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 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 prevents the reabsorption of glucose in our kidneys, increasing how much is excreted in our urine. It works by inhibiting the sodium-glucose cotransporter 2 (SGLT2), which is present in the proximal renal tubules and is responsible for the reabsorption of filtered glucose. By inhibiting this it 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 was first FDA-approved on January 8, 2014. It belongs to the class of medicines known as selective sodium-glucose cotransporter-2 inhibitors.

You should not use Farxiga if you have a history of serious hypersensitivity reactions to dapagliflozin or any of the other ingredients in Farxiga.

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

Not recommended for people with type 2 diabetes mellitus with an eGFR of less than 45 mL/min/1.73 m2 to improve blood sugar control (likely to be ineffective in this setting). For other indications initiation in patients with an eGFR less than 25 mL/min/1.73 m2 is not recommended; however patients may continue on 10mg orally once daily to reduce the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure.

Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for the treatment of kidney disease (likely to be ineffective in this setting).

May not be suitable for patients at increased risk for ketoacidosis. Extra monitoring may be required and Farxiga will need to be withheld in those who develop ketoacidosis or in clinical situations known to predispose to ketoacidosis.

Taking Farxiga can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up). Patients should be properly hydrated before starting treatment and patients should be monitored for signs and symptoms of dehydration while taking Farxiga, especially the elderly, those with renal impairment or low systolic blood pressure, and patients on diuretics. Tell your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

Dosages of insulin or insulin secretagogues may need reducing to avoid the risk of hypoglycemia.

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.

May increase the risk of fungal infections in the genital area. The risk is higher in those with a prior history of genital fungal infections. Get medical help right away if you have burning, itching, odor, or discharge. Urinary tract infections should be monitored for and treated promptly.

Take Farxiga exactly as prescribed by your doctor. 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.
• Your treatment may also include diet, 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. 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 high ketones in the urine.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injections in case of severe hypoglycemia.

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

Patients should be well hydrated before initiating therapy.

Usual Adult Dose for Diabetes Type 2 to improve blood sugar control

• Initial dose: 5mg once daily
• May increase to 10 mg orally once a day for additional glycemic control if a lower dose has been tolerated
• Maximum dose: 10 mg/day

Usual Adult dose for other indications

• Initial and maintenance dose: 10 mg orally once a day
• Maximum dose: 10 mg/day

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

• 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:

• polycystic kidney disease
• liver disease
• bladder infections or other urination problems
• problems with your pancreas, including surgery
• alcoholism, or if you currently drink large amounts of alcohol or
• if you are on a low-salt diet.

Farxiga is not recommended during the second or third trimester of pregnancy. Follow your doctor's instructions about using Farxiga if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

Farxiga is not recommended during breastfeeding because of the risk of serious adverse reactions in the breastfed infant.

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 drinking alcohol.

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 such as hives; difficulty breathing; and swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a genital infection (penis or vagina) such as burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or not feeling well. These symptoms may get worse quickly.

Call your doctor at once if you have:

• Dehydration - dizziness, confusion, feeling very thirsty, less urination
• Kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath
• 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 side effects may be more likely to occur in older adults.

Common Farxiga side effects occurring with a 5% or greater incidence include:

• Female genital yeast infections
• Urinary tract infections
• Nasopharyngitis (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 the FDA at 1-800-FDA-1088.

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" or
• 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 1,5-anhydroglucitol (1,5-AG) Assay.

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.