Farxiga®

Pronunciation: FAR-SEE-GUH
Generic name: dapagliflozin
Dosage form: oral tablets
Drug class: SGLT-2 inhibitors

What is Farxiga?

Farxiga (dapagliflozin) is an oral medication that may be given to certain people with diabetes, heart disease, or kidney disease to improve their outcomes. Specifically, Farxiga is used to:

Improve blood sugar control in adults and children aged 10 years and older with type 2 diabetes mellitus alongside diet and exercise

Lower the risk of going to hospital for heart failure in adults with type 2 diabetes who also have cardiovascular disease or multiple risk factors for cardiovascular disease

Reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure

Lower the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Farxiga mechanism of action involves preventing glucose reabsorption in the kidneys, and increasing how much is excreted in the urine. Farxiga works by inhibiting sodium-glucose cotransporter 2 (SGLT2), which is present in the proximal renal tubules and reabsorbs filtered glucose. By inhibiting this, Farxiga promotes the excretion of glucose in the urine.

Farxiga also works by reducing the amount of sodium reabsorbed by the kidneys and increasing how much reaches the distal tubule. This is thought to influence several physiological functions including lowering the preload and afterload of the heart, downregulating sympathetic activity, and decreasing pressure inside the kidneys.

Farxiga first gained FDA approval on January 8, 2014. There is no Farxiga generic.

Farxiga side effects

The most common side effects of Farxiga are:

Female genital yeast infections (vaginal thrush)

Urinary tract infections

Nasopharyngitis (a runny or stuffy nose).

Serious side effects

Farxiga can cause the following serious side effects.

Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. Farxiga can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition that needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin, or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking FARXIGA and call your healthcare provider or get medical help right away if you get any of the following:

nausea

tiredness

vomiting

trouble breathing

stomach area (abdominal) pain

ketones in your urine or blood.

If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.

Dehydration. Farxiga can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury in people with Type 2 diabetes who are taking Farxiga. You may be at a higher risk of dehydration if you:

take medicines to lower your blood pressure, including water pills (diuretics)

are on a low-salt diet

have kidney problems

are 65 years of age or older.

Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink daily. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example, if you cannot eat or you start to lose liquid from your body, for example from vomiting, diarrhea, or being in the sun too long.

Vaginal yeast infections. Women who take Farxiga may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:

vaginal odor

white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)

vaginal itching.

Yeast infection of the penis (balanitis). Swelling of an uncircumcised penis may develop in men who take Farxiga which makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:

redness, itching, or swelling of the penis

foul-smelling discharge from the penis

rash of the penis

pain in the skin around the penis.

Allergic reactions. Farxiga may cause an allergic reaction. Do not take Farxiga if you have a history of serious hypersensitivity reactions to dapagliflozin, Farxiga, or any of the inactive ingredients in the tablets. Serious reactions, including anaphylaxis and angioedema, have been reported.

Farxiga should not be used in patients with type 1 diabetes to improve blood sugar control because it may increase their risk of diabetic ketoacidosis.

Not recommended to improve blood sugar control in people with type 2 diabetes with moderate to severe kidney disease (an eGFR of less than 45 mL/min/1.73 m2) (likely to be ineffective in this setting).

Dosages of insulin or other medications that increase insulin release may need reducing to avoid the risk of hypoglycemia. Farxiga may increase the risk of hypoglycemia developing when combined with these medications.

Serious, life-threatening cases of necrotizing fasciitis of the perineum (Fournier’s Gangrene) have been reported in patients with diabetes prescribed Farxiga. If you develop pain or tenderness, redness, or swelling in your genital or perineal area, along with fever or malaise, see your doctor immediately.

Some side effects may be more likely to occur in older adults.

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 the FDA at 1-800-FDA-1088.

Before taking this medicine

You should not use Farxiga if you are allergic to dapagliflozin, or if you have:

severe kidney disease (or if you are on dialysis)

diabetic ketoacidosis (call your doctor for treatment).

To make sure Farxiga is safe for you, tell your doctor if you:

have type 1 diabetes or have had diabetic ketoacidosis

have polycystic kidney disease

have a decrease in your insulin dose

have a serious infection

have a history of infection of the vagina or penis

have liver problems

have a history of urinary tract infections or problems with urination

are on a low sodium (salt) diet. Your healthcare provider may ask you to change your diet

are going to have surgery. Your healthcare provider may stop your Farxiga before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking Farxiga and when to start it again

are eating less or there is a change in your diet

are dehydrated

have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas

drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking)

are pregnant or plan to become pregnant

are breastfeeding or plan to breastfeed.

Pregnancy

Farxiga may cause harm to an unborn baby, especially the developing kidneys of an unborn baby. If you become pregnant while taking Farxiga, your healthcare provider may switch you to a different medicine to control your blood sugar. Talk to your healthcare provider about the best way to control your blood
sugar if you plan to become pregnant or while you are pregnant.

Breastfeeding

It is not known if Farxiga passes into your breast milk. You should not breastfeed if you take Farxiga.

How should I take Farxiga?

Take Farxiga exactly as your doctor prescribed. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Farxiga is taken 1 time per day.

You may take Farxiga with or without food.

Your treatment may include dietary changes, exercise, weight control, and special medical care.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Farxiga can cause life-threatening ketoacidosis. Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in the urine.

During prolonged illness, you may become dehydrated. Call your doctor if you are sick with vomiting or diarrhea or if you eat or drink less than usual.

Farxiga dosing information

Patients should be well hydrated before starting treatment with Farxiga.

Recommended Farxiga dose for adults and children aged 10 and older for Type 2 diabetes to improve blood sugar control

Initial dose: Farxiga 5 mg once daily

May increase to 10 mg orally once a day for additional glycemic control if a lower dose has been tolerated

Maximum dose: Farxiga 10 mg/day

Usual adult dose of Farxiga for heart failure and kidney disease

Initial and maintenance dose: Farxiga 10 mg orally once a day

Maximum dose: Farxiga 10 mg/day.

Should Farxiga be stopped for surgery?

The Farxiga Package Insert recommends withholding Farxiga for at least 3 days, if possible, before major surgery or procedures associated with prolonged fasting. Farxiga should be restarted once the person is clinically stable and has started eating or receiving nutrition again.

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?

call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away

What should I avoid while taking Farxiga?

Avoid drinking alcohol.

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

What other drugs will affect Farxiga?

Other drugs may increase or decrease the effects of Farxiga on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

Insulin or other oral diabetes medicines

A diuretic or "water pill", such as furosemide or HCTZ

Lithium.

Farxiga will increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative ways to monitor glycemic control. It also interferes with some other laboratory assays.

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.

Farxiga and Medicare

Because of the prescription drug law, known as the Inflation Reduction Act, Medicare can negotiate directly with drug companies to improve access to some of the costliest single-source brand-name Medicare Part B and Part D drugs.

Farxiga is one of 10 drugs covered under Medicare Part D that were selected in 2024 for the first cycle of negotiation based on Total Expenditures under Part D and other criteria as required by the law. Negotiations with participating drug companies are ongoing, and any negotiated prices for the first cycle of negotiation is effective from 2026.

Storage

Store at room temperature 20°C to 25°C (68°F to 77°F) away from moisture and heat. Excursions are permitted between 15°C and 30°C (59°F and 86°F).

Farxiga ingredients

Active: dapagliflozin.

Inactive: microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, and magnesium stearate. Film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.

Available as Farxiga 5 mg and Farxiga 10 mg tablets.

Who makes Farxiga?

AstraZeneca Pharmaceuticals LP. makes Farxiga.

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