Bexagliflozin is used with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus (not for type 1 diabetes).

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

You should not use bexagliflozin if you have severe kidney disease or diabetic ketoacidosis.

Bexagliflozin may increase your risk of lower leg amputation, especially if you have had a prior amputation, a foot ulcer, heart disease, circulation problems, or nerve damage.

You can easily become dehydrated while taking bexagliflozin, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Bexagliflozin 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take bexagliflozin in the morning with or without food.

Swallow the tablet whole and do not crush, or chew.

Your treatment may also include diet, exercise, weight control, and special medical care.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

bexagliflozin can affect the results of certain medical tests. Tell any doctor who treats you that you are using bexagliflozin.

Your blood pressure may get too low while you are taking bexagliflozin. Call your doctor if you are sick with vomiting or diarrhea.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Diabetes Type 2:

20 mg orally once daily in the morning

Comments:
-Assess renal function before initiating this treatment and at periodic intervals during the treatment.
-Not recommended for patients with an eGFR less than 30 mL/min/1.73 m2.
-Assess and correct volume depletion before initiating treatment with this drug.

Use: For the improvement of glycemic control in adults with type 2 diabetes mellitus

You should not use bexagliflozin if you are allergic to it, or if you have:

• severe kidney disease (or if you are on dialysis).

Bexagliflozin may increase your risk of lower leg amputation, especially if you have had a prior amputation, a foot ulcer, heart disease, circulation problems, or nerve damage.

Tell your doctor if you have ever had:

• type I diabetes or diabetic ketoacidosis;

• low blood pressure;

• bladder infections or other urination problems;

• a diabetic foot ulcer or amputation;

• circulation problems or nerve problems in your legs or feet;

• problems with your pancreas, including surgery;

• liver or kidney disease;

• if you drink alcohol often;

• if you also take blood pressure medication, including a diuretic ("water pill");

• if you have a planned surgery; or

• if you are eating less, there is a change in your diet, or you are on a low salt diet.

Follow your doctor's instructions about using this medicine if you are pregnant. Controlling diabetes is very important during pregnancy, and your dose needs may be different during each trimester.

You should not use bexagliflozin during the second or third trimester of pregnancy.

Do not breastfeed.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

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.

Bexagliflozin may cause serious side effects. Stop using bexagliflozin and call your doctor at once if you have:

• nausea, vomiting, stomach pain; or

• tiredness or trouble breathing.

Bexagliflozin may cause serious side effects. Call your doctor at once if you have:

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

• low blood sugar--headache, weakness, drowsiness, confusion, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or

• fever, feeling tired or uneasy, redness, swelling, pain or tenderness in your genital or anal area.

Common side effects of bexagliflozin may include:

• increased or urgent need to urinate large amounts or at night;

• pain and burning when you urinate; or

• vaginal itching or discharge.

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.

Tell your doctor about all your other medicines, especially:

• diabetes medications.

This list is not complete. Other drugs may affect bexagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order a lab test before and during your treatment with bexagliflozin to check how well your kidneys are working. Your blood sugar levels should be checked regularly to determine your response to bexagliflozin. Your doctor will order other lab tests, including glycosylated hemoglobin (HbA1c), to check your response to bexagliflozin. 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 bexagliflozin. Because of the way this medication works, your urine may test positive for glucose.

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.