FAQs About FARXIGA

FARXIGA (far-SEE-guh) is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

FARXIGA is a once-daily pill, taken in the morning, with or without food.

FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

Do not take FARXIGA if you have severe kidney problems or are on dialysis. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with FARXIGA.

Do not take FARXIGA if you:

• 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.

• Have severe kidney problems or are on dialysis

FARXIGA works with the body to flush sugar away in urine. In a clinical trial of adults with type 2 diabetes, FARXIGA 10 mg was shown to remove approximately 70 grams of sugar in the urine per day at the end of a 12-week period.

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

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.

Individual results may vary.

*With FARXIGA at 12 weeks.

^†When used with metformin.

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

FARXIGA may cause serious side effects including:

• Dehydration (the loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure; take medicines to lower your blood pressure, including water pills (diuretics); are 65 years of age or older; are on a low salt diet, or have kidney problems

FARXIGA has been tested in 24 clinical studies that looked at its benefits and safety. The studies had more than 11,000 adults with type 2 diabetes, including more than 6,000 patients treated with FARXIGA.

FARXIGA, combined with diet and exercise, was studied alone as well as in combination with other diabetes medicines you may be taking. The other medicines included metformin, glimepiride, pioglitazone, insulin, and sitagliptin.

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.

Do not take FARXIGA if you have severe kidney problems or are on dialysis. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with FARXIGA.

FARXIGA may cause serious side effects including dehydration (the loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure; take medicines to lower your blood pressure, including water pills (diuretics); are 65 years of age or older; are on a low salt diet, or have kidney problems.

FARXIGA can cause serious side effects, including:

• Dehydration (the loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure; take medicines to lower your blood pressure, including water pills (diuretics); are 65 years of age or older; are on a low salt diet, or have kidney problems
• Vaginal yeast infections in women who take FARXIGA. Talk to your healthcare provider if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching
• Yeast infection of skin around the penis (balanitis) in men who take FARXIGA. Talk to your healthcare provider if you experience redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; or pain in the skin around penis. Certain uncircumcised men may have swelling of the penis that makes it difficult to pull back the skin around the tip of 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.

• Bladder cancer. In studies of FARXIGA in people with diabetes, bladder cancer occurred in a few more people who were taking FARXIGA than in people who were taking other diabetes medications. There were too few cases of bladder cancer to know if bladder cancer was related to FARXIGA. Tell your healthcare provider right away if you have blood or a red color in your urine or pain while you urinate

FARXIGA is a tablet taken once daily, in the morning, with or without food. The recommended starting dose of FARXIGA is 5 mg once daily.

When taking FARXIGA, it is important to remember the following:

• 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
• 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
• Stay on your prescribed diet and exercise program while taking FARXIGA
• Your healthcare provider may do certain blood tests before you start FARXIGA and during your treatment
• Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your A1C
• 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
• 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.

FARXIGA can cause serious side effects, including:

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

• Dehydration (the loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure; take medicines to lower your blood pressure, including water pills (diuretics); are 65 years of age or older; are on a low salt diet, or have kidney problems
• Ketoacidosis occurred in people with type 1 and type 2 diabetes during treatment with FARXIGA. Ketoacidosis is a serious condition which may require hospitalization and may lead to death. Symptoms may include nausea, tiredness, vomiting, trouble breathing, and abdominal pain. If you get any of these symptoms, stop taking FARXIGA and call your healthcare provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL
• Kidney problems. Sudden kidney injury occurred in people taking FARXIGA. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, from vomiting, diarrhea, or excessive heat exposure
• Serious urinary tract infections (UTI), some that lead to hospitalization, occurred in people taking FARXIGA. Tell your doctor if you have any signs or symptoms of UTI including 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 with or without fever, back pain, nausea, or vomiting

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, please read the Medication Guide; ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

BEFORE YOU TAKE FARXIGA, TELL YOUR HEALTHCARE PROVIDER:

• all of your medical conditions, including problems with your kidneys, liver, bladder, or pancreas
• if you have had, or have risk factors for, ketoacidosis (including type 1 diabetes, are eating less due to illness, surgery, or a change in your diet, are going to have surgery, or binge drink)
• if you are pregnant, or plan to become pregnant. FARXIGA may harm your unborn baby
• if you are breastfeeding, or plan to breastfeed. It is unknown if FARXIGA passes into your breast milk
• about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements

Store FARXIGA at room temperature between 68°F and 77°F (20°C and 25°C).

Please see Important Safety Information and Medication Guide and US Full Prescribing Information.