Answers to frequently asked questions

FARXIGA is one small prescription pill that can be used:

• To reduce the risk of further worsening of your kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease
• To reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visit in adults with heart failure, when the heart cannot pump enough blood to the rest of your body
  
• To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes who also have known cardiovascular disease or multiple cardiovascular risk factors
• Along with diet and exercise to improve blood sugar (glucose) control in adults and children who are 10 years of age or older with type 2 diabetes

FARXIGA is not for use to improve blood sugar (glucose) control in people with type 1 diabetes.

FARXIGA is not for use to improve blood sugar (glucose) control in people with type 2 diabetes who have moderate to severe kidney problems, because it may not work.

FARXIGA is not for people with certain genetic forms of polycystic kidney disease, or who are taking or have recently received immunosuppressive therapy to treat kidney disease. FARXIGA is not expected to work if you have these conditions.

It is not known if FARXIGA is safe and effective to lower blood sugar (glucose) in children younger than 10 years of age with type 2 diabetes.

It is not known if FARXIGA is safe and effective for treatment of heart failure or chronic kidney disease in children younger than 18 years of age.

Do not take FARXIGA if you are allergic to dapagliflozin or any of the ingredients in FARXIGA. See the Medication Guide for a list of ingredients in FARXIGA. Symptoms of a serious allergic reaction may include:

• raised red patches on your skin (hives)
• swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
  

If you have any of these symptoms, stop taking FARXIGA and contact your healthcare provider or go to the nearest hospital emergency room right away.

FARXIGA is part of a class of medications called sodium-glucose cotransporter-2 (SGLT2) inhibitors. It blocks some of the sugar and sodium reabsorption in the kidneys.

FARXIGA works with the body to flush sugar away in urine. In a clinical trial of adults with type 2 diabetes, FARXIGA was shown to remove approximately 70 grams of sugar in the urine per day at the end of a 12-week period. The effect of FARXIGA on the kidneys may also help improve your heart's ability to pump blood to the body. FARXIGA also works to lower the increased kidney pressure that comes with chronic kidney disease.

With the FARXIGA Savings Card, most commercially insured patients can get FARXIGA for as little as $0* per month for as long as their doctor prescribes any available dose. You can even register to receive savings and prescription refill reminders via text!

^{*Eligible commercially insured patients can get FARXIGA for as low as $0 as long as their doctor prescribes it. Not available for government-insured patients. Subject to eligibility and monthly savings limit. Restrictions apply.}

The Food and Drug Administration granted FARXIGA its “Breakthrough Therapy Designation" for its review in chronic kidney disease. That means it may provide substantial improvement over treatments that are currently available for chronic kidney disease.

High blood sugar from diabetes can damage the blood vessels in your kidneys, which may cause CKD.

• #1 cause of CKD is diabetes
• About 1 in 3 adults with diabetes has CKD

High blood pressure can damage your kidneys. The damage can impact how well the kidneys can do their job. This can lead to chronic kidney disease.

• #2 cause of CKD is high blood pressure
• About 1 in 5 adults with high blood pressure may have CKD

FARXIGA is not a blood pressure drug.

eGFR stands for “estimated glomerular filtration rate” and it is one of your kidney numbers.

Tracking your eGFR is important because it tells your doctor:

• How well your kidneys are doing their job
• What stage of CKD you could be in
• If your kidney function may be declining

If your eGFR is less than 60, it may mean you have CKD.

_{*eGFR is measured in mL/min/1.73 m².}

UACR stands for “urine albumin-to-creatinine ratio” and is also one of your kidney numbers. UACR tests show if you have increased protein in your pee. If your UACR is over 30 for 3 or more months, it could mean there's kidney damage and may mean you have CKD.

Talk to your doctor if you notice changes in how often you pee or what your pee looks like.

_{^†UACR is measured in mg/g.}

For adults with chronic kidney disease, FARXIGA can help reduce the risk of further worsening of kidney disease, end-stage kidney disease, death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease.

The heart is a muscular pump that squeezes and relaxes to deliver blood to the body. Heart failure doesn’t mean the heart has stopped. It means the heart isn’t filling or pumping as well as it should. Almost 7 million people in the United States are living with heart failure.

Two types of heart failure are:

1. HFrEF (heart failure with reduced ejection fraction) – when the heart muscle is weak, so it can’t pump enough blood to keep up with the body’s needs
2. HFpEF (heart failure with preserved ejection fraction) – when the heart muscle gets stiff and can’t fill properly, so it pumps out less blood to the body

Unlike a heart attack, heart failure happens slowly. It’s a chronic condition that gets worse over time and can lead to hospitalization or death.

• Almost 1 million hospitalizations a year for heart failure
• One in 8 deaths a year are associated with heart failure
• #1 diagnosis for going back in the hospital within a month

For adults with heart failure, FARXIGA can help save lives by reducing the risk of cardiovascular death, lowering the risk of hospitalization for heart failure, and reducing the risk of urgent heart failure visit.

People with type 2 diabetes are at a greater risk of developing heart failure than those who don’t have the disease.

• 68% of adults with type 2 diabetes showed loss of heart function within 5 years of their type 2 diabetes diagnosis
• Up to 50% of people with type 2 diabetes may develop heart failure
• People with type 2 diabetes have a 33% higher risk of landing in the hospital from heart failure than those without it

FARXIGA may help reduce the risk of heart failure hospitalization if you’re an adult with type 2 diabetes and heart disease or other cardiovascular risk factors—like advanced age, high cholesterol, high blood pressure, and smoking.

FARXIGA (far-see-guh) is a once-daily pill taken in the morning with or without food.

In studies, FARXIGA:

• Removed some blood sugar through the urine*
• Significantly lowered A1C

Additionally, FARXIGA may help you:
Lose weight—on average 3%^†
Reduce systolic blood pressure^†

FARXIGA is not a weight loss or blood pressure drug.

And, if you’re not reaching your A1C goal on metformin alone, read this important information about FARXIGA.

Individual results may vary.

*_{With FARXIGA at 12 weeks.}

†_{When used with metformin.}

For some people, taking metformin alone can lower their A1C to goal. For others, adding FARXIGA may be the extra help they need. A study has shown that adding once-daily FARXIGA to metformin therapy helped some patients lower their A1C more than metformin alone.

And, although not a weight loss or blood pressure drug, FARXIGA may help you lose weight and lower systolic blood pressure.

Individual results may vary.

FARXIGA can cause serious side effects, including:

• 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 which 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. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.
  • nausea
  • vomiting
  • stomach area (abdominal) pain
  • tiredness
  • trouble breathing
  • ketones in your urine or blood
    
    
• 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 on a daily basis. 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 liquids from your body, for example from vomiting, diarrhea, or being in the sun too long.

• Vaginal yeast infection. 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 that 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

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

FARXIGA can cause serious side effects, including:

See “What is the most important information I should know about FARXIGA?”.

• Serious urinary tract infections (UTI). Serious urinary tract infections that may lead to hospitalization have happened in people who are taking FARXIGA. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
• Low blood sugar (hypoglycemia) in patients with diabetes mellitus. If you take FARXIGA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take FARXIGA. Signs and symptoms of low blood sugar may include:
  • headache
  • shaking or feeling jittery
  • irritability
  • fast heartbeat
  • weakness
  • drowsiness
  • sweating
  • confusion
  • dizziness
  • hunger

Follow your healthcare provider's instructions for treating low blood sugar

• A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men with diabetes mellitus who take FARXIGA. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention right away if you have fever or you are feeling very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals:
  • pain or tenderness
  • swelling
  • redness of skin (erythema)
• Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking FARXIGA and call your healthcare provider right away or go to the nearest hospital emergency room. See “Who should not take FARXIGA?”. Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

The most common side effects of FARXIGA include:

• vaginal yeast infections and yeast infections of the penis
• stuffy or runny nose and sore throat
• changes in urination, including urgent need to urinate more often, in larger amounts, or at night

These are not all the possible side effects of FARXIGA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may report side effects related to AstraZeneca products.