Steglujan (ertugliflozin/sitagliptin) - Uses, Side Effects, and More

What are the most common side effects of Steglujan?

The most common side effects of Steglujan are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

• Infection in the nose or throat, sore throat, or common cold symptoms
• Headache
• Low blood sugar (see below)
• Yeast infection of the vagina or penis

There may be other side effects of Steglujan that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Steglujan?

While less common, the most serious side effects of Steglujan are described below, along with what to do if they happen.

Severe Allergic Reactions. Steglujan may cause allergic reactions, which can be serious. Stop taking Steglujan and get help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing
• Racing heart
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Trouble swallowing or throat tightness
• Itching, skin rash, or pale red bumps on the skin called hives
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain

Diabetic Ketoacidosis (DKA). Steglujan may cause diabetic ketoacidosis (a serious complication of diabetes). DKA can be life threatening. Stop taking Steglujan and get help right away if you have any of the following symptoms of diabetic ketoacidosis.

• Nausea/vomiting
• Stomach pain
• Feeling very tired, woozy, or confused
• Difficulty breathing
• Your breath smells fruity or sweet
• Very high blood sugar levels (>300 mg/dL)

Dehydration. Steglujan may cause dehydration. Dehydration may lead to low blood pressure, especially when you stand up (orthostatic hypotension) or kidney damage. Call your healthcare provider right away if you have any of the following symptoms of dehydration, low blood pressure, or kidney damage.

• Dizziness or lightheadedness
• Weakness or unusual tiredness
• Confusion
• Unsteadiness
• Peeing less than normal
• Swelling in your legs, ankles, and feet
• Loss of appetite/nausea
• Difficulty catching your breath or chest pain/pressure
• Seizures

Urosepsis and Pyelonephritis. Steglujan may cause pyelonephritis (a kidney infection) or urosepsis (an untreated urinary tract infection that spreads to your kidney). These are serious infections and may need to be treated in the hospital. Get help right away if you have any of the following symptoms of these serious infections.

• Dark, cloudy, or bloody pee or pee that smells bad
• Fever and chills
• Loss of appetite
• Needing to pee a lot or feeling pain when you pee
• Pain in your lower back, side, or groin
• Upset stomach, nausea, and vomiting

Low Blood Sugar (Hypoglycemia). Steglujan can cause low blood sugar, especially when used with insulin or other medicines that increase your insulin levels. Low blood sugar can be serious and may lead to death. The doses of your other diabetes medicines may need to be changed when taken with Steglujan. Call your healthcare provider right away if you have any of the following symptoms of hypoglycemia.

• Headache
• Crankiness or anxiety
• Hunger
• Dizziness or confusion
• Blurry vision
• Slurred speech
• Sweating
• Feeling jittery or shakiness
• Fast heartbeat
• Seizures

Necrotizing Fasciitis (Fournier’s Gangrene). Steglujan can cause necrotizing fasciitis, which is an aggressive skin and tissue infection that causes some of the tissue involved to die. Necrotizing fasciitis is rare, but very serious, can lead to death, and may require surgery to treat it. Get help right away if you have any of the following symptoms of this serious infection.

• Pain, redness, tenderness, or swelling of the perineum (of and around the anus and genitals)
• Fever
• General feeling of illness or discomfort

Inflammation of the Pancreas (Pancreatitis). Steglujan may cause inflammation of the pancreas, which is called pancreatitis. Stop taking Steglujan and call your healthcare provider right away if you have symptoms of pancreatitis including vomiting or severe pain in the upper part of your belly that travels to your back.

Amputations. People who take Steglujan may be more likely to have an amputation (limb or part of a limb cut off) than people who do not take Steglujan. The toe, part of the foot, or part of the leg were most often involved. Amputations seem more likely in people with diabetes, peripheral artery disease (narrowing of your blood vessels, often in your legs), diabetic foot infections, nerve damage in your legs, or who already had an amputation. Inspect your feet and legs regularly and contact your healthcare provider right away if you have sores, ulcers, or new pain or tenderness, as these may lead to the need for an amputation if not treated.

Kidney Damage. Kidney damage can happen when taking Steglujan. Call your healthcare provider right away if you have any of the following symptoms of kidney damage.

• Reduced need to pee
• Swelling in your feet, ankles, or legs
• Weakness or unusual tiredness
• Difficulty catching your breath or chest pain/pressure
• Confusion
• Nausea
• Seizures

Heart Failure. Steglujan may increase your risk of heart failure. Tell your healthcare provider right away if you have any of the following symptoms of heart failure.

• Shortness of breath or trouble breathing, especially while lying down
• Swelling in your feet, ankles, or legs
• Unusually fast weight gain
• Unusual tiredness

Severe Joint Pain. Steglujan may cause joint pain that can be severe. Call your healthcare provider if you have new or increased joint pain while taking this medicine.

Severe Skin Reactions. Steglujan can cause a rare skin reaction called bullous pemphigoid. This reaction may start as an itchy skin rash and large blisters may form on the skin. You may need treatment in a hospital if this reaction happens. Call your healthcare provider right away if you develop a rash or blisters on the skin while taking this medicine.