Get to Know STEGLATRO™ (ertugliflozin)

What is STEGLATRO?

STEGLATRO is for adults with type 2 diabetes, in addition to diet and exercise. Not for treating type 1 diabetes or diabetic ketoacidosis.

Important Safety Information

Do not take STEGLATRO^TM (ertugliflozin) if you:

have severe kidney problems or are on dialysis
are allergic to ertugliflozin or any of the ingredients in STEGLATRO. Symptoms of a serious allergic reaction to STEGLATRO may include skin rash, raised red patches on your skin (hives), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking STEGLATRO and call your doctor right away.

STEGLATRO may cause serious side effects including:

Dehydration (loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you have low blood pressure; take medicines to lower your blood pressure, including water pills (diuretics); have kidney problems; are on a low-salt diet; or are 65 years of age or older.

Vaginal yeast infection in women. Talk to your doctor if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching.

Yeast infection of the penis (balanitis or balanoposthitis) in men. Talk to your doctor if you experience redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or pain in the skin around your penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of your penis.

Ketoacidosis in people with type 1 and type 2 diabetes during treatment. Ketoacidosis is a serious condition, which may require hospitalization and may lead to death. Symptoms may include nausea, tiredness, vomiting, trouble breathing, and abdominal (stomach area) pain. If you get any of these symptoms, stop taking STEGLATRO and call your doctor. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.

Kidney problems. Talk to your doctor right away if you reduce the amount you eat or drink (for example, if you are sick or cannot eat), or if you lose liquids from vomiting, diarrhea, or excessive heat exposure.

Serious urinary tract infections (UTI), some that lead to hospitalization. Tell your doctor if you have any symptoms of a UTI, including a burning feeling when passing urine, a need to urinate often, an urgent need to urinate, pain in the lower part of your stomach (pelvis), or blood in the urine with or without fever, back pain, nausea, or vomiting.

Amputations. STEGLATRO may increase your risk of lower limb amputations. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your STEGLATRO for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care. You may be at a higher risk of lower limb amputation if you have or have had: a history of amputation; blocked or narrowed blood vessels; damage to the nerves (neuropathy) in your leg; and/or diabetic foot ulcers or sores.

Low blood sugar (hypoglycemia) can occur if you take STEGLATRO with another medicine that can cause low blood sugar, such as sulfonylureas or insulin. Symptoms of low blood sugar include headache, drowsiness, hunger, irritability, dizziness, confusion, sweating, feeling jittery or shaky, weakness, and/or fast heartbeat. Follow your doctor’s instructions for treating low blood sugar.

A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take medicines that lower blood sugar in the same way as STEGLATRO, which may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have fever or feel very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, or redness of skin.

Increased fats in your blood (bad cholesterol or LDL).

The most common side effects of STEGLATRO include yeast infections of the vagina or penis, and changes in urination, including an urgent need to urinate more often, in larger amounts, or at night.

What is STEGLATRO?

STEGLATRO is a prescription pill that, along with diet and exercise, helps lower blood sugar levels in adults with type 2 diabetes. STEGLATRO is not for people with type 1 diabetes and/or diabetic ketoacidosis (increased ketones in your blood or urine).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for STEGLATRO and discuss it with your doctor. The physician Prescribing Information also is available.