Ertugliflozin Tablets

What is this medication?

ERTUGLIFLOZIN (er TOO 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): Steglatro

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 ertugliflozin, 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 a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take this medication in the morning. Take your dose at the same time each day. Do not take more often than directed. Do not stop taking except on your care team's advice.

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
• Lithium
• Steroid medications, such as prednisone or cortisone
• Sulfonylureas, such as glimepiride, glipizide, glyburide

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. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication. Your care team will monitor your HbA1C (A1C). This test shows what your average blood sugar (glucose) level was over the past 2 to 3 months.

Know the symptoms of low blood sugar and know how to treat it. Always carry a source of quick sugar with you. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink if your blood sugar is too low and you are unable to care for yourself. Get medical help at once.

Tell your care team if you have high blood sugar. Your medication dose may change if your body is under stress. Some types of stress that may affect your blood sugar include fever, infection, and surgery.

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

Make sure you stay hydrated while taking this medication. Drink water often. Eat fruits and veggies that have a high water content. Drink more water when it is hot or you are active. Talk to your care team right away if you have fever, infection, vomiting, diarrhea, or if you sweat a lot while taking this medication. The loss of too much body fluid may make it dangerous for you to take this medication.

Tell your care team you are taking this medication before you have surgery or an imaging scan, such as a CT or X-ray. You may need to stop taking this medication for a while before and after the procedure. Your care team will tell you when to stop and when to start taking it again.

This medication may cause you to ovulate, which may increase your chances of becoming pregnant. Talk with your care team about contraception while you are taking this medication. Contact your care team if you think you might be pregnant.

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 15 and 30 degrees C (59 and 86 degrees F). Throw away 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.