Farxiga

Generic Name: dapagliflozin (DAP-a-gli-FLOE-zin)
Brand Name: Farxiga

Farxiga is used for:

Treating type 2 diabetes in certain patients. It is used along with diet and exercise.

Farxiga is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It works by decreasing the amount of sugar the body absorbs and increasing the amount of sugar that leaves the body in the urine.

Do NOT use Farxiga if:

  • you are allergic to any ingredient in Farxiga
  • you have type 1 diabetes
  • you have high blood or urine ketone levels (diabetic ketoacidosis)
  • you have bladder cancer or severe kidney problems, or if you are on dialysis

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Farxiga:

Some medical conditions may interact with Farxiga. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have kidney problems, low or high blood pressure, or high cholesterol
  • if you have a history of bladder cancer or yeast infections of the penis or vagina, or if you are a man who has not been circumcised
  • if you are dehydrated or have low blood volume, or if you are on a low salt (sodium) diet

Some MEDICINES MAY INTERACT with Farxiga. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Insulin or other oral diabetes medicine (eg, repaglinide, glipizide) because the risk of low blood sugar may be increased
  • Diuretics (eg, furosemide, hydrochlorothiazide, spironolactone) because the risk of low blood pressure may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Farxiga may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Farxiga:

Use Farxiga as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Farxiga comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Farxiga refilled.
  • Take Farxiga by mouth in the morning with or without food.
  • Check with your doctor to see if you should drink extra fluids while taking Farxiga.
  • Take Farxiga on a regular schedule to get the most benefit from it. Taking Farxiga at the same time each day will help you remember to take it.
  • Continue to take Farxiga even if you feel well. Do not miss any doses.
  • If you miss a dose of Farxiga, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Farxiga.

Important safety information:

  • Dizziness may occur while you take Farxiga. This effect may be worse if you take it with alcohol or certain medicines. Use Farxiga with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Farxiga may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Carry an ID card at all times that says you have diabetes.
  • Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Farxiga.
  • Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Farxiga exactly as prescribed, tell your doctor.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
  • Be careful not to become dehydrated, especially during hot weather or while you are being active. Dehydration may increase the risk of Farxiga's side effects.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • Tell your doctor or dentist that you take Farxiga before you receive any medical or dental care, emergency care, or surgery.
  • Farxiga may be associated with an increased risk of bladder cancer. Tell your doctor right away if you notice symptoms that could be associated with bladder cancer (eg, a red color or blood in the urine, difficult or painful urination, an increased need to urinate). Discuss any questions or concerns with your doctor.
  • Farxiga usually does not cause low blood sugar. However, low blood sugar may occur when it is used along with certain other medicines for diabetes (eg, insulin, sulfonylureas). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or nondiet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
  • Farxiga will cause your urine to test positive for glucose. Be sure your doctor and lab personnel know you are taking Farxiga.
  • Lab tests, including cholesterol levels, kidney function, fasting blood glucose, hemoglobin A1c, and complete blood cell counts, may be performed while you use Farxiga. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Farxiga with caution in the ELDERLY; they may be more sensitive to its effects, including dehydration, dizziness, low blood pressure, and kidney problems.
  • Farxiga should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Farxiga while you are pregnant. It is not known if Farxiga is found in breast milk. Do not breast-feed while you are taking Farxiga.

Possible side effects of Farxiga:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Runny or stuffy nose; sore throat.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); fainting; fast or irregular heartbeat; increased urination; muscle weakness; penis discharge, redness, rash, itching, pain, or swelling; severe or persistent headache, dizziness, or light-headedness; sluggishness; symptoms of low blood sugar (eg, confusion, increased sweating, weakness, tremors, dizziness, fainting, drowsiness, headache, irritability, chills, fast heartbeat, vision changes, increased hunger); symptoms of kidney problems or urinary tract infection (eg, blood in the urine, change in the amount of urine produced, difficult or painful urination, unusual or persistent pain in the mid to lower back, unexplained swelling); unusual tiredness or weakness; vaginal discharge, itching, or odor; very dry mouth or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Farxiga:

Store Farxiga at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Farxiga out of the reach of children and away from pets.

General information:

  • If you have any questions about Farxiga, please talk with your doctor, pharmacist, or other health care provider.
  • Farxiga is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Farxiga or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Farxiga. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Farxiga. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Farxiga.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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