Steglatro is an oral diabetes medicine that helps control blood sugar levels. Ertugliflozin works by helping the kidneys get rid of glucose from your bloodstream.

Steglatro is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Steglatro is not for treating type 1 diabetes.

You should not use Steglatro 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.

Steglatro 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.

Steglatro is usually taken once per day in the morning. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Steglatro 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. Steglatro 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.

Steglatro 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 or for the treatment of diabetic ketoacidosis.

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

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

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

Steglatro 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.

To make sure Steglatro is safe for you, 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 Steglatro 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 breast-feed while using this medicine.

Steglatro is not approved for use by anyone younger than 18 years old.

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.

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 to Steglatro: 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.

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 Steglatro side effects 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 Steglatro, your doctor may need to adjust the doses of any other diabetes medicines you use on a regular basis.

Other drugs may interact with 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.