"The European Medicines Agency (EMA) is alerting doctors and other healthcare professionals to the possibility of atypical cases of diabetic ketoacidosis (DKA) associated with use of sodium-glucose cotransporter-2 (SGLT2) inhibitors, a relatively "...
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). You may be at a higher risk of dehydration if you:
- Vaginal yeast infection. Women who take FARXIGA may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
- 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
- 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
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.
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.
- have severe kidney problems or are on dialysis.
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.
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.
- 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.
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 (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 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:
- trouble breathing
- stomach area (abdominal) pain
- Kidney problems. Sudden kidney injury has happened to people taking FARXIGA. Talk to your doctor right away if you:
- reduce the amount of food or liquid you drink for example, if you are sick and 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 doctor 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). 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:
- shaking or feeling jittery
- fast heartbeat
- Increased fats in your blood (bad cholesterol or LDL)
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.
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 healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.
How should I store FARXIGA?
Store FARXIGA at room temperature between 68°F and 77°F (20°C and 25°C).
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.
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.
Last reviewed on RxList: 3/27/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Farxiga Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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