For adults with type 2 diabetes, in addition to diet and exercise

What You Should Know About FARXIGA

FARXIGA®  (dapagliflozin)—discuss benefits and possible risks

FARXIGA® (dapagliflozin)—discuss benefits and possible risks

You and your doctor may have discussed the benefits as well as the possible risks of taking FARXIGA (far-SEE-guh), and how it may help you achieve your treatment goals.

 

Potential benefits of using FARXIGA for adults with type 2 diabetes, in addition to diet and exercise:

  • FARXIGA is a once-daily pill for adults with type 2 diabetes who need improvement in A1C and additionally may benefit from weight and systolic blood pressure reduction. Patients experienced an average 3% weight loss when used with metformin

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.

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 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.

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 medication 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 related to AstraZeneca products by clicking here.

 

Tips for taking FARXIGA

Learn how to take FARXIGA

Important Safety Information

Who should not take 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. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with FARXIGA

What are the possible side effects of 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
  • 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
  • Low blood sugar (hypoglycemia) can occur if you take FARXIGA with another medicine that can cause low blood sugar, such as sulfonylureas or insulin. Symptoms of low blood sugar include shaking, sweating, fast heartbeat, dizziness, hunger, headache, and irritability. Follow your healthcare provider's instructions for treating low blood sugar
  • Bacterial infections under the skin of the genitals and areas around them. Rare but serious infections that cause severe tissue damage under the skin of the genitals and areas around them have happened with FARXIGA. This infection has happened in women and men and may lead to hospitalization, surgeries and death. Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable and you also develop any pain or tenderness, swelling, or redness of the skin in the genitals and areas around them
  • 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
  • Increase in bad cholesterol (LDL-C). Your healthcare provider should check your LDL-C during treatment with FARXIGA
  • 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

The most common side effects of FARXIGA include yeast infections of the vagina or penis, and changes in urination, including urgent need to urinate more often, in larger amounts, or at night.

What should I tell my healthcare provider before taking FARXIGA?

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

What is FARXIGA?

FARXIGA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

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

Please see full Prescribing Information and Medication Guide for FARXIGA.

You may report side effects related to AstraZeneca products by clicking here.