Ertugliflozin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Ertugliflozin is not for treating type 1 diabetes.

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

Ertugliflozin 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.

Ertugliflozin 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. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take ertugliflozin 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. Ertugliflozin 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 affect the results of certain medical tests. Tell any doctor who treats you that you are using ertugliflozin.

Ertugliflozin 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. Keep unused tablets in the foil blister pack in its original container.

Usual Adult Dose for Diabetes Type 2:

Initial dose: 5 mg orally once a day in the morning
-May increase to 15 mg orally once a day for patients tolerating therapy and requiring additional glycemic control
Maximum dose: 15 mg per day

Comments:
-Volume depletion should be corrected prior to initiating therapy.
-This drug is not recommended for patients with type 1 diabetes mellitus; it may increase the risk of diabetic ketoacidosis in these patients.

Use: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.

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

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

Ertugliflozin 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:

• heart problems;

• a diabetic foot ulcer or amputation;

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

• liver or kidney disease;

• bladder infections or other urination problems;

• low blood pressure;

• diabetic ketoacidosis;

• problems with your pancreas, including surgery;

• if you drink alcohol often;

• if you have a planned surgery;

• if you have type 1 diabetes; or

• if you are on a low salt diet.

Follow your doctor's instructions about using ertugliflozin if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.

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

You should not breastfeed while using ertugliflozin.

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.

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.

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.

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

• new pain, tenderness, sores, ulcers, or infections in your legs or feet;

• little or no urination;

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

• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;

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

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

Some side effects may be more likely to occur in older adults.

Common side effects of ertugliflozin may include:

• vaginal odor, discharge, or itching;

• redness, itching, swelling, rash, discharge, or pain in the skin around the penis; or

• urinating more than usual.

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.

When you start or stop taking ertugliflozin, your doctor may need to adjust the doses of any other diabetes medicines you use on a regular basis.

Other drugs may affect ertugliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order a lab test before and during your treatment with ertugliflozin to check how well your kidneys are working. 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.

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.

• Segluromet® (containing Ertugliflozin, Metformin)
• Steglujan® (containing Ertugliflozin, Sitagliptin)