Ertugliflozin/sitagliptin (By mouth)

Steglujan

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how ertugliflozin/sitagliptin works. Tell your doctor if you are using digoxin, insulin, or other diabetes medicine.
• Several other medicines may affect your blood sugar levels. Closely monitor your blood sugar levels when you start or stop another medicine while you are using ertugliflozin/sitagliptin.
• Limit the amount of alcohol you drink. Heavy alcohol use increases your risk for lactic acidosis.

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Drink plenty of fluids to help prevent dehydration.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the medicine dry and in its original container.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Ertugliflozin (er-too-gli-FLOE-zin), Sitagliptin (sit-a-GLIP-tin)

Treats type 2 diabetes.

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate, bloody urine, difficult or painful urination, lower back or side pain, fever, chills
• Fast breathing, nausea, vomiting, severe weakness, tiredness
• Large, hard skin blisters
• Lightheadedness, dizziness, or fainting
• Pain, tenderness, sores or ulcers, or infections on the leg or foot
• Severe joint pain
• Shaking, trembling, sweating, fast or pounding heartbeat, faintness, hunger, confusion
• Sudden and severe stomach pain
• Swelling in your hands, ankles, or feet
• Trouble breathing, cold sweat, bluish-colored skin

If you notice these less serious side effects, talk with your doctor:

• White or yellow vaginal or penile discharge, vaginal or penile itching or odor

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, low blood pressure, high cholesterol, blood vessel problems, nerve problems, or a history of pancreatitis, heart failure, leg surgery, or foot ulcers, or urinary or genital yeast infections. Tell your doctor if you are on a low-salt diet.
• This medicine may cause the following problems:
  • Pancreatitis (swelling of the pancreas)
  • Low blood pressure
  • Ketoacidosis (high ketones and acid in the blood)
  • Kidney problems
  • Increased risk of genital yeast or urinary tract infections
  • Increased risk for lower leg or toe amputation (removal)
  • Heart failure
  • Low blood sugar, when used with other diabetes medicine
  • Serious skin reactions
  • High cholesterol level
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

This medicine is not right for everyone. Do not use it if you had an allergic reaction to ertugliflozin or sitagliptin.