Ertugliflozin

WHY is this medicine prescribed?

Ertugliflozin is to lower blood sugar levels in adults with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Ertugliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. Ertugliflozin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood).

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking ertugliflozin, making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ertugliflozin comes as a tablet to take by mouth. It is usually taken once a day in the morning with or without food. Take ertugliflozin at around the same time every day.

Take ertugliflozin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of ertugliflozin and gradually increase your dose.

Ertugliflozin controls type 2 diabetes but does not cure it. Continue to take ertugliflozin even if you feel well. Do not stop taking ertugliflozin without talking to your doctor.

You will be given the Medication Guide when you begin treatment with ertugliflozin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking ertugliflozin,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking ertugliflozin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you regularly drink alcohol or sometimes drink large amounts of alcohol in a short time (binge drinking), have ever had an amputation, are on a low sodium diet, or if you have an infection. Also, tell your doctor if you have or have ever had low blood pressure, urinary tract infections or urinary problems, pancreatic disease including pancreatitis or have had surgery on your pancreas, yeast infections in the genital area, peripheral vascular disease, neuropathy, foot ulcers or sores, or kidney or liver disease. If you are male, tell your doctor if you have never been circumcised. Tell your doctor if you are eating or drinking less due to illness, surgery, or a change in your diet; if you are following a ketogenic diet (a high fat, low carbohydrate diet); or have recently had diarrhea, vomiting, been in the sun too long, or have been sweating a lot, which may cause dehydration (loss of a large amount of body fluids).

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Do not breastfeed while you are taking ertugliflozin. If you become pregnant while taking ertugliflozin, call your doctor.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ertugliflozin. Your doctor may tell you to stop taking ertugliflozin at least 4 days before a surgery.

• alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking ertugliflozin.

• you should know that ertugliflozin may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. If you have this problem, call your doctor. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of ertugliflozin you may need.

What SPECIAL DIETARY instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet.

Follow your doctor's instructions about drinking enough fluids throughout the day while you are on this medication.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Ertugliflozin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• urinating a lot, including at night
• increased thirst
• dry mouth
• headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• frequent, urgent, burning, or painful urination; decrease in amount of urine; urine that is cloudy, red, pink, or brown; strong smelling urine; pelvic or rectal pain; or fever, back pain, nausea, or vomiting
• vaginal odor, white or yellowish vaginal discharge (may be lumpy or look like cottage cheese), or vaginal itching
• redness, itching, or swelling of the penis; rash on the penis; foul smelling discharge from the penis; or pain in the skin around the penis
• feeling tired, weak, or uncomfortable; along with a fever and pain, tenderness, redness, and swelling of the genitals or the area between the genitals and the rectum

If you experience any of the following symptoms, stop taking ertugliflozin and call your doctor immediately or get emergency medical treatment:

• rash; hives; itching; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, mouth, or eyes; or hoarseness

If you experience any of the following symptoms of ketoacidosis, stop taking ertugliflozin and call your doctor immediately or get emergency medical treatment. If possible, check for ketones in your urine if you have these symptoms, even if your blood sugar is less than 250 mg/dL:

• nausea, vomiting, stomach-area pain, tiredness, or difficulty breathing

You should know that ertugliflozin can increase the risk of having a lower limb (toe, foot, or leg) amputation. Your doctor will tell you how to take care of your legs and feet properly to help avoid infections and complications that could lead to an amputation. Follow the doctor's instructions carefully and call your doctor right away if you have any pain, tenderness, sores, ulcers, or swollen, warm, reddened area in your leg or foot, fever or chills, or other signs and symptoms of infection.

Ertugliflozin can cause dehydration. It is important that you drink plenty of water while taking ertugliflozin. Talk to your doctor or pharmacist about the right amount of water to drink to prevent dehydration while taking ertugliflozin.

Ertugliflozin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will probably order certain laboratory tests before and during your treatment to check your body's response to ertugliflozin.

Your blood sugar levels should be checked regularly to determine your response to ertugliflozin. Your doctor will order other lab tests, including glycosylated hemoglobin (HbA1c), to check your response to ertugliflozin. 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 ertugliflozin. Because of the way this medication works, your urine may test positive for glucose.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.