Steglujan

Steglujan is used to improve blood sugar control in adults with type 2 diabetes mellitus, together with diet and exercise.

Steglujan contains a combination of ertugliflozin and sitagliptin. Ertugliflozin and sitagliptin help control blood sugar levels. Ertugliflozin works by helping the kidneys get rid of glucose from your bloodstream. Sitagliptin works by regulating the levels of insulin your body produces after eating.

Steglujan is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Steglujan is not for treating type 1 diabetes.

Steglujan is usually taken once per day in the morning. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

• You may take Steglujan with or without food.
• Call your doctor if you are sick with vomiting or diarrhea, if you consume less food or fluid than usual, or if you are sweating more than usual.

Tell your doctor if you have a planned surgery. Your doctor may have you stop taking Steglujan for at least 4 days before surgery or any procedure that involves prolonged fasting.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Ertugliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have ketones in the urine.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

• Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or 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.

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.

This medicine can cause unusual results with certain lab tests. Tell any doctor who treats you that you are using Steglujan.

Store at room temperature away from moisture and heat. Keep unused tablets in the foil blister pack in its original container.

You should not use Steglujan if you have severe kidney disease, if you are on dialysis, or if you have diabetic ketoacidosis.

This medicine can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).

Stop taking Steglujan and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, with or without nausea and vomiting.

In rare cases, this medicine can cause serious infections in the genital or urinary tract, including the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.

You should not use Steglujan if you are allergic to ertugliflozin or sitagliptin, or if you have:

• severe kidney problems, end-stage renal disease, or if you are on dialysis.

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

• diabetic ketoacidosis;
• liver or kidney disease;
• a bladder infection or urination problems;
• problems with your pancreas, including surgery;
• a diabetic foot ulcer or amputation;
• heart problems, high or low blood pressure;
• blood circulation problems, especially in your legs;
• nerve damage in your legs;
• gallstones;
• high triglycerides (a type of fat in blood);
• alcoholism;
• type 1 diabetes; or
• if you are eating less, there is a change in your diet, or you are on a low-salt diet.

Follow your doctor's instructions about using Steglujan if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.

You should not use Steglujan during the second or third trimester of pregnancy.

You should not breastfeed while using this medicine.

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

Get emergency medical help if you have signs of an allergic reaction to Steglujan (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical attention right away if you have signs of a rare but serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Call your doctor at once if you have:

• severe autoimmune reaction - itching, blisters, breakdown of the outer layer of skin;
• new pain, tenderness, sores, ulcers, or infections in your legs or feet;
• severe or ongoing pain in your joints;
• little or no urination;
• ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
• dehydration symptoms - dizziness, weakness, feeling light-headed (like you might pass out);
• signs of a bladder infection - pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back;
• symptoms of heart failure - shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain; or
• symptoms of pancreatitis - severe pain in your upper stomach spreading to your back, with or without nausea and vomiting.

Some side effects may be more likely to occur in older adults.

Common Steglujan side effects may include:

• urinating more than usual;
• upset stomach, diarrhea;
• headache; or
• cold symptoms such as a stuffy nose, sneezing, or a sore throat.

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: 1 tablet (ertugliflozin 5 mg/sitagliptin 100 mg) orally once a day, taken in the morning

• For patients tolerating therapy and requiring additional glycemic control, the dose may be increased to 1 tablet (ertugliflozin 15 mg/sitagliptin 100 mg) orally once a day

Maximum dose: ertugliflozin 15 mg/sitagliptin 100 mg per day

For patients already receiving ertugliflozin: Switch to combination product with the same ertugliflozin dose

Comments:

• Assess renal function before initiating therapy and as clinically indicated.
• Volume depletion should be corrected before initiating therapy.
• Use is not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2.
• Withhold therapy for at least 4 days, if possible, before surgery or procedures associated with prolonged fasting.
• This drug is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
• This drug has not been studied in patients with a history of pancreatitis; it is not known whether this may increase the risk of developing pancreatitis during therapy.

Use: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Avoid drinking alcohol.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

When you start or stop taking Steglujan, your doctor may need to adjust the doses of any other diabetes medicines you use on a regular basis.

Using Steglujan with insulin or an insulin secretagogue (such as a sulfonylurea) can increase your risk of low blood sugar. Your doctor may lower the dose of your insulin or sulfonylurea to reduce this risk.

Steglujan may also lower the level of lithium in your blood. If you take lithium, your doctor may check your lithium level more often when you start Steglujan or change your dose.

Other drugs may interact with ertugliflozin and sitagliptin, 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.

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

Active ingredients: ertugliflozin and sitagliptin.

Inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, croscarmellose sodium, sodium stearyl fumarate, magnesium stearate, and propyl gallate.

The tablet film coating contains the following inactive ingredients: hypromellose, hydroxypropyl cellulose, titanium dioxide, iron oxide red, iron oxide yellow, ferrosoferric oxide/black iron oxide, and carnauba wax.

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

• What drugs are contained in Steglujan?