Possible Risks and Side Effects of STEGLATRO
What is the most important information I should know about STEGLATRO?
STEGLATRO may cause serious side effects, including:
- Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes during treatment with STEGLATRO. Ketoacidosis has also happened 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. 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.
- 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 sodium (salt) diet
- 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. Women who take STEGLATRO may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
- vaginal odor
- white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
- vaginal itching
- Yeast infection of the penis (balanitis or balanoposthitis). Men who take STEGLATRO may get a yeast infection of the skin around the 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. Other symptoms of yeast infection of the penis include:
- redness, itching, or swelling of the penis
- foul smelling discharge from the penis
- rash of the penis
- pain in the skin around your penis
Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Your doctor may suggest you use an over-the-counter antifungal medicine. Talk to your doctor right away if you use an over-the-counter antifungal medicine and your symptoms do not go away.
Who should not take STEGLATRO?
Who should not take STEGLATRO?
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.
- are on dialysis.
What should I tell my doctor before taking STEGLATRO?
What should I tell my doctor before taking STEGLATRO?
Before you take STEGLATRO, tell your doctor about all of your medical conditions, including if you:
- have type 1 diabetes or have had diabetic ketoacidosis.
- have kidney problems.
- have liver problems.
- have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
- have a history of urinary tract infections or problems with urination.
- have a history of amputation.
- have had blocked or narrowed blood vessels, usually in the leg.
- have damage to the nerves (neuropathy) in your leg.
- have had diabetic foot ulcers or sores.
- are going to have surgery. Your doctor may stop your STEGLATRO before you have surgery. Talk to your doctor if you are having surgery about when to stop taking STEGLATRO and when to start it again.
- are eating less or there is a change in your diet.
- drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).
- are pregnant or plan to become pregnant. STEGLATRO may harm your unborn baby. If you become pregnant while taking STEGLATRO, your doctor may switch you to a different medicine to control your blood sugar. Talk to your doctor about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
- are breastfeeding or plan to breastfeed. It is not known if STEGLATRO passes into your breast milk. You should not breastfeed if you take STEGLATRO.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- STEGLATRO may affect the way other medicines work, and other medicines may affect how STEGLATRO works.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What are the possible side effects of STEGLATRO?
What are the possible side effects of STEGLATRO?
STEGLATRO may cause serious side effects, including:
See “What is the most important information I should know about STEGLATRO?”
- 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.
- 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
- 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. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have fever above 100.4ºF or you are feeling 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
- redness of skin (erythema)
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 FDA at 1-800-FDA-1088.
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.
