Ertugliflozin

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

Ertugliflozin may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

You can take ertugliflozin with or without food.

Call your doctor if you are sick with vomiting or diarrhea, if you eat or drink less than usual, or if you are sweating more than usual.

You will need to check your blood sugar often, and you may also need to test for ketones in 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 your urine.

Low blood sugar (hypoglycemia) can happen to anyone with 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 for use in case you have severe hypoglycemia and cannot eat or drink. Make 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. Inform 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 their original container.

Ertugliflozin may raise your chance of having a lower leg amputation, particularly if you have previously had an amputation, a foot ulcer, heart disease, circulation issues, or nerve damage.

Ertugliflozin can lead to serious infections in the penis or vagina. Seek medical attention immediately if you experience burning, itching, odor, discharge, pain, tenderness, redness, or swelling in the genital or rectal area, fever, or if you feel unwell.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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, feeling unwell. These symptoms may worsen quickly.

Ertugliflozin may cause serious side effects. Call your doctor immediately 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 faint); 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 happen 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.

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 controlMaximum dose: 15 mg per dayComments:-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.

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

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

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

When you begin or stop taking ertugliflozin, your doctor may need to change the doses of any other diabetes medicines you regularly take.

Other drugs can impact ertugliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all your current medicines and any medicines you start or stop taking.