinical Studies

Genital Mycotic Infections

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).

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., 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. If hypersensitivity reactions occur, discontinue use of FARXIGA; treat per standard of care and monitor until signs and symptoms resolve.

Laboratory Tests

Increase In Hematocrit

In the pool of 13 placebo-controlled studies, 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 Serum Inorganic Phosphorus

In the pool of 13 placebo-controlled studies, increases from baseline in mean serum phosphorus levels were reported at Week 24 in FARXIGA-treated patients compared with placebo-treated patients (mean increase of 0.13 versus -0.04 mg/dL, respectively). Higher proportions of patients with marked laboratory abnormalities of hyperphosphatemia (≥ 5.6 mg/dL for age 17-65 years or ≥ 5.1 mg/dL for age ≥ 66 years) were reported on FARXIGA at Week 24 (0.9% versus 1.7% for placebo and FARXIGA 10 mg, respectively).

Increase In Low-Density Lipoprotein Cholesterol

In the pool of 13 placebo-controlled studies, 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.

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 .

Postmarketing Experience

Additional adverse reactions have been identified during postapproval use of FARXIGA. 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.

  • Ketoacidosis
  • Acute Kidney Injury and Impairment in Renal Function
  • Urosepsis and Pyelonephritis
  • Rash

Read the entire FDA prescribing information for Farxiga (Dapagliflozin Film-coated Tablets)

Farxiga Online Prescription

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Farxiga (Dapagliflozin) – Overview

Dapagliflozin, marketed under the name Farxiga, is a medication used in improving glucose control in some people with type 2 diabetes mellitus. People who need a dapagliflozin prescription can use Push Health to connect with a medical provider who can prescribe Farxiga when appropriate to do so.

What Is Farxiga Used For?

Farxiga (dapagliflozin), similar to the medications Invokana and Jardiance, belongs to a drug class known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. As an SGLT2 inhibitor, Farxiga helps lower the reabsorption of glucose from the lumens of tubules in the kidneys by blocking the cotransporter, resulting in increased excretion of glucose in the urine. Increased excretion of glucose can help stabilize glycemic levels in some people with diabetes. Farxiga and metformin may be beneficial if used concomitantly. Farxiga should not be used for the treatment of diabetic ketoacidosis or type I diabetes mellitus.

Farxiga – Coupon and Cost

People paying out of pocket will find Farxiga to be expensive. Farxiga costs approximately $16 per Farxiga 10 mg tablet at most pharmacies in the US. Farxiga coupons are sometimes available online or through the manufacturer. Insurance plans may also cover the costs associated with a Farxiga prescription (depending on the insurance plan). As Farxiga, dapagliflozin is available as Farxiga 5mg tablets and Farxiga 10 mg tablets. Farxiga tablets are yellow in color and biconvex in shape. Many providers will use a starting dose of Farxiga 5 mg once daily in the morning but the final regimen used depends on the judgment of the prescribing medical practitioner. Farxiga can be taken with or without food. After being taken orally, Farxiga has been observed to reach a peak plasma concentration within 2 hours in most healthy people and is mostly bound to proteins. While some dapagliflozin is excreted in the feces, most dapagliflozin and metabolites are excreted in the urine.

Can I Buy Farxiga Online?

Farxiga (dapagliflozin) is a prescription medication in the United States which means Farxiga OTC (over the counter) is not available at US pharmacies. Also, one cannot simply buy Farxiga online as the first step to getting a Farxiga prescription is consulting with a medical provider. People who need a dapagliflozin prescription can use Push Health to connect with a medical provider who can prescribe Farxiga when appropriate and indicated to do so.

Farxiga – Side Effects

Before using Farxiga, it is recommended to discuss possible side effects with one’s pharmacist and medical provider. Side effects that can result from Farxiga use include nasopharyngitis, urinary tract infections, and, in females, yeast infections. Before and while using Farxiga, it is important to assess kidney function. Farxiga should be used cautiously in people with hypovolemia, metabolic acidosis, and kidney disease. Farxiga and alcohol should not be used together. Anyone with a known hypersensitivity to dapagliflozin, Farxiga or similar medications should not use the medication.

More Farxiga Information

Last updated October 3, 2019. Given the evolving nature of medicine and science, this information might not be accurate and should not be construed as medical advice or diagnosis / treatment recommendations. Please consult a licensed medical provider if you have additional questions.

Farxiga (Dapagliflozin) Uses

What is Farxiga (Forxiga,Dapagliflozin)?

Farxiga is the brand name of dapagliflozin that comes in tablet form to help diabetic patients reduce their blood sugar levels. When you take this medication, it works by helping the body excrete excess glucose from the bloodstream via urine. It is recommended you exercise regularly and have a healthy diet while using dapagliflozin. Usually, the blood glucose that is excreted via urine, carries calories with it. Hence, this medicine might help overweight people lose weight as well as control their levels of blood sugar.

What is It Used For?

Dapagliflozin is supposed to be used in patients with type 2 diabetes, a medical condition where the body becomes insulin resistant. Forxiga belongs to a class of drugs known as SGLT-2 or sodium glucose co-transporter 2. This class of diabetes drugs works in the body by increasing glucose removal by the kidneys. This process helps to lower high levels of blood sugar in type 2 diabetic people. The drug should not be used in type 1 diabetic patients or those with diabetic ketoacidosis.

How does Dapagliflozin work?

This medication works by blocking reabsorption of glucose by the kidney. This will lead to 70g of glucose being excreted via urine every day for people who are diabetic. However, for people who have normal blood sugar levels, the glucose excreted would be less. It is important you maintain a healthy diet and stay physically active as you take this medicine.

Who is suitable to take Farxiga?

This medication is suitable for adults with type 2 diabetes and need improvements in A1C, as well as benefit from systolic blood pressure and weight reduction. However, note that dapagliflozin is not a blood pressure or weight loss drug. As you take the medicine, your doctor will need to check your type 2 diabetes through regular blood tests. Also, they will need to check your A1C and blood sugar levels. Before you start taking this medication, you need to inform your doctor about other drugs you are taking. This includes both prescription and non prescription drugs and herbal and vitamin supplements.

Who should not take this medicine?

If you are allergic to dapagliflozin or any other ingredient contained in farxiga. Symptoms of allergic reactions include skin rash, swelling of the tongue and face or red patches on the skin. In case you have any of these symptoms, you should discontinue the medication and contact your doctor immediately. If you have severe kidney problems or you are on dialysis, you should not take this medication. Your doctor will need to carry out blood tests to monitor how well your kidneys are functioning before and during your medication treatment. It is not yet known whether taking this drug during treatment is harmful to unborn baby. To stay safe, you should tell your doctor if you are pregnant or planning to become pregnant while taking dapagliflozin.

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