Chronic kidney disease to:
- reduce the risk of further worsening of kidney disease and end-stage kidney disease
- reduce the risk of death due to cardiovascular disease and hospitalization for heart failure
- improve blood sugar (glucose) control along with diet and exercise
- reduce the risk of hospitalization for heart failure in people who also have known cardiovascular disease or multiple cardiovascular risk factors
- reduce the risk of cardiovascular death
- reduce the risk of hospitalization for heart failure
FARXIGA is a once-daily pill, taken in the morning, with or without food.
FARXIGA is not for people with type 1 diabetes. FARXIGA may increase the risk of diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes.
FARXIGA is not for use to improve blood sugar (glucose) control in adults 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.
- are allergic to dapagliflozin or any of the ingredients in FARXIGA. Symptoms of a serious allergic reaction may include:
- Skin rash
- 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.
- are on dialysis
FARXIGA is part of a class of medications called SGLT2 (sodium-glucose cotransporter 2) 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 SavingsRx 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. Subject to eligibility and monthly savings limit. Restrictions apply. Not available for government-insured patients.
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
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.
High blood sugar from diabetes can damage the blood vessels in your kidneys, which may cause CKD.
- #1 cause of chronic kidney disease is diabetes
- About 1 in 3 adults with diabetes has CKD
People with type 2 diabetes are at 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 T2D 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 have type 2 diabetes and heart disease or other cardiovascular risk factors—like advanced age, high cholesterol, high blood pressure, and smoking.
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. In fact, FARXIGA is the first chronic kidney disease treatment approved in 20 years for patients with or without type 2 diabetes.
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.
A healthy heart is a muscular pump that squeezes and relaxes to deliver blood to the body. Heart failure doesn’t mean the heart has stopped. For people with HFrEF (a type of heart failure called “reduced ejection fraction”), it means the heart muscle is weak, so it can’t pump enough blood to keep up with the body’s needs. About half of people with heart failure have HFrEF.
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
- 1 in 8 deaths a year are associated with heart failure
- #1 diagnosis for going back in the hospital within a month
For adults with a type of heart failure when the heart is weak and cannot pump enough blood to the rest of your body, FARXIGA can help save lives by reducing risk of cardiovascular death, lowering risk of hospitalizations for heart failure, and fitting into your current heart failure treatment plan.
- 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 65 years of age or older
- are on a low salt diet
- have kidney problems
Talk to your doctor about what you can do to prevent dehydration including how much fluid you should drink on a daily basis.
- 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). Men who take FARXIGA may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis 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
- rash of the penis
- foul smelling discharge from 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.
- Take FARXIGA exactly as your healthcare provider tells you to take it
- Do not change your dose of FARXIGA without talking to your healthcare provider
- Take FARXIGA by mouth 1 time each day, with or without food
- Stay on your prescribed diet and exercise program while taking FARXIGA
- FARXIGA will cause your urine to test positive for glucose
- Your healthcare provider may do certain blood tests before you start FARXIGA and during your treatment
- If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 2 doses of FARXIGA at the same time
- If you take too much FARXIGA, call your healthcare provider or go to the nearest emergency room right away
- If you have diabetes
- When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider’s instructions
- Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c
- Follow your healthcare provider’s instructions for treating low blood sugar (hypoglycemia). Talk to your healthcare provider if low blood sugar is a problem for you
FARXIGA can cause serious side effects, including:
See the What is the most important information I should know about FARXIGA? section.
- Ketoacidosis in people with diabetes mellitus (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with FARXIGA. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with FARXIGA. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with FARXIGA even if your blood sugar is less than 250 mg/dL. Stop taking FARXIGA and call your healthcare provider right away if you get any of the following symptoms:
- stomach area (abdominal) pain
- trouble breathing
If you get any of these symptoms during treatment with FARXIGA, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
- Serious urinary tract infections. 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:
- shaking or feeling jittery
- fast heartbeat
- 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 immediately 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
- redness of skin (erythema)
- 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-1088.1-800-FDA-1088.
You may report side effects related to AstraZeneca products by clicking here.
Before you take FARXIGA, tell your healthcare provider if you:
- have type 1 diabetes or have had diabetic ketoacidosis
- have liver problems
- have a history of urinary tract infections or problems urinating
- are going to have surgery. Your doctor may stop your FARXIGA before you have surgery. Talk to your doctor if you are having surgery about when to stop taking FARXIGA and when to start it again
- are eating less due to illness, surgery or a change in your diet
- 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. FARXIGA may harm your 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
- are breastfeeding or plan to breastfeed. It is not known if FARXIGA passes into your breast milk. You should not breastfeed if you take FARXIGA
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.