What is the most important information I should know about STEGLUJAN?
STEGLUJAN may cause serious side effects, including:
- Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
Before you start taking STEGLUJAN, tell your doctor if you have ever had:
- a history of alcoholism
- kidney problems
- stones in your gallbladder (gallstones)
- high blood triglyceride levels
Stop taking STEGLUJAN and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
- 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 STEGLUJAN. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with STEGLUJAN. 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 STEGLUJAN and call your doctor right away if you get any of the following symptoms:
- stomach-area (abdominal) pain
- trouble breathing
If you get any of these symptoms during treatment with STEGLUJAN, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
- Amputations. STEGLUJAN 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 STEGLUJAN for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care.
- Dehydration. STEGLUJAN 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 STEGLUJAN.
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 STEGLUJAN 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 STEGLUJAN 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.
- Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking STEGLUJAN, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms:
- increasing shortness of breath or trouble breathing, especially when you lie down
- swelling or fluid retention, especially in the feet, ankles or legs
- an unusually fast increase in weight
- unusual tiredness
These may be symptoms of heart failure.
What is STEGLUJAN?
- STEGLUJAN contains 2 prescription medicines called ertugliflozin (STEGLATRO®) and sitagliptin (JANUVIA®). STEGLUJAN is used in adults with type 2 diabetes to improve blood sugar (glucose) along with diet and exercise.
- STEGLUJAN is not for people with type 1 diabetes. It may increase the risk of diabetic ketoacidosis in these people.
- If you have had pancreatitis (inflammation of the pancreas) in the past, it is not known if you have a higher chance of getting pancreatitis while you take STEGLUJAN.
- It is not known if STEGLUJAN is safe and effective in children under 18 years of age.
Do not take STEGLUJAN if you:
- have severe kidney problems, end stage renal disease (ESRD), or are on dialysis.
- are allergic to ertugliflozin, sitagliptin, or any of the ingredients in STEGLUJAN. See the end of the Medication Guide for a list of ingredients in STEGLUJAN. Symptoms of a serious allergic reaction to STEGLUJAN may include skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Before you take STEGLUJAN, 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 STEGLUJAN before you have surgery. Talk to your doctor if you are having surgery about when to stop taking STEGLUJAN 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. STEGLUJAN may harm your unborn baby. If you become pregnant while taking STEGLUJAN, 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.
Pregnancy Registry: If you take STEGLUJAN at any time during your pregnancy, talk with your doctor about how you can join the STEGLUJAN pregnancy registry. The purpose of this registry is to collect information about the health of you and your baby. You can enroll in this registry by calling 1-800-986-8999.
- are breastfeeding or plan to breastfeed. It is not known if STEGLUJAN passes into your breast milk. You should not breastfeed if you take STEGLUJAN.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take STEGLUJAN?
- Take STEGLUJAN exactly as your doctor tells you to take it.
- Take STEGLUJAN by mouth 1 time in the morning each day, with or without food.
- Your doctor may change your dose if needed.
- If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 2 doses of STEGLUJAN at the same time.
- Your doctor may tell you to take STEGLUJAN along with other diabetes medicines. Low blood sugar can happen more often when STEGLUJAN is taken with certain other diabetes medicines. See “What are the possible side effects of STEGLUJAN?”
- Stay on your prescribed diet and exercise program while taking STEGLUJAN.
- Check your blood sugar as your doctor tells you to.
- Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.
- Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), complications of diabetes.
- Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with STEGLUJAN.
- When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor’s instructions.
- When taking STEGLUJAN, you may have sugar in your urine, which will show up on a urine test.
- If you take too much STEGLUJAN, call your doctor or go to the nearest hospital emergency room right away.
What are the possible side effects of STEGLUJAN?
STEGLUJAN may cause serious side effects, including:See “What is the most important information I should know about STEGLUJAN?”
- Kidney problems (sometimes requiring dialysis). Sudden kidney injury has happened to people treated with STEGLUJAN. 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 STEGLUJAN. 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 STEGLUJAN 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 STEGLUJAN. Signs and symptoms of low blood sugar may include:
- feeling jittery or shaky
- 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 one of the medicines in STEGLUJAN. 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 100.4°F 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
- redness of skin (erythema)
- Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking STEGLUJAN and call your doctor right away. See “Do not take STEGLUJAN if you:”. Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
- Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in STEGLUJAN, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
- Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in STEGLUJAN, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking STEGLUJAN.
The most common side effects of ertugliflozin include:
- vaginal yeast infections and yeast infections of the penis (See “What is the most important information I should know about STEGLUJAN?”)
- changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
The most common side effects of sitagliptin include:
- upper respiratory infection
- stuffy or runny nose and sore throat
- stomach upset and diarrhea
STEGLUJAN may have other side effects including swelling of the hands or legs. Swelling of the hands and legs can happen when sitagliptin, one of the medicines in STEGLUJAN, is used with rosiglitazone (Avandia). Rosiglitazone is another type of diabetes medicine.
These are not all the possible side effects of STEGLUJAN.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.