Farxiga

What is Farxiga?

Farxiga is a prescription medicine used in adults with:

• Type 2 diabetes to:
  • 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
• Heart failure when the heart is weak and cannot pump enough blood to the rest of your body to:
• reduce the risk of cardiovascular death, hospitalization for heart failure

Farxiga is not for people with type 1 diabetes.

Farxiga is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

It is not known if Farxiga is safe and effective in children younger than 18 years of age.

What is the most important information I should know about Farxiga?

Farxiga can cause serious side effects, including:

• 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.

Who should not take Farxiga?

Do not take Farxiga if you:

• Are allergic to dapagliflozin or any of the ingredients in Farxiga. See the end of this Medication Guide for a list of ingredients in Farxiga. Symptoms of a serious allergic reaction to Farxiga 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 and are taking Farxiga to lower your blood sugar
• are on dialysis.

What should I tell my healthcare provider before taking Farxiga?

Before you take Farxiga, tell your healthcare provider if you:

• have type 1 diabetes or have had diabetic ketoacidosis.
• have kidney problems.
• 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 or there is 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.

How should I take Farxiga?

• 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.

What are the possible side effects of Farxiga?

Farxiga may cause serious side effects, including:

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

• 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:
  • nausea
  • vomiting
  • stomach area (abdominal) pain
  • tiredness
  • 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.
• Dehydration (loss of body water and salt). Dehydration leading to symptoms of low blood pressure and changes in kidney function have happened in people who are taking Farxiga. 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.
• 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:
  • headache
  • shaking or feeling jittery
  • irritability
  • fast heartbeat
  • weakness
  • drowsiness
  • sweating
  • confusion
  • dizziness
  • hunger
• 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
  • swelling
  • redness of skin (erythema)

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.

General information about the safe and effective use of Farxiga

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Farxiga for a condition for which it is not prescribed. Do not give Farxiga to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Farxiga. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Farxiga that is written for healthcare professionals.

For more information about Farxiga, go to www.Farxiga.com or call 1-800-236-9933.

How should I store Farxiga?

Store Farxiga at room temperature between 68°F to 77°F (20°C to 25°C).

What are the ingredients in Farxiga?

Active ingredient: dapagliflozin.

Inactive ingredients: microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, and magnesium stearate. The film coating contains: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.