Ertugliflozin and sitagliptin

Ertugliflozin and sitagliptin is a combination medicine that helps control blood sugar levels in adults with type 2 diabetes mellitus when used along with diet and exercise. Ertugliflozin and sitagliptin is not for treating type 1 diabetes.

Ertugliflozin and sitagliptin may also be used for other reasons that are not mentioned in this medication guide.

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

You can take ertugliflozin and sitagliptin with or without food.

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.

Let your doctor know if you have a scheduled surgery.

You will need to check your blood sugar frequently, and you may also need to test for ketones in your urine. Ertugliflozin can lead to serious ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test indicates ketones in your urine.

You might experience low blood sugar (hypoglycemia), which can make you feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, consume a fast-acting source of sugar such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor may give you a glucagon injection kit in case you have severe hypoglycemia. Make sure your family or close friends know how to administer this injection in an emergency.

Also, be alert for signs of high blood sugar (hyperglycemia), like increased thirst or urination.

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

ertugliflozin and sitagliptin can cause unusual results in certain lab tests. Inform any doctor treating 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.

Stop taking ertugliflozin and sitagliptin and call your doctor immediately if you have symptoms of pancreatitis: severe pain in your upper stomach that spreads to your back, with or without nausea and vomiting.

In rare cases, ertugliflozin and sitagliptin can cause serious infections in the penis or vagina. Seek medical help right away if you experience burning, itching, odor, discharge, pain, tenderness, redness, or swelling in the genital or rectal area, fever, or if you feel unwell.

You should not use this medicine 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.

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.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, a 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 or urinary tract infection, including the penis or vagina. Get medical help immediately if you have burning, itching, odor, discharge, pain, tenderness, redness, or swelling of the genital or rectal area, fever, or if you feel unwell. These symptoms may worsen quickly.

Ertugliflozin and sitagliptin may cause serious side effects. Call your doctor right away 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 that spreads 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.

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 dayMaximum dose: ertugliflozin 15 mg/sitagliptin 100 mg per dayFor patients already receiving ertugliflozin: Switch to combination product with same ertugliflozin doseComments:-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.

Take the medicine as soon as you remember, but if it is nearly time for your next dose, skip the missed dose. Do not take two doses at the same 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 begin or stop taking ertugliflozin and sitagliptin, your doctor might need to change the doses of any other diabetes medicines you regularly use.

Other medications can influence how ertugliflozin and sitagliptin work, including prescription and over-the-counter drugs, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any new medicines you start or stop.