is has happened in people who have type 1 diabetes or type 2 diabetes during treatment with STEGLATRO. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Stop taking STEGLATRO and call your doctor right away if you get any of the following symptoms:
nausea
vomiting
stomach-area (abdominal) pain
tiredness
trouble breathing
If you get any of these symptoms during treatment with STEGLATRO, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL. kidney problems. Sudden kidney injury has happened to people treated with STEGLATRO. Talk to your doctor right away if you: reduce the amount of food or liquid you drink, for example, if you are sick or cannot eat or
you start to lose liquids from your body, for example, from vomiting, diarrhea, or being in the sun too long
serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking STEGLATRO. Tell your doctor if you have any signs or symptoms of a urinary tract infection 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.
amputations. STEGLATRO may increase your risk of lower limb amputations. Amputations mainly involve removal of the toe.
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. low blood sugar (hypoglycemia). If you take STEGLATRO with another medicine that can cause low blood sugar such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered while you take STEGLATRO. Signs and symptoms of low blood sugar may include:
headache
drowsiness
hunger
irritability
dizziness
confusion
sweating
feeling jittery or shaky
weakness
fast heartbeat
increased fats in your blood (bad cholesterol or LDL).
The most common side effects of STEGLATRO include: vaginal yeast infections and yeast infections of the penis (See "What is the most important information I should know about STEGLATRO?")
changes in urination, including urgent need to urinate more often, in larger amounts, or at night
These are not all the possible side effects of STEGLATRO.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store STEGLATRO? Store STEGLATRO at room temperature between 68°F to 77°F (20°C to 25°C).
Keep STEGLATRO dry.
Store blister packs of STEGLATRO in the original package.
Keep STEGLATRO and all medicines out of the reach of children.
General information about the s