Steglujan Side Effects

Generic name: ertugliflozin / sitagliptin

Medically reviewed by Drugs.com. Last updated on Jul 16, 2024.

Note: This document provides detailed information about Steglujan.

Applies to ertugliflozin / sitagliptin: oral tablet Side Effects associated with ertugliflozin / sitagliptin. Some dosage forms listed on this page may not apply specifically to the brand name Steglujan.

Applies to ertugliflozin / sitagliptin: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine during the second and later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

It is very important to follow carefully any instructions from your doctor about:

• Alcohol—Drinking alcohol may cause severe high blood sugar. Discuss this with your doctor.
• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about the changes in the dosing of their diabetes medicine that might occur because of lifestyle changes, such as changes in exercise, diet, and illness. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have a sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.

Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Drinking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.

Diabetic ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, or increased thirst or urination.

Check with your doctor right away if you have bloody urine, decrease in how much or how often you urinate, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

This medicine may increase your risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.

This medicine may increase your risk of having lower leg or foot amputation (leg removal surgery). Check with your doctor right away if you have pain, tenderness, sores or ulcers, or infections on your leg or foot.

Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These may be symptoms of heart failure.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with other diabetes medicines (eg, insulin, glipizide, or glyburide). Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual. Some symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed and dry skin, a fruit-like breath odor, increased frequency and amount of urination, ketones in the urine, loss of appetite, nausea or vomiting, rapid and deep breathing, tiredness, or unusual thirst. If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.

This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.

This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause damage to the skin tissue in the area between and around the anus and genitals (perineum). Fournier's gangrene may lead to hospitalization, multiple surgeries, or death. Check with your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome), which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a blistering, peeling, or loosening of the skin. chills, cough, diarrhea, joint or muscle pain. red irritated eyes, red skin lesions, often with a purple center, rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, , trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine may cause severe and disabling joint pain. Call your doctor right away if you have severe joint pain while using this medicine.

This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine 4 days before you have surgery or other procedures that require fasting. This medicine may also affect the results of certain medical tests (eg, urine glucose tests may not be accurate).

Limit the amount of alcohol you drink while you are using this medicine. Heavy alcohol use or binge drinking can increase your chances of serious side effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Steglujan

Along with its needed effects, ertugliflozin/sitagliptin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ertugliflozin / sitagliptin:

Other side effects of Steglujan

Some side effects of ertugliflozin / sitagliptin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to ertugliflozin / sitagliptin: oral tablet.

General adverse events

The most commonly reported adverse events with have included genital mycotic infections, more common in females, but also occurring in males.^[Ref]

Gastrointestinal

Ertugliflozin:

• Common (1% to 10%): Thirst

Sitagliptin:

• Frequency not reported: Abdominal pain, nausea, diarrhea
• Postmarketing reports: Acute pancreatitis (including fatal and non-fatal hemorrhagic and necrotizing pancreatitis), constipation, vomiting, mouth ulceration, stomatitis

Thirst includes thirst, dry mouth, polydipsia, and dry throat.

In pooled analysis of clinical trials including data from 5429 patients receiving sitagliptin 100 mg daily and 4817 patients receiving comparator or placebo, the incidence of non-adjudicated acute pancreatitis was 0. Per 100 patient-years in each group.

Genitourinary

Ertugliflozin:

• Very common (10% or more): Female genital mycotic infections (up to 12.2%)
• Common (1% to 10%): Male genital mycotic infections, urinary tract infections, vaginal pruritus, increased urination
• Frequency not reported: Pyelonephritis

SGLT2 Inhibitors:

• Postmarketing reports: Serious urinary tract infections including urosepsis and pyelonephritis, Fournier's gangrene^[Ref]

Female genital mycotic infections include genital candidiasis, genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis. Male genital mycotic infections balanitis candida, balanoposthitis, genital infection, and genital infection fungal. Urinary tract infections include cystitis, dysuria, streptococcal urinary tract infection, urethritis, urinary tract infection. Vaginal pruritus includes vulvovaginal pruritus and pruritus genital. Increased urination includes pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia.

In the 5 years (2013 to 2018) since SGLT2 inhibitor approval, 12 cases of Fournier's gangrene have been reported. Reports were almost equal in men and women (men=7; women=5), ages ranged from 38 to 78 years, and the average time to onset after starting an SGLT2 inhibitor was 9.2 months (range 7 days to 25 months). All SGLT2 inhibitor drugs except ertugliflozin were included in the reports. Ertugliflozin being the most recently approved agent, is expected to have the same risk, but insufficient patient use to assess risk. All patients were hospitalized, all required surgery, all required surgical debridement, 5 required more than 1 surgery and 1 required skin grafting. Four cases were complicated by diabetic ketoacidosis, acute kidney injury, and septic shock, leading to prolonged hospitalization, and death in 1 case. In the general population, Fournier's gangrene occurs in about 1.6 out of 100,000 males annually, with the highest incidence in men 50 to 79 years. Since diabetes is a risk factor for Fournier's gangrene, a review of the FAERS database for the last 34 years was done and only 6 cases (all males, median age 57 years) were found with several other classes of antidiabetic drugs. Findings with SGLT2 inhibitors appear to show an association over a shorter time frame and involve both males and females.^[Ref]

Hypersensitivity

Sitagliptin:

• Postmarketing reports: Anaphylaxis, angioedema

Dermatologic

Sitagliptin:

• Postmarketing reports: Angioedema, rash urticaria, cutaneous vasculitis, exfoliative skin conditions including Stevens-Johnson syndrome, bullous pemphigoid, pruritus

Renal

Ertugliflozin:

• Common (1% to 10%): Renal related adverse reactions
• Frequency not reported: Increased serum creatinine, decreased eGFR

SGLT2 Inhibitors:

• Postmarketing reports: Acute Kidney Injury

Sitagliptin:

• Postmarketing reports: Worsening renal function

During clinical trials with ertugliflozin, renal related adverse reactions included acute kidney injury, renal impairment, acute prerenal failure; the incidence of renal related adverse reactions was 0.6%, 2.5%, and 1.3% in patients receiving placebo, ertugliflozin 5 mg, and 15 mg, respectively. There have been postmarketing reports of worsening renal function including acute renal failure, sometimes requiring dialysis with sitagliptin use. A subset of these reports involved patients with renal insufficiency, some of who received inappropriate doses.

Musculoskeletal

Ertugliflozin:

• Common (1% to 10%): Back pain
• Uncommon (0.1% to 1%): Nontraumatic lower limb amputation

Sitagliptin:

• Postmarketing reports: Severe and disabling arthralgia, extremity pain, back pain

Nontraumatic lower limb amputation was reported in 3 (0.2%) patients receiving 5 mg and 8 patients (0.5%) receiving 15 mg; there was 1 report (0.1%) in the comparator group. A causal association between this drug and lower limb amputation has not been definitively established.

Cardiovascular

Ertugliflozin:

• Common (1% to 10%): Adverse reactions related to volume depletion

DPP-4 inhibitors

• Frequency not reported: Heart failure

Adverse reactions related to volume depletion include dehydration, dizziness, postural, presyncope, syncope, hypotension, and orthostatic hypotension.

In a cardiovascular outcomes trials with 2 other dipeptidyl peptidase-4 (DPP-4) inhibitors, an association was observed with the use of DPP-4 inhibitors and heart failure. Subjects had type 2 diabetes and atherosclerotic cardiovascular disease.

Hepatic

Sitagliptin:

• Postmarketing reports: Hepatic enzyme elevations

Nervous system

• Common (1% to 10%): Headache

Hematologic

Ertugliflozin:

• Rare (0.01% to 0.1%): Hemoglobin increased greater than 2 g/dL and above the upper limit of normal

Respiratory

• Common (1% to 10%): Nasopharyngitis

Sitagliptin:

• Frequency not reported: Upper respiratory infection

Metabolic

Ertugliflozin:

• Very common (10% or more): Hypoglycemia (in combination with insulin and/or insulin secretagogue in patients with moderate renal impairment; up to 27%)
• Common (1% to 10%): Decreased weight, hypoglycemia
• Rare (0.01% to 0.1%): Ketoacidosis
• Frequency not reported: Increases in low-density lipoprotein cholesterol (LDL-C), increased serum phosphate

Ketoacidosis was reported in 3 of 3409 (0.1%) patients treated with ertugliflozin during clinical trials; no cases were identified in comparator-treated patients. Mean increases in low-density lipoprotein cholesterol (LDL-C) relative to placebo were 2.6% and 5.4%, in the 5 mg and 15 mg groups, respectively.

See also:

Frequently asked questions

• What drugs are contained in Steglujan?

Further information

Steglujan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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