To understand how FARXIGA works to help lower blood glucose (sugar) levels, it’s important to know that the food you eat is made up of different nutrients, like…

proteins… fats… and carbohydrates.

These and other nutrients are broken down within your body during digestion.

The carbohydrates break down into sugars.

These sugars travel through your body in the blood as blood sugar.

Some of this blood sugar will reach your kidneys.

Among their many roles, the kidneys filter the sugar that’s in your blood and either absorb it back into your body for energy or remove it through your urine.

In people with type 2 diabetes, as blood sugar levels rise, the kidneys and the body may hold on to more sugar instead of getting rid of it.

This means that blood sugar levels may remain higher than normal.

Introducing FARXIGA.

Here’s how it works:

It’s a once-daily pill that works with your kidneys to remove some of the sugar in your blood.

FARXIGA flushes some sugar out of your body through your urine.

By getting rid of this sugar, it may help lower your blood sugar.

FARXIGA was shown to remove approximately 70 grams of sugar in the urine per day, at week 12 with FARXIGA 10 mg per day.

FARXIGA is a prescription medicine used to:

• improve blood sugar control along with diet and exercise in adults with type 2 diabetes and
• reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors

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

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. Call your healthcare provider 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 healthcare provider 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

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

Please see full Prescribing Information and Medication Guide on FARXIGA.com.

You are encouraged to report negative side effects of AstraZeneca products by calling 1-800-236-9933. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.