Dapagliflozin is a prescription medication that is mainly used alongside diet and exercise to help treat type 2 diabetes, but it is also used in the treatment of heart failure. It was first approved by the US Food and Drug Administration (FDA) in 2014.

Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. This class of drug uses the kidneys to help control your glucose (blood sugar) levels. It works by increasing the amount of glucose removed from the body when you urinate. It also reduces the amount of effort your heart has to put in to pumping blood around your body.

What is dapagliflozin used for?

• Dapagliflozin is a prescription medicine used:
  • along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes
  • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes who also have known cardiovascular disease or multiple cardiovascular risk factors
  • to reduce the risk of cardiovascular death, hospitalization for heart failure in adult patients with heart failure, when the heart is weak and cannot pump enough blood to the rest of your body
  • to reduce the risk of further worsening of your kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease.
• Dapagliflozin is not for people with type 1 diabetes. Dapagliflozin may increase the risk of diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes.
• Dapagliflozin is not for use to improve blood sugar (glucose) control in adults with type 2 diabetes who have moderate to severe kidney problems, because it may not work.
• Dapagliflozin is not for people with certain genetic forms of polycystic kidney disease, or who are taking or have recently received immunosuppressive therapy to treat kidney disease. Dapagliflozin is not expected to work if you have these conditions.
• It is not known if dapagliflozin is safe and effective in children younger than 18 years of age.

Dapagliflozin can cause serious side effects, including:

• Dehydration. Dapagliflozin 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 dapagliflozin. 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 healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. 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.
• Vaginal yeast infection. Women who take dapagliflozin 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 dapagliflozin 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.

• Take dapagliflozin exactly as your healthcare provider tells you to take it.
• Do not change your dose of dapagliflozin without talking to your healthcare provider.
• Take dapagliflozin by mouth 1 time each day, with or without food.
• Stay on your prescribed diet and exercise program while taking dapagliflozin.
• Dapagliflozin will cause your urine to test positive for glucose.
• Your healthcare provider may do certain blood tests before you start dapagliflozin and during your treatment.
• 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.

• Estimated glomerular filtration rate (eGFR) 45 mL/min/1.73m² or greater: To improve glycemic control, the recommended starting dose is 5mg orally once daily. Dose can be increased to 10mg orally once daily for additional glycemic control. For all other indications, the recommended starting dose is 10mg orally once daily.
• eGFR 25 mL/min/1.73m²to less than 45: 10 mg orally once daily
• eGFR less than 25 mL/min/1.73m²: Initiation is not recommended, however patients may continue 10mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF.
• On dialysis: Contraindicated

Do not take dapagliflozin if you:

• are allergic to dapagliflozin or any of the ingredients in dapagliflozin. See below for a list of ingredients in dapagliflozin. Symptoms of a serious allergic reaction to dapagliflozin 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 dapagliflozin and contact your healthcare provider or go to the nearest hospital emergency room right away.
• are on dialysis.

What should I tell my doctor before taking dapagliflozin?

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

• have type 1 diabetes or have had diabetic ketoacidosis.
• have liver problems.
• have a history of urinary tract infections or problems urinating.
• are going to have surgery. Your doctor may stop your dapagliflozin before you have surgery. Talk to your doctor if you are having surgery about when to stop taking dapagliflozin 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).

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 dapagliflozin at the same time.

If you take too much dapagliflozin, call your healthcare provider or go to the nearest emergency room right away.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet and exercise regularly.

Follow your doctor's instructions about drinking enough fluids throughout the day while you are on this medication.

Dapagliflozin may cause serious side effects, including:

• See “Important information” above.
• 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 dapagliflozin. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with dapagliflozin. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with dapagliflozin even if your blood sugar is less than 250 mg/dL. Stop taking dapagliflozin 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 dapagliflozin, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. 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 dapagliflozin 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 dapagliflozin. 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 dapagliflozin. 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 dapagliflozin 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 dapagliflozin. 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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Keep all appointments with your doctor and the laboratory. Your doctor will probably order certain laboratory tests before and during your treatment to check your body's response to dapagliflozin.

Your blood sugar levels should be checked regularly to determine your response to dapagliflozin. Your doctor will order other lab tests, including glycosylated hemoglobin (HbA1c), to check your response to dapagliflozin. Your doctor will also tell you how to check your response to this medication by measuring your blood sugar levels at home. Follow these instructions carefully.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking dapagliflozin. Because of the way this medication works, your urine may test positive for glucose.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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