Generic name: dapagliflozin (DAP a gli FLOE zin)
Brand name: Farxiga
Dosage forms: oral tablet (10 mg; 5 mg)
Dapagliflozin is an oral diabetes medicine that helps control blood sugar levels. Dapagliflozin works by helping the kidneys get rid of glucose from your bloodstream.
Dapagliflozin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Dapagliflozin is also used to lower the risk of needing to be in the hospital for heart failure in adults with type 2 diabetes who also have heart disease.
Dapagliflozin is not for treating type 1 diabetes.
Dapagliflozin may also be used for purposes not listed in this medication guide.
Warnings
You should not use dapagliflozin if you have diabetic ketoacidosis, severe kidney disease, or if you are on dialysis.
Taking dapagliflozin can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).
Dapagliflozin can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.
Before taking this medicine
You should not use dapagliflozin if you are allergic to it, or if you have:
- severe kidney disease (or if you are on dialysis); or
- diabetic ketoacidosis (call your doctor for treatment).
Tell your doctor if you have ever had:
- liver or kidney disease;
- bladder infections or other urination problems;
- low blood pressure;
- problems with your pancreas, including surgery;
- if you are dehydrated;
- if you drink alcohol often; or
- if you are on a low salt diet.
Follow your doctor's instructions about using dapagliflozin if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.
You should not use dapagliflozin during the second or third trimester of pregnancy.
You should not breast-feed while using this medicine.
Dapagliflozin is not approved for use by anyone younger than 18 years old.
How should I take dapagliflozin?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
You may take dapagliflozin with or without food.
Call your doctor if you are sick with vomiting or diarrhea, if you consume less food or fluid than usual, or if you are sweating more than usual.
Your blood sugar will need to be checked often, and you may also need to test the level of ketones your urine. Dapagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have ketones in the urine.
You may have low blood sugar (hypoglycemia)and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).
Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. You may need to stop taking dapagliflozin for at least 3 days before a surgery. Ask your doctor before changing your dose or medication schedule.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using dapagliflozin.
Dapagliflozin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking dapagliflozin?
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Dapagliflozin side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention right away if you have signs of a genital infection (penis or vagina):burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.
Call your doctor at once if you have:
- little or no urination;
- dehydration symptoms--dizziness, weakness, feeling light-headed (like you might pass out);
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
- ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
- signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back.
Side effects may be more likely to occur in older adults.
Common side effects may include:
- genital yeast infection;
- urinating more than usual; or
- sore throat and runny or stuffy nose.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Dapagliflozin dosing information
Usual Adult Dose for Diabetes Type 2:
To improve glycemic control:
Initial dose: 5 mg orally once a day
-May increase to 10 mg orally once a day for additional glycemic control if lower dose has been tolerated
Maximum dose: 10 mg/day
To reduce the risk of hospitalization for heart failure: 10 mg orally once a day
Comments:
-Correct volume depletion prior to initiating therapy.
-Ensure adequate renal function (eGFR greater than 45 mL/min/1.73 m2) as glycemic efficacy is dependent on adequate renal function.
-If used in combination with insulin or an insulinsecretagogue, a lower dose of insulin or the insulin secretagogue should be considered to reduce the risk of hypoglycemia.
Uses:
-As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
-To reduce the risk of hospitalization for heart failure in patients with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
Usual Adult Dose for Heart Failure with Reduced Ejection Fraction:
10 mg orally once a day
Comments:
-Correct volume depletion prior to initiating therapy.
-This drug is not recommended for patients with type 1 diabetes mellitus.
Use: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.
Usual Adult Dose for Chronic Kidney Disease:
10 mg orally once a day
Comments:
-Correct volume depletion prior to initiating therapy.
-This drug is not recommended in patients with polycystic kidney disease or patients requiring, or with a recent history of immunosuppressive therapy for kidney disease, as it is not expected to be effective.
-This drug is not recommended for patients with type 1 diabetes mellitus.
Use: To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and
hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
What other drugs will affect dapagliflozin?
Tell your doctor about all your other medicines, especially:
- insulin or other oral diabetes medicines; or
- a diuretic or "water pill."
This list is not complete. Other drugs may affect dapagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.