Ertugliflozin

What it is used for

SEGLUROMET ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SEGLUROMET is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

The most important thing to know

STEGLATRO may cause serious side effects, including: Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. STEGLATRO can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital.

People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who: are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery.

Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking STEGLATRO and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL: nausea vomiting stomach-area (abdominal) pain tiredness trouble breathing ketones in your urine or blood 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 healthcare provider right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot.

Talk to your healthcare provider 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: take medicines to lower your blood pressure, including water pills (diuretics) are on a low sodium (salt) diet have kidney problems are 65 years of age or older Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis.

Call your healthcare provider 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. Genital and urinary tract infections. STEGLATRO can cause serious infections in your genital area or urinary tract that could require hospitalization.

A rare but serious bacterial infection called necrotizing fasciitis can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). This infection may require hospitalization, multiple surgeries, and could lead to death. Seek medical attention immediately if you have a fever 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) Also tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast infections: Urinary tract infection: burning feeling when you urinate need to urinate often or right away pain in the lower part of your stomach (pelvis) blood in your urine You may also have a fever, back pain, nausea, or vomiting.

Vaginal yeast infection: vaginal odor white or yellowish vaginal discharge (may be lumpy or look like cottage cheese) vaginal itching Yeast infection of the skin around the penis (balanitis or bala

How to take it

Take STEGLATRO by mouth 1 time in the morning each day, with or without food, exactly as your healthcare provider tells you to take it. Your healthcare provider may tell you to take STEGLATRO along with other diabetes medicines. Low blood sugar can happen more often when STEGLATRO is taken with certain other diabetes medicines.

See “

Side effects, and when to stop

”. 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 STEGLATRO at the same time. Talk with your healthcare provider if you have questions about a missed dose. If you take too much STEGLATRO, call your healthcare provider or go to the nearest hospital emergency room right away.

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 healthcare provider right away if you have any of these conditions and follow your healthcare provider’s instructions. STEGLATRO will cause your urine to test positive for glucose.

Your healthcare provider may do certain blood tests before you start STEGLATRO and during treatment as needed. Your healthcare provider may change your dose of STEGLATRO based on the results of your blood tests. What are the possible side effects of STEGLATRO? STEGLATRO may cause serious side effects, including: 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 confusion hunger shaking or feeling jittery drowsiness dizziness fast heartbeat weakness sweating irritability Serious allergic reaction.

If you have any symptoms of a serious allergic reaction, stop taking STEGLATRO and call your healthcare provider right away or go to the nearest hospital emergency room. See “ Who should not take STEGLATRO? ”. Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

The most common side effects of STEGLATRO include: vaginal yeast infections and yeast infections of the penis () 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 healthcare provider for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Who should not take it

Do not take STEGLATRO if you: are allergic to ertugliflozin or any of the ingredients in STEGLATRO. See the end of this Medication Guide for a list of ingredients in STEGLATRO. Symptoms of a serious allergic reaction to STEGLATRO 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 If you have any of these symptoms, stop taking STEGLATRO and call your healthcare provider right away or go to the nearest hospital emergency room.

Before you take STEGLATRO, tell your healthcare provider about all of your medical conditions, including if you: have type 1 diabetes or have had diabetic ketoacidosis. have a decrease in your insulin dose. have a serious infection. have a history of infection of the vagina or penis. 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. have kidney problems. have liver problems. have a history of urinary tract infections or problems with urination. are on a low sodium (salt) diet. Your healthcare provider may change your diet or your dose. are going to have surgery.

Your healthcare provider may stop your STEGLATRO before you have surgery. Talk to your healthcare provider 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. are dehydrated. have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.

drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking). have ever had an allergic reaction to STEGLATRO. are pregnant or plan to become pregnant. STEGLATRO may harm your unborn baby. If you become pregnant while taking STEGLATRO, your healthcare provider may switch you to a different medicine to control your blood sugar.

Talk to your healthcare provider 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 healthcare provider 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.

Storing it

Store STEGLATRO at room temperature between 68°F to 77°F (20°C to 25°C). Keep STEGLATRO dry. Keep STEGLATRO and all medicines out of the reach of children.