Do not take STEGLATRO if you:
- 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.
- are on dialysis
STEGLATRO may cause serious side effects including:
- Ketoacidosis (increased ketones in the blood or urine) has happened in people with type 1 or type 2 diabetes during treatment and also in people with diabetes who were sick or who had surgery during treatment with STEGLATRO. Ketoacidosis is a serious condition, which may need to be treated in a hospital and may lead to death. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Symptoms may include nausea, vomiting, stomach-area (abdominal) pain, tiredness, and trouble breathing. If you get any of these symptoms, stop taking STEGLATRO and call your doctor right away. If possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
- Amputations. STEGLATRO may increase your risk of lower limb amputations. You may be at a higher risk of lower limb amputation if you: have a history of amputation; have had blocked or narrowed blood vessels, usually in your leg; have damage to the nerves (neuropathy) in your leg; have had diabetic foot ulcers or sores. 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.
- Dehydration. STEGLATRO can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people who are taking STEGLATRO. You may be at 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. Talk to your doctor about what you can do to prevent dehydration including how much fluid you should drink on a daily basis.
- Vaginal yeast infection. Talk to your doctor if you have 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). Talk to your doctor if you experience redness, itching, or swelling of the penis; foul-smelling discharge from the penis; rash of 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.
- Serious urinary tract infections (UTI) that may lead to hospitalization can occur. Tell your doctor if you have any symptoms of a UTI, such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people may also have a fever, back pain, nausea, or vomiting.
- Low blood sugar (hypoglycemia) can occur if you take STEGLATRO with another medicine that can cause low blood sugar, such as a sulfonylurea 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.
- Necrotizing fasciitis, a rare but serious infection that causes damage to the tissue under the skin in the area between and around the anus and genitals (perineum) has happened in women and men who take medicines that lower blood sugar in the same way as STEGLATRO and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have fever above 100.4°F 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.
- 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.
You are encouraged to report 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.
