Ertugliflozin and sitagliptin is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. ertugliflozin and sitagliptin is not for treating type 1 diabetes.

Ertugliflozin and sitagliptin may also be used for purposes not listed in this medication guide.

Stop taking ertugliflozin and sitagliptin 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, ertugliflozin and sitagliptin can cause serious infections in 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take ertugliflozin and sitagliptin 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 blood sugar will need to be checked often, and you may also need to test the level of ketones 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.

ertugliflozin and sitagliptin can cause unusual results with certain lab tests. Tell any doctor who treats you that you are using ertugliflozin and sitagliptin.

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

Usual Adult Dose for Diabetes Type 2:

Initial dose: 1 tablet (ertugliflozin 5 mg/sitagliptin 100 mg) orally once a day
-For patients tolerating therapy and requiring additional glycemic control, may increase 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 same ertugliflozin dose

Comments:
-Volume depletion should be corrected prior to initiating therapy.
-This drug is not recommended for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis in these patients.
-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: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

You should not use this medicine if you are allergic to ertugliflozin o sitagliptin, or if you have:

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

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 this medicine 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 ertugliflozin and sitagliptin during the second or third trimester of pregnancy.

You should not breastfeed while using this medicine.

Ertugliflozin and sitagliptin is not approved for use by anyone younger than 18 years old.

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.

Get emergency medical help if you have signs of an allergic reaction (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.

Ertugliflozin and sitagliptin may cause serious side effects. 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 side effects of ertugliflozin and sitagliptin may include:

• urinating more than usual;

• upset stomach, diarrhea;

• headache; or

• cold symptoms such as stuffy nose, sneezing, 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 FDA at 1-800-FDA-1088.

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

Other drugs may affect 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.