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Note: This document contains side effect information about ertugliflozin. Some of the dosage forms listed on this page may not apply to the brand name Steglatro.For the Consumer
Applies to ertugliflozin: oral tablet
Along with its needed effects, ertugliflozin (the active ingredient contained in Steglatro) 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:
Some side effects of ertugliflozin 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: oral tabletGeneral
The most commonly reported adverse events have included genital mycotic infections, more common in females, but also occurring in males.Genitourinary
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
Postmarketing reports: Serious urinary tract infections including urosepsis and pyelonephritis, Fournier's gangrene
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.Musculoskeletal
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.
Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Nontraumatic lower limb amputationMetabolic
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 this drug 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.Renal
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, 5 mg, and 15 mg, respectively.
Common (1% to 10%): Renal related adverse reactions
Frequency not reported: Increased serum creatinine, decreased eGFR
Postmarketing reports: Acute Kidney InjuryNervous system
Common (1% to 10%): HeadacheCardiovascular
Adverse reactions related to volume depletion include dehydration, dizziness, postural, presyncope, syncope, hypotension, and orthostatic hypotension.
Common (1% to 10%): Adverse reactions related to volume depletionGastrointestinal
Thirst includes thirst, dry mouth, polydipsia, and dry throat
Common (1% to 10%): ThirstRespiratory
Common (1% to 10%): NasopharyngitisHematologic
Rare (0.01% to 0.1%): Hemoglobin increased greater than 2 g/dL and above the upper limit of normal
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