Farxiga® (Dapagliflozin)

What is dapagliflozin?

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 improve blood sugar control in adults with type 2 diabetes mellitus. Dapagliflozin is not for treating type 1 diabetes.

Dapagliflozin may also be used for purposes not listed in this medication guide.

Important Information

You should not use dapagliflozin if you have severe kidney disease, if you are on dialysis, or if you have diabetic ketoacidosis. Dapagliflozin is not for treating type 1 diabetes.

Taking dapagliflozin can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).

Dapagliflozin can also cause infections in the bladder or genitals (penis or vagina). Call your doctor if you have genital pain or itching, genital odor or discharge, increased urination, pain or burning when you urinate, or blood in your urine.

Some people taking this medicine have had bladder cancer, but it is not clear if dapagliflozin was the actual cause.

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 with insulin).

To make sure dapagliflozin is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• bladder cancer;

• a bladder infection;

• low blood pressure;

• heart problems;

• problems with your pancreas, including surgery;

• if you drink alcohol often; or

• if you are on a low salt diet.

It is not known whether dapagliflozin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether dapagliflozin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take dapagliflozin?

Dapagliflozin is usually taken once per day in the morning. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and 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, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

This medicine can cause positive results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using dapagliflozin.

Dapagliflozin is only part of a treatment program that may also include diet, exercise, weight control, regular 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 missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I avoid while taking dapagliflozin?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

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.

Call your doctor at once if you have:

• little or no urination;

• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;

• dehydration symptoms--dizziness, weakness, feeling light-headed (like you might pass out);

• signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back; or

• signs of a genital infection (penis or vagina)--pain, burning, itching, rash, redness, odor, or discharge.

Some people taking this medicine have had bladder cancer, but it is not clear if dapagliflozin was the actual cause.

Side effects may be more likely to occur in older adults.

Common side effects may include:

• 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.

What other drugs will affect dapagliflozin?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin or oral diabetes medicine;

• a diuretic or "water pill";

• heart or blood pressure medication; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with dapagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.