Bexagliflozin Tablets

What is this medication?

BEXAGLIFLOZIN (BEX a gli FLOE zin) treats type 2 diabetes. It works by helping your kidneys remove sugar (glucose) from your blood through the urine, which decreases your blood sugar. Changes to diet and exercise are often combined with this medication.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): BRENZAVVY

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Change in diet, eating less
• Changes to your insulin dose
• Dehydration
• Diet low in salt
• Frequently drink alcohol
• Having surgery
• History of amputation
• History of diabetic ketoacidosis (DKA)
• History of foot sores caused by diabetes
• History of genital infections
• History of pancreatitis or pancreas problems
• History of urinary tract infections (UTI)
• Kidney disease
• Liver disease
• Nerve condition that causes pain, tingling, or numbness in the hands or feet
• Peripheral vascular disease, narrowing of the blood vessels
• Serious infection
• Trouble passing urine
• Type 1 diabetes
• An unusual or allergic reaction to bexagliflozin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Take this medication in the morning. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Alcohol
• Insulin
• Lithium
• Sulfonylureas, such as glimepiride, glipizide, glyburide
• This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress.

This medication can cause a serious condition in which there is too much acid in your blood. If you develop nausea, vomiting, stomach pain, unusual tiredness, or trouble breathing, stop taking this medication and call your care team right away. If possible, use a ketone dipstick to check for ketones in your urine.

A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Using this medication with insulin or a sulfonylurea may increase your risk of hypoglycemia. Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. Get medical help at once.

Tell your care team if you have high blood sugar. You might need to change the dose of your medication. If you are sick or exercising more than usual, you might need to change the dose of your medication.

Do not skip meals. Ask your care team if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
• Diabetic ketoacidosis (DKA)—increased thirst or amount of urine, dry mouth, fatigue, fruity odor to breath, trouble breathing, stomach pain, nausea, vomiting
• Genital yeast infection—redness, swelling, pain, or itchiness, odor, thick or lumpy discharge
• Infection or redness, swelling, tenderness, or pain in the genitals, or area from the genitals to the back of the rectum
• New pain or tenderness, change in skin color, sores or ulcers, infection of the leg or foot
• Urinary tract infection (UTI)—burning when passing urine, passing frequent small amounts of urine, bloody or cloudy urine, pain in the lower back or sides

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.