IMPORTANT INFORMATION ABOUT FARXIGA (far-SEE-guh)
Please read this summary carefully and then ask your doctor about FARXIGA® (dapagliflozin).
No advertisement can provide all the information needed to determine if a drug is right for you or take the place of careful discussions with your healthcare provider. Only your healthcare provider has the training to weigh the risks and benefits of a prescription drug. What is the most important information I should know about FARXIGA?
FARXIGA can cause serious side effects, including:
• 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). 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 have kidney problems
• 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-thecounter 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 to know if bladder cancer was related to FARXIGA. You should not take FARXIGA if you have bladder cancer. Tell your healthcare provider right away if you have any of the following symptoms: blood or a red color in your urine pain while you urinate
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 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.
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 or are
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. • have or have had bladder cancer. • are going to have surgery. • 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 are pregnant or plan to become pregnant, talk to your healthcare provider about the best way to control your blood sugar. • are breastfeeding or plan to breastfeed. It is not known if FARXIGA passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you are taking 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. • 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.