Steglatro

Steglatro (ertugliflozin) is used to improve glycemic control in adults with type 2 diabetes, along with diet and exercise. It belongs to a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by helping the kidneys remove glucose from your bloodstream through your urine.

Steglatro is an oral tablet taken once daily and is not recommended for people with type 1 diabetes.

Steglatro (ertugliflozin) was FDA-approved on December 19, 2017. There is no generic.

Steglatro is usually taken once a day in the morning, with or without food. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Call your doctor if you are sick with vomiting or diarrhea, if you eat or drink less than usual, or if you are sweating more than usual. Losing too much fluid while taking Steglatro can cause dehydration, low blood pressure, or kidney problems.

Your blood sugar will need to be checked often, and you may also be asked to test the level of ketones in your blood or urine. Steglatro can cause life-threatening ketoacidosis, even if your blood sugar is normal. Contact your doctor if a test shows that you have ketones, even if you feel well.

Low blood sugar (hypoglycemia) can happen to anyone who has diabetes, and the risk is higher if you take Steglatro with insulin or a sulfonylurea. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you, such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

If you need surgery or a procedure that involves fasting, your doctor may tell you to stop taking Steglatro at least 4 days beforehand to lower your risk of ketoacidosis. You can usually restart it once you are stable and eating and drinking normally again.

This medicine can affect the results of certain medical tests, and your urine will test positive for glucose while you are taking it. Tell any doctor who treats you that you are using ertugliflozin.

Steglatro is only part of a treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat, in the original container.

Do not use Steglatro if you have severe kidney disease or if you are on dialysis. Steglatro is not recommended if your estimated glomerular filtration rate (eGFR) is below 45 mL/min/1.73 m2. Your doctor will check your kidney function before you start treatment and while you are taking it.

Steglatro can cause life-threatening ketoacidosis (too much acid in the blood), even if your blood sugar is normal. Stop taking Steglatro and get medical help right away if you have nausea, vomiting, stomach pain, tiredness, or trouble breathing.

Steglatro can cause serious infections in the genital area, including a rare but life-threatening infection called Fournier's gangrene. Get medical help right away if you have pain, tenderness, redness, or swelling of the genitals or the area between the genitals and rectum, along with a fever or feeling unwell.

Steglatro may increase your risk of lower leg amputation, especially if you have had a previous amputation, a foot ulcer, heart disease, circulation problems, or nerve damage.

You should not use Steglatro if you are allergic to ertugliflozin or any of the ingredients in the tablets.

To make sure Steglatro is safe for you, tell your doctor if you have ever had:

• heart problems
• a diabetic foot ulcer or amputation
• circulation problems or nerve problems in your legs or feet
• liver or kidney disease
• bladder infections, genital infections, or other urination problems
• low blood pressure, or if you take a diuretic (water pill)
• diabetic ketoacidosis
• problems with your pancreas, including pancreatitis or pancreas surgery
• type 1 diabetes
• a planned surgery
• if you follow a ketogenic (very low carbohydrate) diet
• if you drink alcohol often; or
• if you are on a low salt diet
• are pregnant or planning a pregnancy
• are breastfeeding or plan to breastfeed.

Pregnancy and breastfeeding

Follow your doctor's instructions about using Steglatro if you are pregnant or planning to become pregnant. You should not use ertugliflozin during the second or third trimester of pregnancy because it may harm the baby's developing kidneys. Blood sugar control is very important during pregnancy, and your treatment needs may be different during each trimester.

You should not breastfeed while using this medicine.

Steglatro is not approved for use by anyone younger than 18 years old.

The most common Steglatro side effects are genital yeast infections, which occurred in up to 12.2% of women and 4.2% of men taking Steglatro in clinical trials.

Other common Steglatro side effects may include:

• vaginal yeast infection, with itching, odor, or discharge
• yeast infection of the penis, with redness, itching, swelling, rash, discharge, or pain in the skin around the penis
• urinary tract infection (UTI)
• headache
• vaginal itching
• urinating more than usual, including at night
• cold symptoms such as a stuffy or runny nose and sore throat
• back pain
• weight loss
• increased thirst or a dry mouth.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction to Steglatro: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Allergic reactions, including angioedema (swelling under the skin), have been reported with Steglatro.

Seek medical attention right away if you have pain, tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, together with a fever above 100.4 degrees F (38 degrees C) or feeling generally unwell. These symptoms may get worse quickly and can be signs of a rare but life-threatening bacterial infection called necrotizing fasciitis of the perineum (Fournier's gangrene), which requires urgent treatment.

Serious urinary tract infections, including kidney infection (pyelonephritis) and a life-threatening blood infection that starts in the urinary tract (urosepsis), have also occurred in people taking SGLT2 inhibitors like Steglatro, and some people have needed hospital treatment. You may be more likely to develop these infections if you have had them before.

Call your doctor at once if you have:

• new pain, tenderness, sores, ulcers, or infections in your legs or feet
• little or no urination
• ketoacidosis (too much acid in the blood): nausea, vomiting, stomach pain, tiredness, confusion, unusual drowsiness, or trouble breathing
• low blood sugar (hypoglycemia): headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery
• dehydration or low blood pressure: dizziness, weakness, feeling light-headed (like you might pass out)
• signs of a bladder or kidney infection: pain or burning when you urinate, increased urination, blood in your urine, fever, or pain in your pelvis or back.

Steglatro may increase your risk of lower leg amputation, especially if you have had a previous amputation, a foot ulcer, heart disease, circulation problems, or nerve damage. Tell your doctor straight away if you notice any new pain, sores, or signs of infection in your legs or feet.

Steglatro can also increase LDL (bad) cholesterol. Your doctor may check your cholesterol levels during treatment.

Some side effects, such as those related to dehydration and low blood pressure, may be more likely in older adults, people with kidney problems, and people taking diuretics (water pills).

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual adult dose for type 2 diabetes:

• Initial dose: 5 mg orally once a day, taken in the morning
• The dose may be increased to 15 mg orally once a day for patients tolerating therapy and requiring additional glycemic control
• Maximum dose: 15 mg per day.

Comments:

• Volume depletion should be corrected before starting therapy.
• Use is not recommended in patients with an eGFR below 45 mL/min/1.73 m2.
• This drug is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Use: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Take the missed dose as soon as you remember. Do not double your next dose to make up for a missed one.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Steglatro can lower your blood pressure, especially when you first start taking it.

Avoid becoming dehydrated. Drink plenty of fluids, especially during exercise, hot weather, or illness.

Taking Steglatro with insulin or medicines that increase insulin release (such as a sulfonylurea like glimepiride or glipizide) can raise your risk of low blood sugar. Your doctor may lower the dose of your other diabetes medicines when you start Steglatro.

Tell your doctor if you take lithium. SGLT2 inhibitors like Steglatro may lower the level of lithium in your blood, and your doctor may need to check your lithium levels more often when you start Steglatro or change your dose.

Steglatro will make urine glucose tests read positive, and it can make some blood tests used to monitor blood sugar (1,5-AG assays) unreliable. Your doctor will use other methods, such as HbA1c, to monitor your blood sugar control.

Other drugs may interact with ertugliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Active: Contains 6.48 or 19.43 mg of ertugliflozin L-pyroglutamic acid, which is equivalent to 5 and 15 mg of ertugliflozin.

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, and magnesium stearate. The film coating contains: hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide, and iron oxide red.

Steglatro is manufactured for Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA.