Generic Name: dapagliflozin
Date of Approval: January 8, 2014
Company: Bristol-Myers Squibb Company and AstraZeneca
Treatment for: Type 2 Diabetes
FDA Approves Farxiga
The United States Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Farxiga Medication Guide
Read the Medication Guide that comes with this medicine before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about Farxiga?
Farxiga can cause serious side effects, including:
- Dehydration. This medicine can cause some people to have dehydration (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 this medicine 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 this medicine 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
What is Farxiga?
Farxiga is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
It is not for people with type 1 diabetes.
It 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. 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
- have severe kidney problems or 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 or have had bladder cancer.
- 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 this medicine 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 exactly as your healthcare provider tells you to take it.
- Do not change your dose without talking to your healthcare provider.
- Take tablets by mouth one 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 this medicine.
- 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 two doses at the same time.
- If you take too much Farxiga, call your healthcare provider or go to the nearest emergency room right away.
Farxiga side effects
Farxiga may cause serious side effects, including:
- See What is the most important information I should know about Farxiga?
- 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
- Kidney problems.
- Increased fats in your blood (bad cholesterol or LDL)
The most common side effects include:
- vaginal yeast infections and yeast infections of the penis
- stuffy or runny nose and sore throat
- urinary tract infections
- 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-FDA-1088.
See also: Side effects (in more detail)
How should I store Farxiga?
Store at room temperature between 68°F and 77°F (20°C and 25°C).
General information about the safe and effective use of Farxiga
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, go to www.Farxiga.com or call 1-800-321-1335.
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.